222 Studies | All Studies
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Type(s) of Cancer
Prostate Cancer
Prostate Cancer
Study Phase
Phase 3
Study Completion Date
November 2017
November 2017
NCT01238172Uploaded 03-17-2023
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The Men's Eating and Living (MEAL) Study: A Randomized Trial of Diet to Alter Disease Progression in Prostate Cancer Patients on Active Surveillance
Provider Information
Provider Data DescriptionDataset NCT01238172-D1-Dataset.csv (baseline) is one of 5 datasets associated with PubMed ID 31935026. This dataset contains information for the baseline characteristics table.
SponsorAlliance for Clinical Trials in Oncology
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: Eating a diet high in vegetables may slow down disease progression in patients with prostate cancer.
PURPOSE: This randomized clinical trial is studying how well diet works in altering disease progression in patients with prostate cancer on active surveillance.
ConditionsProstate Cancer
Intervention TypeOther: dietary education and counseling
Other: prostate cancer foundation booklet
Other: prostate cancer foundation booklet
Drug(s)N/A
Total Enrolled478
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionArm A - MEAL Program Intervention - Experimental
Arm B - Prostate Cancer Foundation Booklet - Experimental
Arm B - Prostate Cancer Foundation Booklet - Experimental
Secondary IDCALGB-70807
PubMed (PMID)31935026
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Age Range50 Years to 80 Years (Adult, Older Adult)
Type(s) of Cancer
Lung Cancer
Lung Cancer
Study Phase
Phase 3
Study Completion Date
January 2019
January 2019
NCT01107626Uploaded 03-15-2023
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Randomized Phase III Study of Maintenance Therapy With Bevacizumab, Pemetrexed, or a Combination of Bevacizumab and Pemetrexed Following Carboplatin, Paclitaxel and Bevacizumab for Advanced Non-Squamous NSCLC
Provider Information
Provider Data DescriptionThere are two different submissions for PMID 31361535 from trial E5508. This dataset, NCT01107626-D1, contains baseline, treatment, and efficacy data. Dataset NCT01107626-D2 contains toxicity data.
SponsorECOG-ACRIN Cancer Research Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of non-small cell lung cancer by blocking blood flow to the tumor. Pemetrexed disodium may stop the growth of tumor cells by blocking some enzymes needed for cell growth. It is not yet known whether giving bevacizumab or pemetrexed disodium alone or in combination is more effective in treating non-squamous non-small cell lung cancer.
PURPOSE: This randomized phase III trial is studying bevacizumab and pemetrexed disodium alone or in combination after induction therapy to see how well they work in treating patients with advanced non-squamous non-small cell lung cancer.
ConditionsLung Cancer
Intervention TypeDrug: Paclitaxel
Drug: Carboplatin
Biological: Bevacizumab
Drug: Pemetrexed Disodium Heptahydrate
Drug: Carboplatin
Biological: Bevacizumab
Drug: Pemetrexed Disodium Heptahydrate
Drug(s)Drug: Paclitaxel
Drug: Carboplatin
Drug: Pemetrexed Disodium Heptahydrate
Drug: Carboplatin
Drug: Pemetrexed Disodium Heptahydrate
Total Enrolled1516
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionArm A (Induction then Maintenance with Bevacizumab) - Experimental
Arm B (Induction then Maintenance with Pemetrexed) - Experimental
Arm C (Induction then Maintenance with Bevacizumab & Pemetrexed) - Experimental
Arm B (Induction then Maintenance with Pemetrexed) - Experimental
Arm C (Induction then Maintenance with Bevacizumab & Pemetrexed) - Experimental
Secondary IDNCT01107626
PubMed (PMID)31361535
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Adult Solid Neoplasm, Lymphoma
Adult Solid Neoplasm, Lymphoma
Study Phase
Not Applicable
Study Completion Date
May 2017
May 2017
NCT02107443Uploaded 02-14-2023
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Improving Communication for Cancer Treatment: Addressing Concerns of Older Cancer Patients and Caregivers
Provider Information
Provider Data DescriptionThis dataset contains patient satisfaction (HCCQ_sum) age-related data and number of communications (concern_sum) age-related data from trial NCT02107443 to reproduce the results in PubMed ID (PMID) 31697365.
SponsorSupriya Mohile
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryOver 60% of cancers occur in older persons, and the number of older persons with cancer is expected to grow as the population ages. Oncology clinical trials have traditionally excluded older patients with advanced cancer and chronic health conditions. In this context, where data is limited and risk from treatment is high, older patients with advanced cancer and their caregivers must understand how cancer treatment can affect quality of life in light of underlying health status. Better communication about age-related health conditions between oncologists, older patients with advanced cancer, and their caregivers may improve decision-making for cancer treatment and quality of life. A geriatric assessment (GA), a validated set of patient-centered outcomes, has been shown to identify concerns (e.g., function, cognition) important to older persons with cancer and their caregivers. In this cluster randomized clinical trial we examined whether providing a web-generated GA summary with targeted recommendations to older patients with advanced cancer, their caregivers, and their oncologists can improve communication about age-related concerns that could affect efficacy and tolerance of cancer treatment. We also determined whether the intervention improves patient-reported quality of life and patient and caregiver satisfaction.
ConditionsAdult Solid Neoplasm
Lymphoma
Lymphoma
Intervention TypeBehavioral: Geriatric Assessment Summary
Behavioral: Geriatric Assessment Targeted Recommendations
Behavioral: Geriatric Assessment (GA)
Behavioral: Geriatric Assessment Targeted Recommendations
Behavioral: Geriatric Assessment (GA)
Drug(s)N/A
Total Enrolled546
RandomizationRandomized
Blinding MethodSingle
Arms InterventionArm I: Geriatric Assessment Intervention - Experimental
Arm II: Usual Care - Active Comparator
Arm II: Usual Care - Active Comparator
Secondary IDNCI-2014-00619
PubMed (PMID)35984998
35302628
35179585
34762734
34371137
34228510
33858803
31697365
30924548
35302628
35179585
34762734
34371137
34228510
33858803
31697365
30924548
Collaborator(s)National Cancer Institute (NCI)
Patient-Centered Outcomes Research Institute
Patient-Centered Outcomes Research Institute
Region(s)United States
Age Range70 Years and older (Older Adult)
Type(s) of Cancer
Prostate
Prostate
Study Phase
Phase 3
Study Completion Date
October 2018
October 2018
NCT00430183Uploaded 02-07-2023
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A Randomized Phase III Study of Neo-Adjuvant Docetaxel and Androgen Deprivation Prior to Radical Prostatectomy Versus Immediate Radical Prostatectomy in Patients With High-Risk, Clinically Localized Prostate Cancer
Provider Information
Provider Data DescriptionDataset NCT00430183-D1-Dataset.csv (baseline) is one of 2 datasets associated with PubMed ID 32706639. This dataset contains information that is presented in the manuscript excluding the toxicity data.
SponsorAlliance for Clinical Trials in Oncology
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as goserelin and leuprolide, may stop the adrenal glands from making androgens. Giving docetaxel and leuprolide or goserelin before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known whether giving docetaxel and leuprolide or goserelin before surgery is more effective than surgery alone in treating patients with prostate cancer.
PURPOSE: This randomized phase III trial is studying docetaxel and leuprolide or goserelin to see how well they work when given before surgery compared with surgery alone in treating patients with high-risk localized prostate cancer.
ConditionsProstate Cancer
Intervention TypeDrug: docetaxel
Drug: LHRH agonist
Procedure: surgery
Drug: LHRH agonist
Procedure: surgery
Drug(s)Drug: docetaxel
Drug: LHRH agonist
Drug: LHRH agonist
Total Enrolled788
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionArm A: docetaxel + LHRH agonist + surgical intervention - Experimental
Arm B: surgical intervention - Other
Arm B: surgical intervention - Other
Secondary IDU10CA031946
PubMed (PMID)32706639
Collaborator(s)National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
NCIC Clinical Trials Group
Southwest Oncology Group
Eastern Cooperative Oncology Group
NCIC Clinical Trials Group
Southwest Oncology Group
Region(s)United States
Canada
Canada
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Breast
Breast
Study Phase
Phase 2
Study Completion Date
August 2014
August 2014
NCT00861705Uploaded 01-07-2023
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Randomized Phase II 2 x 2 Factorial Trial of the Addition of Carboplatin +/- Bevacizumab to Neoadjuvant Weekly Paclitaxel Followed by Dose-Dense AC in Hormone Receptor-Poor/HER2-Negative Resectable Breast Cancer
Provider Information
Provider Data DescriptionThe NCT00861705-D1-Dataset.csv (aeclean) dataset is one of 2 datasets associated with PubMed ID 25092775. This dataset contains adverse event data for each treated patient (N=443).
SponsorNational Cancer Institute (NCI)
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis randomized phase II trial studies how well paclitaxel with or without carboplatin and/or bevacizumab followed by doxorubicin and cyclophosphamide works in treating patients with breast cancer that can be removed by surgery. Drugs used in chemotherapy, such as paclitaxel, carboplatin, doxorubicin, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Bevacizumab may stop the growth of tumor cells by blocking blood flow to the tumor. Giving chemotherapy together with bevacizumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
ConditionsMale Breast Carcinoma
Stage IIA Breast Cancer AJCC v6 and v7
Stage IIB Breast Cancer AJCC v6 and v7
Stage IIIA Breast Cancer AJCC v7
Triple-Negative Breast Carcinoma
Stage IIA Breast Cancer AJCC v6 and v7
Stage IIB Breast Cancer AJCC v6 and v7
Stage IIIA Breast Cancer AJCC v7
Triple-Negative Breast Carcinoma
Intervention TypeBiological: Bevacizumab
Drug: Carboplatin
Drug: Cyclophosphamide
Drug: Doxorubicin Hydrochloride
Other: Laboratory Biomarker Analysis
Drug: Paclitaxel
Drug: Carboplatin
Drug: Cyclophosphamide
Drug: Doxorubicin Hydrochloride
Other: Laboratory Biomarker Analysis
Drug: Paclitaxel
Drug(s)Drug: Cyclophosphamide
Drug: Doxorubicin Hydrochloride
Drug: Paclitaxel
Drug: Carboplatin
Drug: Doxorubicin Hydrochloride
Drug: Paclitaxel
Drug: Carboplatin
Total Enrolled454
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionArm I (paclitaxel, doxorubicin, cyclophosphamide) - Active Comparator
Arm II (paclitaxel, ddAC, bevacizumab) - Experimental
Arm III (paclitaxel, ddAC, carboplatin) - Experimental
Arm IV (paclitaxel, ddAC, bevacizumab, carboplatin) - Experimental
Arm II (paclitaxel, ddAC, bevacizumab) - Experimental
Arm III (paclitaxel, ddAC, carboplatin) - Experimental
Arm IV (paclitaxel, ddAC, bevacizumab, carboplatin) - Experimental
Secondary IDNCI-2009-01172
PubMed (PMID)35044810
25092775
25092775
Collaborator(s)N/A
Region(s)United States
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Joint Pain
Joint Pain
Study Phase
Phase 3
Study Completion Date
February 2018
February 2018
NCT01573442Uploaded 11-17-2022
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Randomized Double-Blind Placebo Controlled Study of Testosterone in the Adjuvant Treatment of Postmenopausal Women With Aromatase Inhibitor Induced Arthralgias
Provider Information
Provider Data DescriptionDataset NCT01573442-D1-Dataset.csv (consort) is one of 14 datasets associated with PubMed ID 32372176. This dataset contains data presented in the consort diagram.
SponsorAlliance for Clinical Trials in Oncology
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial studies testosterone to see how well it works compared to placebo in treating postmenopausal patients with arthralgia (joint pain) caused by anastrozole or letrozole. Testosterone may help relieve moderate or severe arthralgia associated with the use of aromatase inhibitors, such as anastrozole or letrozole.
ConditionsArthralgia
Breast Cancer
Hot Flashes
Musculoskeletal Complications
Sexual Dysfunction
Breast Cancer
Hot Flashes
Musculoskeletal Complications
Sexual Dysfunction
Intervention TypeDrug: testosterone
Other: placebo
Other: placebo
Drug(s)Drug: testosterone
Total Enrolled227
RandomizationRandomized
Blinding MethodDouble
Arms InterventionArm I - Experimental
Arm II - Placebo Comparator
Arm II - Placebo Comparator
Secondary IDCDR0000730083
PubMed (PMID)32372176
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Puerto Rico
Puerto Rico
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Liver
Liver
Study Phase
Phase 3
Study Completion Date
May 2015
May 2015
NCT01015833Uploaded 10-21-2022
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Phase III Randomized Study of Sorafenib Plus Doxorubicin Versus Sorafenib in Patients With Advanced Hepatocellular Carcinoma (HCC)
Provider Information
Provider Data DescriptionDataset NCT01015833-D1-Dataset.csv (nctn_d1) is the only dataset associated with PubMed ID 31486832. This dataset contains the information for the entire primary analysis.
SponsorNational Cancer Institute (NCI)
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial studies sorafenib tosylate and doxorubicin hydrochloride to see how well they work compared with sorafenib tosylate alone in treating patients with liver cancer that has spread to nearby tissue or lymph nodes or has spread to other places in the body. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving sorafenib tosylate together with doxorubicin hydrochloride is more effective than sorafenib tosylate alone in treating liver cancer.
ConditionsAdvanced Adult Hepatocellular Carcinoma
Recurrent Hepatocellular Carcinoma
Stage III Hepatocellular Carcinoma AJCC v7
Stage IIIA Hepatocellular Carcinoma AJCC v7
Stage IIIB Hepatocellular Carcinoma AJCC v7
Stage IIIC Hepatocellular Carcinoma AJCC v7
Stage IV Hepatocellular Carcinoma AJCC v7
Stage IVA Hepatocellular Carcinoma AJCC v7
Stage IVB Hepatocellular Carcinoma AJCC v7
Unresectable Hepatocellular Carcinoma
Recurrent Hepatocellular Carcinoma
Stage III Hepatocellular Carcinoma AJCC v7
Stage IIIA Hepatocellular Carcinoma AJCC v7
Stage IIIB Hepatocellular Carcinoma AJCC v7
Stage IIIC Hepatocellular Carcinoma AJCC v7
Stage IV Hepatocellular Carcinoma AJCC v7
Stage IVA Hepatocellular Carcinoma AJCC v7
Stage IVB Hepatocellular Carcinoma AJCC v7
Unresectable Hepatocellular Carcinoma
Intervention TypeDrug: Doxorubicin Hydrochloride
Other: Laboratory Biomarker Analysis
Other: Pharmacogenomic Study
Drug: Sorafenib Tosylate
Other: Laboratory Biomarker Analysis
Other: Pharmacogenomic Study
Drug: Sorafenib Tosylate
Drug(s)Drug: Doxorubicin Hydrochloride
Drug: Sorafenib Tosylate
Drug: Sorafenib Tosylate
Total Enrolled356
RandomizationRandomized
Blinding MethodSingle
Arms InterventionArm I (doxorubicin hydrochloride, sorafenib tosylate) - Experimental
Arm II (sorafenib tosylate) - Experimental
Arm II (sorafenib tosylate) - Experimental
Secondary IDNCI-2011-01989
PubMed (PMID)35484400
31486832
31486832
Collaborator(s)N/A
Region(s)United States
Canada
Puerto Rico
Canada
Puerto Rico
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Breast
Breast
Study Phase
Phase 3
Study Completion Date
December 2006
December 2006
NCT00002920Uploaded 10-20-2022
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A Randomized Comparison Of Medroxyprogesterone Acetate (MA) And Observation For Prevention Of Endometrial Pathology In Postmenopausal Breast Cancer Patients Treated With Tamoxifen, Phase III
Provider Information
Provider Data DescriptionNCT00002920-D1 and -D2 contain the data presented in NPJ Breast Cancer (Potkul et al., NPJ, 2016; PMID 28721383). This dataset, NCT00002920-D1, contains patient-level data (one row per patient), including eligibility, evaluability, treatment, demographic, and baseline information. It also contains assessment data.
SponsorSouthwest Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: It is not yet known whether medroxyprogesterone is effective in preventing endometrial disorder in patients with breast cancer who are taking tamoxifen.
PURPOSE: Randomized phase III trial to study the effectiveness of medroxyprogesterone in preventing endometrial disorder in postmenopausal women who have ductal carcinoma in situ, lobular carcinoma in situ, Paget's disease of the nipple, stage I breast cancer, or stage II breast cancer and who are taking tamoxifen.
ConditionsBreast Cancer
Endometrial Cancer
Endometrial Cancer
Intervention TypeDrug: medroxyprogesterone
Drug: tamoxifen citrate
Procedure: adjuvant therapy
Drug: tamoxifen citrate
Procedure: adjuvant therapy
Drug(s)Drug: tamoxifen citrate
Drug: medroxyprogesterone
Drug: medroxyprogesterone
Total Enrolled313
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionTamoxifen alone - Active Comparator
Tamoxifen plus MPA - Experimental
Tamoxifen plus MPA - Experimental
Secondary IDCALGB-49901
PubMed (PMID)N/A
Collaborator(s)National Cancer Institute (NCI)
Cancer and Leukemia Group B
Cancer and Leukemia Group B
Region(s)United States
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Colorectal
Colorectal
Study Phase
Phase 3
Study Completion Date
December 2012
December 2012
NCT01099449Uploaded 10-18-2022
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A Phase III Randomized, Placebo-Controlled, Double-Blind Study of Intravenous Calcium/Magnesium in Two Different Versions to Prevent Oxaliplatin-Induced Sensory Neurotoxicity
Provider Information
Provider Data DescriptionDataset NCT01099449-D1-Dataset.csv (table1) is one of 7 datasets associated with PubMed ID 24297951. This dataset contains the information in table 1: Baseline Patient Characteristics.
SponsorAlliance for Clinical Trials in Oncology
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: Chemoprotective drugs, such as calcium gluconate and magnesium sulfate, may prevent neurotoxicity caused by oxaliplatin. It is not yet known which administration schedule of calcium gluconate and magnesium sulfate is more effective in preventing neurotoxicity.
PURPOSE: This randomized phase III trial is studying different administration schedules of calcium gluconate and magnesium sulfate and comparing how well they work in neurotoxicity in patients with colon cancer or rectal cancer receiving oxaliplatin-based combination chemotherapy.
ConditionsChemotherapeutic Agent Toxicity
Colorectal Cancer
Neuropathy
Neurotoxicity
Colorectal Cancer
Neuropathy
Neurotoxicity
Intervention TypeDrug: calcium gluconate
Drug: magnesium sulfate
Other: placebo
Drug: oxaliplatin
Drug: magnesium sulfate
Other: placebo
Drug: oxaliplatin
Drug(s)Drug: calcium gluconate
Drug: magnesium sulfate
Drug: oxaliplatin
Drug: magnesium sulfate
Drug: oxaliplatin
Total Enrolled362
RandomizationRandomized
Blinding MethodDouble
Arms InterventionArm I - Experimental
Arm II - Placebo Comparator
Arm III - Experimental
Arm II - Placebo Comparator
Arm III - Experimental
Secondary IDNCCTG-N08CB
PubMed (PMID)34176021
24297951
24297951
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Puerto Rico
Puerto Rico
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Breast
Breast
Study Phase
Phase 3
Study Completion Date
December 2013
December 2013
NCT00785291Uploaded 09-30-2022
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A Randomized Phase III Trial of Weekly Paclitaxel Compared to Weekly Nanoparticle Albumin Bound Nab-paclitaxel or Ixabepilone With or Without Bevacizumab as First-Line Therapy for Locally Recurrent or Metastatic Breast Cancer
Provider Information
Provider Data DescriptionThe NCT00785291_D1_(c40502_ae) dataset is one of 3 datasets associated with PubMed ID 26056183. This dataset contains one record per adverse event (AE) per patient for those who began treatment.
SponsorNational Cancer Institute (NCI)
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial studies the side effects and how well different chemotherapy regimens with or without bevacizumab work in treating patients with stage IIIC or stage IV breast cancer. Drugs used in chemotherapy, such as paclitaxel, paclitaxel albumin-stabilized nanoparticle formulation (nab-paclitaxel), and ixabepilone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bevacizumab may block tumor growth by targeting certain cells and slowing the growth of blood vessels to the tumor. It is not yet known which treatment regimen is more effective in treating patients with breast cancer.
ConditionsEstrogen Receptor Negative
Estrogen Receptor Positive
HER2/Neu Negative
HER2/Neu Positive
Progesterone Receptor Negative
Progesterone Receptor Positive
Recurrent Breast Carcinoma
Stage IIIC Breast Cancer AJCC v6
Stage IV Breast Cancer AJCC v6 and v7
Estrogen Receptor Positive
HER2/Neu Negative
HER2/Neu Positive
Progesterone Receptor Negative
Progesterone Receptor Positive
Recurrent Breast Carcinoma
Stage IIIC Breast Cancer AJCC v6
Stage IV Breast Cancer AJCC v6 and v7
Intervention TypeBiological: Bevacizumab
Drug: Ixabepilone
Other: Laboratory Biomarker Analysis
Drug: Nab-paclitaxel
Drug: Paclitaxel
Other: Questionnaire Administration
Drug: Ixabepilone
Other: Laboratory Biomarker Analysis
Drug: Nab-paclitaxel
Drug: Paclitaxel
Other: Questionnaire Administration
Drug(s)Drug: Paclitaxel
Drug: Nab-paclitaxel
Drug: Ixabepilone
Drug: Nab-paclitaxel
Drug: Ixabepilone
Total Enrolled799
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionArm A (Paclitaxel) - Active Comparator
Arm B (Nab-paclitaxel) - Experimental
Arm C (Ixabepilone) - Experimental
Arm B (Nab-paclitaxel) - Experimental
Arm C (Ixabepilone) - Experimental
Secondary IDNCI-2009-00476
PubMed (PMID)34616010
28620884
26056183
28620884
26056183
Collaborator(s)N/A
Region(s)United States
Puerto Rico
Puerto Rico
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Breast
Breast
Study Phase
Phase 3
Study Completion Date
April 2021
April 2021
NCT02445391Uploaded 09-23-2022
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A Randomized Phase III Post-operative Trial of Platinum Based Chemotherapy vs. Capecitabine in Patients With Residual Triple-Negative Basal-Like Breast Cancer Following Neoadjuvant Chemotherapy
Provider Information
Provider Data DescriptionThere are three submissions for PMID 34092112. This dataset, NCT02445391-D1, contains baseline, treatment, and efficacy data. Dataset NCT02445391-D2 contains data on dose modification. Dataset NCT02445391-D3 contains toxicity data.
SponsorECOG-ACRIN Cancer Research Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial studies how well cisplatin or carboplatin (platinum based chemotherapy) works compared to capecitabine in treating patients with remaining (residual) basal-like triple-negative breast cancer following chemotherapy after surgery (neoadjuvant). Drugs used in chemotherapy, such as cisplatin, carboplatin and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether cisplatin or carboplatin is more effective than capecitabine in treating patients with residual triple negative basal-like breast cancer.
ConditionsEstrogen Receptor Negative
HER2/Neu Negative
Invasive Breast Carcinoma
Progesterone Receptor Negative
Stage II Breast Cancer
Stage IIA Breast Cancer
Stage IIB Breast Cancer
Stage III Breast Cancer
Stage IIIA Breast Cancer
Stage IIIB Breast Cancer
Stage IIIC Breast Cancer
Triple-Negative Breast Carcinoma
HER2/Neu Negative
Invasive Breast Carcinoma
Progesterone Receptor Negative
Stage II Breast Cancer
Stage IIA Breast Cancer
Stage IIB Breast Cancer
Stage III Breast Cancer
Stage IIIA Breast Cancer
Stage IIIB Breast Cancer
Stage IIIC Breast Cancer
Triple-Negative Breast Carcinoma
Intervention TypeDrug: Capecitabine
Drug: Carboplatin
Drug: Cisplatin
Drug: Carboplatin
Drug: Cisplatin
Drug(s)Drug: Carboplatin
Drug: Cisplatin
Drug: Capecitabine
Drug: Cisplatin
Drug: Capecitabine
Total Enrolled415
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionArm A (observation) (closed to accrual 05/16/2016) - No Intervention
Arm B (cisplatin or carboplatin) - Experimental
Arm C (capecitabine) - Active Comparator
Arm B (cisplatin or carboplatin) - Experimental
Arm C (capecitabine) - Active Comparator
Secondary IDNCI-2014-01820
PubMed (PMID)34092112
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
South Africa
South Africa
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
CNS
CNS
Study Phase
Phase 3
Study Completion Date
August 2016
August 2016
NCT01372774Uploaded 09-14-2022
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A Phase III Trial of Post-Surgical Stereotactic Radiosurgery (SRS) Compared With Whole Brain Radiotherapy (WBRT) for Resected Metastatic Brain Disease
Provider Information
Provider Data DescriptionDataset NCT01372774-D1-Dataset.csv (baseline) is one of 5 datasets associated with PubMed ID 28687377. This dataset contains information that will allow you to reproduce the baseline characteristics table and time to event analyses.
SponsorAlliance for Clinical Trials in Oncology
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: Stereotactic radiosurgery may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Radiation therapy uses high-energy x rays to kill tumor cells. It is not yet known whether stereotactic radiosurgery is more effective than whole-brain radiation therapy in treating patients with brain metastases that have been removed by surgery.
PURPOSE: This randomized phase III trial studies how well stereotactic radiosurgery works compared to whole-brain radiation therapy in treating patients with brain metastases that have been removed by surgery.
ConditionsCognitive/Functional Effects
Metastatic Cancer
Neurotoxicity
Radiation Toxicity
Unspecified Adult Solid Tumor, Protocol Specific
Metastatic Cancer
Neurotoxicity
Radiation Toxicity
Unspecified Adult Solid Tumor, Protocol Specific
Intervention TypeRadiation: stereotactic radiosurgery
Radiation: whole-brain radiation therapy
Radiation: whole-brain radiation therapy
Drug(s)N/A
Total Enrolled194
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionArm I - WBRT - Active Comparator
Arm II - SRS - Experimental
Arm II - SRS - Experimental
Secondary IDNCCTG-N107C
PubMed (PMID)36264568
28687377
28687377
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
CNS
CNS
Study Phase
Phase 3
Study Completion Date
October 2014
October 2014
NCT00377156Uploaded 09-13-2022
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Phase III Randomized Trial of the Role of Whole Brain Radiation Therapy in Addition to Radiosurgery in Patients With One to Three Cerebral Metastases
Provider Information
Provider Data DescriptionThe NCT00377156-D1 (BASE) dataset is one of 5 datasets associated with PubMed ID 27458945. This dataset provides information on patient evaluability, baseline demographics, stratification factors, baseline QOL measures, baseline cognitive scores, and intracranial (brain) tumor progression and survival status and time. There is one observation per patient accrued to this study (N=213).
Due to data cleaning efforts subsequent to publication, data may contain slight discrepancies from that reported in Table 1 and Figure1.
SponsorAlliance for Clinical Trials in Oncology
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: Stereotactic radiation therapy can send x-rays directly to the tumor and cause less damage to normal tissue. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether stereotactic radiation therapy is more effective with or without whole-brain radiation therapy in treating patients with brain metastases.
PURPOSE: This randomized phase III trial is studying stereotactic radiation therapy and whole-brain radiation therapy to see how well they work compared with stereotactic radiation therapy alone in treating patients with brain metastases.
ConditionsBreast Cancer
Cognitive/Functional Effects
Lung Cancer
Metastatic Cancer
Prostate Cancer
Cognitive/Functional Effects
Lung Cancer
Metastatic Cancer
Prostate Cancer
Intervention TypeRadiation: radiation therapy
Radiation: stereotactic radiosurgery
Radiation: stereotactic radiosurgery
Drug(s)N/A
Total Enrolled213
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionArm I - Active Comparator
Arm II - Experimental
Arm II - Experimental
Secondary IDNCCTG-N0574
PubMed (PMID)28939223
27458945
27458945
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Canada
Canada
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Colorectal
Colorectal
Study Phase
Phase 3
Study Completion Date
February 2020
February 2020
NCT01150045Uploaded 02-19-2022
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A Phase III Trial of 6 Versus 12 Treatments of Adjuvant FOLFOX Plus Celecoxib or Placebo for Patients With Resected Stage III Colon Cancer
Provider Information
Provider Data DescriptionDataset NCT01150045-D1-Dataset.csv (Figure1) is one of 4 datasets associated with PubMed ID 33821899. This dataset contains the data presented in the CONSORT diagram (Figure 1) from the manuscript. The dataset has one row-per-patient.
SponsorAlliance for Clinical Trials in Oncology
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryPURPOSE: This randomized phase III trial is studying giving oxaliplatin, leucovorin calcium, and fluorouracil together to compare how well they work when given together with or without celecoxib in treating patients with stage III colon cancer previously treated with surgery.
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving oxaliplatin, leucovorin calcium, and fluorouracil is more effective with or without celecoxib in treating colon cancer.
ConditionsColorectal Cancer
Intervention TypeDrug: celecoxib
Drug: 5-fluorouracil
Other: placebo
Drug: oxaliplatin
Drug: leucovorin
Drug: 5-fluorouracil
Other: placebo
Drug: oxaliplatin
Drug: leucovorin
Drug(s)Drug: 5-fluorouracil
Drug: oxaliplatin
Drug: leucovorin
Drug: celecoxib
Drug: oxaliplatin
Drug: leucovorin
Drug: celecoxib
Total Enrolled2527
RandomizationRandomized
Blinding MethodDouble
Arms InterventionArm A - FOLFOX and placebo (12 treatments) - Active Comparator
Arm B - FOLFOX and celecoxib (12 treatments) - Experimental
Arm C - FOLFOX and placebo (6 treatments) - Active Comparator
Arm D - FOLFOX and celecoxib (6 treatments) - Experimental
Arm B - FOLFOX and celecoxib (12 treatments) - Experimental
Arm C - FOLFOX and placebo (6 treatments) - Active Comparator
Arm D - FOLFOX and celecoxib (6 treatments) - Experimental
Secondary IDU10CA031946
PubMed (PMID)36367997
36306483
33821899
36306483
33821899
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Canada
Puerto Rico
Canada
Puerto Rico
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Prostate
Prostate
Study Phase
Phase 3
Study Completion Date
April 2014
April 2014
NCT00288080Uploaded 02-03-2022
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A Phase III Protocol of Androgen Suppression (AS) and 3DCRT/IMRT Vs AS and 3DCTR/IMRT Followed by Chemotherapy With Docetaxel and Prednisone for Localized, High-Risk, Prostate Cancer
Provider Information
Provider Data DescriptionThis dataset, NCT00288080-D1, contains the data presented in the RTOG-0521 primary publication (PMID: 30860948).
SponsorRadiation Therapy Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: Androgens can cause the growth of prostate cancer cells. Hormone therapy using drugs, such as leuprolide, goserelin, flutamide, or bicalutamide, may fight prostate cancer by lowering the amount of androgens the body makes. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving hormone therapy and radiation therapy together with chemotherapy is more effective than giving hormone therapy together with radiation therapy in treating prostate cancer.
PURPOSE: This randomized phase III trial is studying hormone therapy and radiation therapy followed by docetaxel and prednisone to see how well it works compared to hormone therapy and radiation therapy in treating patients with localized prostate cancer.
ConditionsProstate Cancer
Intervention TypeDrug: Dexamethasone
Drug: Prednisone
Drug: docetaxel
Drug: Oral antiandrogen
Radiation: Radiation therapy
Drug: LHRH agonist
Drug: Prednisone
Drug: docetaxel
Drug: Oral antiandrogen
Radiation: Radiation therapy
Drug: LHRH agonist
Drug(s)Drug: Oral antiandrogen
Drug: LHRH agonist
Drug: Dexamethasone
Drug: Prednisone
Drug: docetaxel
Drug: LHRH agonist
Drug: Dexamethasone
Drug: Prednisone
Drug: docetaxel
Total Enrolled612
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionAndrogen suppression + Radiation Therapy - Active Comparator
Androgen suppression + Radiation Therapy + Chemotherapy - Experimental
Androgen suppression + Radiation Therapy + Chemotherapy - Experimental
Secondary IDCDR0000462375
PubMed (PMID)16425991
Collaborator(s)National Cancer Institute (NCI)
NRG Oncology
NRG Oncology
Region(s)United States
Canada
Canada
Age Range18 Years to 120 Years (Adult, Older Adult)
Type(s) of Cancer
Breast
Breast
Study Phase
Phase 3
Study Completion Date
April 2012
April 2012
NCT00041119Uploaded 12-31-2021
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Cyclophosphamide And Doxorubicin (CA) (4 VS 6 Cycles) Versus Paclitaxel (4 VS 6 Cycles) As Adjuvant Therapy For Breast Cancer in Women With 0-3 Positive Axillary Lymph Nodes:A 2X2 Factorial Phase III Randomized Study
Provider Information
Provider Data DescriptionThe NCT00041119_D1_(FactorA_Patients) dataset is one of 2 datasets associated with PubMed ID 22826271. This dataset contains de-identified patient-level information. The information includes baseline characteristics, eligibility, and endpoint data.
SponsorAlliance for Clinical Trials in Oncology
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial studies cyclophosphamide and doxorubicin hydrochloride compared with paclitaxel as adjuvant therapy in treating breast cancer in women with 0-3 positive axillary lymph nodes. Giving additional cancer treatment after surgery may help to lower the risk that the cancer will come back (adjuvant therapy). Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether the standard adjuvant therapy of cyclophosphamide and doxorubicin hydrochloride is more effective than paclitaxel in treating women with breast cancer
ConditionsBreast Cancer
Intervention TypeDrug: AC regimen
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: paclitaxel
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: paclitaxel
Drug(s)Drug: AC regimen
Drug: doxorubicin hydrochloride
Drug: cyclophosphamide
Drug: paclitaxel
Drug: doxorubicin hydrochloride
Drug: cyclophosphamide
Drug: paclitaxel
Total Enrolled3871
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionArm I (CA for 4 courses) - Active Comparator
Arm II (CA for 6 courses [closed to accrual 12/15/2007]) - Experimental
Arm III (paclitaxel for 4 courses) - Experimental
Arm IV (paclitaxel for 6 courses [closed 12/15/2007]) - Experimental
Arm II (CA for 6 courses [closed to accrual 12/15/2007]) - Experimental
Arm III (paclitaxel for 4 courses) - Experimental
Arm IV (paclitaxel for 6 courses [closed 12/15/2007]) - Experimental
Secondary IDCDR0000069444
PubMed (PMID)22843789
22826271
30409792
24934787
22826271
30409792
24934787
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
South Africa
South Africa
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Prostate
Prostate
Study Phase
Phase 3
Study Completion Date
February 2016
February 2016
NCT00134056Uploaded 10-09-2021
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Phase III Study of Docetaxel and Atrasentan Versus Docetaxel and Placebo for Patients With Advanced Hormone Refractory Prostate Cancer
Provider Information
Provider Data DescriptionThis dataset contains quality of life (QOL) data from trial NCT00134056 to reproduce the results reported in the Journal of Patient-Reported Outcomes (Unger et al, JPRO, 2018, PMID29951640).
SponsorSouthwest Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: Drugs used in chemotherapy, such as docetaxel, prednisone, and atrasentan work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether docetaxel, prednisone, and atrasentan are more effective than docetaxel and prednisone in treating prostate cancer.
PURPOSE: This randomized phase III trial is studying docetaxel, prednisone, and atrasentan to see how well they work compared to docetaxel and prednisone in treating patients with stage IV prostate cancer and bone metastases that did not respond to previous hormone therapy.
ConditionsMetastatic Cancer
Prostate Cancer
Prostate Cancer
Intervention TypeDrug: atrasentan hydrochloride
Drug: docetaxel
Drug: prednisone
Other: placebo
Drug: docetaxel
Drug: prednisone
Other: placebo
Drug(s)Drug: docetaxel
Drug: prednisone
Drug: atrasentan hydrochloride
Drug: prednisone
Drug: atrasentan hydrochloride
Total Enrolled1038
RandomizationRandomized
Blinding MethodTriple
Arms InterventionArm I: placebo - Active Comparator
Arm II: atrasentan hydrochloride - Experimental
Arm II: atrasentan hydrochloride - Experimental
Secondary IDS0421
PubMed (PMID)24616308
24565955
23871417
24565955
23871417
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Prostate
Prostate
Real World Data
Completion Date
2017
2017
Uploaded 09-01-2021
Available for Download
Intermittent hormonal therapy of prostate cancer patients in Spain: a prevalence study
Provider Information
Provider Data DescriptionWe estimated the use of the intermittent androgen deprivation therapy (%IAD) and the prevalence of patients under intermittent androgen therapy (PIAD) overall and stratified by region.
SponsorAsociación Colaboración Cochrane Iberoamericana (ACCIb)
Data ProviderAsociación Colaboración Cochrane Iberoamericana (ACCIb)
Partial set or SubsetOriginal Data
Patients in dataset65752
DOIhttps://doi.org/10.34949/fzzk-ye57
Data StandardNot CDISC
Type(s) of Cancer
Breast, Gynecological
Breast, Gynecological
Study Phase
Phase 3
Study Completion Date
August 2013
August 2013
NCT01376349Uploaded 08-21-2021
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Vaginal DHEA for Vaginal Symptoms: A Phase III Randomized, Double Blind, Placebo- Controlled Trial
Provider Information
Provider Data DescriptionDataset NCT01376349-D1-Dataset.csv (consort) is one of 6 datasets associated with PubMed ID 28921241. This dataset contains information regarding whether patients were included in the primary analysis.
At the time of publication, 353 (Placebo=118; DHEA 3.25 mg=123; DHEA 6.5 mg=112) patients were used in the primary analysis. The updated data in NCT01376349-D1-Dataset includes a variable ?endpoint? which identifies which patients are currently evaluable for the primary endpoint based on updated data. This includes 344 (Placebo=108; DHEA 3.25 mg=123; DHEA 6.5 mg=113).
SponsorAlliance for Clinical Trials in Oncology
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: Dehydroepiandrosterone (DHEA) may help relieve vaginal symptoms in female cancer survivors.
PURPOSE: This randomized phase III trial studies DHEA to see how well it works compared to placebo in treating postmenopausal cancer survivors with vaginal symptoms.
ConditionsBreast Cancer
Gynecologic Cancer
Gynecologic Cancer
Intervention TypeDrug: prasterone
Other: placebo
Other: placebo
Drug(s)Drug: prasterone
Total Enrolled464
RandomizationRandomized
Blinding MethodDouble
Arms InterventionArm I low dose DHEA - Experimental
Arm II high dose DHEA - Experimental
Arm III placebo - Placebo Comparator
Arm II high dose DHEA - Experimental
Arm III placebo - Placebo Comparator
Secondary IDNCCTG-N10C1
PubMed (PMID)N/A
Collaborator(s)National Cancer Institute (NCI)
Mayo Clinic
Mayo Clinic
Region(s)United States
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Sarcoma
Sarcoma
Study Phase
Phase 3
Study Completion Date
September 2014
September 2014
NCT00346164Uploaded 08-12-2021
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Risk-Based Treatment for Non-Rhabdomyosarcoma Soft Tissue Sarcomas (NRSTS) in Patients Under 30 Years of Age
Provider Information
Provider Data DescriptionDataset NCT00346164 -D1 is for recreating the results of the manuscript, which includes demographic and clinical characteristics, and survival outcomes. Each row corresponds with data from a single, unique patient.
SponsorChildren's Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis phase III trial is studying observation to see how well a risk based treatment strategy works in patients with soft tissue sarcoma. In the study, patients are assigned to receive surgery +/- radiotherapy +/- chemotherapy depending on their risk of recurrence. Sometimes, after surgery, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as ifosfamide and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery.
ConditionsAdult Alveolar Soft-part Sarcoma
Adult Angiosarcoma
Adult Epithelioid Sarcoma
Adult Extraskeletal Chondrosarcoma
Adult Extraskeletal Osteosarcoma
Adult Fibrosarcoma
Adult Leiomyosarcoma
Adult Liposarcoma
Adult Malignant Fibrous Histiocytoma
Adult Malignant Hemangiopericytoma
Adult Malignant Mesenchymoma
Adult Neurofibrosarcoma
Adult Synovial Sarcoma
Childhood Alveolar Soft-part Sarcoma
Childhood Angiosarcoma
Childhood Epithelioid Sarcoma
Childhood Fibrosarcoma
Childhood Leiomyosarcoma
Childhood Liposarcoma
Childhood Malignant Mesenchymoma
Childhood Neurofibrosarcoma
Childhood Synovial Sarcoma
Dermatofibrosarcoma Protuberans
Metastatic Childhood Soft Tissue Sarcoma
Nonmetastatic Childhood Soft Tissue Sarcoma
Stage I Adult Soft Tissue Sarcoma
Stage II Adult Soft Tissue Sarcoma
Stage III Adult Soft Tissue Sarcoma
Stage IV Adult Soft Tissue Sarcoma
Adult Angiosarcoma
Adult Epithelioid Sarcoma
Adult Extraskeletal Chondrosarcoma
Adult Extraskeletal Osteosarcoma
Adult Fibrosarcoma
Adult Leiomyosarcoma
Adult Liposarcoma
Adult Malignant Fibrous Histiocytoma
Adult Malignant Hemangiopericytoma
Adult Malignant Mesenchymoma
Adult Neurofibrosarcoma
Adult Synovial Sarcoma
Childhood Alveolar Soft-part Sarcoma
Childhood Angiosarcoma
Childhood Epithelioid Sarcoma
Childhood Fibrosarcoma
Childhood Leiomyosarcoma
Childhood Liposarcoma
Childhood Malignant Mesenchymoma
Childhood Neurofibrosarcoma
Childhood Synovial Sarcoma
Dermatofibrosarcoma Protuberans
Metastatic Childhood Soft Tissue Sarcoma
Nonmetastatic Childhood Soft Tissue Sarcoma
Stage I Adult Soft Tissue Sarcoma
Stage II Adult Soft Tissue Sarcoma
Stage III Adult Soft Tissue Sarcoma
Stage IV Adult Soft Tissue Sarcoma
Intervention TypeDrug: doxorubicin hydrochloride
Other: clinical observation
Procedure: therapeutic conventional surgery
Radiation: 3-dimensional conformal radiation therapy
Drug: ifosfamide
Other: clinical observation
Procedure: therapeutic conventional surgery
Radiation: 3-dimensional conformal radiation therapy
Drug: ifosfamide
Drug(s)Drug: doxorubicin hydrochloride
Drug: ifosfamide
Drug: ifosfamide
Total Enrolled588
RandomizationNon-Randomized
Blinding MethodNone (Open Label)
Arms InterventionArm A: No adjuvant treatment - Experimental
Arm B: Low risk; adjuvant radiotherapy - Experimental
Arm C: Intermediate & High risk; adjuvant chemoradiotherapy - Experimental
Arm D: Intermediate & High Risk; Neoadjuvant chemoradiotherapy - Experimental
Arm B: Low risk; adjuvant radiotherapy - Experimental
Arm C: Intermediate & High risk; adjuvant chemoradiotherapy - Experimental
Arm D: Intermediate & High Risk; Neoadjuvant chemoradiotherapy - Experimental
Secondary IDNCI-2009-00426
PubMed (PMID)34623899
33548339
31786124
30954717
28391003
33548339
31786124
30954717
28391003
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Australia
Canada
New Zealand
Puerto Rico
Australia
Canada
New Zealand
Puerto Rico
Age Range29 Years and younger (Child, Adult)
Type(s) of Cancer
Breast
Breast
Study Phase
Phase 3
Study Completion Date
January 2016
January 2016
NCT00382070Uploaded 08-11-2021
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A Clinical Trial to Determine the Efficacy of Five Years of Letrozole Compared to Placebo in Patients Completing Five Years of Hormonal Therapy Consisting of an Aromatase Inhibitor (AI) or Tamoxifen Followed by an AI in Prolonging Disease-Free Survival in Postmenopausal Women With Hormone Receptor Positive Breast Cancer
Provider Information
Provider Data DescriptionThere are two data submissions (NCT00382070-D1 and NCT00382070-D2) for PMID 30509771, the primary publication for NCT00382070 (NSABP-B-42). This dataset, NCT00382070-D1, contains baseline characteristic, survival, disease recurrence, and serious adverse event data.
SponsorNSABP Foundation Inc
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by lowering the amount of estrogen the body makes. It is not yet known whether letrozole is more effective than a placebo in treating patients with hormone receptor-positive breast cancer.
PURPOSE: This randomized phase III trial is studying letrozole to see how well it works compared with a placebo in treating postmenopausal women who have received hormone therapy for hormone receptor-positive breast cancer.
ConditionsBreast Cancer
Intervention TypeDrug: Letrozole
Other: Placebo
Other: Placebo
Drug(s)Drug: Letrozole
Total Enrolled3966
RandomizationRandomized
Blinding MethodDouble
Arms InterventionGroup 2 Letrozole - Experimental
Group 1 Placebo - Placebo Comparator
Group 1 Placebo - Placebo Comparator
Secondary IDU10CA012027
PubMed (PMID)17239269
30509771
30509771
Collaborator(s)National Cancer Institute (NCI)
Novartis
Novartis
Region(s)United States
Canada
Ireland
Canada
Ireland
Age Range18 Years to 120 Years (Adult, Older Adult)
Type(s) of Cancer
Other
Other
Study Phase
Phase 3
Study Completion Date
July 2017
July 2017
NCT02349412Uploaded 07-23-2021
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Randomized Study of Early Palliative Care Integrated With Standard Oncology Care Versus Standard Oncology Care Alone in Patients With Incurable Lung or Non-Colorectal Gastrointestinal Malignancies
Provider Information
Provider Data DescriptionDataset NCT02349412-D1-Dataset.csv (nctn_consort) is one of 9 datasets associated with PubMed ID 32031887. This dataset contains information that will allow you to reproduce the consort diagram.
SponsorAlliance for Clinical Trials in Oncology
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThe study intervention consists of the early integration of palliative care services into standard oncology care in an outpatient setting for patients with advanced lung and non-colorectal gastrointestinal malignancies who are not being treated with curative intent. The palliative care services provided to patients randomized to the intervention will be provided by board-certified physicians and/or advanced practice nurses and will focus on the following areas: (1) developing and maintaining the therapeutic relationship with the patients and family caregivers; (2) assessing and treating patient symptoms; (3) providing support and reinforcement of coping with advanced cancer in patients and family caregivers; (4) assessing and enhancing prognostic awareness and illness understanding in patients and family caregivers; (5) assisting with treatment decision-making; and (6) end-of-life care planning.
ConditionsLiver Cancer
Anxiety Disorder
Depression
Small Cell Lung Cancer
Extrahepatic Bile Duct Cancer
Malignant Mesothelioma
Pancreatic Cancer
Esophageal Cancer
Gastric Cancer
Non-small Cell Lung Cancer
Anxiety Disorder
Depression
Small Cell Lung Cancer
Extrahepatic Bile Duct Cancer
Malignant Mesothelioma
Pancreatic Cancer
Esophageal Cancer
Gastric Cancer
Non-small Cell Lung Cancer
Intervention TypeOther: Early palliative care
Drug(s)N/A
Total Enrolled405
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionArm 1 - Experimental
Arm 2 - Experimental
Arm 2 - Experimental
Secondary IDU10CA037447
PubMed (PMID)32031887
28097515
28097515
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Nasopharyngeal
Nasopharyngeal
Study Phase
Phase 3
Study Completion Date
December 2014
December 2014
NCT00274937Uploaded 07-09-2021
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Treatment of Childhood Nasopharyngeal Carcinoma With Neoadjuvant Chemotherapy and Concomitant Chemoradiotherapy: A Groupwide Phase III Study
Provider Information
Provider Data DescriptionNCT00274937-D1-Dataset (Main)
This dataset provides data required for reproducing all quantitative statements in the manuscript except for the toxicity table presented as Table A1 in the APPENDIX.
Blanks represent missing data or not applicable for analysis. All patients are eligible.
There is one row per patient.
SponsorChildren's Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis phase III trial is studying how well radiation therapy, amifostine, and chemotherapy work in treating young patients with newly diagnosed nasopharyngeal cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs, such as amifostine, may protect normal cells from the side effects of radiation therapy. Drugs used in chemotherapy, such as cisplatin and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with amifostine and chemotherapy may kill more tumor cells.
ConditionsStage I Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7
Stage I Nasopharyngeal Undifferentiated Carcinoma AJCC v7
Stage II Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7
Stage II Nasopharyngeal Undifferentiated Carcinoma AJCC v7
Stage III Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7
Stage III Nasopharyngeal Undifferentiated Carcinoma AJCC v7
Stage IV Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7
Stage IV Nasopharyngeal Undifferentiated Carcinoma AJCC v7
Stage I Nasopharyngeal Undifferentiated Carcinoma AJCC v7
Stage II Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7
Stage II Nasopharyngeal Undifferentiated Carcinoma AJCC v7
Stage III Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7
Stage III Nasopharyngeal Undifferentiated Carcinoma AJCC v7
Stage IV Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7
Stage IV Nasopharyngeal Undifferentiated Carcinoma AJCC v7
Intervention TypeDrug: Amifostine
Drug: Cisplatin
Drug: Fluorouracil
Other: Laboratory Biomarker Analysis
Radiation: Radiation Therapy
Drug: Cisplatin
Drug: Fluorouracil
Other: Laboratory Biomarker Analysis
Radiation: Radiation Therapy
Drug(s)Drug: Amifostine
Drug: Cisplatin
Drug: Fluorouracil
Drug: Cisplatin
Drug: Fluorouracil
Total Enrolled111
RandomizationNon-Randomized
Blinding MethodNone (Open Label)
Arms InterventionStratum I (radiotherapy, chemoprotective agent) - Experimental
Stratum II (chemotherapy, chemoprotective agent, radiotherapy) - Experimental
Stratum II (chemotherapy, chemoprotective agent, radiotherapy) - Experimental
Secondary IDNCI-2009-00412
PubMed (PMID)31657981
31553639
31553639
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Australia
Canada
Australia
Canada
Age Range18 Years and younger (Child, Adult)
Type(s) of Cancer
Breast
Breast
Study Phase
Not Applicable
Study Completion Date
June 2017
June 2017
NCT01535066Uploaded 06-19-2021
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Randomized Blinded Sham- and Waitlist-Controlled Trial of Acupuncture for Joint Symptoms Related to Aromatase Inhibitors in Women With Early Stage Breast Cancer
Provider Information
Provider Data DescriptionThere are two datasets for PMID 29998338 to reproduce the results of the treatment comparison of true acupuncture, sham acupuncture and waitlist control on AI related joint pain. This dataset, NCT01535066-D1, contains baseline characteristic and patient-reported questionnaire data.
SponsorSouthwest Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: Acupuncture may help relieve joint pain.
PURPOSE: This randomized phase III trial studies acupuncture to see how well it works compared to sham acupuncture or waitlist in treating patients with joint pain related to aromatase inhibitors in patients with early-stage breast cancer.
ConditionsBreast Cancer
Pain
Pain
Intervention TypeProcedure: acupuncture therapy
Procedure: sham acupuncture
Procedure: sham acupuncture
Drug(s)N/A
Total Enrolled226
RandomizationRandomized
Blinding MethodSingle
Arms InterventionArm I - Experimental
Arm II - Sham Comparator
Arm III - No Intervention
Arm II - Sham Comparator
Arm III - No Intervention
Secondary IDS1200
PubMed (PMID)36367721
29998338
29998338
Collaborator(s)National Cancer Institute (NCI)
National Center for Complementary and Integrative Health (NCCIH)
National Center for Complementary and Integrative Health (NCCIH)
Region(s)United States
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
All, Bacterial Infection
All, Bacterial Infection
Study Phase
Phase 3
Study Completion Date
March 2019
March 2019
NCT01817075Uploaded 06-19-2021
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Impact of Cleansing With Chlorhexidine Gluconate (CHG) on Reducing Central Line Associated Bloodstream Infection (CLABSI) and Acquisition of Multi-drug Resistant Organisms (MDRO) in Children With Cancer or Those Receiving Allogeneic Hematopoietic Cell Transplantation (HCT)
Provider Information
Provider Data DescriptionNCT01817075-D1: There are 5 datasets associated with PMID 33079403. This dataset, NCT01817075-D1, provides the information for the consort diagram in the manuscript (Figure 1). Data provided for all enrolled patients (N=177). There is one row per patient.
SponsorChildren's Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial studies chlorhexidine gluconate cleansing to see how well it works compared to control cleansing in preventing central line associated bloodstream infection and acquisition of multi-drug resistant organisms in younger patients with cancer or undergoing donor stem cell transplant. Chlorhexidine gluconate may help reduce bloodstream infections and bacterial infections associated with the central line.
ConditionsBacterial Infection
Benign Neoplasm
Malignant Neoplasm
Methicillin-Resistant Staphylococcus Aureus Infection
Myeloid Neoplasm
Recurrent Childhood Acute Lymphoblastic Leukemia
Recurrent Childhood Acute Myeloid Leukemia
Benign Neoplasm
Malignant Neoplasm
Methicillin-Resistant Staphylococcus Aureus Infection
Myeloid Neoplasm
Recurrent Childhood Acute Lymphoblastic Leukemia
Recurrent Childhood Acute Myeloid Leukemia
Intervention TypeProcedure: Chlorhexidine Gluconate Skin Cleanser
Other: Laboratory Biomarker Analysis
Procedure: Mild Soap Skin Cleanser
Other: Questionnaire Administration
Other: Laboratory Biomarker Analysis
Procedure: Mild Soap Skin Cleanser
Other: Questionnaire Administration
Drug(s)N/A
Total Enrolled177
RandomizationRandomized
Blinding MethodDouble
Arms InterventionArm I (CHG cleansing wipe) - Experimental
Arm II (control) - Active Comparator
Arm II (control) - Active Comparator
Secondary IDNCI-2013-00595
PubMed (PMID)N/A
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Canada
Puerto Rico
Canada
Puerto Rico
Age Range2 Months to 21 Years (Child, Adult)
Type(s) of Cancer
Eye
Eye
Study Phase
Phase 3
Study Completion Date
February 2013
February 2013
NCT00072384Uploaded 06-08-2021
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A Single Arm Trial of Systemic And Subtenon Chemotherapy For Groups C And D Intraocular Retinoblastoma
Provider Information
Provider Data DescriptionNCT00072384 - D1 Dataset Description:
NCT00072384 - D1 is one of 5 data submissions associated with PubMed ID 32589362. This dataset provides the information for patients who were enrolled on ARET0231. There is one row for each patient enrolled. The dataset provides the information of baseline characteristics, eye stage from local and central review, outcome data and ocular toxicity on ARET0231 as reported in the manuscript. It is used to generate the Summary of Baseline Characteristics for eligible patients (Table 1), and the information in the beginning of Section 3 Results, Section 3.2 Patterns of intraocular recurrence, Section 3.3 Extraocular recurrence/deaths, and Section 3.4 Ocular toxicity.
SponsorChildren's Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryPhase III trial to determine the effectiveness of combining systemic chemotherapy and subtenon carboplatin with ophthalmic therapy in treating children who have intraocular retinoblastoma. Drugs used in chemotherapy, such as vincristine, carboplatin, and etoposide, work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether systemic chemotherapy and subtenon (under the conjunctiva of the eye) carboplatin combined with ophthalmic therapy is effective in treating intraocular (within the eyeball) retinoblastoma.
ConditionsIntraocular Retinoblastoma
Intervention TypeDrug: liposomal vincristine sulfate
Procedure: cryosurgery
Procedure: laser surgery
Drug: carboplatin
Drug: etoposide
Biological: filgrastim
Procedure: cryosurgery
Procedure: laser surgery
Drug: carboplatin
Drug: etoposide
Biological: filgrastim
Drug(s)Drug: liposomal vincristine sulfate
Drug: carboplatin
Drug: etoposide
Drug: carboplatin
Drug: etoposide
Total Enrolled30
RandomizationN/A
Blinding MethodNone (Open Label)
Arms InterventionTreatment (chemotherapy, surgery) - Experimental
Secondary IDNCI-2009-00420
PubMed (PMID)N/A
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Age Range17 Years and younger (Child)
Type(s) of Cancer
Lung
Lung
Study Phase
Phase 3
Study Completion Date
August 2017
August 2017
NCT00946712Uploaded 06-05-2021
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A Randomized, Phase III Study Comparing Carboplatin/Paclitaxel or Carboplatin/Paclitaxel/Bevacizumab With or Without Concurrent Cetuximab in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)
Provider Information
Provider Data DescriptionThere are three data submissions associated with PMID 29169877: NCT00946712-D1 , -D2, and -D3. This clinical dataset, NCT00946712-D1, will allow users to reproduce the results reported in the Lancet Oncology (Herbst et al., Lancet Oncology, 2018). This dataset contains patient-level data (one row per patient), including eligibility, evaluability, treatment, demographic, and baseline information. It also contains assessment data.
SponsorSouthwest Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial studies carboplatin and paclitaxel to compare how well they work with or without bevacizumab and/or cetuximab in treating patients with stage IV or non-small cell lung cancer that has returned after a period of improvement (recurrent). Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bevacizumab may prevent the growth of new blood vessels that tumor needs to grow. Cetuximab may also stop cancer cells from growing by binding and interfering with a protein on the surface of the tumor cell that is needed for tumor growth. It is not yet known whether giving carboplatin and paclitaxel are more effective with or without bevacizumab and/or cetuximab in treating patients with non-small cell lung cancer.
ConditionsRecurrent Large Cell Lung Carcinoma
Recurrent Lung Adenocarcinoma
Recurrent Squamous Cell Lung Carcinoma
Stage IV Large Cell Lung Carcinoma
Stage IV Lung Adenocarcinoma
Stage IV Squamous Cell Lung Carcinoma
Recurrent Lung Adenocarcinoma
Recurrent Squamous Cell Lung Carcinoma
Stage IV Large Cell Lung Carcinoma
Stage IV Lung Adenocarcinoma
Stage IV Squamous Cell Lung Carcinoma
Intervention TypeBiological: Bevacizumab
Drug: Carboplatin
Biological: Cetuximab
Other: Laboratory Biomarker Analysis
Drug: Paclitaxel
Drug: Carboplatin
Biological: Cetuximab
Other: Laboratory Biomarker Analysis
Drug: Paclitaxel
Drug(s)Drug: Carboplatin
Drug: Paclitaxel
Drug: Paclitaxel
Total Enrolled1333
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionArm I (chemo +/- bevacizumab) - Experimental
Arm II (chemo, cetuximab, +/- bevacizumab) - Experimental
Arm II (chemo, cetuximab, +/- bevacizumab) - Experimental
Secondary IDNCI-2009-01664
PubMed (PMID)34753703
29169877
29169877
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Mexico
Mexico
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Breast
Breast
Study Phase
Phase 3
Study Completion Date
December 2017
December 2017
NCT00127205Uploaded 06-04-2021
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Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer
Provider Information
Provider Data DescriptionThere are two datasets associated with PMID 31693129: NCT00127205-D1 and NCT00127205-D2. This dataset, NCT00127205-D1, will allow users to reproduce the patient characteristics, treatment completion, and primary outcome results reported in J Natl Cancer Inst. (2020 Jul 1;112(7):698-707. doi: 10.1093/jnci/djz215. PMID: 31693129; PMCID: PMC7357327) for trial NCT00127205.
SponsorSouthwest Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: Zoledronate, clodronate, or ibandronate may delay or prevent bone metastases in patients with nonmetastatic breast cancer. It is not yet known whether zoledronate is more effective than clodronate or ibandronate in treating breast cancer.
PURPOSE: This randomized phase III trial is studying zoledronate to see how well it works compared to clodronate or ibandronate in treating women who have undergone surgery for stage I, stage II, or stage III breast cancer.
ConditionsBreast Cancer
Intervention TypeDrug: clodronate disodium
Drug: ibandronate sodium
Drug: zoledronic acid
Drug: ibandronate sodium
Drug: zoledronic acid
Drug(s)Drug: zoledronic acid
Drug: clodronate disodium
Drug: ibandronate sodium
Drug: clodronate disodium
Drug: ibandronate sodium
Total Enrolled6097
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionArm I - Experimental
Arm II - Active Comparator
Arm III - Experimental
Arm II - Active Comparator
Arm III - Experimental
Secondary IDS0307
PubMed (PMID)32929540
Collaborator(s)National Cancer Institute (NCI)
North Central Cancer Treatment Group
Eastern Cooperative Oncology Group
NSABP Foundation Inc
Cancer and Leukemia Group B
NCIC Clinical Trials Group
North Central Cancer Treatment Group
Eastern Cooperative Oncology Group
NSABP Foundation Inc
Cancer and Leukemia Group B
NCIC Clinical Trials Group
Region(s)N/A
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
CNS
CNS
Study Phase
Phase 3
Study Completion Date
April 2018
April 2018
NCT02360215Uploaded 05-12-2021
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A Randomized Phase III Trial of Memantine and Whole-Brain Radiotherapy With or Without Hippocampal Avoidance in Patients With Brain Metastases
Provider Information
Provider Data DescriptionThis dataset contains baseline, treatment, efficacy, and health-related quality of life data from trial NCT02360215 to reproduce the results in the primary publication (PubMed ID 32058845). Dataset NCT02360215-D2 contains toxicity data for this publication.
SponsorNRG Oncology
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial compares memantine hydrochloride and whole-brain radiotherapy with or without hippocampal avoidance in reducing neurocognitive decline in patients with cancer that has spread from the primary site (place where it started) to the brain. Whole brain radiotherapy (WBRT) is the most common treatment for brain metastasis. Unfortunately, the majority of patients with brain metastases experience cognitive (such as learning and memory) deterioration after WBRT. Memantine hydrochloride may enhance cognitive function by binding to and inhibiting channels of receptors located in the central nervous system. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Using radiation techniques, such as intensity modulated radiotherapy to avoid the hippocampal region during WBRT, may reduce the radiation dose to the hippocampus and help limit the radiation-induced cognitive decline. It is not yet known whether giving memantine hydrochloride and WBRT with or without hippocampal avoidance works better in reducing neurocognitive decline in patients with brain metastases.
ConditionsCognitive Impairment
Metastatic Malignant Neoplasm in the Brain
Solid Neoplasm
Metastatic Malignant Neoplasm in the Brain
Solid Neoplasm
Intervention TypeRadiation: Whole brain radiation therapy with hippocampal avoidance
Drug: Memantine
Radiation: Whole brain radiation therapy
Drug: Memantine
Radiation: Whole brain radiation therapy
Drug(s)Drug: Memantine
Total Enrolled518
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionWBRT + Memantine - Experimental
HA-WBRT/IMRT+ Memantine - Experimental
HA-WBRT/IMRT+ Memantine - Experimental
Secondary IDNCI-2015-00030
PubMed (PMID)32058845
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Canada
Canada
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Colorectal
Colorectal
Study Phase
Phase 3
Study Completion Date
April 2015
April 2015
NCT00303628Uploaded 05-04-2021
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Intergroup Randomized Phase III Study of Postoperative Oxaliplatin, 5-Fluorouracil and Leucovorin vs Oxaliplatin, 5-Fluorouracil, Leucovorin and Bevacizumab for Patients With Stage II or III Rectal Cancer Receiving Pre-operative Chemoradiation
Provider Information
Provider Data DescriptionThere are five different submissions for PMID 31852811 from trial E5204. This dataset, NCT00303628-D1, contains baseline, treatment, and efficacy data. Dataset NCT00303628-D2 contains toxicity data. Dataset NCT00303628-D3 contains PRO Bowel function/uniscale data. Dataset NCT00303628-D4 contains PRO FACT-Diarrhea Data. Dataset NCT00303628-D5 contains PRO FACT/GOG-Ntx Data.
SponsorECOG-ACRIN Cancer Research Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryDrugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving more than one drug (combination chemotherapy) together with bevacizumab after surgery may kill any tumor cells that remain after surgery. It is not yet known whether oxaliplatin, leucovorin, and fluorouracil is more effective with or without bevacizumab in treating rectal cancer. This randomized phase III trial is studying combination chemotherapy to see how well it works with or without bevacizumab in treating patients who have had surgery for stage II or stage III rectal cancer.
ConditionsAdenocarcinoma of the Rectum
Stage II Rectal Cancer
Stage III Rectal Cancer
Stage II Rectal Cancer
Stage III Rectal Cancer
Intervention TypeDrug: oxaliplatin
Drug: fluorouracil
Drug: leucovorin calcium
Drug: bevacizumab
Drug: fluorouracil
Drug: leucovorin calcium
Drug: bevacizumab
Drug(s)Drug: oxaliplatin
Drug: fluorouracil
Drug: leucovorin calcium
Drug: bevacizumab
Drug: fluorouracil
Drug: leucovorin calcium
Drug: bevacizumab
Total Enrolled355
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionArm I - Active Comparator
Arm II - Experimental
Arm II - Experimental
Secondary IDNCI-2009-00563
PubMed (PMID)N/A
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Canada
Peru
Puerto Rico
Canada
Peru
Puerto Rico
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Leukemia/Lymphoma
Leukemia/Lymphoma
Study Phase
Phase 3
Study Completion Date
December 2022
December 2022
NCT02883049Uploaded 04-27-2021
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A Phase III Randomized Trial for Newly Diagnosed High Risk B-Lymphoblastic Leukemia (B-ALL) Including a Stratum Evaluating Dasatinib (NSC#732517) in Patients With Ph-like Tyrosine Kinase Inhibitor (TKI) Sensitive Mutations
Provider Information
Provider Data DescriptionNCT02883049-D1-Dataset Description:
There are three data submissions associated with PMID 30545921. This dataset provides the information for generating the consort diagram of patient enrollment. It includes all patients who enrolled on AALL1131 up to 12/31/2017.
SponsorNational Cancer Institute (NCI)
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial studies how well combination chemotherapy works in treating young patients with newly diagnosed B acute lymphoblastic leukemia that is likely to come back or spread, and in patients with Philadelphia chromosome (Ph)-like tyrosine kinase inhibitor (TKI) sensitive mutations. Chemotherapy drugs, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) and giving the drugs in different doses and in different combinations may kill more cancer cells.
ConditionsB Acute Lymphoblastic Leukemia
B Acute Lymphoblastic Leukemia With BCR-ABL1-Like Features
Central Nervous System Leukemia
Testicular Leukemia
B Acute Lymphoblastic Leukemia With BCR-ABL1-Like Features
Central Nervous System Leukemia
Testicular Leukemia
Intervention TypeDrug: Clofarabine
Drug: Cyclophosphamide
Drug: Cytarabine
Drug: Dasatinib
Drug: Daunorubicin Hydrochloride
Drug: Dexamethasone
Drug: Doxorubicin Hydrochloride
Drug: Etoposide
Drug: Hydrocortisone Sodium Succinate
Other: Laboratory Biomarker Analysis
Drug: Leucovorin Calcium
Drug: Mercaptopurine
Drug: Methotrexate
Drug: Pegaspargase
Drug: Prednisone
Radiation: Radiation Therapy
Drug: Thioguanine
Drug: Vincristine Sulfate
Drug: Cyclophosphamide
Drug: Cytarabine
Drug: Dasatinib
Drug: Daunorubicin Hydrochloride
Drug: Dexamethasone
Drug: Doxorubicin Hydrochloride
Drug: Etoposide
Drug: Hydrocortisone Sodium Succinate
Other: Laboratory Biomarker Analysis
Drug: Leucovorin Calcium
Drug: Mercaptopurine
Drug: Methotrexate
Drug: Pegaspargase
Drug: Prednisone
Radiation: Radiation Therapy
Drug: Thioguanine
Drug: Vincristine Sulfate
Drug(s)Drug: Cyclophosphamide
Drug: Cytarabine
Drug: Dexamethasone
Drug: Doxorubicin Hydrochloride
Drug: Leucovorin Calcium
Drug: Mercaptopurine
Drug: Methotrexate
Drug: Pegaspargase
Drug: Prednisone
Drug: Thioguanine
Drug: Vincristine Sulfate
Drug: Daunorubicin Hydrochloride
Drug: Hydrocortisone Sodium Succinate
Drug: Etoposide
Drug: Clofarabine
Drug: Dasatinib
Drug: Cytarabine
Drug: Dexamethasone
Drug: Doxorubicin Hydrochloride
Drug: Leucovorin Calcium
Drug: Mercaptopurine
Drug: Methotrexate
Drug: Pegaspargase
Drug: Prednisone
Drug: Thioguanine
Drug: Vincristine Sulfate
Drug: Daunorubicin Hydrochloride
Drug: Hydrocortisone Sodium Succinate
Drug: Etoposide
Drug: Clofarabine
Drug: Dasatinib
Total Enrolled5937
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionDS HR B-ALL (RER) - Experimental
DS HR B-ALL (SER) - Experimental
Group I Arm A (HR B-ALL) - Experimental
Group I Arm B (HR B-ALL) (CLOSED 03/19/2018) - Experimental
Group II Arm A (VHR B-ALL - Control Arm) - Active Comparator
Group II Arm B (VHR B-ALL - Exp Arm1) (CLOSED 02/15/2017) - Experimental
Group II Arm C (VHR B-ALL - Exp Arm 2) (CLOSED 09/12/2014) - Experimental
Group III PH-like predicted TKI-sensitive kinase mutation - Experimental
DS HR B-ALL (SER) - Experimental
Group I Arm A (HR B-ALL) - Experimental
Group I Arm B (HR B-ALL) (CLOSED 03/19/2018) - Experimental
Group II Arm A (VHR B-ALL - Control Arm) - Active Comparator
Group II Arm B (VHR B-ALL - Exp Arm1) (CLOSED 02/15/2017) - Experimental
Group II Arm C (VHR B-ALL - Exp Arm 2) (CLOSED 09/12/2014) - Experimental
Group III PH-like predicted TKI-sensitive kinase mutation - Experimental
Secondary IDNCI-2011-03797
PubMed (PMID)32496902
Collaborator(s)N/A
Region(s)United States
Australia
Canada
Ireland
New Zealand
Puerto Rico
Switzerland
Australia
Canada
Ireland
New Zealand
Puerto Rico
Switzerland
Age Range1 Year to 31 Years (Child, Adult)
Type(s) of Cancer
Desmoid Fibromatosis
Desmoid Fibromatosis
Study Phase
Phase 3
Study Completion Date
January 2018
January 2018
NCT02066181Uploaded 04-14-2021
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A Phase III, Double Blind, Randomized, Placebo-Controlled Trial of Sorafenib in Desmoid Tumors or Aggressive Fibromatosis (DT/DF)
Provider Information
Provider Data DescriptionDataset NCT02066181-D1-Dataset.csv (consort) is one of 6 datasets associated with PubMed ID 30575484. This dataset contains information concerning the consort diagram.
SponsorNational Cancer Institute (NCI)
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial compares the effects, good and/or bad, of sorafenib tosylate in treating patients with desmoid tumors or aggressive fibromatosis. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the proteins needed for cell growth. [Funding Source - FDA OOPD]
ConditionsDesmoid Fibromatosis
Intervention TypeOther: Laboratory Biomarker Analysis
Other: Placebo Administration
Other: Quality-of-Life Assessment
Drug: Sorafenib Tosylate
Other: Placebo Administration
Other: Quality-of-Life Assessment
Drug: Sorafenib Tosylate
Drug(s)Drug: Sorafenib Tosylate
Total Enrolled87
RandomizationRandomized
Blinding MethodDouble
Arms InterventionArm I (sorafenib tosylate) - Experimental
Arm II (placebo) - Placebo Comparator
Arm II (placebo) - Placebo Comparator
Secondary IDNCI-2014-00264
PubMed (PMID)34420143
33258687
30575484
33258687
30575484
Collaborator(s)N/A
Region(s)United States
Canada
Canada
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Leukemia/Lymphoma
Leukemia/Lymphoma
Study Phase
Phase 3
Study Completion Date
December 2013
December 2013
NCT00103285Uploaded 04-09-2021
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Standard Risk B-precursor Acute Lymphoblastic Leukemia (ALL)
Provider Information
Provider Data DescriptionThere are five data submissions (NCT00103285-D1, -D2, -D3, -D4, and -D5) for PMID 31825704. This dataset, NCT00103285-D1, provides the information for generating Figure 1 of consort diagram of patient enrollment. There is one row for each patient enrolled. The data cutoff is 06/30/2017.
SponsorChildren's Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial is studying different combination chemotherapy regimens and comparing how well they work in treating patients with newly diagnosed acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
ConditionsAcute Lymphoblastic Leukemia
Childhood B Acute Lymphoblastic Leukemia
Childhood B Acute Lymphoblastic Leukemia
Intervention TypeRadiation: 3-Dimensional Conformal Radiation Therapy
Drug: Cyclophosphamide
Drug: Cytarabine
Drug: Dexamethasone
Drug: Doxorubicin Hydrochloride
Drug: Leucovorin Calcium
Drug: Mercaptopurine
Drug: Methotrexate
Drug: Pegaspargase
Drug: Thioguanine
Drug: Vincristine Sulfate
Drug: Cyclophosphamide
Drug: Cytarabine
Drug: Dexamethasone
Drug: Doxorubicin Hydrochloride
Drug: Leucovorin Calcium
Drug: Mercaptopurine
Drug: Methotrexate
Drug: Pegaspargase
Drug: Thioguanine
Drug: Vincristine Sulfate
Drug(s)Drug: Cytarabine
Drug: Dexamethasone
Drug: Leucovorin Calcium
Drug: Methotrexate
Drug: Pegaspargase
Drug: Vincristine Sulfate
Drug: Cyclophosphamide
Drug: Doxorubicin Hydrochloride
Drug: Mercaptopurine
Drug: Thioguanine
Drug: Dexamethasone
Drug: Leucovorin Calcium
Drug: Methotrexate
Drug: Pegaspargase
Drug: Vincristine Sulfate
Drug: Cyclophosphamide
Drug: Doxorubicin Hydrochloride
Drug: Mercaptopurine
Drug: Thioguanine
Total Enrolled5377
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionGroup 0 Induction Therapy - Experimental
Group 1-SR-low ALL, Arm I (combination chemotherapy) - Active Comparator
Group 1-SR-low ALL, arm II (combination chemotherapy) - Experimental
Group 2-SR-avg ALL, arm I (combination chemotherapy) - Active Comparator
Group 2-SR-avg ALL, arm II (combination chemotherapy) - Experimental
Group 2-SR-avg ALL, arm III (combination chemotherapy) - Active Comparator
Group 2-SR-avg ALL, arm IV (combination chemotherapy) - Active Comparator
Group 3-SR-high ALL, combination chemotherapy - Experimental
Group 1-SR-low ALL, Arm I (combination chemotherapy) - Active Comparator
Group 1-SR-low ALL, arm II (combination chemotherapy) - Experimental
Group 2-SR-avg ALL, arm I (combination chemotherapy) - Active Comparator
Group 2-SR-avg ALL, arm II (combination chemotherapy) - Experimental
Group 2-SR-avg ALL, arm III (combination chemotherapy) - Active Comparator
Group 2-SR-avg ALL, arm IV (combination chemotherapy) - Active Comparator
Group 3-SR-high ALL, combination chemotherapy - Experimental
Secondary IDNCI-2009-00302
PubMed (PMID)29284596
26590194
23678006
26590194
23678006
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Australia
Canada
New Zealand
Switzerland
Australia
Canada
New Zealand
Switzerland
Age Range1 Year to 9 Years (Child)
Type(s) of Cancer
Leukemia/Lymphoma
Leukemia/Lymphoma
Study Phase
Phase 3
Study Completion Date
March 2012
March 2012
NCT00302003Uploaded 03-27-2021
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A Phase III Study for the Treatment of Children and Adolescents With Newly Diagnosed Low Risk Hodgkin Disease
Provider Information
Provider Data DescriptionThere are two datasets associated with PMID 29738613: NCT00302003-D1 and NCT00302003-D2. This dataset, NCT00302003-D1, contains all the data except for toxicities. Specifically, this dataset provides all the numbers and statistics presented under the results section and tables and figures of the publication regarding consort flow, patient enrollment, patient and clinical characteristics and survival endpoints. This dataset is presented at patient level and includes one record per patient.
SponsorChildren's Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis phase III trial is studying how well combination chemotherapy works when given before radiation therapy and/or additional chemotherapy in treating young patients with newly diagnosed Hodgkin's lymphoma. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill cancer cells. Giving more than one drug (combination chemotherapy) and giving them together with radiation therapy may kill more cancer cells.
ConditionsChildhood Favorable Prognosis Hodgkin Lymphoma
Childhood Lymphocyte Depletion Hodgkin Lymphoma
Childhood Mixed Cellularity Hodgkin Lymphoma
Childhood Nodular Sclerosis Hodgkin Lymphoma
Stage I Childhood Hodgkin Lymphoma
Stage II Childhood Hodgkin Lymphoma
Childhood Lymphocyte Depletion Hodgkin Lymphoma
Childhood Mixed Cellularity Hodgkin Lymphoma
Childhood Nodular Sclerosis Hodgkin Lymphoma
Stage I Childhood Hodgkin Lymphoma
Stage II Childhood Hodgkin Lymphoma
Intervention TypeRadiation: radiation therapy
Drug: doxorubicin hydrochloride
Drug: vincristine sulfate
Drug: prednisone
Drug: cyclophosphamide
Drug: ifosfamide
Drug: vinorelbine tartrate
Drug: dexamethasone
Drug: etoposide phosphate
Drug: cisplatin
Drug: cytarabine
Biological: filgrastim
Drug: doxorubicin hydrochloride
Drug: vincristine sulfate
Drug: prednisone
Drug: cyclophosphamide
Drug: ifosfamide
Drug: vinorelbine tartrate
Drug: dexamethasone
Drug: etoposide phosphate
Drug: cisplatin
Drug: cytarabine
Biological: filgrastim
Drug(s)Drug: doxorubicin hydrochloride
Drug: vincristine sulfate
Drug: prednisone
Drug: cyclophosphamide
Drug: ifosfamide
Drug: vinorelbine tartrate
Drug: dexamethasone
Drug: etoposide phosphate
Drug: cisplatin
Drug: cytarabine
Drug: vincristine sulfate
Drug: prednisone
Drug: cyclophosphamide
Drug: ifosfamide
Drug: vinorelbine tartrate
Drug: dexamethasone
Drug: etoposide phosphate
Drug: cisplatin
Drug: cytarabine
Total Enrolled287
RandomizationN/A
Blinding MethodNone (Open Label)
Arms InterventionDoxorubicin, Vincristine, Cyclophosphamide and Filgrastim - Experimental
Secondary IDNCI-2009-00377
PubMed (PMID)35763667
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Age Range21 Years and younger (Child, Adult)
Type(s) of Cancer
Leukemia/Lymphoma
Leukemia/Lymphoma
Study Phase
Phase 3
Study Completion Date
June 2018
June 2018
NCT01307579Uploaded 03-26-2021
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A Randomized Open-Label Trial of Caspofungin Versus Fluconazole to Prevent Invasive Fungal Infections in Children Undergoing Chemotherapy for Acute Myeloid Leukemia (AML)
Provider Information
Provider Data DescriptionThere are four data submissions associated with PMID 31688884: NCT01307579-D1 through -D4. This dataset, NCT01307579-D1, provides the information for the consort diagram (Figure 1). Data provided on all enrolled patients (N=517). There is one row per patient.
SponsorChildren's Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial compares the effectiveness of caspofungin to fluconazole in preventing invasive fungal infections in patients receiving chemotherapy for acute myeloid leukemia (AML). Antifungal prophylaxis is considered standard of care in children and adults with prolonged neutropenia after chemotherapy for AML however the ideal antifungal agent for prophylaxis in children is not known. Caspofungin has activity against yeast and some molds while fluconazole coverage is limited to just yeasts. Adult randomized trials suggest that agents with activity against yeasts and molds are more effective than those with just activity against yeasts. There are limited data to answer this comparative question in children. This study will establish much needed pediatric data to guide clinical decision making on optimal antifungal prophylaxis.
ConditionsAcute Myeloid Leukemia
Adult Acute Monoblastic Leukemia
Adult Acute Monocytic Leukemia
Adult Acute Myeloid Leukemia in Remission
Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11
Adult Acute Myeloid Leukemia With Maturation
Adult Acute Myeloid Leukemia With Minimal Differentiation
Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11
Adult Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1
Adult Acute Myeloid Leukemia With t(9;11)(p22.3;q23.3); MLLT3-KMT2A
Adult Acute Myeloid Leukemia Without Maturation
Adult Acute Myelomonocytic Leukemia
Alkylating Agent-Related Acute Myeloid Leukemia
Childhood Acute Monoblastic Leukemia
Childhood Acute Monocytic Leukemia
Childhood Acute Myeloid Leukemia in Remission
Childhood Acute Myeloid Leukemia With Maturation
Childhood Acute Myeloid Leukemia With Minimal Differentiation
Childhood Acute Myeloid Leukemia Without Maturation
Childhood Acute Myelomonocytic Leukemia
Fungal Infection
Myeloid Neoplasm
Neutropenia
Recurrent Adult Acute Myeloid Leukemia
Recurrent Childhood Acute Myeloid Leukemia
Secondary Acute Myeloid Leukemia
Untreated Adult Acute Myeloid Leukemia
Untreated Childhood Myeloid Neoplasm
Adult Acute Monoblastic Leukemia
Adult Acute Monocytic Leukemia
Adult Acute Myeloid Leukemia in Remission
Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11
Adult Acute Myeloid Leukemia With Maturation
Adult Acute Myeloid Leukemia With Minimal Differentiation
Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11
Adult Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1
Adult Acute Myeloid Leukemia With t(9;11)(p22.3;q23.3); MLLT3-KMT2A
Adult Acute Myeloid Leukemia Without Maturation
Adult Acute Myelomonocytic Leukemia
Alkylating Agent-Related Acute Myeloid Leukemia
Childhood Acute Monoblastic Leukemia
Childhood Acute Monocytic Leukemia
Childhood Acute Myeloid Leukemia in Remission
Childhood Acute Myeloid Leukemia With Maturation
Childhood Acute Myeloid Leukemia With Minimal Differentiation
Childhood Acute Myeloid Leukemia Without Maturation
Childhood Acute Myelomonocytic Leukemia
Fungal Infection
Myeloid Neoplasm
Neutropenia
Recurrent Adult Acute Myeloid Leukemia
Recurrent Childhood Acute Myeloid Leukemia
Secondary Acute Myeloid Leukemia
Untreated Adult Acute Myeloid Leukemia
Untreated Childhood Myeloid Neoplasm
Intervention TypeDrug: Caspofungin Acetate
Drug: Fluconazole
Other: Laboratory Biomarker Analysis
Drug: Fluconazole
Other: Laboratory Biomarker Analysis
Drug(s)Drug: Caspofungin Acetate
Drug: Fluconazole
Drug: Fluconazole
Total Enrolled517
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionArm I (caspofungin acetate) - Experimental
Arm II (fluconazole) - Active Comparator
Arm II (fluconazole) - Active Comparator
Secondary IDNCI-2011-02640
PubMed (PMID)31688884
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Canada
Puerto Rico
Canada
Puerto Rico
Age Range3 Months to 30 Years (Child, Adult)
Type(s) of Cancer
Leukemia/Lymphoma
Leukemia/Lymphoma
Study Phase
Phase 3
Study Completion Date
August 2013
August 2013
NCT00372593Uploaded 03-24-2021
Access via NCI by Request
A Phase III Randomized Trial of Gemtuzumab Ozogamicin (Mylotarg) Combined With Conventional Chemotherapy for De Novo Acute Myeloid Leukemia (AML) in Children, Adolescents, and Young Adults
Provider Information
Provider Data DescriptionAs of November 2019, there is one dataset associated with this publication (PMID 31113932).
The D3 dataset is a patient level dataset which contains patient characteristics, genotypes for the SNP of interest, cytogenetic mutation, and outcome analyses for eligible pediatric acute myeloid leukemia (AML) patients enrolled on the AAML0531 clinical trial.
SponsorChildren's Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as gemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving combination chemotherapy together with gemtuzumab may kill more cancer cells. It is not yet known whether combination chemotherapy is more effective with or without gemtuzumab in treating patients with newly diagnosed acute myeloid leukemia.
PURPOSE: This randomized phase III trial is studying combination chemotherapy and gemtuzumab to see how well they work compared with combination chemotherapy alone in treating young patients with newly diagnosed acute myeloid leukemia.
ConditionsLeukemia
Intervention TypeDrug: asparaginase
Drug: cytarabine
Drug: daunorubicin hydrochloride
Drug: etoposide
Drug: gemtuzumab ozogamicin
Drug: mitoxantrone hydrochloride
Drug: cytarabine
Drug: daunorubicin hydrochloride
Drug: etoposide
Drug: gemtuzumab ozogamicin
Drug: mitoxantrone hydrochloride
Drug(s)Drug: asparaginase
Drug: cytarabine
Drug: daunorubicin hydrochloride
Drug: etoposide
Drug: mitoxantrone hydrochloride
Drug: gemtuzumab ozogamicin
Drug: cytarabine
Drug: daunorubicin hydrochloride
Drug: etoposide
Drug: mitoxantrone hydrochloride
Drug: gemtuzumab ozogamicin
Total Enrolled1070
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionArm A: Standard Arm - No GMTZ, AML Pts w/out Down Syndrome - Active Comparator
Arm B: Experimental - with GMTZ, AML Pts w/out Down Syndrome - Experimental
Arm A: Standard Arm - No GMTZ, AML Patients with Down Syndrome - Active Comparator
Arm B: Experimental - with GMTZ, AML Pts w/out Down Syndrome - Experimental
Arm A: Standard Arm - No GMTZ, AML Patients with Down Syndrome - Active Comparator
Secondary IDCOG-AAML0531
PubMed (PMID)22378848
25092781
34596937
33080007
28883080
27133823
23471307
25092781
34596937
33080007
28883080
27133823
23471307
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Australia
Canada
New Zealand
Puerto Rico
Switzerland
Australia
Canada
New Zealand
Puerto Rico
Switzerland
Age Range29 Years and younger (Child, Adult)
Type(s) of Cancer
Leukemia/Lymphoma,Sarcoma
Leukemia/Lymphoma,Sarcoma
Study Phase
Phase 3
Study Completion Date
March 2019
March 2019
NCT01371981Uploaded 03-24-2021
Access via NCI by Request
A Phase III Randomized Trial for Patients With De Novo AML Using Bortezomib and Sorafenib (NSC# 681239, NSC# 724772) for Patients With High Allelic Ratio FLT3/ITD
Provider Information
Provider Data DescriptionNCT01371981 ? D4 Dataset
As of April 2020, there is one dataset associated with this publication (PMID 32029509). The D4 dataset is a patient level dataset which contains patient characteristics, consort diagram classifications, toxicity and outcome analyses in the manuscript for eligible pediatric acute myeloid leukemia (AML) patients enrolled on the AAML1031 clinical trial.
SponsorNational Cancer Institute (NCI)
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial studies how well bortezomib and sorafenib tosylate work in treating patients with newly diagnosed acute myeloid leukemia. Bortezomib and sorafenib tosylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib and sorafenib tosylate together with combination chemotherapy may be an effective treatment for acute myeloid leukemia.
ConditionsAcute Myeloid Leukemia
Leukemia Cutis
Myeloid Neoplasm
Myeloid Sarcoma
Leukemia Cutis
Myeloid Neoplasm
Myeloid Sarcoma
Intervention TypeDrug: Asparaginase
Drug: Bortezomib
Drug: Cytarabine
Drug: Daunorubicin Hydrochloride
Drug: Etoposide
Other: Laboratory Biomarker Analysis
Drug: Mitoxantrone Hydrochloride
Other: Pharmacological Study
Other: Quality-of-Life Assessment
Other: Questionnaire Administration
Drug: Sorafenib Tosylate
Drug: Bortezomib
Drug: Cytarabine
Drug: Daunorubicin Hydrochloride
Drug: Etoposide
Other: Laboratory Biomarker Analysis
Drug: Mitoxantrone Hydrochloride
Other: Pharmacological Study
Other: Quality-of-Life Assessment
Other: Questionnaire Administration
Drug: Sorafenib Tosylate
Drug(s)Drug: Asparaginase
Drug: Cytarabine
Drug: Daunorubicin Hydrochloride
Drug: Etoposide
Drug: Mitoxantrone Hydrochloride
Drug: Bortezomib
Drug: Sorafenib Tosylate
Drug: Cytarabine
Drug: Daunorubicin Hydrochloride
Drug: Etoposide
Drug: Mitoxantrone Hydrochloride
Drug: Bortezomib
Drug: Sorafenib Tosylate
Total Enrolled1645
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionArm A - Experimental
Arm B - Experimental
Arm C (Cohort 1) - Experimental
Arm C (Cohort 2) - Experimental
Arm C (Cohort 3) - Experimental
Arm D - Experimental
Arm B - Experimental
Arm C (Cohort 1) - Experimental
Arm C (Cohort 2) - Experimental
Arm C (Cohort 3) - Experimental
Arm D - Experimental
Secondary IDNCI-2011-02670
PubMed (PMID)35349331
34855461
34596937
32029509
30987448
30773463
28419486
34855461
34596937
32029509
30987448
30773463
28419486
Collaborator(s)N/A
Region(s)United States
Australia
Canada
New Zealand
Puerto Rico
Australia
Canada
New Zealand
Puerto Rico
Age Range29 Years and younger (Child, Adult)
Type(s) of Cancer
Cancer prevention
Cancer prevention
Study Phase
Phase 3
Study Completion Date
November 2018
November 2018
NCT01169259Uploaded 03-19-2021
Available for Download
Vitamin D and Omega-3 Trial (VITAL)
Provider Information
Provider Data DescriptionThe VITamin D and OmegA-3 TriaL (VITAL) was a randomized factorial clinical trial in 25,871 U.S. men and women investigating whether taking daily dietary supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses. The 5-year intervention phase (study pill-taking, median 5.3 years) ended on December 31, 2017.
The primary aims were:
1. To test whether vitamin D3 supplementation reduces the risk of (a) total cancer (excluding non-melanoma skin cancer) and (b) major CVD events (a composite endpoint of myocardial infarction [MI], stroke, and cardiovascular mortality).
2. To test whether EPA+DHA supplementation reduces the risk of (a) total cancer (excluding non-melanoma skin cancer) and (b) major CVD events.
Secondary aims were:
1. To test whether vitamin D3 or EPA+DHA supplementation reduces the risk of (a) incident colorectal cancer, (b) incident breast cancer (in women), (c) incident prostate cancer (in men), and (d) total cancer mortality.
2. To test whether vitamin D3 or EPA+DHA supplementation reduces the risk of (a) an expanded composite cardiovascular endpoint of MI, stroke, cardiovascular mortality, and coronary revascularization (i.e., coronary artery bypass grafting [CABG] or percutaneous coronary intervention [PCI]) and (b) the individual components of the primary cardiovascular endpoint, particularly total CVD mortality.
SponsorBrigham and Women's Hospital
Data ProviderBrigham and Women's Hospital
Partial set or SubsetComposite
Patients in dataset25871
# of Patients Control25871
# of Patients Experimental0
DOIhttps://doi.org/10.34949/n4c7-zm25
CDISC StandardNot CDISC
Study ArmsBoth comparator and experimental arm data
Clinical Trials.gov Information
Brief SummaryThe VITamin D and OmegA-3 TriaL (VITAL) is a randomized clinical trial in 25,871 U.S. men and women investigating whether taking daily dietary supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses. The 5-year intervention phase (study pill-taking, median 5.3 years) has ended; post-intervention observational follow-up of study participants is ongoing.
ConditionsCancer
Cardiovascular Disease
Cardiovascular Disease
Intervention TypeDietary Supplement: vitamin D3
Drug: omega-3 fatty acids (fish oil)
Dietary Supplement: Vitamin D3 placebo
Dietary Supplement: Fish oil placebo
Drug: omega-3 fatty acids (fish oil)
Dietary Supplement: Vitamin D3 placebo
Dietary Supplement: Fish oil placebo
Drug(s)Drug: omega-3 fatty acids (fish oil)
Total Enrolled25871
RandomizationRandomized
Blinding MethodTriple
Arms InterventionVitamin D + fish oil - Active Comparator
Vitamin D + fish oil placebo - Active Comparator
Vitamin D placebo + fish oil - Active Comparator
Vitamin D placebo + fish oil placebo - Placebo Comparator
Vitamin D + fish oil placebo - Active Comparator
Vitamin D placebo + fish oil - Active Comparator
Vitamin D placebo + fish oil placebo - Placebo Comparator
Secondary IDU01CA138962
PubMed (PMID)26767629
25864623
21986389
30415629
30415637
31750855
32062040
36378553
36285795
36098968
35361440
35082139
34932079
34853363
34678177
34543425
34366734
33724323
33513226
33206192
32749491
32205068
31923341
31895658
31733345
31699704
31669447
29526608
25864623
21986389
30415629
30415637
31750855
32062040
36378553
36285795
36098968
35361440
35082139
34932079
34853363
34678177
34543425
34366734
33724323
33513226
33206192
32749491
32205068
31923341
31895658
31733345
31699704
31669447
29526608
Collaborator(s)National Cancer Institute (NCI)
National Heart, Lung, and Blood Institute (NHLBI)
Office of Dietary Supplements (ODS)
National Institute of Neurological Disorders and Stroke (NINDS)
National Center for Complementary and Integrative Health (NCCIH)
Pharmavite LLC
Pronova BioPharma
BASF
National Heart, Lung, and Blood Institute (NHLBI)
Office of Dietary Supplements (ODS)
National Institute of Neurological Disorders and Stroke (NINDS)
National Center for Complementary and Integrative Health (NCCIH)
Pharmavite LLC
Pronova BioPharma
BASF
Region(s)United States
Age Range50 Years and older (Adult, Older Adult)
Type(s) of Cancer
Colorectal
Colorectal
Study Phase
Phase 3
Study Completion Date
August 2013
August 2013
NCT00058474Uploaded 03-02-2021
Access via NCI by Request
A Clinical Trial Comparing Preoperative Radiation Therapy And Capecitabine With or Without Oxaliplatin With Preoperative Radiation Therapy And Continuous Intravenous Infusion Of 5-Fluorouracil With or Without Oxaliplatin In The Treatment Of Patients With Operable Carcinoma Of The Rectum
Provider Information
Provider Data DescriptionThe file NCT00058474-D1-Dataset.csv contains all data necessary to produce the results reported in the above manuscript.
SponsorNSABP Foundation Inc
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: Drugs used in chemotherapy, such as capecitabine, fluorouracil, and oxaliplatin work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.
PURPOSE: This randomized phase III trial is studying radiation therapy and either capecitabine or fluorouracil with or without oxaliplatin and comparing them to see how well they work when given before surgery in treating patients with resectable rectal cancer. It is not yet known whether radiation therapy and either capecitabine or fluorouracil is more effective with or without oxaliplatin in treating rectal cancer.
ConditionsColorectal Cancer
Intervention TypeDrug: capecitabine
Drug: fluorouracil
Drug: oxaliplatin
Radiation: radiation therapy
Drug: fluorouracil
Drug: oxaliplatin
Radiation: radiation therapy
Drug(s)Drug: fluorouracil
Drug: oxaliplatin
Drug: capecitabine
Drug: oxaliplatin
Drug: capecitabine
Total Enrolled1608
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionArm 1: 5-FU + RT - Active Comparator
Arm 2: 5-FU + RT + Oxaliplatin - Experimental
Arm 3: Capecitabine + RT - Experimental
Arm 4: Capecitabine + RT + Oxaliplatin - Experimental
Arm 2: 5-FU + RT + Oxaliplatin - Experimental
Arm 3: Capecitabine + RT - Experimental
Arm 4: Capecitabine + RT + Oxaliplatin - Experimental
Secondary IDNSABP-R-04
PubMed (PMID)24799484
24670844
35749631
24670844
35749631
Collaborator(s)National Cancer Institute (NCI)
Cancer and Leukemia Group B
Cancer and Leukemia Group B
Region(s)N/A
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Kidney
Kidney
Study Phase
Phase 3
Study Completion Date
June 2002
June 2002
NCT00002611Uploaded 02-24-2021
Access via NCI by Request
NATIONAL WILMS TUMOR STUDY-5 -- THERAPEUTIC TRIAL AND BIOLOGY STUDY
Provider Information
Provider Data DescriptionThere are five data submissions associated with PMID 30255545: NCT00002611-D1 through -D5. This dataset, NCT00002611-D1, is used to create the main results of the NWTS 5 study.
SponsorChildren's Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high energy x-rays to damage tumor cells. It is not yet known whether combination chemotherapy alone or combination chemotherapy plus radiation therapy is more effective for childhood kidney cancer.
PURPOSE: Phase III trial to compare the effectiveness of combination chemotherapy with or without radiation therapy in treating children who have kidney cancer.
ConditionsKidney Cancer
Intervention TypeBiological: dactinomycin
Biological: filgrastim
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: vincristine sulfate
Procedure: conventional surgery
Radiation: radiation therapy
Biological: filgrastim
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: vincristine sulfate
Procedure: conventional surgery
Radiation: radiation therapy
Drug(s)Drug: vincristine sulfate
Drug: doxorubicin hydrochloride
Drug: cyclophosphamide
Drug: etoposide
Drug: doxorubicin hydrochloride
Drug: cyclophosphamide
Drug: etoposide
Total Enrolled3031
RandomizationN/A
Blinding MethodN/A
Arms InterventionStratum 1 - Active Comparator
Stratum 2 - Active Comparator
Stratum 3 - Active Comparator
Stratum 4 - Active Comparator
Stratum 5 - Active Comparator
Stratum 6 - Active Comparator
Stratum 7 - Active Comparator
Stratum 8 - Active Comparator
Stratum 9 - Active Comparator
Stratum 2 - Active Comparator
Stratum 3 - Active Comparator
Stratum 4 - Active Comparator
Stratum 5 - Active Comparator
Stratum 6 - Active Comparator
Stratum 7 - Active Comparator
Stratum 8 - Active Comparator
Stratum 9 - Active Comparator
Secondary IDCOG-Q9401
PubMed (PMID)22422736
22498384
21683387
20457352
19730241
18778996
18095319
16700047
15590168
22952427
21189373
18989885
19208794
17539021
16710034
16410127
30255545
16172460
15868587
16129848
15654272
22498384
21683387
20457352
19730241
18778996
18095319
16700047
15590168
22952427
21189373
18989885
19208794
17539021
16710034
16410127
30255545
16172460
15868587
16129848
15654272
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Australia
Canada
Netherlands
New Zealand
Puerto Rico
Switzerland
Australia
Canada
Netherlands
New Zealand
Puerto Rico
Switzerland
Age Range0 Years to 15 Years (Child)
Type(s) of Cancer
Eye
Eye
Study Phase
Phase 3
Study Completion Date
September 2011
September 2011
NCT00335738Uploaded 02-16-2021
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A Study of Unilateral Retinoblastoma With and Without Histopathologic High-Risk Features and the Role of Adjuvant Chemotherapy
Provider Information
Provider Data DescriptionNCT00335738-D1 is one of 2 data submissions associated with PubMed ID 31539297. There is one row for each patient enrolled. The dataset provides the information of consort flow of patient enrollment, baseline characteristics, central pathology review results, and outcome data on ARET0332 as reported in the manuscript.
SponsorChildren's Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis phase III trial is studying vincristine, carboplatin, and etoposide to see how well they work compared to observation only in treating patients who have undergone surgery for newly diagnosed retinoblastoma. Drugs used in chemotherapy, such as vincristine, carboplatin, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) after surgery may kill any tumor cells that remain after surgery. Sometimes, after surgery, no additional treatment is needed for the tumor until it progresses. In this case, observation may be sufficient.
ConditionsIntraocular Retinoblastoma
Intervention TypeDrug: liposomal vincristine sulfate
Drug: carboplatin
Drug: etoposide
Drug: carboplatin
Drug: etoposide
Drug(s)Drug: liposomal vincristine sulfate
Drug: carboplatin
Drug: etoposide
Drug: carboplatin
Drug: etoposide
Total Enrolled331
RandomizationNon-Randomized
Blinding MethodNone (Open Label)
Arms InterventionGroup 1 (identified by central review as high risk) - Experimental
Group 2 (identified by central review as not high risk) - No Intervention
Group 2 (identified by central review as not high risk) - No Intervention
Secondary IDNCI-2009-00423
PubMed (PMID)N/A
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Australia
Canada
India
New Zealand
Australia
Canada
India
New Zealand
Age Range6 Years and younger (Child)
Type(s) of Cancer
Oral Mucositis
Oral Mucositis
Study Phase
Phase 3
Study Completion Date
May 2016
May 2016
NCT02229539Uploaded 02-10-2021
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A Phase III Placebo-Controlled, Randomized Three-Arm Study of Doxepin and a Topical Rinse in the Treatment of Acute Oral Mucositis Pain in Patients Receiving Radiotherapy With or Without Chemotherapy
Provider Information
Provider Data DescriptionDataset NCT02229539-D1-Dataset.csv (Fig1_allptchar) is one of 4 datasets associated with PubMed ID 30990550. This dataset contains information that will allow you to reproduce the Table 1, the baseline characteristics.
SponsorAlliance for Clinical Trials in Oncology
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThe purpose of this study is to test whether a mouthwash made with a drug called doxepin can reduce the pain caused by mouth sores resulting from radiation therapy. A number of mouth rinse preparations exist for patients with treatment-related oral mucositis pain such as the DLA rinse, an over-the-counter medication. This study will evaluate the effects of doxepin compared to DLA (diphenhydramine, lidocaine and antacids) and placebo.Doxepin is approved by the Food and Drug Administration (FDA) for the treatment of depression, anxiety, long-term pain management, as well as management of rash.
ConditionsAcute Oral Mucositis Pain
Intervention TypeDrug: doxepin hydrochloride oral solution
Drug: DLA (diphenhydramine, lidocaine and antacids) rinse
Other: Placebo
Drug: DLA (diphenhydramine, lidocaine and antacids) rinse
Other: Placebo
Drug(s)Drug: doxepin hydrochloride oral solution
Drug: DLA (diphenhydramine, lidocaine and antacids) rinse
Drug: DLA (diphenhydramine, lidocaine and antacids) rinse
Total Enrolled275
RandomizationRandomized
Blinding MethodDouble
Arms Interventiondoxepin rinse - Experimental
DLA (diphenhydramine, lidocaine and antacid) rinse - Active Comparator
placebo rinse - Placebo Comparator
DLA (diphenhydramine, lidocaine and antacid) rinse - Active Comparator
placebo rinse - Placebo Comparator
Secondary IDU10CA037447
PubMed (PMID)30990550
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Sarcoma
Sarcoma
Study Phase
Phase 3
Study Completion Date
September 2016
September 2016
NCT00653068Uploaded 01-29-2021
Access via NCI by Request
Treatment of Atypical Teratoid/Rhabdoid Tumors (AT/RT) of the Central Nervous System With Surgery, Intensive Chemotherapy, and 3-D Conformal Radiation
Provider Information
Provider Data DescriptionThere are 3 data submissions (NCT00653068-D1, -D2, and -D3) associated with PMID 32105509. This dataset, NCT00653068-D1, provides information on the flow of patients enrolled in ACNS0333 through therapy shown in the CONSORT diagram in Figure 2, the variable categories of Table 3 and Table 4, and other variables to define patient attributes and outcomes as reported in the manuscript. There is one row for each patient enrolled.
SponsorChildren's Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis phase III trial studies the side effects of combination chemotherapy, 3-dimensional conformal radiation therapy, and an autologous peripheral blood stem cell transplant, and to see how well they work in treating young patients with atypical teratoid/rhabdoid tumor of the central nervous system. Giving high-dose chemotherapy before an autologous peripheral blood stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as G-CSF, helps stem cells move from the bone marrow to the blood so they can be collected and stored. Chemotherapy or radiation therapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy or radiation therapy.
ConditionsChildhood Atypical Teratoid/Rhabdoid Tumor
Intervention TypeRadiation: 3-Dimensional Conformal Radiation Therapy
Procedure: Autologous Hematopoietic Stem Cell Transplantation
Drug: Carboplatin
Drug: Cisplatin
Drug: Cyclophosphamide
Drug: Etoposide
Biological: Filgrastim
Other: Laboratory Biomarker Analysis
Drug: Leucovorin Calcium
Drug: Methotrexate
Drug: Thiotepa
Drug: Vincristine Sulfate
Procedure: Autologous Hematopoietic Stem Cell Transplantation
Drug: Carboplatin
Drug: Cisplatin
Drug: Cyclophosphamide
Drug: Etoposide
Biological: Filgrastim
Other: Laboratory Biomarker Analysis
Drug: Leucovorin Calcium
Drug: Methotrexate
Drug: Thiotepa
Drug: Vincristine Sulfate
Drug(s)Drug: Carboplatin
Drug: Cisplatin
Drug: Cyclophosphamide
Drug: Etoposide
Drug: Leucovorin Calcium
Drug: Methotrexate
Drug: Thiotepa
Drug: Vincristine Sulfate
Drug: Cisplatin
Drug: Cyclophosphamide
Drug: Etoposide
Drug: Leucovorin Calcium
Drug: Methotrexate
Drug: Thiotepa
Drug: Vincristine Sulfate
Total Enrolled70
RandomizationNon-Randomized
Blinding MethodNone (Open Label)
Arms InterventionArm I (chemotherapy, autologous PBSC, 3D-CRT) - Experimental
Arm II (chemotherapy, 3D-CRT, autologous PBSC) - Experimental
Arm II (chemotherapy, 3D-CRT, autologous PBSC) - Experimental
Secondary IDNCI-2009-00337
PubMed (PMID)32730180
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Australia
Canada
Australia
Canada
Age Range21 Years and younger (Child, Adult)
Type(s) of Cancer
Clinical Trial Education
Clinical Trial Education
Study Phase
Not Applicable
Study Completion Date
August 2016
August 2016
NCT02054715Uploaded 01-23-2021
Access via NCI by Request
Evaluation of Psychoeducation for Cancer Patients Eligible for Clinical Trials
Provider Information
Provider Data DescriptionThis dataset from trial NCT02054715 contains patients' preparedness for decision making about clinical trials (via the Preparation for Decision Making Scale**), comparing Multimedia Psychoeducation (MP) and Print Education (PE) interventions. The results are documented in PubMed (PMID) 30291797.
** Bennett C, Graham ID, Kristjansson E, Kearing SA, Clay KF, O'Connor AM. Validation of a preparation for decision making scale. Patient education and counseling. 2010;78:130-133.
SponsorGary Morrow
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis randomized clinical trial compares multimedia psychoeducation to print education in preparing patients with cancer for decision making about clinical trial participation. Multimedia psychoeducation includes a digital video disc (DVD) and written materials with a combined focus on knowledge and attitude change, and may be an effective method to help patients prepare for decision making about clinical trial participation. It is not yet known whether a multimedia psychoeducation is more effective than print education in preparing patients for decision making about clinical trials.
ConditionsMalignant Neoplasm
Intervention TypeBehavioral: print educational intervention
Behavioral: multimedia psychoeducational intervention
Behavioral: multimedia psychoeducational intervention
Drug(s)N/A
Total Enrolled418
RandomizationRandomized
Blinding MethodDouble
Arms InterventionArm I (print educational) - Experimental
Arm II (multimedia psychoeducational) - Experimental
Arm II (multimedia psychoeducational) - Experimental
Secondary IDNCI-2013-02237
PubMed (PMID)N/A
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Leukemia/Lymphoma
Leukemia/Lymphoma
Study Phase
Phase 3
Study Completion Date
September 2017
September 2017
NCT00408005Uploaded 01-06-2021
Access via NCI by Request
Intensified Methotrexate, Nelarabine (Compound 506U78) and Augmented BFM Therapy for Children and Young Adults With Newly Diagnosed T-cell Acute Lymphoblastic Leukemia (ALL) or T-cell Lymphoblastic Lymphoma
Provider Information
Provider Data DescriptionThere are two data submissions (NCT00408005-D1 and -D2) for PMID 30138085. This dataset, NCT00408005-D1, has one row for each patient enrolled. The dataset provides the information of consort diagram of patient enrollment, baseline characteristics, induction response, and primary outcome for the patients on AALL0434 as reported in the manuscript.
SponsorNational Cancer Institute (NCI)
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial is studying different combination chemotherapy regimens and their side effects and comparing how well they work in treating young patients with newly diagnosed T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma. After a common induction therapy, patients were risk assigned and eligible for one or both post-induction randomizations: Escalating dose Methotrexate versus High Dose Methotrexate in Interim Maintenance therapy, No Nelarabine versus Nelarabine in Consolidation therapy. T-ALL patients are risk assigned as Low Risk, Intermediate Risk or High Risk. Low Risk patients are not eligible for the Nelarabine randomization, Patients with CNS disease at diagnosis were assgined to receive High Dose Methotrexate, patients who failed induction therapy were assigned to receive Nelarabine and High Dose Methotrexate. T-LLy patients were all assigned to escalating dose Methotrexate and were risk assigned as Standard Risk, High Risk and induction failures. Standard risk patients did not receive nelarabine, High risk T-LLy patients were randomized to No Nelarabine versus Nelarabine, and Induction failures were assigned to receive Nelarabine.
ConditionsT Acute Lymphoblastic Leukemia
T Lymphoblastic Lymphoma
T Lymphoblastic Lymphoma
Intervention TypeDrug: Asparaginase
Drug: Cyclophosphamide
Drug: Cytarabine
Drug: Daunorubicin Hydrochloride
Drug: Dexamethasone
Drug: Doxorubicin Hydrochloride
Other: Laboratory Biomarker Analysis
Drug: Leucovorin Calcium
Drug: Mercaptopurine
Drug: Methotrexate
Drug: Nelarabine
Drug: Pegaspargase
Drug: Prednisone
Radiation: Radiation Therapy
Drug: Thioguanine
Drug: Vincristine Sulfate
Drug: Cyclophosphamide
Drug: Cytarabine
Drug: Daunorubicin Hydrochloride
Drug: Dexamethasone
Drug: Doxorubicin Hydrochloride
Other: Laboratory Biomarker Analysis
Drug: Leucovorin Calcium
Drug: Mercaptopurine
Drug: Methotrexate
Drug: Nelarabine
Drug: Pegaspargase
Drug: Prednisone
Radiation: Radiation Therapy
Drug: Thioguanine
Drug: Vincristine Sulfate
Drug(s)Drug: Cytarabine
Drug: Daunorubicin Hydrochloride
Drug: Methotrexate
Drug: Pegaspargase
Drug: Prednisone
Drug: Vincristine Sulfate
Drug: Cyclophosphamide
Drug: Mercaptopurine
Drug: Nelarabine
Drug: Leucovorin Calcium
Drug: Dexamethasone
Drug: Doxorubicin Hydrochloride
Drug: Thioguanine
Drug: Asparaginase
Drug: Daunorubicin Hydrochloride
Drug: Methotrexate
Drug: Pegaspargase
Drug: Prednisone
Drug: Vincristine Sulfate
Drug: Cyclophosphamide
Drug: Mercaptopurine
Drug: Nelarabine
Drug: Leucovorin Calcium
Drug: Dexamethasone
Drug: Doxorubicin Hydrochloride
Drug: Thioguanine
Drug: Asparaginase
Total Enrolled1895
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionGroup 0 Induction Therapy - Experimental
Group 1 Arm IV (Consolidation chemotherapy) - Active Comparator
Group I Arm I (Consolidation chemotherapy) - Active Comparator
Group I Arm I (Delayed intensification chemotherapy - Active Comparator
Group I Arm I (Maintenance chemotherapy) - Active Comparator
Group I Arm I (Interim maintenance chemotherapy) - Active Comparator
Group I Arm II (Consolidation chemotherapy) - Active Comparator
Group I Arm II (Delayed intensification chemotherapy) - Active Comparator
Group I Arm II (Interim maintenance chemotherapy) - Active Comparator
Group I Arm II (Maintenance chemotherapy) - Active Comparator
Group I Arm III (Consolidation chemotherapy) - Active Comparator
Group I Arm III (Delayed intensification chemotherapy) - Active Comparator
Group I Arm III (Interim maintenance chemotherapy) - Active Comparator
Group I Arm III (Maintenance chemotherapy) - Active Comparator
Group I Arm IV (Delayed intensification chemotherapy) - Active Comparator
Group I Arm IV (Interim maintenance chemotherapy) - Active Comparator
Group I Arm IV (Maintenance chemotherapy) - Active Comparator
Group 1 Arm IV (Consolidation chemotherapy) - Active Comparator
Group I Arm I (Consolidation chemotherapy) - Active Comparator
Group I Arm I (Delayed intensification chemotherapy - Active Comparator
Group I Arm I (Maintenance chemotherapy) - Active Comparator
Group I Arm I (Interim maintenance chemotherapy) - Active Comparator
Group I Arm II (Consolidation chemotherapy) - Active Comparator
Group I Arm II (Delayed intensification chemotherapy) - Active Comparator
Group I Arm II (Interim maintenance chemotherapy) - Active Comparator
Group I Arm II (Maintenance chemotherapy) - Active Comparator
Group I Arm III (Consolidation chemotherapy) - Active Comparator
Group I Arm III (Delayed intensification chemotherapy) - Active Comparator
Group I Arm III (Interim maintenance chemotherapy) - Active Comparator
Group I Arm III (Maintenance chemotherapy) - Active Comparator
Group I Arm IV (Delayed intensification chemotherapy) - Active Comparator
Group I Arm IV (Interim maintenance chemotherapy) - Active Comparator
Group I Arm IV (Maintenance chemotherapy) - Active Comparator
Secondary IDNCI-2009-00307
PubMed (PMID)34302711
32813610
32552472
30138085
32813610
32552472
30138085
Collaborator(s)N/A
Region(s)United States
Australia
Canada
New Zealand
Switzerland
Australia
Canada
New Zealand
Switzerland
Age Range1 Year to 30 Years (Child, Adult)
Type(s) of Cancer
Pancreas
Pancreas
Study Phase
Phase 2B
Study Completion Date
December 2013
December 2013
NCT01016483Uploaded 12-16-2020
Available for Download
Phase II Randomized Trial of MEK Inhibitor MSC1936369B or Placebo Combined With Gemcitabine in Metastatic Pancreas Cancer Subjects
Provider Information
Provider Data DescriptionPrimary Objective:
- To evaluate the anti-tumor activity of MSC1936369B combined with gemcitabine compared
to gemcitabine alone as first line treatment in subjects with metastatic pancreatic
adenocarcinoma.
Secondary Objectives:
- To determine the safety and tolerability of MSC1936369B combined to gemcitabine in
subjects with metastatic pancreatic cancer.
- To evaluate the anti-tumor activity in each treatment arm in terms of response rate, clinical
benefit, overall survival and time to progression.
- To assess the pharmacokinetics (PK) of MSC1936369B when given in combination, in
subjects with metastatic pancreatic cancer.
Tertiary Objectives:
- To explore potential markers in plasma
- To explore the expression of predictive and prognostic markers in tumor tissue.
- To explore genes that may be involved in the absorption, distribution, metabolism and
elimination (ADME) of MSC1936369B and gemcitabine in combination, to identify potential
genetic variations that may be predictive of differences of PK profile (optional).
- To explore potential genetic variations in blood and tumor tissue (e.g. K-RAS and other
known genetic variations in candidate genes) that may be predictive of differences in response
to MSC1936369B and gemcitabine in combination.
- To assess the anti-tumor activity, safety and tolerability of MSC1936369B treatment in
subjects with metastatic pancreatic adenocarcinoma who failed previous gemcitabine
treatment.
SponsorEMD Serono
Data ProviderEMD Serono
Partial set or SubsetOriginal Data
Patients in dataset141
# of Patients Control44
# of Patients ExperimentalN/A
DOIhttps://doi.org/10.34949/kdzs-bz42
CDISC StandardSDTM
Study ArmsComparator arm data only
Clinical Trials.gov Information
Brief SummaryThe research trial is testing the experimental treatment MSC1936369B in combination with Gemcitabine, in subjects with metastatic pancreatic adenocarcinoma. The study will be run in two parts:
Safety Run-In: Will determine the Maximum Tolerated Dose (MTD) and the recommended Phase II dose of MSC1936369B, when combined with gemcitabine, in subjects with metastatic pancreatic adenocarcinoma.
Phase II: Will assess the anti-tumor activity of MSC1936369B combined with gemcitabine compared to gemcitabine alone as first line treatment in subjects with metastatic pancreatic adenocarcinoma.
ConditionsPancreatic Adenocarcinoma
Intervention TypeDrug: Pimasertib
Drug: Gemcitabine
Drug: Placebo
Drug: Gemcitabine
Drug: Placebo
Drug(s)Drug: Pimasertib
Drug: Gemcitabine
Drug: Placebo
Drug: Gemcitabine
Drug: Placebo
Total Enrolled141
RandomizationRandomized
Blinding MethodQuadruple
Arms InterventionSafety Run-in Part: Regimen 1 - Experimental
Safety Run-in Part: Regimen 2 - Experimental
Phase II: Arm 1 (Gemcitabine + Placebo) - Active Comparator
Phase II: Arm 2 (Gemcitabine + Pimasertib) - Experimental
Safety Run-in Part: Regimen 2 - Experimental
Phase II: Arm 1 (Gemcitabine + Placebo) - Active Comparator
Phase II: Arm 2 (Gemcitabine + Pimasertib) - Experimental
Secondary ID2009-011992-61
PubMed (PMID)29756206
Collaborator(s)Merck KGaA, Darmstadt, Germany
Region(s)United States
Germany
Germany
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
CNS
CNS
Study Phase
Phase 2B
Study Completion Date
February 2013
February 2013
NCT00813943Uploaded 12-15-2020
Available for Download
Cilengitide in Subjects With Newly Diagnosed Glioblastoma and Unmethylated MGMT Gene Promoter - a Multicenter, Open-label Phase II Study, Investigating Two Cilengitide Regimens in Combination With Standard Treatment (Temozolomide With Concomitant Radiation Therapy, Followed by Temozolomide Maintenance Therapy). [The CORE Study]
Provider Information
Provider Data DescriptionTo determine the safety and tolerability of a 5-day administration schedule of 2000 mg cilengitide given in combination with radiation therapy (RTX) and temozolomide (TMZ) standard treatment in the safety run-in part of the trial: To investigate the overall survival (OS) in subjects receiving 2 different regimens of 2000 mg cilengitide in combination with RTX and TMZ standard treatment in the randomized part of the trial.
SponsorEMD Serono
Data ProviderEMD Serono
Partial set or SubsetOriginal Data
Patients in dataset265
# of Patients Control89
# of Patients ExperimentalN/A
DOIhttps://doi.org/10.34949/067t-vx73
CDISC StandardSDTM
Study ArmsComparator arm data only
Clinical Trials.gov Information
Brief SummaryCORE is a Phase 2 clinical trial in newly diagnosed glioblastoma in subjects with an unmethylated O6-methylguanine-deoxyribonucleic acid methyltransferase (MGMT) gene promoter in the tumor tissue.
The MGMT gene promoter is a section of deoxyribonucleic acid (DNA) that acts as a controlling element in the expression of MGMT. Methylation of the MGMT gene promoter has been found to appear to be a predictive marker for benefit from temozolomide (TMZ) treatment.
In a safety run-in period in dedicated study centers, the safety and tolerability of Cilengitide given as an intense treatment in combination with the first part of standard therapy will be assessed. Thereafter the trial will investigate the overall survival and progression-free survival in subjects receiving two different regimens of Cilengitide in combination with standard treatment versus standard treatment alone.
ConditionsGlioblastoma
Intervention TypeDrug: Cilengitide (2-times weekly)
Drug: cilengitide (5-times weekly)
Drug: Temozolomide
Radiation: Radiotherapy
Drug: cilengitide (5-times weekly)
Drug: Temozolomide
Radiation: Radiotherapy
Drug(s)Drug: Cilengitide (2-times weekly)
Drug: Temozolomide
Drug: cilengitide (5-times weekly)
Drug: Temozolomide
Drug: cilengitide (5-times weekly)
Total Enrolled265
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionCilengitide (2-times weekly) + Temozolomide + Radiotherapy - Experimental
Cilengitide (5-times weekly) + Temozolomide + Radiotherapy - Experimental
Temozolomide + Radiotherapy - Active Comparator
Cilengitide (5-times weekly) + Temozolomide + Radiotherapy - Experimental
Temozolomide + Radiotherapy - Active Comparator
Secondary IDN/A
PubMed (PMID)N/A
Collaborator(s)Merck KGaA, Darmstadt, Germany
Region(s)United States
Germany
Germany
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
CNS
CNS
Study Phase
Phase 3
Study Completion Date
November 2012
November 2012
NCT00689221Uploaded 12-15-2020
Available for Download
Cilengitide for Subjects With Newly Diagnosed Glioblastoma and Methylated MGMT Gene Promoter - A Multicenter, Open-label, Controlled Phase III Study, Testing Cilengitide in Combination With Standard Treatment (Temozolomide With Concomitant Radiation Therapy, Followed by Temozolomide Maintenance Therapy) Versus Standard Treatment Alone (CENTRIC)
Provider Information
Provider Data DescriptionThe primary objective of this study is to assess whether overall survival time in subjects
receiving 2000 mg cilengitide in combination with standard treatment (TMZ with
concomitant RTX, followed by TMZ maintenance therapy: TMZ/RTX?TMZ) is
statistically significantly prolonged compared to subjects receiving standard treatment only
(TMZ/RTX?TMZ). Only subjects with newly diagnosed GBM and tumors with
methylated MGMT gene promoter will be randomized.
Secondary objective is to investigate the Progression Free Survival (PFS). PFS will be
assessed by the IRC according to the Macdonald criteria in an independent and blinded
manner (details specified in the IRC charter). This will provide an objective, unbiased
review of the eligible subject population based on the baseline assessment of the disease
and the benefit of the respective study treatment.
SponsorEMD Serono
Data ProviderEMD Serono
Partial set or SubsetOriginal Data
Patients in dataset545
# of Patients Control273
# of Patients ExperimentalN/A
DOIhttps://doi.org/10.34949/wqh9-tx27
CDISC StandardSDTM
Study ArmsComparator arm data only
Clinical Trials.gov Information
Brief SummaryCENTRIC is a Phase 3 clinical trial assessing efficacy and safety of the investigational integrin inhibitor, cilengitide, in combination with standard treatment versus standard treatment alone in newly diagnosed glioblastoma subjects with a methylated O6-methylguanine-deoxyribonucleic acid methyltransferase (MGMT) gene promoter in the tumor tissue.
The MGMT gene promoter is a section of deoxyribonucleic acid (DNA) that acts as a controlling element in the expression of MGMT. Methylation of the MGMT gene promoter has been found to be a predictive marker for benefit from temozolomide (TMZ) treatment.
ConditionsGlioblastoma
Intervention TypeDrug: Cilengitide
Drug: Temozolomide
Radiation: Radiotherapy
Drug: Temozolomide
Radiation: Radiotherapy
Drug(s)Drug: Cilengitide
Drug: Temozolomide
Drug: Temozolomide
Total Enrolled545
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionCilengitide + Temozolomide + Radiotherapy - Experimental
Temozolomide + Radiotherapy - Active Comparator
Temozolomide + Radiotherapy - Active Comparator
Secondary IDEORTC 26071-22072
PubMed (PMID)25163906
Collaborator(s)European Organisation for Research and Treatment of Cancer - EORTC
Merck KGaA, Darmstadt, Germany
Merck KGaA, Darmstadt, Germany
Region(s)United States
Germany
Germany
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Lung
Lung
Study Phase
Phase 2
Study Completion Date
November 2016
November 2016
NCT00887159Uploaded 12-11-2020
Access via NCI by Request
A Randomized Phase II Study of Cisplatin and Etoposide in Combination With Either Hedgehog Inhibitor GDC-0449 or IGF-1R MOAB IMC-A12 for Patients With Extensive Stage Small Cell Lung Cancer
Provider Information
Provider Data DescriptionThere are two different submissions (each with one dataset) for PMID 27163943 from trial ECOG-ACRIN 1508. This dataset, NCT00887159-D1, contains baseline, treatment, and efficacy data. Dataset NCT00887159-D2 contains toxicity data.
SponsorNational Cancer Institute (NCI)
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis randomized phase II trial studies cisplatin and etoposide to see how well they work when given with or without Hedgehog inhibitor GDC-0449 (vismodegib) or IGF-1R MOAB IMC-A12 (cixutumumab) in treating patients with extensive-stage small cell lung cancer. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Etoposide may slow the growth of tumor cells by blocking some of the enzymes needed for cell growth. Vismodegib may slow the growth of tumor cells. Monoclonal antibodies, such as cixutumumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving cisplatin and etoposide are more effective when given together with vismodegib or cixutumumab in treating small cell lung cancer.
ConditionsExtensive Stage Small Cell Lung Carcinoma
Recurrent Small Cell Lung Carcinoma
Recurrent Small Cell Lung Carcinoma
Intervention TypeDrug: Cisplatin
Biological: Cixutumumab
Drug: Etoposide
Other: Laboratory Biomarker Analysis
Drug: Vismodegib
Biological: Cixutumumab
Drug: Etoposide
Other: Laboratory Biomarker Analysis
Drug: Vismodegib
Drug(s)Drug: Cisplatin
Drug: Etoposide
Drug: Vismodegib
Drug: Etoposide
Drug: Vismodegib
Total Enrolled168
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionArm A (CE) - Active Comparator
Arm B (CE + GDC-0449) - Experimental
Arm C (CE + IMC-A12) - Experimental
Arm B (CE + GDC-0449) - Experimental
Arm C (CE + IMC-A12) - Experimental
Secondary IDNCI-2011-01917
PubMed (PMID)N/A
Collaborator(s)N/A
Region(s)United States
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Lung
Lung
Study Phase
Phase 3
Study Completion Date
2009
2009
N/AUploaded 12-07-2020
Available for Download
Randomized, Open-Label, Phase 3 Study of Pemetrexed plus Carboplatin Followed by Maintenance Pemetrexed versus Paclitaxel plus Carboplatin and Bevacizumab Followed by Maintenance Bevacizumab in Patients with Advanced Non-Small Cell Lung Cancer of Nonsquamous Histology
Provider Information
Provider Data DescriptionThe primary objective is to compare progression-free survival without grade 4 toxicity (G4PFS) according to Common Terminology Criteria for Adverse Events (CTCAE) for the following: Arm A: pemetrexed plus carboplatin, followed by maintenance pemetrexed, Arm B: paclitaxel plus carboplatin plus bevacizumab, followed by maintenance bevacizumab.
in the first-line induction and maintenance therapy for the treatment of patients with Stage IV NSCLC as defined by the American Joint Committee on Cancer Staging Criteria (AJCC) version 7, including both M1a and M1b disease (Goldstraw 2009; Rami- Porta 2009).
The secondary objectives of the study are as follows:
Efficacy: to compare PFS between the 2 treatment arms; to compare overall survival between the 2 treatment arms; to compare the overall response rates (ORRs) and the disease control rates (DCRs), assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) (Therasse et al. 2000), between treatment arms;
Safety:
to examine the safety and toxicity profile of study treatments, graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (NCI 2006).
SponsorEli Lilly
Data ProviderEli Lilly
Partial set or SubsetOriginal Data
Patients in dataset361
# of Patients Control179
# of Patients ExperimentalN/A
DOIhttps://doi.org/10.34949/fv7a-0v28
CDISC StandardADS
Study ArmsComparator arm data only
Type(s) of Cancer
Leukemia/Lymphoma, Stem Cell Transplants
Leukemia/Lymphoma, Stem Cell Transplants
Study Phase
Phase 3
Study Completion Date
June 2017
June 2017
NCT01371656Uploaded 11-24-2020
Access via NCI by Request
A Randomized Trial of Levofloxacin to Prevent Bacteremia in Children Being Treated for Acute Leukemia (AL) or Undergoing Hematopoietic Stem Cell Transplantation (HSCT)
Provider Information
Provider Data DescriptionThere are six datasets associated with PubMed ID 30208456 (NCT01371656-D1 through -D6). NCT01371656-D1 provides the information for the consort diagram (Figure 1).
Data provided on all enrolled patients (N=624). There is one row per patient.
SponsorChildren's Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial studies how well levofloxacin works in preventing infection in young patients with acute leukemia receiving chemotherapy or undergoing stem cell transplant. Giving antibiotics may be effective in preventing or controlling early infection in patients receiving chemotherapy or undergoing stem cell transplant for acute leukemia. It is not yet known whether levofloxacin is effective in preventing infection.
ConditionsAcute Leukemias of Ambiguous Lineage
Bacterial Infection
Diarrhea
Fungal Infection
Musculoskeletal Complications
Neutropenia
Recurrent Childhood Acute Lymphoblastic Leukemia
Recurrent Childhood Acute Myeloid Leukemia
Secondary Acute Myeloid Leukemia
Untreated Childhood Acute Myeloid Leukemia and Other Myeloid Malignancies
Bacterial Infection
Diarrhea
Fungal Infection
Musculoskeletal Complications
Neutropenia
Recurrent Childhood Acute Lymphoblastic Leukemia
Recurrent Childhood Acute Myeloid Leukemia
Secondary Acute Myeloid Leukemia
Untreated Childhood Acute Myeloid Leukemia and Other Myeloid Malignancies
Intervention TypeDrug: levofloxacin
Drug(s)Drug: levofloxacin
Total Enrolled624
RandomizationRandomized
Blinding MethodSingle
Arms InterventionArm I (levofloxacin) - Experimental
Arm II (standard of care) - No Intervention
Arm II (standard of care) - No Intervention
Secondary IDNCI-2011-02636
PubMed (PMID)N/A
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Canada
Canada
Age Range6 Months to 21 Years (Child, Adult)
Type(s) of Cancer
Sarcoma
Sarcoma
Study Phase
Phase 3
Study Completion Date
August 2012
August 2012
NCT00075582Uploaded 11-11-2020
Access via NCI by Request
Vincristine, Dactinomycin, and Lower Doses of Cyclophosphamide With or Without Radiation Therapy for Patients With Newly Diagnosed Low-Risk Embryonal/Botryoid/Spindle Cell Rhabdomyosarcoma
Provider Information
Provider Data DescriptionNCT00075582-D1 is the only dataset for this manuscript (PMID 28211936). There is one row for each patient enrolled. The dataset contains the baseline patient characteristics, radiation received, delayed surgery received, adverse events and survival outcomes for patients on ARST0331 as reported in the manuscript.
SponsorChildren's Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis phase III trial is studying how well combination chemotherapy and radiation therapy work in treating patients with newly diagnosed low-risk rhabdomyosarcoma. Drugs used in chemotherapy, such as vincristine, dactinomycin, and cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells. It is not yet known which treatment regimen is more effective in treating low-risk rhabdomyosarcoma.
ConditionsAdult Rhabdomyosarcoma
Embryonal Childhood Rhabdomyosarcoma
Embryonal-botryoid Childhood Rhabdomyosarcoma
Previously Untreated Childhood Rhabdomyosarcoma
Embryonal Childhood Rhabdomyosarcoma
Embryonal-botryoid Childhood Rhabdomyosarcoma
Previously Untreated Childhood Rhabdomyosarcoma
Intervention TypeProcedure: conventional surgery
Drug: dactinomycin
Drug: cyclophosphamide
Drug: vincristine sulfate
Radiation: radiation therapy
Drug: dactinomycin
Drug: cyclophosphamide
Drug: vincristine sulfate
Radiation: radiation therapy
Drug(s)Drug: dactinomycin
Drug: cyclophosphamide
Drug: vincristine sulfate
Drug: cyclophosphamide
Drug: vincristine sulfate
Total Enrolled390
RandomizationNon-Randomized
Blinding MethodNone (Open Label)
Arms InterventionRegimen I (chemotherapy, radiotherapy) - Experimental
Regimen II (chemotherapy, radiotherapy, surgery) - Experimental
Regimen II (chemotherapy, radiotherapy, surgery) - Experimental
Secondary IDNCI-2009-00425
PubMed (PMID)N/A
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Australia
Canada
New Zealand
Puerto Rico
Switzerland
Australia
Canada
New Zealand
Puerto Rico
Switzerland
Age Range49 Years and younger (Child, Adult)
Type(s) of Cancer
Lung
Lung
Study Phase
Phase 2B
Study Completion Date
July 2017
July 2017
NCT02499770Uploaded 11-05-2020
Available for Download
Phase 1b/2a Safety and Pharmacokinetic Study of G1T28 in Patients With Extensive Stage Small Cell Lung Cancer (SCLC) Receiving Etoposide and Carboplatin
Provider Information
Provider Data DescriptionPrimary (control portion of the study): Assess the safety and tolerability of G1T28 administered with E/P therapy
Secondary (control portion of the study): Assess the hematologic profile (kinetics and incidence/duration/frequency of toxicities) of G1T28 administered with E/P therapy; Assess the incidence of febrile neutropenia; Assess the incidence of infections; Assess the utilization of RBC and platelet transfusions; Assess the utilization of hematopoietic growth factors ; Assess the utilization of systemic antibiotics; Assess the incidence of chemotherapy dose reductions and dose interruptions overall; Assess the incidence of Grade 2 or greater nephrotoxicity ; Assess tumor response based on RECIST, Version 1.1; Assess PFS and overall survival
***Complete list can be found in the NCT listing.
SponsorG1 Therapeutics, Inc.
Data ProviderG1 Therapeutics, Inc.
Partial set or SubsetOriginal Data
Patients in dataset77
# of Patients Control38
# of Patients ExperimentalN/A
DOIhttps://doi.org/10.34949/gt37-js55
CDISC StandardADS
Study ArmsComparator arm data only
Clinical Trials.gov Information
Brief SummaryThis is a study to investigate the potential clinical benefit of trilaciclib (G1T28) in preserving the bone marrow and the immune system, and enhancing chemotherapy antitumor efficacy when administered prior to carboplatin and etoposide in first line treatment for patients with newly diagnosed extensive-stage SCLC.
The study consists of 2 parts: a limited open-label, dose-finding portion (Part 1), and a randomized double-blind portion (Part 2). Both parts include 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. The Treatment Phase begins on the day of first dose with study treatment and completes at the Post-Treatment Visit. Approximately, 90 patients will be enrolled in the study; 20 patients in the Part 1 and 70 patients in the Part 2 portion.
ConditionsSmall Cell Lung Cancer
Intervention TypeDrug: Carboplatin
Drug: Placebo
Drug: Trilaciclib
Drug: Etoposide
Drug: Placebo
Drug: Trilaciclib
Drug: Etoposide
Drug(s)Drug: Carboplatin
Drug: Trilaciclib
Drug: Etoposide
Drug: Placebo
Drug: Trilaciclib
Drug: Etoposide
Drug: Placebo
Total Enrolled122
RandomizationRandomized
Blinding MethodDouble
Arms Interventiontrilaciclib + carboplatin/etoposide - Experimental
trilaciclib/placebo + carboplatin/etoposide - Experimental
trilaciclib/placebo + carboplatin/etoposide - Experimental
Secondary ID2016-001583-11
PubMed (PMID)34408488
34405547
33595690
33004541
31504118
34405547
33595690
33004541
31504118
Collaborator(s)N/A
Region(s)United States
France
Georgia
Hungary
Moldova, Republic of
Poland
Spain
France
Georgia
Hungary
Moldova, Republic of
Poland
Spain
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Lung
Lung
Study Phase
Phase 2B
Study Completion Date
September 2018
September 2018
NCT02514447Uploaded 11-05-2020
Available for Download
Phase 1b/2a Safety and Pharmacokinetic Study of G1T28 in Patients With Previously Treated Extensive Stage Small Cell Lung Cancer (SCLC) Receiving Topotecan Chemotherapy
Provider Information
Provider Data DescriptionPrimary (control portion of the study): Assess the safety and tolerability of G1T28 administered with topotecan
Key secondary (control portion of the study): Assess the hematologic profile (kinetics and incidence/duration/frequency of toxicities) of G1T28 administered with topotecan; Assess the utilization of RBC and platelet transfusions; Assess the utilization of hematopoietic growth factors; Assess the incidence of chemotherapy dose reductions and dose interruptions overall; Assess PFS and overall survival
SponsorG1 Therapeutics, Inc.
Data ProviderG1 Therapeutics, Inc.
Partial set or SubsetOriginal Data
Patients in dataset91
# of Patients Control29
# of Patients ExperimentalN/A
DOIhttps://doi.org/10.34949/z3wz-rx52
CDISC StandardADS
Study ArmsComparator arm data only
Clinical Trials.gov Information
Brief SummaryThis was a study to investigate the potential clinical benefit of trilaciclib (G1T28), a Cyclin Dependent Kinase (CDK) 4/6 inhibitor, in preserving the bone marrow and the immune system, in order to decrease chemotherapy-induced myelosuppression and improve anti-tumor efficacy when administered prior to topotecan in patients previously treated for extensive-stage SCLC.
The study consisted of 2 parts: a limited open-label, dose-finding portion (Part 1), and a randomized double-blind portion (Part 2). Both parts included 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. The Treatment Phase began on the day of first dose with study treatment and completes at the Post-Treatment Visit.
ConditionsSmall Cell Lung Cancer
Intervention TypeDrug: Trilaciclib
Drug: Placebo
Drug: Topotecan
Drug: Placebo
Drug: Topotecan
Drug(s)Drug: Placebo
Drug: Topotecan
Drug: Trilaciclib
Drug: Topotecan
Drug: Trilaciclib
Total Enrolled123
RandomizationRandomized
Blinding MethodDouble
Arms InterventionPlacebo + Topotecan 1.5 mg/m² - Parts 2a and 2b - Experimental
Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Part 2a - Experimental
Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m² - Part 2b - Experimental
Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.5 mg/m² - Cohort 1- Part 1 - Experimental
Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.25 mg/m² - Cohort 2- Part 1 - Experimental
Trilaciclib (G1T28) 200 mg/m² + Topotecan 0.75 mg/m² - Cohort 3- Part 1 - Experimental
Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Cohorts 4 and 6- Part 1 - Experimental
Trilaciclib (G1T28) 280 mg/m² + Topotecan 0.75 mg/m² - Cohort 5- Part 1 - Experimental
Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.0 mg/m² - Cohort 7- Part 1 - Experimental
Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Part 2a - Experimental
Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m² - Part 2b - Experimental
Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.5 mg/m² - Cohort 1- Part 1 - Experimental
Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.25 mg/m² - Cohort 2- Part 1 - Experimental
Trilaciclib (G1T28) 200 mg/m² + Topotecan 0.75 mg/m² - Cohort 3- Part 1 - Experimental
Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Cohorts 4 and 6- Part 1 - Experimental
Trilaciclib (G1T28) 280 mg/m² + Topotecan 0.75 mg/m² - Cohort 5- Part 1 - Experimental
Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.0 mg/m² - Cohort 7- Part 1 - Experimental
Secondary ID2016-004611-13
PubMed (PMID)33123968
35842567
34408488
34405547
33595690
35842567
34408488
34405547
33595690
Collaborator(s)N/A
Region(s)United States
Belgium
Bosnia and Herzegovina
Croatia
North Macedonia
Serbia
Slovakia
Slovenia
Belgium
Bosnia and Herzegovina
Croatia
North Macedonia
Serbia
Slovakia
Slovenia
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Lung
Lung
Study Phase
Phase 2B
Study Completion Date
August 2018
August 2018
NCT03041311Uploaded 11-05-2020
Available for Download
Phase 2 Study of Carboplatin, Etoposide, and Atezolizumab With or Without Trilaciclib in Patients With Untreated Extensive-Stage Small Cell Lung Cancer (SCLC)
Provider Information
Provider Data DescriptionPrimary: Evaluate potential of trilaciclib, compared with placebo, to reduce chemotherapy-induced myelosuppression in patients with SCLC undergoing treatment with etoposide, carboplatin, and atezolizumab (E/P/A)
Key Secondary: Evaluate potential of trilaciclib, compared with placebo, to reduce chemotherapy-induced myelosuppression and its consequences in patients with SCLC undergoing treatment with E/P/A
*** A complete list can be found in the NCT listing;
SponsorG1 Therapeutics, Inc.
Data ProviderG1 Therapeutics, Inc.
Partial set or SubsetOriginal Data
Patients in dataset107
# of Patients Control53
# of Patients ExperimentalN/A
DOIhttps://doi.org/10.34949/54pc-ep24
CDISC StandardADS
Study ArmsComparator arm data only
Clinical Trials.gov Information
Brief SummaryThis was a study to investigate the potential clinical benefit of trilaciclib (G1T28) in preserving the bone marrow and the immune system, and enhancing antitumor efficacy when administered with carboplatin, etoposide, and atezolizumab (E/P/A) therapy in first line treatment for patients with newly diagnosed extensive-stage SCLC.
The study was a randomized, double-blinded, placebo-controlled design. Approximately, 100 patients were randomized to trilaciclib + E/P/A or placebo + E/P/A in the study.
ConditionsSmall Cell Lung Cancer
Intervention TypeDrug: Trilaciclib
Drug: Placebo
Drug: Carboplatin
Drug: Etoposide
Drug: Atezolizumab
Drug: Placebo
Drug: Carboplatin
Drug: Etoposide
Drug: Atezolizumab
Drug(s)Drug: Trilaciclib
Drug: Carboplatin
Drug: Etoposide
Drug: Atezolizumab
Drug: Placebo
Drug: Carboplatin
Drug: Etoposide
Drug: Atezolizumab
Drug: Placebo
Total Enrolled107
RandomizationRandomized
Blinding MethodDouble
Arms Interventiontrilaciclib+etoposide/carboplatin/atezolizumab - Experimental
placebo+etoposide/carboplatin/atezolizumab - Experimental
placebo+etoposide/carboplatin/atezolizumab - Experimental
Secondary ID2017-000358-20
PubMed (PMID)33348420
33895103
34873975
34777341
34408488
34405547
33895103
34873975
34777341
34408488
34405547
Collaborator(s)Roche-Genentech
Region(s)United States
Bulgaria
Estonia
France
Latvia
Spain
Ukraine
Bulgaria
Estonia
France
Latvia
Spain
Ukraine
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Leukemia/Lymphoma
Leukemia/Lymphoma
Study Phase
Phase 3
Study Completion Date
October 2017
October 2017
NCT00118209Uploaded 10-31-2020
Access via NCI by Request
Phase III Randomized Study of R-CHOP V. Dose-Adjusted EPOCH-R With Molecular Profiling in Untreated De Novo Diffuse Large B-Cell Lymphomas
Provider Information
Provider Data Description Dataset NCT00118209-D1-Dataset.csv (master) is one of 2 datasets (NCT00118209-D1 and NCT00118209-D2) associated with PubMed ID 30939090. This dataset contains information that will allow you to reproduce the baseline characteristics table, primary and secondary analyses, and the primary cause of death.
SponsorAlliance for Clinical Trials in Oncology
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial studies rituximab when given together with two different combination chemotherapy regimens to compare how well they work in treating patients with diffuse large B-cell non-Hodgkin's lymphoma. Monoclonal antibodies, such as rituximab, may block cancer growth in different ways by targeting certain cells. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving rituximab together with combination chemotherapy may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective when given with rituximab in treating diffuse large B-cell non-Hodgkin's lymphoma.
PURPOSE: This randomized phase III trial is studying rituximab when given together with two different combination chemotherapy regimens to compare how well they work in treating patients with diffuse large B-cell lymphoma.
ConditionsLarge B Cell Lymphoma
Intervention TypeBiological: rituximab
Drug: cyclophosphamide
Drug: doxorubicin
Drug: vincristine
Drug: prednisone
Drug: etoposide
Drug: filgrastim
Drug: pegfilgrastim
Drug: cyclophosphamide
Drug: doxorubicin
Drug: vincristine
Drug: prednisone
Drug: etoposide
Drug: filgrastim
Drug: pegfilgrastim
Drug(s)Drug: cyclophosphamide
Drug: doxorubicin
Drug: vincristine
Drug: prednisone
Drug: filgrastim
Drug: pegfilgrastim
Drug: etoposide
Drug: doxorubicin
Drug: vincristine
Drug: prednisone
Drug: filgrastim
Drug: pegfilgrastim
Drug: etoposide
Total Enrolled524
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionArm A - R-CHOP - Active Comparator
Arm B - DA-EPOCH-R - Experimental
Arm B - DA-EPOCH-R - Experimental
Secondary IDCDR0000433265
PubMed (PMID)32232481
30939090
22180164
30939090
22180164
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Sarcoma
Sarcoma
Study Phase
Phase 3
Study Completion Date
December 2014
December 2014
NCT00354835Uploaded 10-06-2020
Access via NCI by Request
Randomized Study of Vincristine, Dactinomycin and Cyclophosphamide (VAC) Versus VAC Alternating With Vincristine and Irinotecan (VI) for Patients With Intermediate-Risk Rhabdomyosarcoma (RMS)
Provider Information
Provider Data DescriptionThere are three datasets associated with PubMed ID 30091945: NCT00354835-D1, NCT00354835-D2, and NCT00354835-D3. Dataset NCT00354835-D1 is required for re-creating the main results of the manuscript. The data contains information including histology, group, adverse events, stage, EFS and OS, and demographics.
SponsorChildren's Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial is studying two different combination chemotherapy regimens to compare how well they work when given together with radiation therapy in treating patients with newly diagnosed rhabdomyosarcoma. Drugs used in chemotherapy, such as vincristine sulfate, dactinomycin, cyclophosphamide, and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective when given together with radiation therapy in treating patients with rhabdomyosarcoma.
ConditionsAdult Rhabdomyosarcoma
Childhood Alveolar Rhabdomyosarcoma
Childhood Botryoid-Type Embryonal Rhabdomyosarcoma
Childhood Embryonal Rhabdomyosarcoma
Localized Childhood Soft Tissue Sarcoma
Rhabdomyosarcoma
Sarcoma
Stage I Adult Soft Tissue Sarcoma AJCC v7
Stage II Adult Soft Tissue Sarcoma AJCC v7
Stage III Adult Soft Tissue Sarcoma AJCC v7
Childhood Alveolar Rhabdomyosarcoma
Childhood Botryoid-Type Embryonal Rhabdomyosarcoma
Childhood Embryonal Rhabdomyosarcoma
Localized Childhood Soft Tissue Sarcoma
Rhabdomyosarcoma
Sarcoma
Stage I Adult Soft Tissue Sarcoma AJCC v7
Stage II Adult Soft Tissue Sarcoma AJCC v7
Stage III Adult Soft Tissue Sarcoma AJCC v7
Intervention TypeDrug: Cyclophosphamide
Biological: Dactinomycin
Drug: Irinotecan Hydrochloride
Other: Laboratory Biomarker Analysis
Other: Questionnaire Administration
Radiation: Radiation Therapy
Drug: Vincristine Sulfate
Biological: Dactinomycin
Drug: Irinotecan Hydrochloride
Other: Laboratory Biomarker Analysis
Other: Questionnaire Administration
Radiation: Radiation Therapy
Drug: Vincristine Sulfate
Drug(s)Drug: Cyclophosphamide
Drug: Vincristine Sulfate
Drug: Irinotecan Hydrochloride
Drug: Vincristine Sulfate
Drug: Irinotecan Hydrochloride
Total Enrolled481
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionArm I (chemotherapy, radiotherapy) - Active Comparator
Arm II (chemotherapy, radiotherapy) - Experimental
Arm II (chemotherapy, radiotherapy) - Experimental
Secondary IDNCI-2009-00427
PubMed (PMID)31174239
30091945
30091945
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Australia
Canada
New Zealand
Puerto Rico
Switzerland
Australia
Canada
New Zealand
Puerto Rico
Switzerland
Age Range49 Years and younger (Child, Adult)
Type(s) of Cancer
Pancreas
Pancreas
Study Phase
Phase 2BPhase 3
Study Completion Date
November 2012
November 2012
NCT01124786Uploaded 10-02-2020
Available for Download
A Phase II Randomized, Open-Label, Multicenter Study Comparing CO-1.01 With Gemcitabine as First-Line Therapy in Patients With Metastatic Pancreatic Adenocarcinoma
Provider Information
Provider Data DescriptionThis data enhancement project seeks to further advance the mission of the PDS platform by enabling new explorations into the potential influence of health care access, socioeconomic factors, and health behaviors on the patient-level efficacy and outcomes data contained in the PDS online service. This was achieved using a statistical linkage method in which patient-level records from PDS dataset, Pancrea_ClovisO_2010_186, were matched with pancreatic cancer survivors from the nationally representative Medical Expenditure Panel Survey (MEPS). Linkage criteria were based on age, sex, race, and a quality of life assessment called the EQ-5D index score. The use of the EQ-5D score as a linkage criterion reduces the multitude of many-to-many exact matches that would have occurred using only age, race, and sex. The addition of the MEPS data to the patient-level data within the PDS enclave will facilitate hypothesis-generating research efforts that explore the level of variation in patient outcomes potentially attributable to differentials in access to basic health care services and their utilization, to socioeconomic characteristics, and to health behaviors and preferences. It will support exploratory analyses designed to examine questions such as How are variations in cancer patients' access to health care and income impacting patient outcomes in specific phase III clinical trials? What variations in patient outcomes are associated with specific demographic, socioeconomic, and health-related factors? Are the demographic characteristics of those cancer patients enrolled in specific phase III clinical trials comparable to cancer patients with the same disease in the general population?
SponsorResearcher Curated
Data ProviderRTI International
Partial set or SubsetOriginal Data
Patients in dataset0
# of Patients Control0
# of Patients ExperimentalN/A
DOIhttps://doi.org/10.34949/yqx7-0m42
CDISC StandardN/A
Study ArmsComparator arm data only
Clinical Trials.gov Information
Brief SummaryThe purpose of this study is to determine whether CO-1.01 is safe and effective in the treatment of patients with metastatic pancreatic cancer and low hENT1 expression compared with gemcitabine.
ConditionsMetastatic Pancreatic Adenocarcinoma
Intervention TypeDrug: CO-1.01
Drug: Gemcitabine
Drug: Gemcitabine
Drug(s)Drug: CO-1.01
Drug: Gemcitabine
Drug: Gemcitabine
Total Enrolled367
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionCO-1.01 - Experimental
gemcitabine - Active Comparator
gemcitabine - Active Comparator
Secondary IDN/A
PubMed (PMID)N/A
Collaborator(s)N/A
Region(s)United States
Argentina
Australia
Belgium
Brazil
Canada
France
Germany
Italy
Netherlands
Norway
Russian Federation
Sweden
Ukraine
United Kingdom
Argentina
Australia
Belgium
Brazil
Canada
France
Germany
Italy
Netherlands
Norway
Russian Federation
Sweden
Ukraine
United Kingdom
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Neuroblastoma
Neuroblastoma
Study Phase
Phase 3
Study Completion Date
December 2013
December 2013
NCT00033293Uploaded 09-30-2020
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A Phase III Randomized Trial of Intravenous Gammaglobulin Therapy for Patients With Neuroblastoma Associated Opsoclonus-Myoclonus-Ataxia Syndrome Treated With Chemotherapy and Prednisone
Provider Information
Provider Data DescriptionThere are three datasets: NCT00033293-D1 NCT00033293-D2 and NCT00033293-D3 for PMID 29376112. USI is the patient identifier in all datasets. NCT00033293-D1 There is one row for each patient enrolled on ANBL00P3. The dataset provides the information necessary to reproduce patient baseline characteristics, evaluability, treatment received, disease response, and survival.
SponsorChildren's Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial is studying cyclophosphamide, prednisone, and immunoglobulin to see how well they work compared to cyclophosphamide and prednisone alone in treating patients with abnormal trunk muscle movements associated with neuroblastoma. Drugs used in chemotherapy, work in different ways to stop tumor cells from dividing so they stop growing or die. Steroid therapy decreases inflammation. Combining chemotherapy and steroid therapy with immunoglobulin may be effective in treating abnormal muscle movement associated with neuroblastoma.
ConditionsLocalized Resectable Neuroblastoma
Localized Unresectable Neuroblastoma
Regional Neuroblastoma
Stage 4 Neuroblastoma
Stage 4S Neuroblastoma
Localized Unresectable Neuroblastoma
Regional Neuroblastoma
Stage 4 Neuroblastoma
Stage 4S Neuroblastoma
Intervention TypeOther: Clinical Observation
Drug: Cyclophosphamide
Other: Laboratory Biomarker Analysis
Procedure: Magnetic Resonance Imaging
Drug: Prednisone
Biological: Therapeutic Immune Globulin
Drug: Cyclophosphamide
Other: Laboratory Biomarker Analysis
Procedure: Magnetic Resonance Imaging
Drug: Prednisone
Biological: Therapeutic Immune Globulin
Drug(s)Drug: Cyclophosphamide
Drug: Prednisone
Drug: Prednisone
Total Enrolled53
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionArm I (chemotherapy, immunoglobulin therapy) - Experimental
Arm II (chemotherapy, observation) - Active Comparator
Arm II (chemotherapy, observation) - Active Comparator
Secondary IDNCI-2009-00399
PubMed (PMID)29376112
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Australia
Canada
Australia
Canada
Age Range8 Years and younger (Child)
Type(s) of Cancer
Neuroblastoma
Neuroblastoma
Study Phase
Phase 3
Study Completion Date
February 2015
February 2015
NCT00567567Uploaded 09-29-2020
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Phase III Randomized Trial of Single vs. Tandem Myeloablative Consolidation Therapy for High-Risk Neuroblastoma
Provider Information
Provider Data DescriptionThere is one dataset associated with the publication: NCT00567567-D1.
USI is the patient identifier and blanks or "." represent missing data or not applicable for analyses. Data can be used to approximate published study findings, but exact reproduction of previous manuscripts may not be possible in some cases (e.g., when data must be modified for de-identification purposes or have undergone further data cleaning).
NCT00567567-D1: There is one row for each patient enrolled on the study ANBL0532. The dataset provides the information necessary to reproduce the manuscript.
SponsorChildren's Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial compares two different high-dose chemotherapy regimens followed by a stem cell transplant in treating younger patients with high-risk neuroblastoma. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments before a peripheral blood stem cell transplant helps kill any tumor cells that are in the body and helps make room in the patient?s bone marrow for new blood-forming cells (stem cells) to grow. After treatment, stem cells are collected from the patient's blood and stored. High-dose chemotherapy and radiation therapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the high- chemotherapy. It is not yet known which regimen of high-dose chemotherapy is more effective for patients with high-risk neuroblastoma undergoing a peripheral blood stem cell transplant.
ConditionsLocalized Resectable Neuroblastoma
Localized Unresectable Neuroblastoma
Recurrent Neuroblastoma
Regional Neuroblastoma
Stage 4 Neuroblastoma
Stage 4S Neuroblastoma
Localized Unresectable Neuroblastoma
Recurrent Neuroblastoma
Regional Neuroblastoma
Stage 4 Neuroblastoma
Stage 4S Neuroblastoma
Intervention TypeProcedure: Autologous Hematopoietic Stem Cell Transplantation
Drug: Carboplatin
Drug: Cisplatin
Drug: Cyclophosphamide
Drug: Doxorubicin Hydrochloride
Drug: Etoposide
Radiation: External Beam Radiation Therapy
Biological: Filgrastim
Drug: Isotretinoin
Other: Laboratory Biomarker Analysis
Drug: Melphalan
Procedure: Peripheral Blood Stem Cell Transplantation
Other: Pharmacological Study
Drug: Thiotepa
Drug: Topotecan Hydrochloride
Drug: Vincristine Sulfate Liposome
Drug: Carboplatin
Drug: Cisplatin
Drug: Cyclophosphamide
Drug: Doxorubicin Hydrochloride
Drug: Etoposide
Radiation: External Beam Radiation Therapy
Biological: Filgrastim
Drug: Isotretinoin
Other: Laboratory Biomarker Analysis
Drug: Melphalan
Procedure: Peripheral Blood Stem Cell Transplantation
Other: Pharmacological Study
Drug: Thiotepa
Drug: Topotecan Hydrochloride
Drug: Vincristine Sulfate Liposome
Drug(s)Drug: Carboplatin
Drug: Cisplatin
Drug: Cyclophosphamide
Drug: Doxorubicin Hydrochloride
Drug: Etoposide
Drug: Isotretinoin
Drug: Melphalan
Drug: Topotecan Hydrochloride
Drug: Vincristine Sulfate Liposome
Drug: Thiotepa
Drug: Cisplatin
Drug: Cyclophosphamide
Drug: Doxorubicin Hydrochloride
Drug: Etoposide
Drug: Isotretinoin
Drug: Melphalan
Drug: Topotecan Hydrochloride
Drug: Vincristine Sulfate Liposome
Drug: Thiotepa
Total Enrolled665
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionConsolidation Arm A: single myeloablative consolidation - Active Comparator
Consolidation Arm B: tandem myeloablative consolidation - Experimental
Consolidation Arm B: tandem myeloablative consolidation - Experimental
Secondary IDNCI-2009-01065
PubMed (PMID)32530765
31454045
31454045
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Australia
Canada
New Zealand
Puerto Rico
Switzerland
Australia
Canada
New Zealand
Puerto Rico
Switzerland
Age Range30 Years and younger (Child, Adult)
Type(s) of Cancer
Kidney
Kidney
Study Phase
Phase 3
Study Completion Date
December 2014
December 2014
NCT00352534Uploaded 09-24-2020
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Treatment for Very Low and Standard Risk Favorable Histology Wilms Tumor
Provider Information
Provider Data DescriptionNCT00352534-D1
This dataset is associated with the manuscript titled, ?Clinical Outcome and Biological Predictors of Relapse After Nephrectomy Only for Very Low-risk Wilms Tumor: A Report From Children's Oncology Group AREN0532.?
SponsorChildren's Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis phase III trial is studying vincristine, dactinomycin, and doxorubicin with or without radiation therapy or observation only to see how well they work in treating patients undergoing surgery for newly diagnosed stage I, stage II, or stage III Wilms' tumor. Drugs used in chemotherapy, such as vincristine, dactinomycin, and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving these treatments after surgery may kill any tumor cells that remain after surgery. Sometimes, after surgery, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient.
ConditionsStage I Kidney Wilms Tumor
Stage II Kidney Wilms Tumor
Stage III Kidney Wilms Tumor
Stage II Kidney Wilms Tumor
Stage III Kidney Wilms Tumor
Intervention TypeRadiation: 3-Dimensional Conformal Radiation Therapy
Biological: Dactinomycin
Drug: Doxorubicin Hydrochloride
Procedure: Therapeutic Conventional Surgery
Drug: Vincristine Sulfate
Biological: Dactinomycin
Drug: Doxorubicin Hydrochloride
Procedure: Therapeutic Conventional Surgery
Drug: Vincristine Sulfate
Drug(s)Drug: Doxorubicin Hydrochloride
Drug: Vincristine Sulfate
Drug: Vincristine Sulfate
Total Enrolled808
RandomizationNon-Randomized
Blinding MethodNone (Open Label)
Arms InterventionStratum I (very low-risk disease) - Experimental
Stratum II (standard-risk, stage I or II) - Experimental
Stratum III (standard-risk, stage III) - Experimental
Stratum II (standard-risk, stage I or II) - Experimental
Stratum III (standard-risk, stage III) - Experimental
Secondary IDNCI-2009-01067
PubMed (PMID)31449468
29211618
27811504
29211618
27811504
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Australia
Canada
Israel
New Zealand
Puerto Rico
Switzerland
Australia
Canada
Israel
New Zealand
Puerto Rico
Switzerland
Age Range29 Years and younger (Child, Adult)
Type(s) of Cancer
Neuroblastoma
Neuroblastoma
Study Phase
Phase 3
Study Completion Date
December 2013
December 2013
NCT01041638Uploaded 09-23-2020
Access via NCI by Request
A Comprehensive Safety Trial of Chimeric Antibody 14.18 (Ch14.18) With GM-CSF, IL-2 and Isotretinoin in High-Risk Neuroblastoma Patients Following Myeloablative Therapy
Provider Information
Provider Data DescriptionThe data and analysis for the results reported in Table 6 in the paper published was completed externally. Given the limited access to the original data, Table 6 subsequently has not been able to be replicated. There is one row for each patient enrolled on ANBL0931. The dataset provides the information necessary to reproduce patient baseline characteristics, disease outcome, and survival for patients on ANBL0931.
SponsorNational Cancer Institute (NCI)
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis phase III trial is studying the side effects of giving monoclonal antibody Ch14.18 together with sargramostim, aldesleukin, and isotretinoin after autologous stem cell transplant in treating patients with neuroblastoma. Monoclonal antibodies, such as Ch14.18, may find tumor cells and help kill them. Colony-stimulating factors, such as sargramostim, may increase the number of immune cells found in bone marrow or peripheral blood. Aldesleukin may stimulate the white blood cells to kill tumor cells. Isotretinoin may help neuroblastoma cells become more like normal cells, and to grow and spread more slowly. Giving monoclonal antibody Ch14.18 with sargramostim, aldesleukin, and isotretinoin after autologous stem cell transplant may be an effective treatment for neuroblastoma.
ConditionsHigh Risk Neuroblastoma
Intervention TypeBiological: Aldesleukin
Other: Diagnostic Laboratory Biomarker Analysis
Biological: Dinutuximab
Drug: Isotretinoin
Biological: Sargramostim
Other: Diagnostic Laboratory Biomarker Analysis
Biological: Dinutuximab
Drug: Isotretinoin
Biological: Sargramostim
Drug(s)Drug: Isotretinoin
Total Enrolled105
RandomizationN/A
Blinding MethodNone (Open Label)
Arms InterventionTreatment (Ch14.18, GM-CSF, IL-2, isotretinoin) - Experimental
Secondary IDNCI-2011-01997
PubMed (PMID)N/A
Collaborator(s)N/A
Region(s)United States
Age RangeN/A (Child, Adult, Older Adult)
Type(s) of Cancer
Neuroblastoma
Neuroblastoma
Study Phase
Phase 3
Study Completion Date
June 2014
June 2014
NCT00499616Uploaded 09-15-2020
Access via NCI by Request
Response- and Biology-Based Therapy for Intermediate-Risk Neuroblastoma
Provider Information
Provider Data DescriptionThere are two datasets associated with the publication: NCT00499616?D6 and NCT00499616?D7.
USI is the patient identifier in all datasets. Blanks represent missing data or not applicable for analyses. Data can be used to approximate published study findings, but exact reproduction of previous manuscripts may not be possible in some cases (e.g., when data must be modified for de-identification purposes or have undergone further data cleaning).
NCT00499616?D6: There is one row for each patient enrolled on ANBL0531. The dataset provided provides the information necessary to reproduce the manuscript, except for the toxicities.
SponsorChildren's Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: Drugs used in chemotherapy, such as carboplatin, cyclophosphamide, etoposide, and doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Isotretinoin may help neuroblastoma cells become more like normal cells, and grow and spread more slowly. Giving combination chemotherapy before surgery may make the tumor smaller and make it more likely that the tumor can be surgically removed. It is not yet known what is the minimal amount of chemotherapy needed to achieve sufficient tumor shrinkage to control intermediate risk neuroblastoma and prevent tumor recurrence or metastases.
PURPOSE: This phase III trial is designed to reduce therapy for patients with favorable biology intermediate risk neuroblastoma by decreasing the number of chemotherapy cycles administered and by allowing for up to 50% residual tumor volume for patients with localized disease.
ConditionsNeuroblastoma
Intervention TypeDrug: carboplatin
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: topotecan hydrochloride
Drug: Isotretinoin
Procedure: Surgery
Drug: Filgrastim
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: topotecan hydrochloride
Drug: Isotretinoin
Procedure: Surgery
Drug: Filgrastim
Drug(s)Drug: carboplatin
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: topotecan hydrochloride
Drug: Filgrastim
Drug: Isotretinoin
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: topotecan hydrochloride
Drug: Filgrastim
Drug: Isotretinoin
Total Enrolled464
RandomizationNon-Randomized
Blinding MethodNone (Open Label)
Arms InterventionGroup 2 (chemotherapy, surgery) - Experimental
Group 3 (chemotherapy, surgery) - Experimental
Group 4 (chemotherapy, surgery, antineoplastic therapy) - Experimental
Non-intermediate risk enrolled on intermediate risk trial - Experimental
Group 3 (chemotherapy, surgery) - Experimental
Group 4 (chemotherapy, surgery, antineoplastic therapy) - Experimental
Non-intermediate risk enrolled on intermediate risk trial - Experimental
Secondary IDCOG-ANBL0531
PubMed (PMID)31386611
30444686
30444686
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Australia
Canada
Netherlands
New Zealand
Puerto Rico
Australia
Canada
Netherlands
New Zealand
Puerto Rico
Age Range12 Years and younger (Child)
Type(s) of Cancer
Esophageal
Esophageal
Study Phase
Phase 3
Study Completion Date
April 2015
April 2015
NCT00655876Uploaded 09-02-2020
Access via NCI by Request
A Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation for Patients With Esophageal Cancer Who Are Treated Without Surgery
Provider Information
Provider Data DescriptionThis dataset will allow users to reproduce the treatment comparison in trial NCT00655876.
SponsorRadiation Therapy Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: Drugs used in chemotherapy, such as paclitaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may stop the growth of esophageal cancer by blocking blood flow to the tumor. It is not yet known whether giving paclitaxel and cisplatin together with radiation therapy is more effective with or without cetuximab in treating esophageal cancer.
PURPOSE: This randomized phase III trial is comparing how well giving paclitaxel and cisplatin together with radiation therapy works with or without cetuximab in treating patients with locally advanced esophageal cancer.
ConditionsEsophageal Cancer
Intervention TypeDrug: cetuximab
Drug: cisplatin
Drug: paclitaxel
Radiation: radiation therapy
Drug: cisplatin
Drug: paclitaxel
Radiation: radiation therapy
Drug(s)Drug: cetuximab
Drug: cisplatin
Drug: paclitaxel
Drug: cisplatin
Drug: paclitaxel
Total Enrolled344
RandomizationRandomized
Blinding MethodQuadruple
Arms InterventionChemoradiation + Cetuximab - Experimental
Chemoradiation - Active Comparator
Chemoradiation - Active Comparator
Secondary IDCDR0000538085
PubMed (PMID)28687830
Collaborator(s)National Cancer Institute (NCI)
NRG Oncology
NRG Oncology
Region(s)United States
Canada
Canada
Age Range18 Years to 74 Years (Adult, Older Adult)
Type(s) of Cancer
Leukemia/Lymphoma
Leukemia/Lymphoma
Study Phase
Phase 3
Study Completion Date
March 2012
March 2012
NCT01026220Uploaded 09-02-2020
Access via NCI by Request
A Non-Randomized Phase III Study of Response Adapted Therapy for the Treatment of Children With Newly Diagnosed High Risk Hodgkin Lymphoma
Provider Information
Provider Data DescriptionNCT01026220-D1 Dataset contains all the data which provides all the numbers, statistics, figures and tables in this publication. The data includes patient demographics, clinical characteristics and survival endpoints. This dataset is presented at patient level and includes one record per patient.
SponsorChildren's Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis phase III trial is studying how well giving combination chemotherapy together with radiation therapy works in treating young patients with newly diagnosed Hodgkin lymphoma. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x-rays to kill cancer cells. Giving combination chemotherapy together with radiation therapy may kill more cancer cells.
ConditionsChildhood Nodular Lymphocyte Predominant Hodgkin Lymphoma
Stage III Childhood Hodgkin Lymphoma
Stage IV Childhood Hodgkin Lymphoma
Stage III Childhood Hodgkin Lymphoma
Stage IV Childhood Hodgkin Lymphoma
Intervention TypeBiological: bleomycin sulfate
Drug: doxorubicin hydrochloride
Drug: liposomal vincristine sulfate
Drug: vinorelbine tartrate
Drug: cyclophosphamide
Drug: etoposide phosphate
Drug: prednisone
Biological: filgrastim
Drug: ifosfamide
Drug: doxorubicin hydrochloride
Drug: liposomal vincristine sulfate
Drug: vinorelbine tartrate
Drug: cyclophosphamide
Drug: etoposide phosphate
Drug: prednisone
Biological: filgrastim
Drug: ifosfamide
Drug(s)Drug: doxorubicin hydrochloride
Drug: liposomal vincristine sulfate
Drug: cyclophosphamide
Drug: etoposide phosphate
Drug: prednisone
Drug: vinorelbine tartrate
Drug: ifosfamide
Drug: liposomal vincristine sulfate
Drug: cyclophosphamide
Drug: etoposide phosphate
Drug: prednisone
Drug: vinorelbine tartrate
Drug: ifosfamide
Total Enrolled166
RandomizationNon-Randomized
Blinding MethodNone (Open Label)
Arms InterventionRegimen I (consolidation therapy) - Experimental
Regimen II (consolidation therapy) - Experimental
Induction: all patient - Experimental
Regimen II (consolidation therapy) - Experimental
Induction: all patient - Experimental
Secondary IDNCI-2011-01994
PubMed (PMID)N/A
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Australia
Canada
Israel
Puerto Rico
Australia
Canada
Israel
Puerto Rico
Age Range21 Years and younger (Child, Adult)
Type(s) of Cancer
Uterine
Uterine
Study Phase
Phase 3
Study Completion Date
September 2015
September 2015
NCT01012297Uploaded 08-21-2020
Access via NCI by Request
A Randomized Phase III Evaluation of Docetaxel (NSC #628503) and Gemcitabine (NSC #613327) Plus G-CSF With Bevacizumab (NSC #704865) Versus Docetaxel (NSC #628503) and Gemcitabine (NSC #613327) Plus G-CSF With Placebo in the Treatment of Recurrent or Advanced Leiomyosarcoma of the Uterus
Provider Information
Provider Data DescriptionThis dataset will allow users to reproduce the treatment comparison between Gemcitabine Plus Docetaxel Plus Bevacizumab and Gemcitabine Plus Docetaxel Plus Placebo
SponsorNational Cancer Institute (NCI)
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial is studying gemcitabine hydrochloride, docetaxel, and bevacizumab to see how well they work compared with gemcitabine hydrochloride, docetaxel, and a placebo in treating patients with advanced or recurrent uterine leiomyosarcoma. Drugs used in chemotherapy, such as gemcitabine hydrochloride and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether gemcitabine hydrochloride and docetaxel are more effective when given with or without bevacizumab in treating uterine leiomyosarcoma.
ConditionsRecurrent Uterine Corpus Sarcoma
Stage IIIA Uterine Sarcoma
Stage IIIB Uterine Sarcoma
Stage IIIC Uterine Sarcoma
Stage IVA Uterine Sarcoma
Stage IVB Uterine Sarcoma
Uterine Corpus Leiomyosarcoma
Stage IIIA Uterine Sarcoma
Stage IIIB Uterine Sarcoma
Stage IIIC Uterine Sarcoma
Stage IVA Uterine Sarcoma
Stage IVB Uterine Sarcoma
Uterine Corpus Leiomyosarcoma
Intervention TypeBiological: Bevacizumab
Drug: Docetaxel
Biological: Filgrastim
Drug: Gemcitabine Hydrochloride
Biological: Pegfilgrastim
Other: Placebo
Drug: Docetaxel
Biological: Filgrastim
Drug: Gemcitabine Hydrochloride
Biological: Pegfilgrastim
Other: Placebo
Drug(s)Drug: Docetaxel
Drug: Gemcitabine Hydrochloride
Drug: Gemcitabine Hydrochloride
Total Enrolled107
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionArm I Gem+Doce+Placebo - Experimental
Arm II Gem+Doce+Bev - Experimental
Arm II Gem+Doce+Bev - Experimental
Secondary IDNCI-2010-01738
PubMed (PMID)34298376
25713428
25713428
Collaborator(s)NRG Oncology
Region(s)United States
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Breast,Lung,Prostate
Breast,Lung,Prostate
Study Phase
Phase 3
Study Completion Date
January 2012
January 2012
NCT00365105Uploaded 07-24-2020
Access via NCI by Request
Randomized Phase III Trial to Evaluate Radiopharmaceuticals and Zoledronic Acid in the Palliation of Osteoblastic Metastases From Lung, Breast, and Prostate Cancer
Provider Information
Provider Data DescriptionData submissions NCT00365105-D1 and NCT00365105-D2 contain patient-reported acute toxicity and health-related quality of life (QOL) data from trial NCT00365105 to reproduce results PubMed ID=30094545.
SponsorRadiation Therapy Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: Zoledronate, vitamin D and calcium may prevent or delay bone pain and other symptoms caused by bone metastases. It is not yet known whether giving zoledronate together with vitamin D and calcium is more effective with or without strontium 89 or samarium 153 in treating patients with bone metastases from prostate cancer, lung cancer, or breast cancer.
PURPOSE: This randomized phase III trial is studying zoledronate, vitamin D, and calcium to see how well they work compared to zoledronate, vitamin D, calcium, and either strontium 89 or samarium 153 in preventing or delaying bone problems in patients with bone metastases from prostate cancer, lung cancer, or breast cancer.
ConditionsBreast Cancer
Lung Cancer
Metastatic Cancer
Pain
Prostate Cancer
Lung Cancer
Metastatic Cancer
Pain
Prostate Cancer
Intervention TypeDietary Supplement: Calcium
Dietary Supplement: Vitamin D
Drug: zoledronic acid
Drug: Sm-153
Radiation: Sr-89
Dietary Supplement: Vitamin D
Drug: zoledronic acid
Drug: Sm-153
Radiation: Sr-89
Drug(s)Drug: zoledronic acid
Drug: Sm-153
Drug: Sm-153
Total Enrolled261
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionZoledronic acid - Active Comparator
Zoledronic acid + Radiopharmaceuticals - Experimental
Zoledronic acid + Radiopharmaceuticals - Experimental
Secondary IDCDR0000491233
PubMed (PMID)30094545
Collaborator(s)National Cancer Institute (NCI)
NRG Oncology
NRG Oncology
Region(s)United States
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Prostate
Prostate
Study Phase
Phase 3
Study Completion Date
May 2011
May 2011
NCT00617669Uploaded 07-16-2020
Available for Download
A Phase III, Randomised, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of 10 mg ZD4054 (Zibotentan) in Combination With Docetaxel in Comparison With Docetaxel in Patients With Metastatic Hormone-resistant Prostate Cancer
Provider Information
Provider Data DescriptionThis data enhancement project seeks to further advance the mission of the PDS platform by enabling new explorations into the potential influence of health care access, socioeconomic factors, and health behaviors on the patient-level efficacy and outcomes data contained in the PDS online service. This was achieved using a statistical linkage method in which patient-level records from PDS dataset, Prostat_AstraZe_2008_104, were matched with prostate cancer survivors from the nationally representative Medical Expenditure Panel Survey (MEPS). Linkage criteria were based on age, sex, race, and a quality of life assessment called the EQ-5D index score. The use of the EQ-5D score as a linkage criterion reduces the multitude of many-to-many exact matches that would have occurred using only age, race, and sex. The addition of the MEPS data to the patient-level data within the PDS enclave will facilitate hypothesis-generating research efforts that explore the level of variation in patient outcomes potentially attributable to differentials in access to basic health care services and their utilization, to socioeconomic characteristics, and to health behaviors and preferences. It will support exploratory analyses designed to examine questions such as How are variations in cancer patients' access to health care and income impacting patient outcomes in specific phase III clinical trials? What variations in patient outcomes are associated with specific demographic, socioeconomic, and health-related factors? Are the demographic characteristics of those cancer patients enrolled in specific phase III clinical trials comparable to cancer patients with the same disease in the general population?
SponsorResearcher Curated
Data ProviderRTI International
Partial set or SubsetOriginal Data
Patients in dataset0
# of Patients Control0
# of Patients ExperimentalN/A
DOIhttps://doi.org/10.34949/16nn-5d22
CDISC StandardN/A
Study ArmsComparator arm data only
Clinical Trials.gov Information
Brief SummaryEnthuse M1C is a large phase III clinical trial studying the safety and efficacy of ZD4054 (Zibotentan) in combination with docetaxel (Taxotere) in patients with metastatic hormone resistant prostate cancer (HRPC).
This clinical trial will test if the Endothelin A Receptor Antagonist ZD4054 (Zibotentan) can further improve survival compared with docetaxel alone.
ZD4054 (Zibotentan) is a new type of agent, which is thought to slow tumour growth and spread by blocking Endothelin A receptor activity. This trial will look at the effects of ZD4054 (Zibotentan) in hormone resistant prostate cancer patients with bone metastases compared with docetaxel.
All patients participating in this clinical trial will receive docetaxel chemotherapy, which is a commonly used chemotherapy to treat prostate cancer in addition to other existing prostate cancer therapies.
Half the patients will receive ZD4054 (Zibotentan), and half the patients will receive placebo in addition to docetaxel and other prostate cancer therapy. By participating in this trial there is a 50% chance that patients will receive an agent that may further slow the progression of the tumour.
No patients will be deprived of standard prostate cancer therapy.
ConditionsProstate Cancer
Intervention TypeDrug: Docetaxel
Drug: ZD4054
Drug: Placebo
Drug: ZD4054
Drug: Placebo
Drug(s)Drug: Docetaxel
Drug: Placebo
Drug: ZD4054
Drug: Placebo
Drug: ZD4054
Total Enrolled1494
RandomizationRandomized
Blinding MethodTriple
Arms InterventionPlacebo + Docetaxel - Active Comparator
ZD4054 + Docetaxel - Experimental
ZD4054 + Docetaxel - Experimental
Secondary IDN/A
PubMed (PMID)23569308
Collaborator(s)N/A
Region(s)United States
Argentina
Australia
Brazil
Canada
Czech Republic
Finland
France
Germany
Hungary
India
Italy
Korea, Republic of
Netherlands
Peru
Poland
Portugal
Romania
Russian Federation
Serbia
South Africa
Spain
Sweden
Switzerland
Taiwan
United Kingdom
Argentina
Australia
Brazil
Canada
Czech Republic
Finland
France
Germany
Hungary
India
Italy
Korea, Republic of
Netherlands
Peru
Poland
Portugal
Romania
Russian Federation
Serbia
South Africa
Spain
Sweden
Switzerland
Taiwan
United Kingdom
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Lung
Lung
Study Phase
Phase 3
Study Completion Date
December 2008
December 2008
NCT00143455Uploaded 06-29-2020
Available for Download
Open Label, Randomised Multicentre Phase III Study Of Irinotecan Hydrochloride (Campto (Registered)) And Cisplatin Versus Etoposide And Cisplatin In Chemotherapy Naive Patients With Extensive Disease - Small Cell Lung Cancer
Provider Information
Provider Data DescriptionPRIMARY: To compare the effects of irinotecan hydrochloride with cisplatin to the ?standard? regimen etoposide plus cisplatin on overall survival, in chemotherapy-naive patients with newly diagnosed ED-SCLC; SECONDARY: 1. To compare the overall response rate, the duration of response and the time to progression between the two treatment regimens, 2. To compare the safety of the two treatment regimens, 3. To compare the quality of life of patients treated with the two regimens, utilizing the EORTC quality of life scale, 4. To compare the tumor-related symptoms (pain, dyspnea and the use of opioids and non-opioids analgesics).
SponsorPfizer
Data ProviderPfizer
Partial set or SubsetOriginal Data
Patients in dataset485
# of Patients Control243
# of Patients ExperimentalN/A
DOIhttps://doi.org/10.34949/231x-9g29
CDISC StandardADS
Study ArmsComparator arm data only
Clinical Trials.gov Information
Brief SummaryTo compare the effects of irinotecan hydrochloride with cisplatin to the "standard" regimen etoposide plus cisplatin on overall survival, in chemotherapy-naive patients with newly diagnosed Extensive Disease-Small Cell Lung Cancer (ED-SCLC).
ConditionsSmall Cell Lung Carcinoma
Intervention TypeDrug: Etoposide + cisplatin
Drug: Irinotecan + cisplatin
Drug: Irinotecan + cisplatin
Drug(s)Drug: Etoposide + cisplatin
Drug: Irinotecan + cisplatin
Drug: Irinotecan + cisplatin
Total Enrolled485
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionB - Experimental
A - Experimental
A - Experimental
Secondary IDN/A
PubMed (PMID)N/A
Collaborator(s)N/A
Region(s)Austria
Belgium
Czech Republic
Egypt
France
Germany
Italy
Netherlands
Poland
Russian Federation
Spain
Switzerland
Taiwan
Belgium
Czech Republic
Egypt
France
Germany
Italy
Netherlands
Poland
Russian Federation
Spain
Switzerland
Taiwan
Age Range18 Years to 75 Years (Adult, Older Adult)
Type(s) of Cancer
Uterine
Uterine
Study Phase
Phase 3
Study Completion Date
December 2015
December 2015
NCT01672892Uploaded 06-17-2020
Access via NCI by Request
A Randomized Phase III Study of Standard vs. IMRT Pelvic Radiation for Post-Operative Treatment of Endometrial and Cervical Cancer (TIME-C)
Provider Information
Provider Data DescriptionThis dataset contains patient-reported acute toxicity and health-related quality of life (QOL) data from trial NCT01672892 to reproduce the results in PubMed ID=29989857.
SponsorRadiation Therapy Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
PURPOSE: This randomized phase III trial is studying two different methods of radiation and their side effects and comparing how well they work in treating endometrial and cervical cancer after surgery.
ConditionsCervical Cancer
Endometrial Cancer
Gastrointestinal Complications
Perioperative/Postoperative Complications
Radiation Toxicity
Urinary Complications
Urinary Tract Toxicity
Endometrial Cancer
Gastrointestinal Complications
Perioperative/Postoperative Complications
Radiation Toxicity
Urinary Complications
Urinary Tract Toxicity
Intervention TypeRadiation: Standard radiation therapy
Radiation: intensity-modulated radiation therapy
Radiation: intensity-modulated radiation therapy
Drug(s)N/A
Total Enrolled289
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionIntensity-Modulated Radiation Therapy - Experimental
Standard Radiation Therapy - Active Comparator
Standard Radiation Therapy - Active Comparator
Secondary IDCDR0000738944
PubMed (PMID)32073955
31104905
29989857
35960897
31104905
29989857
35960897
Collaborator(s)National Cancer Institute (NCI)
NRG Oncology
NRG Oncology
Region(s)United States
Canada
Hong Kong
Singapore
Canada
Hong Kong
Singapore
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Prostate
Prostate
Study Phase
Phase 3
Study Completion Date
July 2010
July 2010
NCT00554229Uploaded 06-09-2020
Available for Download
Enhancing the Analytic Capacity of Prostat_AstraZe_2009_144 using a Statistical Linkage Method to Append Socioeconomic and Health Care Access Variables from the Medical Expenditure Panel Survey
Provider Information
Provider Data DescriptionThis data enhancement project seeks to further advance the mission of the PDS platform by enabling new explorations into the potential influence of health care access, socioeconomic factors, and health behaviors on the patient-level efficacy and outcomes data contained in the PDS online service. This was achieved using a statistical linkage method in which patient-level records from PDS dataset, Prostat_AstraZe_2009_144, were matched with prostate cancer survivors from the nationally representative Medical Expenditure Panel Survey (MEPS). Linkage criteria were based on age, sex, race, and a quality of life assessment called the EQ-5D index score. The use of the EQ-5D score as a linkage criterion reduces the multitude of many-to-many exact matches that would have occurred using only age, race, and sex. The addition of the MEPS data to the patient-level data within the PDS enclave will facilitate hypothesis-generating research efforts that explore the level of variation in patient outcomes potentially attributable to differentials in access to basic health care services and their utilization, to socioeconomic characteristics, and to health behaviors and preferences. It will support exploratory analyses designed to examine questions such as How are variations in cancer patients' access to health care and income impacting patient outcomes in specific phase III clinical trials? What variations in patient outcomes are associated with specific demographic, socioeconomic, and health-related factors? Are the demographic characteristics of those cancer patients enrolled in specific phase III clinical trials comparable to cancer patients with the same disease in the general population?
SponsorResearcher Curated
Data ProviderRTI International
Partial set or SubsetComposite
Patients in dataset266
# of Patients Control0
# of Patients ExperimentalN/A
DOIhttps://doi.org/10.34949/wqb5-8m69
CDISC StandardN/A
Study ArmsComparator arm data only
Clinical Trials.gov Information
Brief SummaryEnthuse M1 is a large phase III clinical trial studying the safety and efficacy of ZD4054 (Zibotentan) in patients with hormone resistant prostate cancer and bone metastases.
This clinical trial will test if the Endothelin A Receptor Antagonist ZD4054 (Zibotentan) can improve survival compared with placebo.
ZD4054(Zibotentan) is a new type of agent, which is thought to slow tumour growth and spread by blocking Endothelin A receptor activity. This trial will look at the effects of ZD4054 (Zibotentan) in hormone resistant prostate cancer patients with bone metastases.
All patients participating in this clinical trial will receive existing standard prostate cancer treatments in addition to trial therapy.
Half the patients will receive ZD4054 (Zibotentan), and half the patients will receive placebo in addition to standard prostate cancer therapy. By participating in this trial there is a 50% chance that patients will receive an agent that may slow the progression of the tumour.
No patients will be deprived of standard prostate cancer therapy.
ConditionsProstate Cancer
Intervention TypeDrug: ZD4054
Drug: Placebo
Drug: Placebo
Drug(s)Drug: ZD4054
Drug: Placebo
Drug: Placebo
Total Enrolled896
RandomizationRandomized
Blinding MethodQuadruple
Arms InterventionZD4054 - Experimental
Placebo - Placebo Comparator
Placebo - Placebo Comparator
Secondary ID2007-003227-20
PubMed (PMID)N/A
Collaborator(s)N/A
Region(s)United States
Argentina
Australia
Austria
Belgium
Brazil
Canada
China
Czech Republic
Denmark
Finland
France
Germany
Hong Kong
Hungary
India
Italy
Japan
Korea, Republic of
Mexico
Netherlands
Poland
Portugal
Russian Federation
Serbia
Singapore
South Africa
Sweden
Switzerland
Taiwan
United Kingdom
Argentina
Australia
Austria
Belgium
Brazil
Canada
China
Czech Republic
Denmark
Finland
France
Germany
Hong Kong
Hungary
India
Italy
Japan
Korea, Republic of
Mexico
Netherlands
Poland
Portugal
Russian Federation
Serbia
Singapore
South Africa
Sweden
Switzerland
Taiwan
United Kingdom
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Esophageal
Esophageal
Study Phase
Phase 3
Study Completion Date
March 2012
March 2012
NCT00678535Uploaded 05-18-2020
Available for Download
Enhancing the Analytic Capacity of Gastric_MerckKG_2008_130 using a Statistical Linkage Method to Append Socioeconomic and Health Care Access Variables from the Medical Expenditure Panel Survey
Provider Information
Provider Data DescriptionThis data enhancement project seeks to further advance the mission of the PDS platform by enabling new explorations into the potential influence of health care access, socioeconomic factors, and health behaviors on the patient-level efficacy and outcomes data contained in the PDS online service. This was achieved using a statistical linkage method in which patient-level records from PDS dataset, Gastric_MerckKG_2008_130, were matched with like cancer survivors from the nationally representative Medical Expenditure Panel Survey (MEPS). Linkage criteria were based on age, sex, race, and a quality of life assessment called the EQ-5D index score. The use of the EQ-5D score as a linkage criterion reduces the multitude of many-to-many exact matches that would have occurred using only age, race, and sex.
The addition of the MEPS data to the patient-level data within the PDS enclave will facilitate hypothesis-generating research efforts that explore the level of variation in patient outcomes potentially attributable to differentials in access to basic health care services and their utilization, to socioeconomic characteristics, and to health behaviors and preferences. It will support exploratory analyses designed to examine questions such as How are variations in cancer patients' access to health care and income impacting patient outcomes in specific phase III clinical trials? What variations in patient outcomes are associated with specific demographic, socioeconomic, and health-related factors? Are the demographic characteristics of those cancer patients enrolled in specific phase III clinical trials comparable to cancer patients with the same disease in the general population?
SponsorResearcher Curated
Data ProviderRTI International
Partial set or SubsetComposite
Patients in dataset436
# of Patients Control0
# of Patients ExperimentalN/A
DOIhttps://doi.org/10.34949/m157-nb03
CDISC StandardN/A
Study ArmsComparator arm data only
Clinical Trials.gov Information
Brief SummaryThe primary objective of this study is to demonstrate that addition of cetuximab to 1st-line treatment with capecitabine (Xeloda, X) and cisplatin (P) [XP] chemotherapy regimen has a clinically relevant benefit for subjects with advanced gastric adenocarcinoma including gastroesophageal junction (GEJ) adenocarcinoma, in terms of progression free survival (PFS).
Secondary objectives are to assess cetuximab plus XP versus XP alone with respect to overall survival, overall tumor response, quality of life (QoL) and safety.
ConditionsGastric Cancer
Intervention TypeDrug: Cetuximab
Drug: Capecitabine
Drug: Cisplatin
Drug: Capecitabine
Drug: Cisplatin
Drug(s)Drug: Cetuximab
Drug: Capecitabine
Drug: Cisplatin
Drug: Capecitabine
Drug: Cisplatin
Total Enrolled904
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionCetuximab plus Capecitabine plus Cisplatin - Experimental
Capecitabine plus Cisplatin - Active Comparator
Capecitabine plus Cisplatin - Active Comparator
Secondary ID2007-004219-75
PubMed (PMID)N/A
Collaborator(s)N/A
Region(s)Argentina
Australia
Austria
Belgium
Brazil
Bulgaria
Chile
China
Czech Republic
France
Germany
Greece
Hong Kong
Hungary
Israel
Italy
Japan
Korea, Republic of
Poland
Portugal
Romania
Russian Federation
Spain
Taiwan
United Kingdom
Australia
Austria
Belgium
Brazil
Bulgaria
Chile
China
Czech Republic
France
Germany
Greece
Hong Kong
Hungary
Israel
Italy
Japan
Korea, Republic of
Poland
Portugal
Romania
Russian Federation
Spain
Taiwan
United Kingdom
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Esophageal
Esophageal
Study Phase
Phase 2BPhase 3
Study Completion Date
April 2012
April 2012
NCT00409188Uploaded 05-18-2020
Available for Download
Enhancing the Analytic Capacity of Gastric_SanofiU_1999_143 using a Statistical Linkage Method to Append Socioeconomic and Health Care Access Variables from the Medical Expenditure Panel Survey
Provider Information
Provider Data DescriptionThis data enhancement project seeks to further advance the mission of the PDS platform by enabling new explorations into the potential influence of health care access, socioeconomic factors, and health behaviors on the patient-level efficacy and outcomes data contained in the PDS online service. This was achieved using a statistical linkage method in which patient-level records from PDS dataset, Gastric_SanofiU_1999_143, were matched with like cancer survivors from the nationally representative Medical Expenditure Panel Survey (MEPS). Linkage criteria were based on age, sex, race, and a quality of life assessment called the EQ-5D index score. The use of the EQ-5D score as a linkage criterion reduces the multitude of many-to-many exact matches that would have occurred using only age, race, and sex.
The addition of the MEPS data to the patient-level data within the PDS enclave will facilitate hypothesis-generating research efforts that explore the level of variation in patient outcomes potentially attributable to differentials in access to basic health care services and their utilization, to socioeconomic characteristics, and to health behaviors and preferences. It will support exploratory analyses designed to examine questions such as How are variations in cancer patients' access to health care and income impacting patient outcomes in specific phase III clinical trials? What variations in patient outcomes are associated with specific demographic, socioeconomic, and health-related factors? Are the demographic characteristics of those cancer patients enrolled in specific phase III clinical trials comparable to cancer patients with the same disease in the general population?
SponsorResearcher Curated
Data ProviderRTI International
Partial set or SubsetComposite
Patients in dataset218
# of Patients Control0
# of Patients ExperimentalN/A
DOIhttps://doi.org/10.34949/jtx7-ve58
CDISC StandardN/A
Study ArmsComparator arm data only
Clinical Trials.gov Information
Brief SummaryThe purpose of this study is to determine whether the cancer vaccine tecemotide (L-BLP25) in addition to best supportive care is effective in prolonging the lives of subjects with unresectable stage III non-small cell lung cancer, compared to best supportive care alone.
A local ancillary (sub) study in European centers will evaluate the immune response in peripheral blood after tecemotide (L-BLP25) or placebo vaccination.
ConditionsNon-small Cell Lung Cancer
Intervention TypeBiological: Tecemotide (L-BLP25)
Drug: Single low dose cyclophosphamide
Drug: Placebo
Drug: Single low dose cyclophosphamide
Drug: Placebo
Drug(s)Drug: Single low dose cyclophosphamide
Drug: Placebo
Drug: Placebo
Total Enrolled1513
RandomizationRandomized
Blinding MethodQuadruple
Arms InterventionTecemotide (L-BLP25) - Experimental
Placebo - Placebo Comparator
Placebo - Placebo Comparator
Secondary IDN/A
PubMed (PMID)24331154
24976972
34870327
25722382
24976972
34870327
25722382
Collaborator(s)Merck KGaA, Darmstadt, Germany
Region(s)United States
Argentina
Australia
Austria
Belgium
Brazil
Canada
China
Czech Republic
Denmark
France
Germany
Greece
Hong Kong
Hungary
India
Ireland
Israel
Italy
Korea, Republic of
Mexico
Netherlands
Poland
Portugal
Romania
Russian Federation
Singapore
Slovakia
Spain
Sweden
Switzerland
Taiwan
United Kingdom
Argentina
Australia
Austria
Belgium
Brazil
Canada
China
Czech Republic
Denmark
France
Germany
Greece
Hong Kong
Hungary
India
Ireland
Israel
Italy
Korea, Republic of
Mexico
Netherlands
Poland
Portugal
Romania
Russian Federation
Singapore
Slovakia
Spain
Sweden
Switzerland
Taiwan
United Kingdom
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Breast
Breast
Study Phase
Phase 3
Study Completion Date
September 2006
September 2006
NCT00081796Uploaded 05-15-2020
Available for Download
Enhancing the Analytic Capacity of Breast_SanofiU_2004_135 using a Statistical Linkage Method to Append Socioeconomic and Health Care Access Variables from the Medical Expenditure Panel Survey
Provider Information
Provider Data DescriptionThis data enhancement project seeks to further advance the mission of the PDS platform by enabling new explorations into the potential influence of health care access, socioeconomic factors, and health behaviors on the patient-level efficacy and outcomes data contained in the PDS online service. This was achieved using a statistical linkage method in which patient-level records from PDS dataset, Breast_SanofiU_2004_135, were matched with like breast cancer survivors from the nationally representative Medical Expenditure Panel Survey (MEPS). Linkage criteria were based on age, sex, race, and a quality of life assessment called the EQ-5D index score. The use of the EQ-5D score as a linkage criterion reduces the multitude of many-to-many exact matches that would have occurred using only age, race, and sex. An optional fifth linkage criterion based on BMI category has also been provided, so researchers can filter the set of linkages to stronger matches as desired.
The addition of the MEPS data to the patient-level data within the PDS enclave will facilitate hypothesis-generating research efforts that explore the level of variation in patient outcomes potentially attributable to differentials in access to basic health care services and their utilization, to socioeconomic characteristics, and to health behaviors and preferences. It will support exploratory analyses designed to examine questions such as How are variations in cancer patients' access to health care and income impacting patient outcomes in specific phase III clinical trials? What variations in patient outcomes are associated with specific demographic, socioeconomic, and health-related factors? Are the demographic characteristics of those cancer patients enrolled in specific phase III clinical trials comparable to cancer patients with the same disease in the general population?
SponsorResearcher Curated
Data ProviderRTI International
Partial set or SubsetComposite
Patients in dataset217
# of Patients Control0
# of Patients ExperimentalN/A
DOIhttps://doi.org/10.34949/fk5j-hx40
CDISC StandardN/A
Study ArmsComparator arm data only
Clinical Trials.gov Information
Brief SummaryThe purpose of this clinical trial is to determine if RPR109881 is a better treatment than capecitabine (Xeloda) for advanced breast cancer in patients that no longer benefit from docetaxel and/or paclitaxel.
ConditionsBreast Cancer
Metastases
Metastases
Intervention TypeDrug: larotaxel (RPR109881, XRP9881)
Drug: capecitabine
Drug: capecitabine
Drug(s)N/A
Total Enrolled438
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionN/A
Secondary IDXRP9881B-3001
PubMed (PMID)N/A
Collaborator(s)N/A
Region(s)United States
Argentina
Australia
Austria
Brazil
Canada
Chile
Colombia
Czech Republic
Finland
France
Germany
Hungary
Israel
Italy
Korea, Republic of
Mexico
New Zealand
Poland
Portugal
Romania
Slovenia
South Africa
Spain
Taiwan
United Kingdom
Argentina
Australia
Austria
Brazil
Canada
Chile
Colombia
Czech Republic
Finland
France
Germany
Hungary
Israel
Italy
Korea, Republic of
Mexico
New Zealand
Poland
Portugal
Romania
Slovenia
South Africa
Spain
Taiwan
United Kingdom
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Liver
Liver
Study Phase
Phase 3
Study Completion Date
June 2020
June 2020
NCT00980460Uploaded 04-29-2020
Access via NCI by Request
Treatment of Children With All Stages of Hepatoblastoma With Temsirolimus (NSC#683864) Added to High Risk Stratum Treatment
Provider Information
Provider Data DescriptionNCT00980460-D1-Dataset (Main)
This dataset provides the information for baseline characteristics, response, surgical outcome plus event-free and overall survival for all evaluable patients as reported in the manuscript. Information is only provided for evaluable patients (analysiset = 1). Variables were left blank for the patients who were not evaluable (analysiset = 0).
There is one row per patient.
SponsorNational Cancer Institute
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis phase III trial studies the side effects and how well risk-based therapy works in treating younger patients with newly diagnosed liver cancer. Surgery, chemotherapy drugs (cancer fighting medicines), and when necessary, liver transplant, are the main current treatments for hepatoblastoma. The stage of the cancer is one factor used to decide the best treatment. Treating patients according to the risk group they are in may help get rid of the cancer, keep it from coming back, and decrease the side effects of chemotherapy.
ConditionsPRETEXT Stage 1 Hepatoblastoma
PRETEXT Stage 2 Hepatoblastoma
PRETEXT Stage 3 Hepatoblastoma
PRETEXT Stage 4 Hepatoblastoma
PRETEXT Stage 2 Hepatoblastoma
PRETEXT Stage 3 Hepatoblastoma
PRETEXT Stage 4 Hepatoblastoma
Intervention TypeDrug: Cisplatin
Drug: Dexrazoxane
Drug: Doxorubicin Hydrochloride
Drug: Fluorouracil
Drug: Irinotecan Hydrochloride
Other: Laboratory Biomarker Analysis
Procedure: Liver Transplantation
Drug: Temsirolimus
Procedure: Therapeutic Conventional Surgery
Drug: Vincristine Sulfate
Drug: Dexrazoxane
Drug: Doxorubicin Hydrochloride
Drug: Fluorouracil
Drug: Irinotecan Hydrochloride
Other: Laboratory Biomarker Analysis
Procedure: Liver Transplantation
Drug: Temsirolimus
Procedure: Therapeutic Conventional Surgery
Drug: Vincristine Sulfate
Drug(s)Drug: Cisplatin
Drug: Doxorubicin Hydrochloride
Drug: Fluorouracil
Drug: Irinotecan Hydrochloride
Drug: Temsirolimus
Drug: Vincristine Sulfate
Drug: Dexrazoxane
Drug: Doxorubicin Hydrochloride
Drug: Fluorouracil
Drug: Irinotecan Hydrochloride
Drug: Temsirolimus
Drug: Vincristine Sulfate
Drug: Dexrazoxane
Total Enrolled236
RandomizationNon-Randomized
Blinding MethodNone (Open Label)
Arms InterventionHigh-risk group (regimen H) - Experimental
High-risk group (regimen W) - Experimental
Intermediate-risk group (regimen F) - Experimental
Low-risk group (regimen T) - Experimental
Very low-risk group - Experimental
High-risk group (regimen W) - Experimental
Intermediate-risk group (regimen F) - Experimental
Low-risk group (regimen T) - Experimental
Very low-risk group - Experimental
Secondary IDNCI-2011-01975
PubMed (PMID)34874751
30975630
30975630
Collaborator(s)N/A
Region(s)United States
Australia
Brazil
Canada
Japan
Puerto Rico
Australia
Brazil
Canada
Japan
Puerto Rico
Age Range21 Years and younger (Child, Adult)
Type(s) of Cancer
Prostate
Prostate
Study Phase
Phase 3
Study Completion Date
January 2011
January 2011
NCT00626548Uploaded 04-28-2020
Available for Download
Enhancing the Analytic Capacity of Prostat_AstraZe_2008_103 using a Statistical Linkage Method to Append Socioeconomic and Health Care Access Variables from the Medical Expenditure Panel Survey
Provider Information
Provider Data DescriptionThis project seeks to further advance the mission of the PDS platform by enabling new explorations into the potential influence of health care access, socioeconomic factors, and health behaviors on the patient-level efficacy and outcomes data contained in the PDS online service. This was achieved using a statistical linkage method in which patient-level records from PDS dataset, Prostat_AstraZe_2008_103, were matched with prostate cancer survivors from the nationally representative Medical Expenditure Panel Survey (MEPS). Linkage criteria were based on age, sex, race, and a quality of life assessment called the EQ-5D index score. The use of the EQ-5D score as a linkage criterion reduces the multitude of many-to-many exact matches that would have occurred using only age, race, and sex. An optional sixth linkage criterion, BMI category, is also provided so that data users can further filter the set of many-to-many linkages to stronger matches. The addition of the MEPS data to the patient-level data within the PDS enclave will facilitate hypothesis-generating research efforts that explore the level of variation in patient outcomes potentially attributable to differentials in access to basic health care services and their utilization, to socioeconomic characteristics, and to health behaviors and preferences. It will support exploratory analyses designed to examine questions such as How are variations in cancer patients' access to health care and income impacting patient outcomes in specific phase III clinical trials? What variations in patient outcomes are associated with specific demographic, socioeconomic, and health-related factors? Are the demographic characteristics of those cancer patients enrolled in specific phase III clinical trials comparable to cancer patients with the same disease in the general population?
SponsorResearcher Curated
Data ProviderRTI International
Partial set or SubsetComposite
Patients in dataset677
# of Patients Control0
# of Patients ExperimentalN/A
DOIhttps://doi.org/10.34949/g0gb-zn20
CDISC StandardN/A
Study ArmsComparator arm data only
Clinical Trials.gov Information
Brief SummaryEnthuse M0 is a large phase III clinical trial studying the efficacy of ZD4054 (Zibotentan) in hormone resistant prostate cancer (HRPC).
This clinical trial will test if the Endothelin A Receptor Antagonist ZD4054 (Zibotentan) can improve progression-free survival and overall survival against a background of existing prostate cancer treatments.
ZD4054 (Zibotentan) is a new type of agent, which is thought to slow tumour growth and spread by blocking Endothelin receptor activity. This trial will look at the effects of ZD4054 (Zibotentan) in hormone resistant prostate cancer (HRPC) patients who have had rising PSA after surgical or medical castration but have no evidence of metastases.
All patients participating in this clinical trial will receive existing prostate cancer treatments in addition to trial therapy.
Half the patients will receive ZD4054 (Zibotentan) , and half the patients will receive placebo in addition to standard prostate cancer therapy. By participating in this trial there is a 50% chance that patients will receive an agent that may slow the progression of the tumour.
No patients will be deprived of standard prostate cancer therapy.
ConditionsProstate Cancer
Intervention TypeDrug: ZD4054
Drug: Palcebo
Drug: Palcebo
Drug(s)Drug: Palcebo
Drug: ZD4054
Drug: ZD4054
Total Enrolled2577
RandomizationRandomized
Blinding MethodTriple
Arms InterventionPlacebo - Placebo Comparator
ZD4054 - Experimental
ZD4054 - Experimental
Secondary IDN/A
PubMed (PMID)N/A
Collaborator(s)N/A
Region(s)United States
Argentina
Australia
Austria
Belgium
Brazil
Canada
Chile
China
Colombia
Czech Republic
Denmark
Finland
France
Germany
Hungary
India
Ireland
Israel
Italy
Japan
Korea, Republic of
Latvia
Mexico
Netherlands
Norway
Peru
Poland
Portugal
Romania
Russian Federation
Serbia
South Africa
Spain
Sweden
Switzerland
Taiwan
Turkey
United Kingdom
Argentina
Australia
Austria
Belgium
Brazil
Canada
Chile
China
Colombia
Czech Republic
Denmark
Finland
France
Germany
Hungary
India
Ireland
Israel
Italy
Japan
Korea, Republic of
Latvia
Mexico
Netherlands
Norway
Peru
Poland
Portugal
Romania
Russian Federation
Serbia
South Africa
Spain
Sweden
Switzerland
Taiwan
Turkey
United Kingdom
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Colorectal
Colorectal
Study Phase
Phase 3
Study Completion Date
November 2012
November 2012
NCT00079274Uploaded 04-28-2020
Access via NCI by Request
A Randomized Phase III Trial of Oxaliplatin (OXAL) Plus 5-Fluorouracil (5-FU)/Leucovorin (CF) With or Without Cetuximab (C225) After Curative Resection for Patients With Stage III Colon Cancer
Provider Information
Provider Data DescriptionThe NCT00079274-D1-Dataset.csv dataset is one of 3 datasets associated with PubMed ID 22474202. This dataset contains information on baseline characteristics, eligibility, and follow-up status.
SponsorNational Cancer Institute
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial was originally designed to compare three different combination chemotherapy regimens to see how well they work. As of September 1, 2004, the study was expanded to a total of 6 arms (the original 3 arms (A, B, C) and 3 additional arms which were the same as the first 3 but with cetuximab) in treating patients who have undergone surgery for stage III colon cancer. Drugs used in chemotherapy, such as irinotecan hydrochloride, fluorouracil, leucovorin calcium, and oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining more than one chemotherapy drug with monoclonal antibody therapy and giving them after surgery may kill any remaining tumor cells. It was not known at the time this study was developed which combination chemotherapy regimen is more effective after surgery in treating colon cancer. This study had several key changes, based on the results of other phase III trials. As of 6/1/2005, patients no longer received irinotecan on this study and treatment arms B, C, E, and F were discontinued. Patients on arms B and C crossed to arm A. Patients on arms E and F crossed to arm D. Patients on arms C and F who had not gotten to irinotecan continued on arms A and D, respectively. As of 8/18/2008, pre-screening for Kirsten rat sarcoma (KRAS) status was added with mutant KRAS (or KRAS not evaluable) patients put on arm G and wild-type KRAS patients randomized between arm A and arm D. Patients on arm G were treated per physician discretion and followed for disease and survival status. KRAS was determined in a central laboratory and was process for all patients on this study. The primary endpoint of this study was modified on 8/18/2008 to focus on patients having wild-type KRAS tumors. All modifications were approved by the Central Institution Review Board, local Institutional Review Boards, NCI, and the NCCTG Data Safety Monitoring Board.
ConditionsAdenocarcinoma of the Colon
Stage III Colon Cancer
Stage III Colon Cancer
Intervention TypeDrug: irinotecan hydrochloride
Drug: oxaliplatin
Drug: leucovorin calcium
Drug: fluorouracil
Biological: cetuximab
Drug: Locally Directed Therapy
Drug: oxaliplatin
Drug: leucovorin calcium
Drug: fluorouracil
Biological: cetuximab
Drug: Locally Directed Therapy
Drug(s)Drug: oxaliplatin
Drug: leucovorin calcium
Drug: fluorouracil
Drug: irinotecan hydrochloride
Drug: Locally Directed Therapy
Drug: leucovorin calcium
Drug: fluorouracil
Drug: irinotecan hydrochloride
Drug: Locally Directed Therapy
Total Enrolled3397
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionArm A (combination chemotherapy) - Experimental
Arm B (combination chemotherapy) - Experimental
Arm C (combination chemotherapy) - Experimental
Arm D (combination chemotherapy, monoclonal antibody) - Experimental
Arm E (combination chemotherapy, monoclonal antibody) - Experimental
Arm F (combination chemotherapy, monoclonal antibody) - Experimental
Arm G (Locally directed therapy) - Other
Arm B (combination chemotherapy) - Experimental
Arm C (combination chemotherapy) - Experimental
Arm D (combination chemotherapy, monoclonal antibody) - Experimental
Arm E (combination chemotherapy, monoclonal antibody) - Experimental
Arm F (combination chemotherapy, monoclonal antibody) - Experimental
Arm G (Locally directed therapy) - Other
Secondary IDN0147
PubMed (PMID)36306483
35963480
33863713
33356421
33203692
32165096
31811950
31268130
28983557
28006055
23623224
22474202
35963480
33863713
33356421
33203692
32165096
31811950
31268130
28983557
28006055
23623224
22474202
Collaborator(s)Eastern Cooperative Oncology Group
Region(s)United States
Canada
Puerto Rico
Canada
Puerto Rico
Age Range18 Years to 99 Years (Adult, Older Adult)
Type(s) of Cancer
Lung
Lung
Study Phase
Phase 3
Study Completion Date
January 2017
January 2017
NCT01041781Uploaded 04-28-2020
Access via NCI by Request
A Randomized Phase III Double Blind Trial Evaluating Selective COX-2 Inhibition in COX-2 Expressing Advanced Non-Small Cell Lung Cancer
Provider Information
Provider Data DescriptionDataset NCT01041781-D1-Dataset.csv (c30801) is one of 2 datasets associated with PubMed ID 28489511. This dataset contains information that will allow you to reproduce the baseline characteristics table and primary analysis.
In Table A5, there is a typo in the median number of OS months for Celecoxib patients with COX-2 >= 2. The correct numbers should be 15.73 (11.50-18.96) and they are the same as those present on this shared dataset.
SponsorAlliance for Clinical Trials in Oncology
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Pemetrexed disodium and celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving gemcitabine hydrochloride or pemetrexed disodium together with carboplatin is more effective with or without celecoxib in treating non-small cell lung cancer.
PURPOSE: This randomized phase III trial is studying gemcitabine hydrochloride, pemetrexed disodium, and carboplatin to compare how well they work when given together with celecoxib or a placebo in treating patients with advanced non-small cell lung cancer.
ConditionsLung Cancer
Intervention TypeDrug: carboplatin
Drug: celecoxib
Drug: gemcitabine hydrochloride
Drug: pemetrexed disodium
Other: placebo
Drug: celecoxib
Drug: gemcitabine hydrochloride
Drug: pemetrexed disodium
Other: placebo
Drug(s)Drug: carboplatin
Drug: celecoxib
Drug: gemcitabine hydrochloride
Drug: pemetrexed disodium
Drug: celecoxib
Drug: gemcitabine hydrochloride
Drug: pemetrexed disodium
Total Enrolled313
RandomizationRandomized
Blinding MethodDouble
Arms InterventionArm I - Experimental
Arm II - Active Comparator
Arm II - Active Comparator
Secondary IDCALGB-30801
PubMed (PMID)28489511
30702971
30702971
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Leukemia/Lymphoma
Leukemia/Lymphoma
Study Phase
Phase 3
Study Completion Date
July 2016
July 2016
NCT00651261Uploaded 04-28-2020
Access via NCI by Request
A Phase III Randomized, Double-Blind Study of Induction (Daunorubicin/Cytarabine) and Consolidation (High-Dose Cytarabine) Chemotherapy + Midostaurin (PKC412) (IND #101261) or Placebo in Newly Diagnosed Patients < 60 Years of Age With FLT3 Mutated Acute Myeloid Leukemia (AML)
Provider Information
Provider Data DescriptionDataset NCT00651261-D1-Dataset.csv (baseline) is one of 5 datasets associated with PubMed ID 28644114. This dataset contains information that will allow you to reproduce the baseline characteristics table.
SponsorAlliance for Clinical Trials in Oncology
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThe purpose of this study is to compare the effects, good and/or bad, of a standard chemotherapy regimen for AML that includes the drugs daunorubicin and cytarabine combined with or without midostaurin (also known as PKC412), to find out which is better. This research is being done because it is unknown whether the addition of midostaurin to chemotherapy treatment is better than chemotherapy treatment alone. Midostaurin has been tested in over 400 patients and is being studied in a number of illnesses, including AML, colon cancer, and lung cancer. Midostaurin blocks an enzyme, produced by a gene known as FLT3, that may have a role in the survival and growth of AML cells. Not all leukemia cells will have the abnormal FLT3 gene. This study will focus only on patients with leukemia cells with the abnormal FLT3 gene.
ConditionsLeukemia
Intervention TypeDrug: cytarabine
Drug: daunorubicin
Drug: midostaurin
Other: placebo
Drug: dexamethasone acetate
Drug: daunorubicin
Drug: midostaurin
Other: placebo
Drug: dexamethasone acetate
Drug(s)Drug: cytarabine
Drug: daunorubicin
Drug: midostaurin
Drug: dexamethasone acetate
Drug: daunorubicin
Drug: midostaurin
Drug: dexamethasone acetate
Total Enrolled717
RandomizationRandomized
Blinding MethodDouble
Arms InterventionInduction and consolidation chemotherapy plus midostaurin - Experimental
Induction and consolidation chemotherapy plus placebo - Active Comparator
Induction and consolidation chemotherapy plus placebo - Active Comparator
Secondary IDCALGB-10603
PubMed (PMID)33049054
31375516
31171508
30382485
28644114
22627678
31375516
31171508
30382485
28644114
22627678
Collaborator(s)National Cancer Institute (NCI)
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Region(s)United States
Canada
Canada
Age Range18 Years to 59 Years (Adult)
Type(s) of Cancer
Germ Cell
Germ Cell
Study Phase
Phase 3
Study Completion Date
October 2013
October 2013
NCT00053352Uploaded 04-28-2020
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A Phase III Study Of Reduced Therapy In The Treatment Of Children With Low And Intermediate Risk Extracranial Germ Cell Tumors
Provider Information
Provider Data DescriptionNCT00053352-D1
The dataset provides the information for the consort diagram (Figure 1).
There is one row per patient.
SponsorChildren's Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis phase III trial is studying surgery followed by combination chemotherapy to see how well it works in treating children with germ cell tumors that are not located in the head. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug, and giving them after surgery, may kill any remaining tumor cells following surgery. It is not yet known whether combination chemotherapy is effective in decreasing the recurrence of childhood germ cell tumors.
ConditionsChildhood Embryonal Tumor
Childhood Extracranial Germ Cell Tumor
Childhood Extragonadal Germ Cell Tumor
Childhood Malignant Ovarian Germ Cell Tumor
Childhood Malignant Testicular Germ Cell Tumor
Childhood Teratoma
Ovarian Embryonal Carcinoma
Ovarian Yolk Sac Tumor
Stage II Malignant Testicular Germ Cell Tumor
Stage IIA Ovarian Germ Cell Tumor
Stage IIB Ovarian Germ Cell Tumor
Stage IIC Ovarian Germ Cell Tumor
Stage III Malignant Testicular Germ Cell Tumor
Stage IIIA Ovarian Germ Cell Tumor
Stage IIIB Ovarian Germ Cell Tumor
Stage IIIC Ovarian Germ Cell Tumor
Testicular Choriocarcinoma and Yolk Sac Tumor
Testicular Embryonal Carcinoma
Childhood Extracranial Germ Cell Tumor
Childhood Extragonadal Germ Cell Tumor
Childhood Malignant Ovarian Germ Cell Tumor
Childhood Malignant Testicular Germ Cell Tumor
Childhood Teratoma
Ovarian Embryonal Carcinoma
Ovarian Yolk Sac Tumor
Stage II Malignant Testicular Germ Cell Tumor
Stage IIA Ovarian Germ Cell Tumor
Stage IIB Ovarian Germ Cell Tumor
Stage IIC Ovarian Germ Cell Tumor
Stage III Malignant Testicular Germ Cell Tumor
Stage IIIA Ovarian Germ Cell Tumor
Stage IIIB Ovarian Germ Cell Tumor
Stage IIIC Ovarian Germ Cell Tumor
Testicular Choriocarcinoma and Yolk Sac Tumor
Testicular Embryonal Carcinoma
Intervention TypeProcedure: conventional surgery
Drug: cisplatin
Drug: etoposide
Biological: bleomycin sulfate
Other: laboratory biomarker analysis
Drug: cisplatin
Drug: etoposide
Biological: bleomycin sulfate
Other: laboratory biomarker analysis
Drug(s)Drug: cisplatin
Drug: etoposide
Drug: etoposide
Total Enrolled302
RandomizationNon-Randomized
Blinding MethodNone (Open Label)
Arms InterventionArm I - Experimental
Arm 2 - No Intervention
Arm 2 - No Intervention
Secondary IDNCI-2009-00373
PubMed (PMID)31355926
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Australia
Canada
New Zealand
Puerto Rico
Switzerland
Australia
Canada
New Zealand
Puerto Rico
Switzerland
Age Range21 Years and younger (Child, Adult)
Type(s) of Cancer
Eye
Eye
Study Phase
Phase 3
Study Completion Date
January 2010
January 2010
NCT00079417Uploaded 04-28-2020
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Trial of Systemic Neoadjuvant Chemotherapy for Group B Intraocular Retinoblastoma
Provider Information
Provider Data DescriptionNCT00079417-D1
Blanks represent missing data or not applicable for analysis. The CONSORT diagram (manuscript Figure 2) can be reconstructed with the variable consort1 through consort4. The dataset contains one line for every patient enrolled on ARET0331. Table 1, Table 2, Figure 3 and the cumulative incidence calculations can be calculated from this data set.
SponsorChildren's Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis phase III trial is studying how well giving carboplatin and vincristine together with standard local ophthalmic therapy works in treating children with intraocular retinoblastoma. Drugs used in chemotherapy, such as carboplatin and vincristine, work in different ways to stop tumor from dividing so they stop growing or die. It is not yet known whether neoadjuvant chemotherapy combined with standard local ophthalmic therapy is effective in treating intraocular retinoblastoma.
ConditionsIntraocular Retinoblastoma
Intervention TypeDrug: Carboplatin
Procedure: Cryosurgery
Procedure: Infrared Laser Therapy
Radiation: Iodine I-125
Radiation: Radiation Therapy
Radiation: Ruthenium Ru-106
Drug: Vincristine Sulfate
Procedure: Cryosurgery
Procedure: Infrared Laser Therapy
Radiation: Iodine I-125
Radiation: Radiation Therapy
Radiation: Ruthenium Ru-106
Drug: Vincristine Sulfate
Drug(s)Drug: Carboplatin
Drug: Vincristine Sulfate
Drug: Vincristine Sulfate
Total Enrolled28
RandomizationN/A
Blinding MethodNone (Open Label)
Arms InterventionTreatment (chemotherapy, surgery) - Experimental
Secondary IDNCI-2009-00422
PubMed (PMID)N/A
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Age Range5 Years and younger (Child)
Type(s) of Cancer
Head and Neck
Head and Neck
Study Phase
Phase 3
Study Completion Date
July 2018
July 2018
NCT01302834Uploaded 04-28-2020
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Phase III Trial of Radiotherapy Plus Cetuximab Versus Chemoradiotherapy in HPV-Associated Oropharynx Cancer
Provider Information
Provider Data DescriptionThis dataset will allow users to reproduce the treatment comparison between arm 1 and arm 2 in trial NCT01302834. Specifically, this dataset contains baseline, treatment, survival, pre-specified treatment related adverse event, swallowing domain, and dental gingival health data.
SponsorNational Cancer Institute
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether radiation therapy is more effective with cisplatin or cetuximab in treating oropharyngeal cancer.
PURPOSE: This phase III trial is studying radiation therapy with cisplatin or cetuximab to see how well it works in treating patients with oropharyngeal cancer.
ConditionsHead and Neck Cancer
Precancerous Condition
Precancerous Condition
Intervention TypeBiological: cetuximab
Drug: cisplatin
Radiation: IMRT
Drug: cisplatin
Radiation: IMRT
Drug(s)Drug: cisplatin
Total Enrolled987
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionIMRT + Cisplatin - Active Comparator
IMRT + Cetuximab - Active Comparator
IMRT + Cetuximab - Active Comparator
Secondary IDCDR0000695731
PubMed (PMID)30449625
25057165
25057165
Collaborator(s)National Cancer Institute (NCI)
NRG Oncology
NRG Oncology
Region(s)United States
Canada
Canada
Age Range18 Years to 120 Years (Adult, Older Adult)
Type(s) of Cancer
Esophageal
Esophageal
Study Phase
Phase 3
Study Completion Date
June 2012
June 2012
NCT00052910Uploaded 02-12-2020
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Phase III Intergroup Trial of Adjuvant Chemoradiation After Resection of Gastric or Gastroesophageal Adenocarcinoma
Provider Information
Provider Data DescriptionNCT00052910-D2-Dataset.csv (efficacy) is one of 2 datasets associated with PubMed ID 28976791. This dataset contains information that will allow you to reproduce the baseline characteristics table and primary analysis.
SponsorAlliance for Clinical Trials in Oncology
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy after surgery may kill any remaining tumor cells following surgery. It is not yet known which chemotherapy and radiation therapy regimen is more effective in treating stomach or esophageal cancer.
PURPOSE: Randomized phase III trial to compare two different chemotherapy and radiation therapy regimens in treating patients who have undergone surgery for stomach or esophageal cancer.
ConditionsEsophageal Cancer
Gastric Cancer
Gastric Cancer
Intervention TypeDrug: cisplatin
Drug: epirubicin hydrochloride
Drug: fluorouracil
Drug: leucovorin calcium
Radiation: radiation therapy
Drug: epirubicin hydrochloride
Drug: fluorouracil
Drug: leucovorin calcium
Radiation: radiation therapy
Drug(s)Drug: fluorouracil
Drug: leucovorin calcium
Drug: cisplatin
Drug: epirubicin hydrochloride
Drug: leucovorin calcium
Drug: cisplatin
Drug: epirubicin hydrochloride
Total Enrolled546
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionArm I - Active Comparator
Arm II - Experimental
Arm II - Experimental
Secondary IDU10CA031946
PubMed (PMID)34149004
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Canada
Canada
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Leukemia/Lymphoma
Leukemia/Lymphoma
Study Phase
Phase 3
Study Completion Date
April 2015
April 2015
NCT02116530Uploaded 02-12-2020
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Olanzapine for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) in Patients Receiving Highly Emetogenic Chemotherapy (HEC): A Randomized, Double-Blind, Placebo-Controlled Trial
Provider Information
Provider Data DescriptionDataset NCT02116530-D2-Dataset.csv (aedat) is one of 2 datasets associated with PubMed ID 27410922. This dataset contains information that will allow you to reproduce the adverse events analyses.
Due to cleaning efforts subsequent to the publication, the data contains some minor discrepancies from those reported in the manuscript.
SponsorAlliance for Clinical Trials in Oncology
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial studies antiemetic therapy with olanzapine to see how well they work compared to antiemetic therapy alone in preventing chemotherapy-induced nausea and vomiting in patients with cancer receiving highly emetogenic (causes vomiting) chemotherapy. Antiemetic drugs, such as palonosetron hydrochloride, ondansetron, and granisetron hydrochloride, may help lessen or prevent nausea and vomiting in patients treated with chemotherapy. Olanzapine may help prevent chemotherapy-induced nausea and vomiting by blocking brain receptors that appear to be involved in nausea and vomiting.
ConditionsHematopoietic/Lymphoid Cancer
Nausea and Vomiting
Unspecified Adult Solid Tumor, Protocol Specific
Nausea and Vomiting
Unspecified Adult Solid Tumor, Protocol Specific
Intervention TypeDrug: Olanzapine
Drug: Chemotherapy (cisplatin or cyclophosphamide and doxorubicin)
Drug: Antiemetic treatment (ondansetron or granisetron or palonosetron; plus dexamethasone; plus fosaprepitant or aprepitant)
Other: Placebo
Drug: Chemotherapy (cisplatin or cyclophosphamide and doxorubicin)
Drug: Antiemetic treatment (ondansetron or granisetron or palonosetron; plus dexamethasone; plus fosaprepitant or aprepitant)
Other: Placebo
Drug(s)Drug: Olanzapine
Drug: Chemotherapy (cisplatin or cyclophosphamide and doxorubicin)
Drug: Antiemetic treatment (ondansetron or granisetron or palonosetron; plus dexamethasone; plus fosaprepitant or aprepitant)
Drug: Chemotherapy (cisplatin or cyclophosphamide and doxorubicin)
Drug: Antiemetic treatment (ondansetron or granisetron or palonosetron; plus dexamethasone; plus fosaprepitant or aprepitant)
Total Enrolled401
RandomizationRandomized
Blinding MethodDouble
Arms InterventionOlanzapine + Chemotherapy + Antiemetic treatment - Experimental
Placebo + Chemotherapy + Antiemetic treatment - Active Comparator
Placebo + Chemotherapy + Antiemetic treatment - Active Comparator
Secondary IDNCI-2014-00446
PubMed (PMID)27410922
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Colorectal
Colorectal
Study Phase
Phase 3
Study Completion Date
February 2015
February 2015
NCT00265850Uploaded 02-12-2020
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A Phase III Trial of Irinotecan / 5-FU / Leucovorin or Oxaliplatin / 5-FU/ Leucovorin With Bevacizumab, or Cetuximab (C225), or With the Combination of Bevacizumab and Cetuximab for Patients With Untreated Metastatic Adenocarcinoma of the Colon or Rectum
Provider Information
Provider Data DescriptionDataset NCT00265850-D6-Dataset.csv (table2) is one of 8 datasets associated with PubMed ID 28632865. This dataset contains information that will allow you to reproduce table 2 of the manuscript.
SponsorAlliance for Clinical Trials in Oncology
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryPURPOSE: This randomized phase III trial is studying cetuximab and/or bevacizumab when given together with combination chemotherapy to compare how well they work in treating patients with metastatic colorectal cancer.
RATIONALE: Monoclonal antibodies, such as cetuximab and bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as fluorouracil, leucovorin, oxaliplatin, and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving monoclonal antibodies together with combination chemotherapy may kill more tumor cells. It is not yet known whether combination chemotherapy is more effective with cetuximab and/or bevacizumab in treating patients with colorectal cancer.
ConditionsColorectal Cancer
Intervention TypeBiological: bevacizumab
Biological: cetuximab
Drug: FOLFOX or
Drug: FOLFIRI
Biological: cetuximab
Drug: FOLFOX or
Drug: FOLFIRI
Drug(s)Drug: FOLFOX or
Drug: FOLFIRI
Drug: FOLFIRI
Total Enrolled2334
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionArm A: FOLFOX or FOLFIRI + bevacizumab - Active Comparator
Arm B: FOLFOX or FOLFIRI + cetuximab - Experimental
Arm C: FOLFOX or FOLFIRI + cetuximab + bevacizumab - Experimental
Arm B: FOLFOX or FOLFIRI + cetuximab - Experimental
Arm C: FOLFOX or FOLFIRI + cetuximab + bevacizumab - Experimental
Secondary IDU10CA037447
PubMed (PMID)17553204
16356309
31548349
31408415
31042420
28632865
16356309
31548349
31408415
31042420
28632865
Collaborator(s)National Cancer Institute (NCI)
Southwest Oncology Group
Bristol-Myers Squibb
Aptuit
Southwest Oncology Group
Bristol-Myers Squibb
Aptuit
Region(s)United States
Canada
Canada
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Unspecified Adult Solid Tumor
Unspecified Adult Solid Tumor
Study Phase
Phase 3
Study Completion Date
December 2007
December 2007
NCT00081250Uploaded 02-12-2020
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Phase III Double-Blind, Placebo-Controlled Randomized Comparison of Creatine for Cancer-Associated Weight Loss
Provider Information
Provider Data DescriptionDataset NCT00081250-D1-Dataset.csv (qol) is one of 2 datasets associated with PubMed ID 28475678. This dataset contains information that will allow you to reproduce the primary analysis as well as other quality of life analyses.
SponsorAlliance for Clinical Trials in Oncology
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: It is not yet known whether the supplement creatine is effective in increasing weight and improving appetite and quality of life in patients who have cancer.
PURPOSE: This randomized phase III trial is studying how well creatine works in increasing weight and improving appetite and quality of life in patients with weight loss caused by cancer.
ConditionsAnorexia
Cachexia
Unspecified Adult Solid Tumor, Protocol Specific
Weight Changes
Cachexia
Unspecified Adult Solid Tumor, Protocol Specific
Weight Changes
Intervention TypeDietary Supplement: creatine monohydrate
Other: placebo
Other: placebo
Drug(s)N/A
Total Enrolled300
RandomizationRandomized
Blinding MethodDouble
Arms InterventionArm I - Experimental
Arm II - Placebo Comparator
Arm II - Placebo Comparator
Secondary IDNCI-2012-02584
PubMed (PMID)N/A
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Uterine
Uterine
Study Phase
Phase 3
Study Completion Date
June 2018
June 2018
NCT01533207Uploaded 02-12-2020
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A Phase III Randomized Trial of Gemcitabine (NSC# 613327) Plus Docetaxel (NSC# 628503) Followed by Doxorubicin (NSC# 123127) Versus Observation for Uterus-Limited, High Grade Uterine Leiomyosarcoma
Provider Information
Provider Data DescriptionThis dataset will allow users to reproduce the treatment comparison between Adjuvant Gemcitabine Plus Docetaxel Followed by
Doxorubicin and Observation from PubMed 30289732.
SponsorGynecologic Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial studies how well gemcitabine hydrochloride and docetaxel followed by doxorubicin hydrochloride work compared to observation in treating patients with high-risk uterine leiomyosarcoma previously removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride, docetaxel, and doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether combination therapy after surgery is an effective treatment for uterine leiomyosarcoma.
ConditionsStage I Uterine Sarcoma AJCC v7
Uterine Corpus Leiomyosarcoma
Uterine Corpus Leiomyosarcoma
Intervention TypeOther: Clinical Observation
Drug: Docetaxel
Drug: Doxorubicin Hydrochloride
Biological: Filgrastim
Drug: Gemcitabine Hydrochloride
Biological: Pegfilgrastim
Drug: Docetaxel
Drug: Doxorubicin Hydrochloride
Biological: Filgrastim
Drug: Gemcitabine Hydrochloride
Biological: Pegfilgrastim
Drug(s)Drug: Docetaxel
Drug: Doxorubicin Hydrochloride
Drug: Gemcitabine Hydrochloride
Drug: Doxorubicin Hydrochloride
Drug: Gemcitabine Hydrochloride
Total Enrolled38
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionArm I (chemotherapy) - Experimental
Arm II (no treatment) - Other
Arm II (no treatment) - Other
Secondary IDNCI-2012-00249
PubMed (PMID)N/A
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Belgium
France
Netherlands
Norway
Spain
United Kingdom
Venezuela
Belgium
France
Netherlands
Norway
Spain
United Kingdom
Venezuela
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Unspecified Adult Solid Tumor
Unspecified Adult Solid Tumor
Study Phase
Phase 3
Study Completion Date
July 2013
July 2013
NCT01198145Uploaded 02-09-2020
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Phase III, Randomized, Study of Sulfasalazine Versus Placebo in the Prevention of Acute Diarrhea in Patients Receiving Pelvic Radiation Therapy
Provider Information
Provider Data DescriptionDataset NCT01198145-D2 (supplemental) is one of 2 datasets associated with PubMed ID 27354129. This dataset contains information that will allow you to reproduce supplemental table 1. All Adverse events reported were collected and graded using Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
SponsorNational Cancer Institute
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: Sulfasalazine may relieve diarrhea in patients with cancer who are undergoing pelvic radiation therapy.
PURPOSE: This randomized phase III trial is studying sulfasalazine to see how well it works in preventing acute diarrhea in patients with cancer who are undergoing pelvic radiation therapy.
ConditionsDiarrhea
Gastrointestinal Complications
Unspecified Adult Solid Tumor, Protocol Specific
Gastrointestinal Complications
Unspecified Adult Solid Tumor, Protocol Specific
Intervention TypeDrug: sulfasalazine
Other: placebo
Other: placebo
Drug(s)Drug: sulfasalazine
Total Enrolled87
RandomizationRandomized
Blinding MethodDouble
Arms InterventionArm I: Sulfasalazine - Experimental
Arm II: Placebo - Placebo Comparator
Arm II: Placebo - Placebo Comparator
Secondary IDNCI-2011-02602
PubMed (PMID)27354129
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Leukemia/Lymphoma
Leukemia/Lymphoma
Study Phase
Phase 3
Study Completion Date
June 2015
June 2015
NCT00866918Uploaded 02-09-2020
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Risk Adapted Treatment of Newly Diagnosed Childhood Acute Promyelocytic Leukemia (APL) Using Arsenic Trioxide (Trisenox® ) During Consolidation
Provider Information
Provider Data DescriptionNCT00866918-D2
These data provide specific incidence of adverse events in interest. This dataset is necessary to construct Table 3 (Toxicities Reported in >10% of Patients During a Course of Therapy) on the manuscript.
SponsorNational Cancer Institute
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis phase III trial is studying combination chemotherapy to see how well it works in treating young patients with newly diagnosed acute promyelocytic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
ConditionsChildhood Acute Promyelocytic Leukemia With PML-RARA
Myeloid Neoplasm
Myeloid Neoplasm
Intervention TypeDrug: Arsenic Trioxide
Drug: Cytarabine
Other: Diagnostic Laboratory Biomarker Analysis
Drug: Idarubicin
Drug: Mercaptopurine
Drug: Methotrexate
Drug: Mitoxantrone Hydrochloride
Drug: Tretinoin
Drug: Cytarabine
Other: Diagnostic Laboratory Biomarker Analysis
Drug: Idarubicin
Drug: Mercaptopurine
Drug: Methotrexate
Drug: Mitoxantrone Hydrochloride
Drug: Tretinoin
Drug(s)Drug: Arsenic Trioxide
Drug: Cytarabine
Drug: Idarubicin
Drug: Mercaptopurine
Drug: Methotrexate
Drug: Mitoxantrone Hydrochloride
Drug: Tretinoin
Drug: Cytarabine
Drug: Idarubicin
Drug: Mercaptopurine
Drug: Methotrexate
Drug: Mitoxantrone Hydrochloride
Drug: Tretinoin
Total Enrolled106
RandomizationNon-Randomized
Blinding MethodNone (Open Label)
Arms InterventionArm I (standard risk, combination chemotherapy) - Experimental
Arm II (high risk, combination chemotherapy) - Experimental
Arm II (high risk, combination chemotherapy) - Experimental
Secondary IDNCI-2011-01904
PubMed (PMID)N/A
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Canada
Puerto Rico
Canada
Puerto Rico
Age Range2 Years to 21 Years (Child, Adult)
Type(s) of Cancer
Breast
Breast
Study Phase
Phase 3
Study Completion Date
January 2014
January 2014
NCT00433511Uploaded 02-09-2020
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A Double-Blind Phase III Trial of Doxorubicin and Cyclophosphamide Followed by Paclitaxel With Bevacizumab or Placebo in Patients With Lymph Node Positive and High Risk Lymph Node Negative Breast Cancer
Provider Information
Provider Data DescriptionThere are four submissions (each with one dataset) for PMID 30040523 (trial NCT00433511). This dataset, NCT00433511-D2, contains toxicity data. Dataset NCT00433511-D1 contains baseline, treatment, and efficacy data. Dataset NCT00433511-D4 contains updated time-to-event data that have undergone further data cleaning from those in NCT00433511-D1. Dataset NCT00433511-D5 contains data on time to local-regional recurrence and time to distant recurrence that were collected on the trial, but not published.
SponsorNational Cancer Institute (NCI)
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial studies doxorubicin hydrochloride, cyclophosphamide, and paclitaxel to see how well they work with or without bevacizumab in treating patients with cancer that has spread to the lymph nodes (lymph node-positive) or cancer that has not spread to the lymph nodes but is at high risk for returning (high-risk, lymph node-negative breast cancer). Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of breast cancer by blocking blood flow to the tumor. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery and help prevent the tumor from returning. It is not yet known whether doxorubicin hydrochloride, cyclophosphamide, and paclitaxel are more effective with or without bevacizumab.
ConditionsBreast Adenocarcinoma
Intervention TypeBiological: Bevacizumab
Drug: Cyclophosphamide
Drug: Doxorubicin Hydrochloride
Other: Laboratory Biomarker Analysis
Drug: Paclitaxel
Other: Placebo Administration
Other: Quality-of-Life Assessment
Drug: Cyclophosphamide
Drug: Doxorubicin Hydrochloride
Other: Laboratory Biomarker Analysis
Drug: Paclitaxel
Other: Placebo Administration
Other: Quality-of-Life Assessment
Drug(s)Drug: Cyclophosphamide
Drug: Doxorubicin Hydrochloride
Drug: Paclitaxel
Drug: Doxorubicin Hydrochloride
Drug: Paclitaxel
Total Enrolled4994
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionArm I (chemotherapy, placebo) - Active Comparator
Arm II (chemotherapy, bevacizumab) - Experimental
Arm III (chemotherapy, bevacizumab monotherapy) - Experimental
Arm II (chemotherapy, bevacizumab) - Experimental
Arm III (chemotherapy, bevacizumab monotherapy) - Experimental
Secondary IDNCI-2009-00561
PubMed (PMID)35226083
34726788
30054636
30040523
28646344
34726788
30054636
30040523
28646344
Collaborator(s)Cancer and Leukemia Group B
Eastern Cooperative Oncology Group
North Central Cancer Treatment Group
Eastern Cooperative Oncology Group
North Central Cancer Treatment Group
Region(s)United States
Peru
South Africa
Peru
South Africa
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Leukemia/Lymphoma
Leukemia/Lymphoma
Study Phase
Phase 3
Study Completion Date
August 2018
August 2018
NCT01886872Uploaded 02-09-2020
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A Randomized Phase III Study of Bendamustine Plus Rituximab Versus Ibrutinib Plus Rituximab Versus Ibrutinib Alone in Untreated Older Patients (>/= 65 Years of Age) With Chronic Lymphocytic Leukemia (CLL)
Provider Information
Provider Data DescriptionDataset NCT01886872-D5-Dataset.csv (bsl_qol) is one of 5 datasets associated with PubMed ID 30501481. This dataset contains information that will allow you to reproduce the baseline QOL analysis (table S3) in the supplemental materials.
SponsorNational Cancer Institute (NCI)
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial studies rituximab with bendamustine hydrochloride or ibrutinib to see how well they work compared to ibrutinib alone in treating older patients with previously untreated chronic lymphocytic leukemia. Monoclonal antibodies, such as rituximab, may block cancer growth in different ways by targeting certain cells. Drugs used in chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether rituximab with bendamustine hydrochloride may work better than rituximab and ibrutinib or ibrutinib alone in treating chronic lymphocytic leukemia.
ConditionsStage I Chronic Lymphocytic Leukemia
Stage II Chronic Lymphocytic Leukemia
Stage III Chronic Lymphocytic Leukemia
Stage IV Chronic Lymphocytic Leukemia
Stage II Chronic Lymphocytic Leukemia
Stage III Chronic Lymphocytic Leukemia
Stage IV Chronic Lymphocytic Leukemia
Intervention TypeDrug: Bendamustine Hydrochloride
Drug: Ibrutinib
Other: Laboratory Biomarker Analysis
Other: Quality-of-Life Assessment
Biological: Rituximab
Drug: Ibrutinib
Other: Laboratory Biomarker Analysis
Other: Quality-of-Life Assessment
Biological: Rituximab
Drug(s)Drug: Bendamustine Hydrochloride
Drug: Ibrutinib
Drug: Ibrutinib
Total Enrolled547
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionArm I (rituximab, bendamustine hydrochloride) - Active Comparator
Arm II (ibrutinib) - Experimental
Arm III (ibrutinib, rituximab) - Experimental
Arm II (ibrutinib) - Experimental
Arm III (ibrutinib, rituximab) - Experimental
Secondary IDNCI-2013-01220
PubMed (PMID)34274940
30501481
30501481
Collaborator(s)N/A
Region(s)United States
Canada
Canada
Age Range65 Years and older (Older Adult)
Type(s) of Cancer
Breast
Breast
Study Phase
Phase 3
Study Completion Date
June 2014
June 2014
NCT00601900Uploaded 01-18-2020
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Endocrine Therapy With or Without Anti-VEGF Therapy: A Randomized, Phase III Trial of Endocrine Therapy Alone or Endocrine Therapy Plus Bevacizumab (NSC 704865) for Women With Hormone Receptor-Positive Advanced Breast Cancer
Provider Information
Provider Data DescriptionNCT00601900-D2 (AE) data set allows you to reproduce the reported adverse events for this study.
SponsorNational Cancer Institute (NCI)
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial studies tamoxifen citrate or letrozole together with bevacizumab to see how well it works compared with tamoxifen citrate or letrozole alone in treating women with stage IIIB or stage IV breast cancer. Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate or letrozole may fight breast cancer by blocking the use of estrogen by the tumor cells. Immunotherapy with monoclonal antibodies, such as bevacizumab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving hormone therapy is more effective with or without bevacizumab in treating advanced breast cancer.
ConditionsInvasive Breast Carcinoma
Recurrent Breast Carcinoma
Stage III Breast Cancer AJCC v6
Stage IV Breast Cancer AJCC v6 and v7
Recurrent Breast Carcinoma
Stage III Breast Cancer AJCC v6
Stage IV Breast Cancer AJCC v6 and v7
Intervention TypeBiological: Bevacizumab
Other: Laboratory Biomarker Analysis
Drug: Letrozole
Other: Questionnaire Administration
Drug: Tamoxifen Citrate
Other: Laboratory Biomarker Analysis
Drug: Letrozole
Other: Questionnaire Administration
Drug: Tamoxifen Citrate
Drug(s)Drug: Letrozole
Drug: Tamoxifen Citrate
Drug: Tamoxifen Citrate
Total Enrolled394
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionArm I (endocrine therapy with monoclonal antibody) - Experimental
Arm II (endocrine therapy) - Active Comparator
Arm II (endocrine therapy) - Active Comparator
Secondary IDNCI-2009-00477
PubMed (PMID)34616010
31276981
29789969
27138575
31276981
29789969
27138575
Collaborator(s)N/A
Region(s)United States
Puerto Rico
Puerto Rico
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Bladder
Bladder
Study Phase
Phase 3
Study Completion Date
June 2017
June 2017
NCT00445601Uploaded 01-08-2020
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A Phase III Blinded Study of Immediate Post TURBT Instillation of Gemcitabine Versus Saline in Patients With Newly Diagnosed or Occasionally Recurring Grade I/II Superficial Bladder Cancer
Provider Information
Provider Data DescriptionThis dataset will allow users to reproduce the toxicity results reported in the Journal of American Medical Association (Messing et al., JAMA, 2018, PMID referenced above) for trial NCT00445601.
SponsorSouthwest Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving gemcitabine directly into the bladder after surgery may kill more tumor cells. It is not yet known whether giving gemcitabine directly into the bladder is more effective than a placebo in treating bladder cancer.
PURPOSE: This randomized phase III trial is studying gemcitabine to see how well it works when given directly into the bladder compared with a placebo after surgery in treating patients with newly diagnosed or recurrent bladder cancer.
ConditionsBladder Cancer
Intervention TypeDrug: gemcitabine hydrochloride
Other: placebo
Other: placebo
Drug(s)Drug: gemcitabine hydrochloride
Total Enrolled406
RandomizationRandomized
Blinding MethodQuadruple
Arms InterventionArm I - Experimental
Arm II - Placebo Comparator
Arm II - Placebo Comparator
Secondary IDS0337
PubMed (PMID)29801011
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Age Range18 Years to 120 Years (Adult, Older Adult)
Type(s) of Cancer
Prostate
Prostate
Study Phase
Phase 3
Study Completion Date
August 2017
August 2017
NCT00004124Uploaded 12-19-2019
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Adjuvant Androgen Deprivation Versus Mitoxantrone Plus Prednisone Plus Androgen Deprivation in Selected High-Risk Prostate Cancer Patients Following Radical Prostatectomy
Provider Information
Provider Data DescriptionThe NCT00004124-D2 Dataset will allow users to reproduce the toxicity results reported in the Journal of Clinical Oncology (Hussain et al., JCO, 2015, PMID referenced above) for trial NCT00004124.
SponsorSouthwest Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: Hormones can stimulate the production of prostate cancer cells. Hormone therapy may fight prostate cancer by reducing the production of androgens. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether hormone therapy plus mitoxantrone and prednisone is more effective than hormone therapy alone for prostate cancer.
PURPOSE: This randomized phase III trial is studying hormone therapy, mitoxantrone, and prednisone to see how well they work compared to hormone therapy alone in treating patients who have undergone radical prostatectomy for prostate cancer.
ConditionsProstate Cancer
Intervention TypeDrug: bicalutamide
Drug: goserelin
Drug: mitoxantrone hydrochloride
Drug: prednisone
Drug: goserelin
Drug: mitoxantrone hydrochloride
Drug: prednisone
Drug(s)Drug: bicalutamide
Drug: goserelin
Drug: mitoxantrone hydrochloride
Drug: prednisone
Drug: goserelin
Drug: mitoxantrone hydrochloride
Drug: prednisone
Total Enrolled983
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms Interventionbicalutamide, goserelin - Active Comparator
bicalutamide, goserelin, mitoxantrone, prednisone - Experimental
bicalutamide, goserelin, mitoxantrone, prednisone - Experimental
Secondary IDS9921
PubMed (PMID)18349405
29624463
21502546
29624463
21502546
Collaborator(s)National Cancer Institute (NCI)
Cancer and Leukemia Group B
Cancer and Leukemia Group B
Region(s)United States
Age Range18 Years to 120 Years (Adult, Older Adult)
Type(s) of Cancer
CNS
CNS
Study Phase
Phase 3
Study Completion Date
July 2012
July 2012
NCT00369785Uploaded 12-18-2019
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Phase III Double Blind, Placebo Controlled Study of Donepezil in the Irradiated Brain
Provider Information
Provider Data DescriptionA total of 198 adult brain tumor survivors were randomly assigned to receive donepezil (5 mg for 6 weeks and 10 mg for 18 weeks) or placebo. Neurocognitive tests were assessed at baseline, 12 weeks post randomization, and 24 weeks post randomization. The primary aim of the study was to assess the effect of donepezil on a cognitive composite outcome (consisting of the average of eight standardized tests) at 24 weeks. A secondary aim was to assess the effect of donepezil on the individual tests. There was no significant effect of donepezil on the composite outcome. However, donepezil did significantly improve memory and motor speed/dexterity. This dataset contains all the data used in the publication PMID 25897156.
SponsorWake Forest University Health Sciences
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: Donepezil may help lessen confusion and fatigue and improve mood and quality of life in patients who have undergone radiation therapy for brain tumors. It is not yet known whether donepezil is more effective than a placebo in lessening side effects of radiation therapy in patients with brain tumors.
PURPOSE: This randomized phase III trial is studying donepezil to see how well it works in lessening side effects of radiation therapy compared with a placebo in patients who have undergone radiation therapy for brain tumors.
ConditionsBrain Tumors
Metastatic Disease
Metastatic Disease
Intervention TypeDrug: donepezil hydrochloride
Drug: Placebo
Drug: Placebo
Drug(s)Drug: donepezil hydrochloride
Drug: Placebo
Drug: Placebo
Total Enrolled198
RandomizationRandomized
Blinding MethodQuadruple
Arms InterventionArm I - Donepezil - Experimental
Arm II - Control - Placebo Comparator
Arm II - Control - Placebo Comparator
Secondary IDU10CA081851
PubMed (PMID)N/A
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Head and Neck
Head and Neck
Study Phase
Phase 3
Study Completion Date
January 2011
January 2011
NCT00265941Uploaded 12-17-2019
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A Randomized Phase III Trial of Concurrent Accelerated Radiation and Cisplatin Versus Concurrent Accelerated Radiation, Cisplatin, and Cetuximab (C225) [Followed by Surgery for Selected Patients] for Stage III and IV Head and Neck Carcinomas
Provider Information
Provider Data DescriptionThis dataset will allow users to reproduce the adverse event tables in trial NCT00265941.
SponsorRadiation Therapy Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Cisplatin may also make tumor cells more sensitive to radiation therapy. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving radiation therapy and cisplatin together with cetuximab may kill more tumor cells. It is not yet known whether radiation therapy and cisplatin are more effective with or without cetuximab in treating head and neck cancer.
PURPOSE: This randomized phase III trial is studying radiation therapy, cisplatin, and cetuximab to see how well they work compared to radiation therapy and cisplatin in treating patients with stage III or stage IV head and neck cancer.
ConditionsHead and Neck Cancer
Intervention TypeDrug: cetuximab
Drug: cisplatin
Radiation: Accelerated Fractionation by Concomitant Boost
Radiation: Intensity-modulated radiation therapy
Drug: cisplatin
Radiation: Accelerated Fractionation by Concomitant Boost
Radiation: Intensity-modulated radiation therapy
Drug(s)Drug: cisplatin
Drug: cetuximab
Drug: cetuximab
Total Enrolled940
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionRT + cisplatin - Active Comparator
RT + cisplatin + cetuximab - Experimental
RT + cisplatin + cetuximab - Experimental
Secondary IDCDR0000458049
PubMed (PMID)25154822
27727066
25752384
31420360
30548235
28006059
27727066
25752384
31420360
30548235
28006059
Collaborator(s)National Cancer Institute (NCI)
NRG Oncology
NRG Oncology
Region(s)United States
Canada
Canada
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Leukemia/Lymphoma
Leukemia/Lymphoma
Study Phase
Phase 2B
Study Completion Date
October 2008
October 2008
NCT00301821Uploaded 09-11-2019
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A Phase II Study of Epratuzumab, Rituximab (ER)-CHOP for Patients With Previously Untreated Diffuse Large B-Cell Lymphoma
Provider Information
Provider Data DescriptionNCT00301821-D2-Dataset.csv (events) is one of 2 datasets associated with PubMed ID 21673350. This dataset contains information that will allow you to reproduce the adverse events reported.
SponsorAlliance for Clinical Trials in Oncology
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: Monoclonal antibodies, such as epratuzumab and rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving monoclonal antibody therapy together with chemotherapy may kill more cancer cells.> PURPOSE: This phase II trial is studying how well giving monoclonal antibody therapy together with combination chemotherapy works in treating patients with stage II, stage III, or stage IV diffuse large B-cell lymphoma.
ConditionsLymphoma
Intervention TypeBiological: epratuzumab
Biological: rituximab
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: prednisone
Drug: vincristine sulfate
Biological: rituximab
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: prednisone
Drug: vincristine sulfate
Drug(s)Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: prednisone
Drug: vincristine sulfate
Drug: doxorubicin hydrochloride
Drug: prednisone
Drug: vincristine sulfate
Total Enrolled107
RandomizationN/A
Blinding MethodNone (Open Label)
Arms InterventionEpratuzumab + Rituximab + CHOP - Experimental
Secondary IDNCI-2012-02685
PubMed (PMID)17099879
21383282
21673350
27282998
21383282
21673350
27282998
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Multiple Myeloma
Multiple Myeloma
Study Phase
Phase 3
Study Completion Date
July 2016
July 2016
NCT00644228Uploaded 08-21-2019
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A Randomized Phase III Trial of CC-5013 (Lenalidomide, NSC-703813) and Low Dose Dexamethasone (LLD) Versus Bortezomib (PS-341, NSC-681239), Lenalidomide and Low Dose Dexamethasone (BLLD) for Induction, in Patients With Previously Untreated Multiple Myeloma Without an Intent for Immediate Autologous Stem Cell Transplant
Provider Information
Provider Data DescriptionThe dataset NCT00644228-D2-Dataset.csv will allow users to reproduce safety analyses included in the aforementioned publication, which compared toxicity between bortezomib, lenalidomide and low dose dexamethasone versus lenalidomide and low dose dexamethasone induction therapy for the treatment of patients with newly diagnosed multiple myeloma in the SWOG phase III trial, S0777.
SponsorNational Cancer Institute
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial studies lenalidomide, dexamethasone, and bortezomib to see how well it works compared to dexamethasone and lenalidomide alone in treating patients with previously untreated multiple myeloma. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the cancer. It is not yet known whether lenalidomide and dexamethasone is more effective with or without bortezomib in treating multiple myeloma.
ConditionsDS Stage I Plasma Cell Myeloma
DS Stage II Plasma Cell Myeloma
DS Stage III Plasma Cell Myeloma
DS Stage II Plasma Cell Myeloma
DS Stage III Plasma Cell Myeloma
Intervention TypeDrug: Bortezomib
Drug: Dexamethasone
Other: Laboratory Biomarker Analysis
Drug: Lenalidomide
Drug: Dexamethasone
Other: Laboratory Biomarker Analysis
Drug: Lenalidomide
Drug(s)Drug: Dexamethasone
Drug: Lenalidomide
Drug: Bortezomib
Drug: Lenalidomide
Drug: Bortezomib
Total Enrolled525
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionArm I (dexamethasone and lenalidomide) - Active Comparator
Arm II (dexamethasone, lenalidomide, bortezomib) - Experimental
Arm II (dexamethasone, lenalidomide, bortezomib) - Experimental
Secondary IDNCI-2009-00798
PubMed (PMID)28586789
28017406
22689675
28017406
22689675
Collaborator(s)N/A
Region(s)United States
Puerto Rico
Saudi Arabia
Puerto Rico
Saudi Arabia
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Kidney
Kidney
Study Phase
Phase 3
Study Completion Date
June 2016
June 2016
NCT00379340Uploaded 08-20-2019
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Treatment of Newly Diagnosed Higher Risk Favorable Histology Wilms Tumors
Provider Information
Provider Data DescriptionNCT00379340-D4
These data provide specific incidences of adverse events. ?NCT00379340-D4? is necessary for recreating table A3 in the manuscript. Each row corresponds to a single Adverse Event.
SponsorChildren's Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis phase III trial is studying how well combination chemotherapy with or without radiation therapy works in treating young patients with newly diagnosed stage III or stage IV Favorable Histology Wilms' tumor. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving more than one drug (combination chemotherapy) with or without radiation therapy may kill more tumor cells.
ConditionsStage III Wilms Tumor With Loss of Heterozygosity (LOH) for 1p and 16q
Stage IV Wilms Tumor
Stage IV Wilms Tumor
Intervention TypeDrug: doxorubicin hydrochloride
Drug: liposomal vincristine sulfate
Procedure: conventional surgery
Radiation: 3-dimensional conformal radiation therapy
Biological: dactinomycin
Drug: cyclophosphamide
Drug: etoposide
Drug: liposomal vincristine sulfate
Procedure: conventional surgery
Radiation: 3-dimensional conformal radiation therapy
Biological: dactinomycin
Drug: cyclophosphamide
Drug: etoposide
Drug(s)Drug: doxorubicin hydrochloride
Drug: liposomal vincristine sulfate
Drug: cyclophosphamide
Drug: etoposide
Drug: liposomal vincristine sulfate
Drug: cyclophosphamide
Drug: etoposide
Total Enrolled395
RandomizationNon-Randomized
Blinding MethodNone (Open Label)
Arms InterventionStage IV and rapid complete response (RCR) of lung metastases - Experimental
Stage IV and slow incomplete response (SIR) of lung metastases - Experimental
Stage III/IV with LOH 1p and 16q treated with Regimen M - Other
Stage IV with non-lung disease treated with Regimen M - Other
Stage IV with lung metastases - Other
Stage IV and slow incomplete response (SIR) of lung metastases - Experimental
Stage III/IV with LOH 1p and 16q treated with Regimen M - Other
Stage IV with non-lung disease treated with Regimen M - Other
Stage IV with lung metastases - Other
Secondary IDNCI-2009-00419
PubMed (PMID)35580298
31449468
29659330
31449468
29659330
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Australia
Canada
Israel
New Zealand
Puerto Rico
Switzerland
Australia
Canada
Israel
New Zealand
Puerto Rico
Switzerland
Age Range29 Years and younger (Child, Adult)
Type(s) of Cancer
Colorectal
Colorectal
Study Phase
Phase 3
Study Completion Date
August 2009
August 2009
NCT00364013Uploaded 07-13-2019
Available for Download
A Randomized, Multicenter, Phase 3 Study to Compare the Efficacy of Panitumumab in Combination With Oxaliplatin/ 5-fluorouracil/ Leucovorin to the Efficacy of Oxaliplatin/ 5-fluorouracil/ Leucovorin Alone in Patients With Previously Untreated Metastatic Colorectal Cancer
Provider Information
Provider Data DescriptionThe primary objective of this study was to assess whether panitumumab in combination with
FOLFOX chemotherapy improves PFS compared to FOLFOX alone as first-line therapy for
mCRC among subjects with wild-type KRAS tumors and subjects with mutant KRAS tumors. The
secondary objectives were to evaluate OS, objective response rate, duration of response, time to progression, and safety and tolerability among subjects with wild-type KRAS tumors and subjects
with mutant KRAS tumors.
SponsorAmgen
Data ProviderAmgen
Partial set or SubsetOriginal Data
Patients in dataset1183
# of Patients Control590
# of Patients Experimental593
DOIhttps://doi.org/10.34949/1m76-9m69
CDISC StandardCRT
Study ArmsBoth comparator and experimental arm data
Clinical Trials.gov Information
Brief SummaryThe purpose of this study is to determine the treatment effect of panitumumab in combination with FOLFOX compared to FOLFOX alone as first line therapy for metastatic colorectal cancer
ConditionsMetastatic Colorectal Cancer
Intervention TypeDrug: Panitumumab
Drug: FOLFOX regimen
Drug: FOLFOX regimen
Drug(s)Drug: Panitumumab
Drug: FOLFOX regimen
Drug: FOLFOX regimen
Total Enrolled1183
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionFOLFOX + Panitumumab - Experimental
FOLFOX - Active Comparator
FOLFOX - Active Comparator
Secondary IDN/A
PubMed (PMID)24024839
24718886
20921465
25956209
31515083
31378656
30679026
30614531
30019318
29627309
28449055
27843597
26049686
22070868
24718886
20921465
25956209
31515083
31378656
30679026
30614531
30019318
29627309
28449055
27843597
26049686
22070868
Collaborator(s)N/A
Region(s)N/A
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Colorectal
Colorectal
Study Phase
Phase 3
Study Completion Date
October 2008
October 2008
NCT00113763Uploaded 07-13-2019
Available for Download
An Open-label, Randomized, Phase 3 Clinical Trial of ABX-EGF Plus Best Supportive Care Versus Best Supportive Care in Subjects With Metastatic Colorectal Cancer
Provider Information
Provider Data DescriptionThe primary objective of this study was to assess whether panitumumab plus BSC
improves progression-free survival compared with BSC alone in this subject population.
Secondary objectives were to evaluate survival time, objective response, duration of
response, time to response, time to disease progression, time to treatment failure,
duration of stable disease, patient-reported outcomes, and the safety profile of
panitumumab plus BSC compared with BSC alone in this subject population.
SponsorAmgen
Data ProviderAmgen
Partial set or SubsetOriginal Data
Patients in dataset463
# of Patients Control232
# of Patients Experimental231
DOIN/A
CDISC StandardCRT
Study ArmsBoth comparator and experimental arm data
Clinical Trials.gov Information
Brief SummaryThe purpose of this study is to determine that panitumumab, using the proposed regimen, will safely increase progression free survival in patients with metastatic colorectal cancer who have failed available treatment options (i.e., patients who developed progressive disease or relapsed while on or after prior fluoropyrimidine, irinotecan and oxaliplatin chemotherapy).
ConditionsColorectal Cancer
Metastases
Metastases
Intervention TypeOther: Best supportive care
Drug: Panitumumab
Drug: Panitumumab
Drug(s)Drug: Panitumumab
Total Enrolled463
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionPanitumumab plus best supportive care - Experimental
Best Supportive Care - Other
Best Supportive Care - Other
Secondary IDN/A
PubMed (PMID)21448748
21190026
19189371
18040272
17470858
34213592
29627309
26049686
23625191
18316791
21190026
19189371
18040272
17470858
34213592
29627309
26049686
23625191
18316791
Collaborator(s)N/A
Region(s)N/A
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Kidney
Kidney
Study Phase
Phase 3
Study Completion Date
December 2016
December 2016
NCT00945009Uploaded 07-10-2019
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Treatment for Patients With Bilateral, Multicentric, or Bilaterally-Predisposed Unilateral Wilms Tumor
Provider Information
Provider Data DescriptionThere is one dataset associated with this publication. This dataset is associated with the manuscript titled, ?Results of the first Prospective Multi-Institutional Treatment Study in Children with Bilateral Wilms Tumor (AREN0534): A report from the Children's Oncology Group.?
SponsorChildren's Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis phase III trial studies how well combination chemotherapy and surgery work in treating young patients with Wilms tumor. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving it after surgery may kill any tumor cells that remain after surgery.
ConditionsAdult Kidney Wilms Tumor
Beckwith-Wiedemann Syndrome
Childhood Kidney Wilms Tumor
Diffuse Hyperplastic Perilobar Nephroblastomatosis
Hemihypertrophy
Rhabdoid Tumor of the Kidney
Stage I Kidney Wilms Tumor
Stage II Kidney Wilms Tumor
Stage III Kidney Wilms Tumor
Stage IV Kidney Wilms Tumor
Stage V Kidney Wilms Tumor
Beckwith-Wiedemann Syndrome
Childhood Kidney Wilms Tumor
Diffuse Hyperplastic Perilobar Nephroblastomatosis
Hemihypertrophy
Rhabdoid Tumor of the Kidney
Stage I Kidney Wilms Tumor
Stage II Kidney Wilms Tumor
Stage III Kidney Wilms Tumor
Stage IV Kidney Wilms Tumor
Stage V Kidney Wilms Tumor
Intervention TypeBiological: Dactinomycin
Drug: Doxorubicin Hydrochloride
Radiation: Radiation Therapy
Procedure: Therapeutic Conventional Surgery
Drug: Vincristine Sulfate
Drug: Doxorubicin Hydrochloride
Radiation: Radiation Therapy
Procedure: Therapeutic Conventional Surgery
Drug: Vincristine Sulfate
Drug(s)Drug: Doxorubicin Hydrochloride
Drug: Vincristine Sulfate
Drug: Vincristine Sulfate
Total Enrolled249
RandomizationNon-Randomized
Blinding MethodNone (Open Label)
Arms InterventionArm 1 (Bilateral Wilms Tumors) - Experimental
Arm 2 (Unilateral High Risk tumors bilaterally predisposed) - Experimental
Arm 3 (DHPLN) - Experimental
Arm 2 (Unilateral High Risk tumors bilaterally predisposed) - Experimental
Arm 3 (DHPLN) - Experimental
Secondary IDNCI-2011-01953
PubMed (PMID)35072864
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Australia
Canada
Israel
New Zealand
Puerto Rico
Australia
Canada
Israel
New Zealand
Puerto Rico
Age Range29 Years and younger (Child, Adult)
Type(s) of Cancer
CNS
CNS
Study Phase
Phase 3
Study Completion Date
June 2019
June 2019
NCT00392327Uploaded 07-10-2019
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Efficacy of Carboplatin Administered Concomitantly With Radiation and Isotretinoin as a Pro-Apoptotic Agent in Other Than Average Risk Medulloblastoma/PNET Patients
Provider Information
Provider Data DescriptionNCT00392327-D2-Dataset
The second dataset (D2) contains data provided by the central pathologist on the 10 patients who were selected for a second central pathology review, given the discrepancies between profiling and centrally reviewed histopathologic diagnoses. This second central pathology review was done at the request of one of the journal article reviewers. The text in the results section of the manuscript and the associated data are geared towards pathologists rather than the general readership.
SponsorChildren's Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial studies different chemotherapy and radiation therapy regimens to compare how well they work in treating young patients with newly diagnosed, previously untreated, high-risk medulloblastoma. Drugs used in chemotherapy, such as vincristine sulfate, cisplatin, cyclophosphamide, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Carboplatin may make tumor cells more sensitive to radiation therapy. It is not yet known which chemotherapy and radiation therapy regimen is more effective in treating brain tumors.
ConditionsAnaplastic Medulloblastoma
Medulloblastoma
Medulloblastoma
Intervention TypeDrug: Carboplatin
Drug: Cisplatin
Drug: Cyclophosphamide
Biological: Filgrastim
Drug: Isotretinoin
Other: Laboratory Biomarker Analysis
Other: Quality-of-Life Assessment
Radiation: Radiation Therapy
Drug: Vincristine Sulfate
Drug: Cisplatin
Drug: Cyclophosphamide
Biological: Filgrastim
Drug: Isotretinoin
Other: Laboratory Biomarker Analysis
Other: Quality-of-Life Assessment
Radiation: Radiation Therapy
Drug: Vincristine Sulfate
Drug(s)Drug: Cisplatin
Drug: Cyclophosphamide
Drug: Vincristine Sulfate
Drug: Carboplatin
Drug: Isotretinoin
Drug: Cyclophosphamide
Drug: Vincristine Sulfate
Drug: Carboplatin
Drug: Isotretinoin
Total Enrolled379
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionArm A (chemoradiotherapy) - Active Comparator
Arm B (chemoradiotherapy) - Experimental
Arm C (chemoradiotherapy, isotretinoin-CLOSED TO ACCRUAL) - Experimental
Arm D (chemoradiotherapy, isotretinoin-CLOSED TO ACCRUAL) - Experimental
Arm B (chemoradiotherapy) - Experimental
Arm C (chemoradiotherapy, isotretinoin-CLOSED TO ACCRUAL) - Experimental
Arm D (chemoradiotherapy, isotretinoin-CLOSED TO ACCRUAL) - Experimental
Secondary IDNCI-2009-00336
PubMed (PMID)30332335
34292305
34292305
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Australia
Canada
Netherlands
Puerto Rico
Australia
Canada
Netherlands
Puerto Rico
Age Range3 Years to 21 Years (Child, Adult)
Type(s) of Cancer
Sarcoma
Sarcoma
Study Phase
Phase 3
Study Completion Date
January 2010
January 2010
NCT00354744Uploaded 05-25-2019
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Intensive Multi-Agent Therapy, Including Dose-Compressed Cycles of Ifosfamide/Etoposide (IE) and Vincristine/Doxorubicin/Cyclophosphamide (VDC) for Patients With High-Risk Rhabdomyosarcoma
Provider Information
Provider Data DescriptionNCT00354744-D2
This dataset contains incidence of adverse events as reported in the manuscript.
SponsorChildren's Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: Drugs used in chemotherapy, such as vincristine, irinotecan, ifosfamide, etoposide, doxorubicin, cyclophosphamide, and dactinomycin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving high-dose combination chemotherapy together with radiation therapy may kill more tumor cells.
PURPOSE: This phase III trial is studying how well giving high-dose combination chemotherapy together with radiation therapy works in treating patients with newly diagnosed metastatic rhabdomyosarcoma or ectomesenchymoma.
ConditionsSarcoma
Intervention TypeBiological: dactinomycin
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: ifosfamide
Drug: irinotecan hydrochloride
Drug: vincristine sulfate
Procedure: conventional surgery
Radiation: radiation therapy
Biological: filgrastim
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: ifosfamide
Drug: irinotecan hydrochloride
Drug: vincristine sulfate
Procedure: conventional surgery
Radiation: radiation therapy
Biological: filgrastim
Drug(s)Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: ifosfamide
Drug: irinotecan hydrochloride
Drug: vincristine sulfate
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: ifosfamide
Drug: irinotecan hydrochloride
Drug: vincristine sulfate
Total Enrolled109
RandomizationN/A
Blinding MethodNone (Open Label)
Arms InterventionHigh Risk Rhabdomyosarcoma - Experimental
Secondary IDCDR0000489215
PubMed (PMID)N/A
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Australia
Canada
Puerto Rico
Switzerland
Australia
Canada
Puerto Rico
Switzerland
Age Range49 Years and younger (Child, Adult)
Type(s) of Cancer
Breast
Breast
Study Phase
Phase 3
Study Completion Date
January 2007
January 2007
NCT00003519Uploaded 04-26-2019
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Phase III Study of Adriamycin/Taxotere Versus Adriamycin/Cytoxan for the Adjuvant Treatment of Node Positive or High Risk Node Negative Breast Cancer
Provider Information
Provider Data DescriptionThis dataset contains the analysis data for the MetaSite BreastTM score analysis (n=600) published in PMID 29138761 with a subset of cases from the parent trial NCT00003519.
SponsorEastern Cooperative Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective for breast cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating women with breast cancer who have undergone surgery to remove the tumor.
ConditionsBreast Cancer
Intervention TypeDrug: cyclophosphamide
Drug: docetaxel
Drug: doxorubicin hydrochloride
Drug: docetaxel
Drug: doxorubicin hydrochloride
Drug(s)N/A
Total Enrolled2778
RandomizationRandomized
Blinding MethodN/A
Arms InterventionN/A
Secondary IDE2197
PubMed (PMID)18487567
18678838
18678838
Collaborator(s)National Cancer Institute (NCI)
Southwest Oncology Group
North Central Cancer Treatment Group
Cancer and Leukemia Group B
Southwest Oncology Group
North Central Cancer Treatment Group
Cancer and Leukemia Group B
Region(s)United States
Age Range18 Years to 120 Years (Adult, Older Adult)
Type(s) of Cancer
Breast
Breast
Study Phase
Phase 3
Study Completion Date
March 2018
March 2018
NCT00310180Uploaded 04-24-2019
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Program for the Assessment of Clinical Cancer Tests (PACCT-1): Trial Assigning Individualized Options for Treatment:The TAILORx Trial
Provider Information
Provider Data DescriptionThis dataset contains the analysis data published in PMID 29860917 from trial TAILORx (NCT00310180).
SponsorNational Cancer Institute
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial studies the best individual therapy for women who have node-negative, estrogen-receptor positive breast cancer by using a special test (Oncotype DX), and whether hormone therapy alone or hormone therapy together with combination chemotherapy is better for women who have an Oncotype DX recurrence score of 11-25. Estrogen can cause the growth of breast cancer cells. Hormone therapy may fight breast cancer by blocking the use of estrogen by the tumor cells or by lowering the amount of estrogen the body makes. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving hormone therapy together with more than one chemotherapy drug (combination chemotherapy) has been shown to reduce the chance of breast cancer recurrence, but the benefit of adding chemotherapy to hormone therapy for women with node-negative, estrogen-receptor positive breast cancer is small. New tests may provide information about which patients are more likely to benefit from chemotherapy.
ConditionsBreast Adenocarcinoma
Hormone Receptor Positive
Stage IA Breast Cancer AJCC v7
Stage IB Breast Cancer AJCC v7
Stage IIA Breast Cancer AJCC v6 and v7
Stage IIB Breast Cancer AJCC v6 and v7
Stage IIIB Breast Cancer AJCC v7
Hormone Receptor Positive
Stage IA Breast Cancer AJCC v7
Stage IB Breast Cancer AJCC v7
Stage IIA Breast Cancer AJCC v6 and v7
Stage IIB Breast Cancer AJCC v6 and v7
Stage IIIB Breast Cancer AJCC v7
Intervention TypeDrug: Anastrozole
Drug: Exemestane
Other: Laboratory Biomarker Analysis
Drug: Letrozole
Other: Quality-of-Life Assessment
Radiation: Radiation Therapy
Drug: Tamoxifen Citrate
Drug: Exemestane
Other: Laboratory Biomarker Analysis
Drug: Letrozole
Other: Quality-of-Life Assessment
Radiation: Radiation Therapy
Drug: Tamoxifen Citrate
Drug(s)Drug: Anastrozole
Drug: Exemestane
Drug: Letrozole
Drug: Tamoxifen Citrate
Drug: Exemestane
Drug: Letrozole
Drug: Tamoxifen Citrate
Total Enrolled10273
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionGroup 1 (Oncotype DX recurrence score =< 10) - Experimental
Group 2, Arm I (experimental) - Experimental
Group 2, Arm II (standard) - Active Comparator
Group 3 (Oncotype DX recurrence score >= 26) - Experimental
Group 2, Arm I (experimental) - Experimental
Group 2, Arm II (standard) - Active Comparator
Group 3 (Oncotype DX recurrence score >= 26) - Experimental
Secondary IDNCI-2009-00707
PubMed (PMID)35175284
34137783
34090143
33626896
32271671
31566680
31409130
31157962
29860917
26412349
34137783
34090143
33626896
32271671
31566680
31409130
31157962
29860917
26412349
Collaborator(s)American College of Surgeons
Cancer and Leukemia Group B
NSABP Foundation Inc
NCIC Clinical Trials Group
North Central Cancer Treatment Group
Southwest Oncology Group
Cancer and Leukemia Group B
NSABP Foundation Inc
NCIC Clinical Trials Group
North Central Cancer Treatment Group
Southwest Oncology Group
Region(s)United States
Australia
Canada
Ireland
New Zealand
Peru
Puerto Rico
United Kingdom
Australia
Canada
Ireland
New Zealand
Peru
Puerto Rico
United Kingdom
Age Range18 Years to 75 Years (Adult, Older Adult)
Type(s) of Cancer
Lung
Lung
Study Phase
Phase 3
Study Completion Date
October 2015
October 2015
NCT00324805Uploaded 04-24-2019
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A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Patients With Completely Resected Stage IB (≥ 4 cm) - IIIA Non-small Cell Lung Cancer (NSCLC)
Provider Information
Provider Data DescriptionThere are four different submissions (each with one dataset) for PMID 29129443 (trial NCT00324805). This dataset, NCT00324805-D4, can be used to derive the number of patients with worst degree 1/2 toxicities (bottom row of Table 2); and the worst degree grade 3-5 events in Table 3 and Supplement. Dataset NCT00324805-D1 contains baseline, treatment, and efficacy data. Dataset NCT00324805-D2 contains toxicity data for duplicating the results in Table 2 of the manuscript. Dataset NCT00324805-D3 contains toxicity data for duplicating the results in Table 3 of the manuscript.
SponsorNational Cancer Institute (NCI)
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial studies chemotherapy and bevacizumab to see how well they work compared to chemotherapy alone in treating patients with stage IB, stage II, or stage IIIA non-small cell lung cancer that was removed by surgery. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Bevacizumab also may stop the growth of non-small cell lung cancer by blocking the growth of new blood vessels necessary for tumor growth. It is not yet known whether chemotherapy is more effective with or without bevacizumab in treating non-small cell lung cancer.
ConditionsStage IB Lung Non-Small Cell Carcinoma AJCC v7
Stage IIA Lung Non-Small Cell Carcinoma AJCC v7
Stage IIB Lung Non-Small Cell Carcinoma AJCC v7
Stage IIIA Lung Non-Small Cell Cancer AJCC v7
Stage IIA Lung Non-Small Cell Carcinoma AJCC v7
Stage IIB Lung Non-Small Cell Carcinoma AJCC v7
Stage IIIA Lung Non-Small Cell Cancer AJCC v7
Intervention TypeBiological: Bevacizumab
Drug: Cisplatin
Drug: Docetaxel
Drug: Gemcitabine Hydrochloride
Other: Laboratory Biomarker Analysis
Drug: Pemetrexed Disodium
Other: Questionnaire Administration
Drug: Vinorelbine Tartrate
Drug: Cisplatin
Drug: Docetaxel
Drug: Gemcitabine Hydrochloride
Other: Laboratory Biomarker Analysis
Drug: Pemetrexed Disodium
Other: Questionnaire Administration
Drug: Vinorelbine Tartrate
Drug(s)Drug: Cisplatin
Drug: Docetaxel
Drug: Gemcitabine Hydrochloride
Drug: Pemetrexed Disodium
Drug: Vinorelbine Tartrate
Drug: Docetaxel
Drug: Gemcitabine Hydrochloride
Drug: Pemetrexed Disodium
Drug: Vinorelbine Tartrate
Total Enrolled1501
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionArm I (chemotherapy) - Active Comparator
Arm II (chemotherapy, bevacizumab) - Experimental
Arm II (chemotherapy, bevacizumab) - Experimental
Secondary IDNCI-2009-00509
PubMed (PMID)29129443
Collaborator(s)Cancer and Leukemia Group B
NCIC Clinical Trials Group
North Central Cancer Treatment Group
Southwest Oncology Group
NCIC Clinical Trials Group
North Central Cancer Treatment Group
Southwest Oncology Group
Region(s)United States
Canada
Ireland
Peru
South Africa
Canada
Ireland
Peru
South Africa
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Lung
Lung
Study Phase
Phase 2B
Study Completion Date
January 2014
January 2014
NCT01439568Uploaded 01-23-2019
Available for Download
A Randomized Phase 2 Study of LY2510924 and Carboplatin/Etoposide Versus Carboplatin/Etoposide in Extensive-Stage Small Cell Lung Carcinoma
Provider Information
Provider Data DescriptionThe primary objective was to compare the progression-free survival (PFS) between treatment arms. Secondary objectives were OS, overall response rate (ORR), duration of overall response (DOR), and safety.
SponsorEli Lilly
Data ProviderEli Lilly
Partial set or SubsetOriginal Data
Patients in dataset92
# of Patients Control46
# of Patients Experimental48
DOIhttps://doi.org/10.34949/bscb-ga21
CDISC StandardSDTM
Study ArmsBoth comparator and experimental arm data
Clinical Trials.gov Information
Brief SummaryThe purpose of this trial is to compare the progression free survival of LY2510924 + carboplatin + etoposide therapy versus carboplatin + etoposide therapy in participants with extensive-stage disease small cell lung cancer (SCLC)
ConditionsExtensive Stage Small Cell Lung Carcinoma
Intervention TypeDrug: LY2510924
Drug: Carboplatin
Drug: Etoposide
Drug: Carboplatin
Drug: Etoposide
Drug(s)Drug: LY2510924
Drug: Carboplatin
Drug: Etoposide
Drug: Carboplatin
Drug: Etoposide
Total Enrolled90
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionLY2510924 + Carboplatin + Etoposide - Experimental
Carboplatin + Etoposide - Active Comparator
Carboplatin + Etoposide - Active Comparator
Secondary IDI2V-MC-CXAC
PubMed (PMID)28236984
Collaborator(s)N/A
Region(s)United States
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Unspecified Adult Solid Tumor
Unspecified Adult Solid Tumor
Study Phase
Not Applicable
Study Completion Date
June 2010
June 2010
NCT00459134Uploaded 01-12-2019
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A Randomized Study to Determine Whether ArginMax Improves the Sexual Function and Quality of Life in Female Cancer Survivors
Provider Information
Provider Data DescriptionThis dataset contains all the data used in the publication cited above (PMID=26287032).
Baseline demographic and clinical variables are provided for time = 0 (baseline visit).
The primary outcome measures for the study are assessed at each time (0=baseline, 4=4 weeks, 8=8 weeks, and 12=12 weeks).
Summary measures that are calculated across the participant?s time on study (e.g., worst toxicities and compliance) are recorded on the time = 99 rows. Note that these are measures determined over the entire study period, not a specific time.
Notes: Missing data are denoted by a blank or a ?.? for each variable.
SponsorWake Forest University Health Sciences
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: L-arginine supplements may improve the quality of life and sexual function in women who are cancer survivors.
PURPOSE: This randomized clinical trial is studying an L-arginine supplement to see how well it works compared with a placebo in treating women who are cancer survivors.
ConditionsSexual Dysfunction
Sexuality and Reproductive Issues
Unspecified Adult Solid Tumor, Protocol Specific
Sexuality and Reproductive Issues
Unspecified Adult Solid Tumor, Protocol Specific
Intervention TypeDietary Supplement: ArginMax
Dietary Supplement: Placebo
Dietary Supplement: Placebo
Drug(s)N/A
Total Enrolled186
RandomizationRandomized
Blinding MethodTriple
Arms InterventionArm I: ArginMax - Experimental
Arm II: Placebo - Placebo Comparator
Arm II: Placebo - Placebo Comparator
Secondary IDU10CA081851
PubMed (PMID)N/A
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
CNS
CNS
Study Phase
Phase 3
Study Completion Date
March 1994
March 1994
NCT03722355Uploaded 01-04-2019
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A Phase III Comparison of Hyperfractionated Radiation Therapy (RT) With BCNU and Conventional RT With BCNU for Supratentorial Malignant Glioma
Provider Information
Provider Data DescriptionThis dataset will allow users to reproduce the treatment comparison between arm 1 and arm 2 in trial NCT03722355.
SponsorRadiation Therapy Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryHyperfractionated radiation therapy (RT) to 72.0 Gy with BCNU will be compared to conventional radiation therapy to 60.0 Gy with BCNU to determine if hyperfractionated RT can improve the median survival time of adults with supratentorial malignant gliomas.
ConditionsGlioma
Glioblastoma Multiforme
Astrocytoma
Glioblastoma Multiforme
Astrocytoma
Intervention TypeRadiation: Conventional RT
Radiation: Hyperfractionated RT
Drug: Carmustine
Radiation: Hyperfractionated RT
Drug: Carmustine
Drug(s)Drug: Carmustine
Total Enrolled712
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionArm 1: Conventional RT + Carmustine - Active Comparator
Arm 2: Hyperfractionated RT + Carmustine - Experimental
Arm 2: Hyperfractionated RT + Carmustine - Experimental
Secondary IDN/A
PubMed (PMID)N/A
Collaborator(s)N/A
Region(s)N/A
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Lung
Lung
Study Phase
Phase 3
Study Completion Date
November 2013
November 2013
NCT00693992Uploaded 12-15-2018
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Randomized, Phase III, Double-Blind Placebo-Controlled Trial of Sunitinib (NSC #736511) as Maintenance Therapy in Non-progressing Patients Following an Initial Four Cycles of Platinum-Based Combination Chemotherapy in Advanced, Stage IIIB / IV Non-small Cell Lung Cancer
Provider Information
Provider Data DescriptionDataset NCT00693992-D3-Dataset.csv (qol) is one of 3 datasets associated with PubMed ID 28161554. This dataset contains information that will allow you to reproduce the quality of life (qol) analysis. Due to data cleaning efforts, values may contain slight discrepancies from that reported in Table 1 of the Supplemental Materials.
SponsorNational Cancer Institute
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial studies sunitinib malate to see how well it works when given as maintenance therapy (meaning it is approved for treatment after chemotherapy) in patients with stage IIIB-IV non-small cell lung cancer who have responded to prior treatment with combination chemotherapy. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking the growth of new blood vessels necessary for tumor growth. It is not yet known whether sunitinib malate is effective in helping tumors continue to shrink or stop growing.
ConditionsStage IIIB Lung Non-Small Cell Cancer AJCC v7
Stage IV Non-Small Cell Lung Cancer AJCC v7
Stage IV Non-Small Cell Lung Cancer AJCC v7
Intervention TypeOther: Laboratory Biomarker Analysis
Other: Placebo
Other: Quality-of-Life Assessment
Drug: Sunitinib Malate
Other: Placebo
Other: Quality-of-Life Assessment
Drug: Sunitinib Malate
Drug(s)Drug: Sunitinib Malate
Total Enrolled210
RandomizationRandomized
Blinding MethodTriple
Arms InterventionArm I (sunitinib malate) - Experimental
Arm II (placebo) - Placebo Comparator
Arm II (placebo) - Placebo Comparator
Secondary IDNCI-2009-00469
PubMed (PMID)28161554
Collaborator(s)N/A
Region(s)United States
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Prostate
Prostate
Study Phase
Phase 3
Study Completion Date
April 2014
April 2014
NCT00033631Uploaded 12-15-2018
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A Phase III Randomized Study Of High Dose 3D-CRT/IMRT Versus Standard Dose 3D-CRT/IMRT In Patients Treated For Localized Prostate Cancer
Provider Information
Provider Data DescriptionThis dataset will allow users to reproduce the treatment comparison between arms in trial NCT00033631.
SponsorRadiation Therapy Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. It is not yet known which dose of radiation therapy is more effective in treating stage II prostate cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of two different doses of specialized radiation therapy in treating patients who have stage II prostate cancer.
ConditionsProstate Cancer
Intervention TypeRadiation: 70.2 Gy 3D-CRT/IMRT
Radiation: 79.2 Gy 3D-CRT/IMRT
Radiation: 79.2 Gy 3D-CRT/IMRT
Drug(s)N/A
Total Enrolled1534
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms Intervention70.2 Gy - Active Comparator
79.2 Gy - Experimental
79.2 Gy - Experimental
Secondary IDCDR0000069306
PubMed (PMID)18674684
17825932
29543933
17825932
29543933
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Canada
Canada
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Leukemia/Lymphoma, Myelodysplastic Syndrome (MDS)
Leukemia/Lymphoma, Myelodysplastic Syndrome (MDS)
Study Phase
Phase 3
Study Completion Date
December 2013
December 2013
NCT00369317Uploaded 12-06-2018
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The Treatment of Down Syndrome Children With Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS) Under the Age of 4 Years
Provider Information
Provider Data DescriptionNCT00369317-D1 is the only dataset associated with this publication. The dataset contains the CONSORT flow of patient enrollment, baseline characteristics, adverse events, MRD, cytogenetics, and primary outcome analyses for patients on AAML0431 as reported in the manuscript. Also, data for patients on A2971 are provided in order to compare brief baseline characteristics and outcome to patients on AAML0431.
SponsorChildren's Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis phase III trial is studying how well combination chemotherapy works in treating young patients with Down syndrome and acute myeloid leukemia or myelodysplastic syndromes. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
ConditionsChildhood Acute Basophilic Leukemia
Childhood Acute Eosinophilic Leukemia
Childhood Acute Erythroleukemia (M6)
Childhood Acute Megakaryocytic Leukemia (M7)
Childhood Acute Minimally Differentiated Myeloid Leukemia (M0)
Childhood Acute Monoblastic Leukemia (M5a)
Childhood Acute Monocytic Leukemia (M5b)
Childhood Acute Myeloblastic Leukemia With Maturation (M2)
Childhood Acute Myeloblastic Leukemia Without Maturation (M1)
Childhood Acute Myelomonocytic Leukemia (M4)
Childhood Myelodysplastic Syndromes
de Novo Myelodysplastic Syndromes
Secondary Acute Myeloid Leukemia
Secondary Myelodysplastic Syndromes
Untreated Childhood Acute Myeloid Leukemia and Other Myeloid Malignancies
Childhood Acute Eosinophilic Leukemia
Childhood Acute Erythroleukemia (M6)
Childhood Acute Megakaryocytic Leukemia (M7)
Childhood Acute Minimally Differentiated Myeloid Leukemia (M0)
Childhood Acute Monoblastic Leukemia (M5a)
Childhood Acute Monocytic Leukemia (M5b)
Childhood Acute Myeloblastic Leukemia With Maturation (M2)
Childhood Acute Myeloblastic Leukemia Without Maturation (M1)
Childhood Acute Myelomonocytic Leukemia (M4)
Childhood Myelodysplastic Syndromes
de Novo Myelodysplastic Syndromes
Secondary Acute Myeloid Leukemia
Secondary Myelodysplastic Syndromes
Untreated Childhood Acute Myeloid Leukemia and Other Myeloid Malignancies
Intervention TypeDrug: asparaginase
Drug: daunorubicin hydrochloride
Drug: cytarabine
Drug: thioguanine
Drug: etoposide
Other: laboratory biomarker analysis
Drug: daunorubicin hydrochloride
Drug: cytarabine
Drug: thioguanine
Drug: etoposide
Other: laboratory biomarker analysis
Drug(s)Drug: asparaginase
Drug: daunorubicin hydrochloride
Drug: cytarabine
Drug: thioguanine
Drug: etoposide
Drug: daunorubicin hydrochloride
Drug: cytarabine
Drug: thioguanine
Drug: etoposide
Total Enrolled205
RandomizationN/A
Blinding MethodNone (Open Label)
Arms InterventionTreatment (combination chemotherapy) - Experimental
Secondary IDNCI-2009-00318
PubMed (PMID)28389462
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Australia
Canada
Puerto Rico
Australia
Canada
Puerto Rico
Age Range4 Years and younger (Child)
Type(s) of Cancer
Breast
Breast
Study Phase
Phase 3
Study Completion Date
December 2015
December 2015
NCT00754845Uploaded 11-22-2018
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A Double Blind Randomization to Letrozole or Placebo for Women Previously Diagnosed With Primary Breast Cancer Completing Five Years of Adjuvant Aromatase Inhibitor Either as Initial Therapy or After Tamoxifen (Including Those in The MA.17 Study)
Provider Information
Provider Data DescriptionThis dataset will allow users to reproduce the treatment comparison between letrozole group and the placebo group in trial NCT00754845.
SponsorCanadian Cancer Trials Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by lowering the amount of estrogen the body makes. It is not yet known whether letrozole is more effective than a placebo in treating in women with breast cancer who have already received 5 years of aromatase inhibitor therapy.
PURPOSE: This randomized phase III trial is studying letrozole to see how well it works compared with a placebo in treating women with primary breast cancer who have received 5 years of aromatase inhibitor therapy.
ConditionsBreast Cancer
Intervention TypeDrug: letrozole
Other: placebo
Other: placebo
Drug(s)Drug: letrozole
Total Enrolled1918
RandomizationRandomized
Blinding MethodTriple
Arms InterventionLetrozole - Experimental
Placebo - Placebo Comparator
Placebo - Placebo Comparator
Secondary IDCAN-NCIC-MA17R
PubMed (PMID)27264120
34825307
33853037
29328860
34825307
33853037
29328860
Collaborator(s)Eastern Cooperative Oncology Group
North Central Cancer Treatment Group
Southwest Oncology Group
Alliance for Clinical Trials in Oncology
North Central Cancer Treatment Group
Southwest Oncology Group
Alliance for Clinical Trials in Oncology
Region(s)Canada
United Kingdom
United Kingdom
Age Range120 Years and younger (Child, Adult, Older Adult)
Type(s) of Cancer
Melanoma
Melanoma
Study Phase
Phase 3
Study Completion Date
October 2012
October 2012
NCT01989572Uploaded 10-31-2018
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A Randomized, Placebo-Controlled Phase III Trial of Yeast Derived GM-CSF Versus Peptide Vaccination Versus GM-CSF Plus Peptide Vaccination Versus Placebo in Patients With "No Evidence of Disease" After Complete Surgical Resection of "Locally Advanced" and/or Stage IV Melanoma
Provider Information
Provider Data DescriptionThere are two different submissions (each with one dataset) for trial NCT01989572. This dataset, NCT01989572-D2, contains toxicity data. The other dataset, NCT01989572-D1, contains baseline and efficacy data.
SponsorNational Cancer Institute
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial studies sargramostim or vaccine therapy alone to see how well they work compared to sargramostim and vaccine therapy together in preventing disease recurrence in patients with melanoma that has been removed by surgery. Sargramostim may stimulate the immune system in different ways and stop tumor cells from growing. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. It is not yet known whether yeast derived sargramostim and vaccine therapy are more effective alone or together in preventing recurrence of melanoma.
ConditionsIris Melanoma
Medium/Large Size Posterior Uveal Melanoma
Mucosal Melanoma
Ocular Melanoma With Extraocular Extension
Recurrent Melanoma
Recurrent Uveal Melanoma
Small Size Posterior Uveal Melanoma
Stage IIA Cutaneous Melanoma AJCC v6 and v7
Stage IIA Uveal Melanoma AJCC v7
Stage IIB Cutaneous Melanoma AJCC v6 and v7
Stage IIB Uveal Melanoma AJCC v7
Stage IIC Cutaneous Melanoma AJCC v6 and v7
Stage IIIA Cutaneous Melanoma AJCC v7
Stage IIIA Uveal Melanoma AJCC v7
Stage IIIB Cutaneous Melanoma AJCC v7
Stage IIIB Uveal Melanoma AJCC v7
Stage IIIC Cutaneous Melanoma AJCC v7
Stage IIIC Uveal Melanoma AJCC v7
Stage IV Cutaneous Melanoma AJCC v6 and v7
Stage IV Uveal Melanoma AJCC v7
Medium/Large Size Posterior Uveal Melanoma
Mucosal Melanoma
Ocular Melanoma With Extraocular Extension
Recurrent Melanoma
Recurrent Uveal Melanoma
Small Size Posterior Uveal Melanoma
Stage IIA Cutaneous Melanoma AJCC v6 and v7
Stage IIA Uveal Melanoma AJCC v7
Stage IIB Cutaneous Melanoma AJCC v6 and v7
Stage IIB Uveal Melanoma AJCC v7
Stage IIC Cutaneous Melanoma AJCC v6 and v7
Stage IIIA Cutaneous Melanoma AJCC v7
Stage IIIA Uveal Melanoma AJCC v7
Stage IIIB Cutaneous Melanoma AJCC v7
Stage IIIB Uveal Melanoma AJCC v7
Stage IIIC Cutaneous Melanoma AJCC v7
Stage IIIC Uveal Melanoma AJCC v7
Stage IV Cutaneous Melanoma AJCC v6 and v7
Stage IV Uveal Melanoma AJCC v7
Intervention TypeOther: Laboratory Biomarker Analysis
Other: Placebo
Other: Placebo
Biological: Sargramostim
Biological: Tyrosinase Peptide
Other: Placebo
Other: Placebo
Biological: Sargramostim
Biological: Tyrosinase Peptide
Drug(s)N/A
Total Enrolled815
RandomizationRandomized
Blinding MethodDouble
Arms InterventionArm I (sargramostim, peptide vaccine) - Experimental
Arm II (sargramostim placebo, peptide vaccine) - Experimental
Arm III (sargramostim, peptide placebo) - Experimental
Arm IV (placebo, peptide placebo) - Placebo Comparator
Arm V (sargramostim) - Experimental
Arm VI (sargramostim placebo) - Placebo Comparator
Arm II (sargramostim placebo, peptide vaccine) - Experimental
Arm III (sargramostim, peptide placebo) - Experimental
Arm IV (placebo, peptide placebo) - Placebo Comparator
Arm V (sargramostim) - Experimental
Arm VI (sargramostim placebo) - Placebo Comparator
Secondary IDNCI-2013-02101
PubMed (PMID)26351350
Collaborator(s)N/A
Region(s)United States
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Lung
Lung
Study Phase
Phase 3
Study Completion Date
June 2013
June 2013
NCT00981058Uploaded 10-16-2018
Available for Download
A Randomized, Multicenter, Open-Label Phase 3 Study of Gemcitabine-Cisplatin Chemotherapy Plus Necitumumab (IMC-11F8) Versus Gemcitabine-Cisplatin Chemotherapy Alone in the First-Line Treatment of Patients With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC)
Provider Information
Provider Data DescriptionPrimary Objective: The primary objective of this study was to evaluate the overall survival (OS) in patients with Stage IV squamous NSCLC (per the American Joint Committee on Cancer [AJCC] Staging Manual, Seventh Edition [AJCC7]) treated with necitumumab plus gemcitabine and cisplatin chemotherapy (GC+N Arm) versus gemcitabine and cisplatin chemotherapy alone (GC Arm) in the first-line metastatic setting.
Key Secondary Objectives: To evaluate progression-free survival (PFS) in each arm; to evaluate the objective response rate (ORR) in each arm; to evaluate the time to treatment failure (TTF) in each arm; to evaluate the safety profile of necitumumab in combination with gemcitabine and cisplatin chemotherapy;
SponsorEli Lilly
Data ProviderEli Lilly
Partial set or SubsetOriginal Data
Patients in dataset1093
# of Patients Control548
# of Patients ExperimentalN/A
DOIhttps://doi.org/10.34949/05tc-jx78
CDISC StandardADAM
Study ArmsComparator arm data only
Clinical Trials.gov Information
Brief SummaryThe research study is testing the investigational drug necitumumab (IMC-11F8) in the treatment of advanced non-small cell lung cancer. The aim of this study is to determine if necitumumab, given together with a standard chemotherapy combination consisting of cisplatin and gemcitabine will be more effective in improving participant disease than the standard chemotherapy combination alone.
ConditionsNon Small Cell Lung Cancer
Intervention TypeBiological: Necitumumab
Drug: Gemcitabine
Drug: Cisplatin
Drug: Gemcitabine
Drug: Cisplatin
Drug(s)Drug: Gemcitabine
Drug: Cisplatin
Drug: Cisplatin
Total Enrolled1093
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionNecitumumab + Gemcitabine + Cisplatin - Experimental
Gemcitabine + Cisplatin - Active Comparator
Gemcitabine + Cisplatin - Active Comparator
Secondary IDCP11-0806
PubMed (PMID)29158123
27207107
26980471
26045340
27207107
26980471
26045340
Collaborator(s)Parexel
PPD
Medidata Solutions
Laboratory Corporation of America
University of Colorado, Denver
Thermo Fisher Scientific FS
ICON Clinical Research
Pacific Biomarkers
Sysmex Inostics GmbH
Intertek
PPD
Medidata Solutions
Laboratory Corporation of America
University of Colorado, Denver
Thermo Fisher Scientific FS
ICON Clinical Research
Pacific Biomarkers
Sysmex Inostics GmbH
Intertek
Region(s)United States
Australia
Austria
Belgium
Brazil
Canada
Croatia
France
Germany
Greece
Hungary
Italy
Korea, Republic of
Philippines
Poland
Portugal
Romania
Russian Federation
Serbia
Singapore
Slovakia
South Africa
Spain
Taiwan
Thailand
United Kingdom
Australia
Austria
Belgium
Brazil
Canada
Croatia
France
Germany
Greece
Hungary
Italy
Korea, Republic of
Philippines
Poland
Portugal
Romania
Russian Federation
Serbia
Singapore
Slovakia
South Africa
Spain
Taiwan
Thailand
United Kingdom
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Breast
Breast
Study Phase
Phase 3
Study Completion Date
December 2016
December 2016
NCT01598298Uploaded 10-16-2018
Access via NCI by Request
A Randomized Placebo-Controlled Phase III Study of Duloxetine for Treatment of Aromatase Inhibitor-Associated Musculoskeletal Symptoms in Women With Early Stage Breast Cancer
Provider Information
Provider Data DescriptionThis dataset will allow users to reproduce the results reported in the Journal of Clinical Oncology (Henry et al., JCO, 2017), which contains patient-level data (one row per patient), including eligibility, evaluability, treatment, demographic, and baseline information.
SponsorSouthwest Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: Duloxetine hydrochloride may lessen muscle, bone, and joint pain caused by hormone therapy. It is not yet known whether duloxetine hydrochloride is more effective than a placebo in treating patients with muscle, bone, and joint pain caused by hormone therapy.
PURPOSE: This randomized phase III trial studies how well duloxetine hydrochloride works compared to a placebo in treating muscle, bone, and joint pain in patients with early-stage breast cancer receiving hormone therapy.
ConditionsBreast Cancer
Musculoskeletal Complications
Pain
Musculoskeletal Complications
Pain
Intervention TypeDrug: duloxetine hydrochloride
Other: placebo
Other: placebo
Drug(s)Drug: duloxetine hydrochloride
Total Enrolled299
RandomizationRandomized
Blinding MethodTriple
Arms InterventionArm I - Experimental
Arm II - Placebo Comparator
Arm II - Placebo Comparator
Secondary IDS1202
PubMed (PMID)29136387
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Age Range120 Years and younger (Child, Adult, Older Adult)
Type(s) of Cancer
Leukemia/Lymphoma
Leukemia/Lymphoma
Study Phase
Phase 3
Study Completion Date
September 2001
September 2001
NCT01230983Uploaded 09-15-2018
Access via NCI by Request
Intensive Treatment For T-CELL Acute Lymphoblastic Leukemia and Advanced Stage Lymphoblastic Non-Hodgkin's Lymphoma: A Pediatric Oncology Group Phase III Study
Provider Information
Provider Data DescriptionDataset 2 Description: NCT01230983-D2 is the subset of the 239 patients with data on Troponin levels. These data were used in the mixed model analyses to assess the effect of Dexrazoxane on the probability of an elevated troponin concentration during treatment.
SponsorChildren's Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Dexrazoxane may lessen the side effects of chemotherapy.
PURPOSE: Randomized phase III trial to compare combination chemotherapy with or without dexrazoxane and with or without high-dose methotrexate in patients with acute lymphoblastic leukemia or advanced lymphoblastic non-Hodgkin's lymphoma.
ConditionsCardiac Toxicity
Leukemia
Lymphoma
Leukemia
Lymphoma
Intervention TypeDrug: asparaginase
Drug: cytarabine
Drug: dexrazoxane hydrochloride
Drug: doxorubicin hydrochloride
Drug: leucovorin calcium
Drug: mercaptopurine
Drug: methotrexate
Drug: prednisone
Drug: therapeutic hydrocortisone
Drug: vincristine sulfate
Radiation: radiation therapy
Drug: cytarabine
Drug: dexrazoxane hydrochloride
Drug: doxorubicin hydrochloride
Drug: leucovorin calcium
Drug: mercaptopurine
Drug: methotrexate
Drug: prednisone
Drug: therapeutic hydrocortisone
Drug: vincristine sulfate
Radiation: radiation therapy
Drug(s)Drug: asparaginase
Drug: cytarabine
Drug: doxorubicin hydrochloride
Drug: mercaptopurine
Drug: methotrexate
Drug: prednisone
Drug: therapeutic hydrocortisone
Drug: vincristine sulfate
Drug: dexrazoxane hydrochloride
Drug: leucovorin calcium
Drug: cytarabine
Drug: doxorubicin hydrochloride
Drug: mercaptopurine
Drug: methotrexate
Drug: prednisone
Drug: therapeutic hydrocortisone
Drug: vincristine sulfate
Drug: dexrazoxane hydrochloride
Drug: leucovorin calcium
Total Enrolled573
RandomizationNon-Randomized
Blinding MethodDouble
Arms InterventionTreatment 1: (No HD MTX / No Zinecard) - Experimental
Treatment 2: (No HD MTX / Zinecard) - Active Comparator
Treatment 3: (HD MTX / No Zinecard) - Active Comparator
Treatment 4: (HD MTX / Zinecard) - Active Comparator
Treatment 2: (No HD MTX / Zinecard) - Active Comparator
Treatment 3: (HD MTX / No Zinecard) - Active Comparator
Treatment 4: (HD MTX / Zinecard) - Active Comparator
Secondary IDU10CA030969
PubMed (PMID)20459861
20016527
20016527
Collaborator(s)National Cancer Institute (NCI)
Region(s)N/A
Age Range21 Years and younger (Child, Adult)
Type(s) of Cancer
Colorectal
Colorectal
Study Phase
Phase 3
Study Completion Date
May 2007
May 2007
NCT00115765Uploaded 08-03-2018
Available for Download
PACCE: A Randomized, Open-Label, Controlled, Clinical Trial of Chemotherapy and Bevacizumab With and Without Panitumumab in the First-Line Treatment of Subjects With Metastatic Colorectal Cancer
Provider Information
Provider Data DescriptionPrimary Objective - To assess whether treatment with panitumumab given concomitantly with every 2 (Q2) week oxaliplatin-based chemotherapy and bevacizumab improves progression- free survival (PFS) compared to treatment with Q2-week oxaliplatin-based chemotherapy and bevacizumab alone.
Secondary Objectives - To assess 1) Whether treatment with panitumumab given concomitantly with oxaliplatin-based chemotherapy and bevacizumab improves the following endpoints compared to treatment with oxaliplatin-based chemotherapy and bevicizumab alone: Overall Survival; Response rates (complete [CR] and partial [PR] responses [at week 12 and best overall response during 1st line treatment]); Time to progression (TTP); Time to treatment failure (TTF); Duration of response and Rate of stable disease (SD) and duration of SD. 2) The safety of panitumumab given concomitantly with oxaliplatin-based chemotherapy and bevicizumab as compared to treatment of oxaliplatin-based chemotherapy and bevicizumab alone and 3) The safety and efficacy of panitumumab given concomitantly with irinotecan-based chemotherapy and bevicizumab as compared to treatment of irinotecan-based chemotherapy and bevicizumab alone.
SponsorAmgen
Data ProviderAmgen
Partial set or SubsetOriginal Data
Patients in dataset1053
# of Patients Control525
# of Patients Experimental528
DOIhttps://doi.org/10.34949/a40v-5664
CDISC StandardADS
Study ArmsBoth comparator and experimental arm data
Clinical Trials.gov Information
Brief SummaryThe purpose of this study is to assess whether treatment with the study drug, panitumumab given concomitantly with every 2 (Q2) week oxaliplatin-based chemotherapy and bevacizumab improves progression-free survival (PFS) compared to treatment Q2-week with oxaliplatin-based chemotherapy and bevacizumab alone. All subjects will receive Q2-week oxaliplatin- or irinotecan-based chemotherapy and bevacizumab. Control arm subjects will not receive concomitant panitumumab therapy.
ConditionsColorectal Cancer
Intervention TypeDrug: Oxaliplatin Based Chemotherapy
Drug: Panitumumab
Drug: Irinotecan Based Chemotherapy
Drug: Bevacizumab
Drug: Panitumumab
Drug: Irinotecan Based Chemotherapy
Drug: Bevacizumab
Drug(s)Drug: Oxaliplatin Based Chemotherapy
Drug: Bevacizumab
Drug: Panitumumab
Drug: Irinotecan Based Chemotherapy
Drug: Bevacizumab
Drug: Panitumumab
Drug: Irinotecan Based Chemotherapy
Total Enrolled1053
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionOxaliplatin and bevacizumab without panitumumab - Active Comparator
Irinotecan and bevacizumab plus panitumumab - Experimental
Irinotecan and bevacizumab without panitumumab - Active Comparator
Oxaliplatin and bevacizumab plus panitumumab - Experimental
Irinotecan and bevacizumab plus panitumumab - Experimental
Irinotecan and bevacizumab without panitumumab - Active Comparator
Oxaliplatin and bevacizumab plus panitumumab - Experimental
Secondary IDN/A
PubMed (PMID)19114685
31378656
30679026
31378656
30679026
Collaborator(s)N/A
Region(s)N/A
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Colorectal
Colorectal
Study Phase
Phase 3
Study Completion Date
April 2009
April 2009
NCT00339183Uploaded 08-03-2018
Available for Download
A Randomized, Multicenter Phase 3 Study to Compare the Efficacy of Panitumumab in Combination With Chemotherapy to the Efficacy of Chemotherapy Alone in Patients With Previously Treated Metastatic Colorectal Cancer
Provider Information
Provider Data DescriptionPrimary Objective - To evaluate the treatment effect of panitumumab plus FOLFIRI on overall survival (OS) and progression-free survival (PFS) compared to FOLFIRI alone as second line therapy for metastatic colorectal cancer (mCRC) among subjects with wild-type KRAS tumors and mutant KRAS tumors Secondary Objectives - To evaluate overall objective response rate (ORR), time to progression (TTP), duration of response (DOR), and safety (subject incidence of AEs and significant laboratory changes) among subjects with wild-type KRAS tumors and mutant KRAS tumors Tertiary Objectives - To evaluate time to response and patient-reported outcomes (PRO) among subjects with wild-type KRAS tumors and mutant KRAS tumors Exploratory Objectives - To investigate potential biomarker development (other than KRAS) based on assessment of blood cells, tumor cells and the proposed mechanism of action of study drugs among subjects with wild-type KRAS tumors and mutant KRAS tumors Primary Endpoints - Efficacy: Overall survival (OS) and progression-free survival (PFS) Secondary Endpoints - Efficacy: overall objective response rate (ORR), time to progression (TTP), duration of response (DOR). Safety: Incidence of AEs and significant laboratory changes Tertiary Endpoints: Time to response, Patient-reported outcomes (EQ-5D health state index score, EQ-5D overall health rating Exploratory Endpoint: Investigation of potential biomarker (other than KRAS) development based on assessment of blood cells, tumor cells and the proposed mechanism of action of study drugs Sample Size: 1100 subjects (approximately 550 per treatment arm)
SponsorAmgen
Data ProviderAmgen
Partial set or SubsetOriginal Data
Patients in dataset1186
# of Patients Control595
# of Patients Experimental591
DOIhttps://doi.org/10.34949/0ws2-w454
CDISC StandardADS
Study ArmsBoth comparator and experimental arm data
Clinical Trials.gov Information
Brief SummaryThe purpose of this study is to evaluate the treatment effect of panitumumab plus FOLFIRI compared to FOLFIRI alone as second line therapy for metastatic colorectal cancer.
ConditionsMetastatic Colorectal Cancer
Intervention TypeDrug: Panitumumab
Drug: FOLFIRI
Drug: FOLFIRI
Drug(s)Drug: Panitumumab
Drug: FOLFIRI
Drug: FOLFIRI
Total Enrolled1186
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionPanitumumab Plus FOLFIRI - Experimental
FOLFIRI Alone - Active Comparator
FOLFIRI Alone - Active Comparator
Secondary IDN/A
PubMed (PMID)24356622
20921462
30013091
31902066
29627309
26341920
26049686
22070868
20921462
30013091
31902066
29627309
26341920
26049686
22070868
Collaborator(s)N/A
Region(s)N/A
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Colorectal
Colorectal
Study Phase
Phase 3
Study Completion Date
August 2009
August 2009
NCT00364013Uploaded 08-03-2018
Available for Download
A Randomized, Multicenter, Phase 3 Study to Compare the Efficacy of Panitumumab in Combination With Oxaliplatin/ 5-fluorouracil/ Leucovorin to the Efficacy of Oxaliplatin/ 5-fluorouracil/ Leucovorin Alone in Patients With Previously Untreated Metastatic Colorectal Cancer
Provider Information
Provider Data DescriptionPrimary Objective - To assess whether panitumumab in combination with infusional 5-fluorouracil, leucovorin and oxaliplatin (FOLFOX) chemotherapy improves progression-free survival (PFS) compared to FOLFOX alone as first-line therapy for metastatic colorectal cancer (mCRC) among subjects with wild-type KRAS tumors and subjects with mutant KRAS tumors. Secondary Objectives - To evaluate overall survival (OS), objective response rate (ORR), duration of response (DOR), time to progression (TTP) and safety and tolerability among subjects with wild-type KRAS tumors and subjects with mutant KRAS tumors. Tertiary Objectives - To evaluate time to response and patient reported outcomes (PRO) among subjects with wild-type KRAS tumors and subjects with mutant KRAS tumors Exploratory Objectives - to investigate potential biomarker development based on assessment of blood cells, tumor cells and the proposed mechanism of action of study drug among subjects with wild-type KRAS tumors and subjects with mutant KRAS tumors. Primary Endpoint - Progression-free survival (PFS) Secondary Endpoints - Efficacy: Overall Survival (OS), Objective Response Rate (ORR), Time to progression (TTP), Duration of response (DOR). Safety: Incidence of AEs and significant laboratory changes Tertiary Endpoints - Time to response, Patient-reported outcomes (EuroQol [EQ-5D]) Exploratory Endpoints - Investigation of potential biomarker development based on assessment of blood cells, tumor cells and the proposed mechanism of action of the study drug. Sample Size - Approximately 1150 subjects (approximately 575 per treatment arm)
SponsorAmgen
Data ProviderAmgen
Partial set or SubsetOriginal Data
Patients in dataset1183
# of Patients Control590
# of Patients Experimental593
DOIhttps://doi.org/10.34949/x1zp-2985
CDISC StandardADS
Study ArmsBoth comparator and experimental arm data
Clinical Trials.gov Information
Brief SummaryThe purpose of this study is to determine the treatment effect of panitumumab in combination with FOLFOX compared to FOLFOX alone as first line therapy for metastatic colorectal cancer
ConditionsMetastatic Colorectal Cancer
Intervention TypeDrug: Panitumumab
Drug: FOLFOX regimen
Drug: FOLFOX regimen
Drug(s)Drug: Panitumumab
Drug: FOLFOX regimen
Drug: FOLFOX regimen
Total Enrolled1183
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionFOLFOX + Panitumumab - Experimental
FOLFOX - Active Comparator
FOLFOX - Active Comparator
Secondary IDN/A
PubMed (PMID)24024839
24718886
20921465
25956209
31515083
31378656
30679026
30614531
30019318
29627309
28449055
27843597
26049686
22070868
24718886
20921465
25956209
31515083
31378656
30679026
30614531
30019318
29627309
28449055
27843597
26049686
22070868
Collaborator(s)N/A
Region(s)N/A
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Head and Neck
Head and Neck
Study Phase
Phase 3
Study Completion Date
May 2010
May 2010
NCT00460265Uploaded 08-03-2018
Available for Download
A Phase 3 Randomized Trial of Chemotherapy With or Without Panitumumab in Patients With Metastatic and/or Recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Provider Information
Provider Data DescriptionPrimary Objective - To assess whether panitumumab plus chemotherapy improves overall survival (OS) compared to chemotherapy alone as first line treatment for metastatic and/or recurrent squamous cell carcinoma of the head and neck (SCCHN) Secondary Objectives - To evaluate progression-free survival (PFS), overall response rate (ORR), duration of response (DOR), time to progression (TTP) and safety. Tertiary Objectives - To evaluate time to response (TTR) and patient reported outcomes (PROs) utilizing the validated EUROQOL EQ-5D health state index score and the overall health rating. Exploratory Objectives - To investigate potential biomarker development based on assessment of blood and tumor cells and the proposed mechanism of action of study drugs. In addition, investigate the effect of genetic variation in cancer genes and drug target genes on subject response to study drugs. Primary Endpoint - Efficacy: OS Secondary Endpoints - Efficacy: PFS, ORR, DOR, TTP. Safety: Incidence of adverse events (AEs), significant laboratory changes and human anti-panitumumab antibody (HAPA) formation. Tertiary Endpoints - TTR, Patient reported outcomes using EUROQOL EQ-5D (Health state index score, Overall health rating) Exploratory Endpoints - Investigation of potential biomarker development based on assessment of blood and tumor cells and the proposed mechanism of action of study drug. In addition, investigate the effect of genetic variation in cancer genes and drug target genes on subject response to study drugs. Sample Size - 650 subjects total (325 per treatment arm)
SponsorAmgen
Data ProviderAmgen
Partial set or SubsetOriginal Data
Patients in dataset657
# of Patients Control330
# of Patients Experimental327
DOIhttps://doi.org/10.34949/3eaj-md88
CDISC StandardADS
Study ArmsBoth comparator and experimental arm data
Clinical Trials.gov Information
Brief SummaryThe purpose of this study is to determine the treatment effect of Panitumumab in combination with chemotherapy versus chemotherapy alone as first line therapy for metastatic and/or recurrent squamous cell carcinoma of the head and neck.
ConditionsRecurrent and/or Metastatic Head and Neck Cancer
Intervention TypeDrug: ARM 2
Drug: ARM 1
Drug: ARM 1
Drug(s)Drug: ARM 2
Drug: ARM 1
Drug: ARM 1
Total Enrolled658
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionARM 2 - Active Comparator
ARM 1 - Experimental
ARM 1 - Experimental
Secondary IDN/A
PubMed (PMID)23746666
Collaborator(s)N/A
Region(s)N/A
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Lung
Lung
Study Phase
Phase 3
Study Completion Date
January 2007
January 2007
NCT00119613Uploaded 08-03-2018
Available for Download
A Randomized, Double Blind, Placebo-Controlled Study of Subjects With Previously Untreated Extensive-Stage Small-Cell Lung Cancer (SCLC) Treated With Platinum Plus Etoposide Chemotherapy With or Without Darbepoetin Alfa
Provider Information
Provider Data DescriptionPrimary Objective - To evaluate whether increasing or maintaining hemoglobin concentrations with darbepoetin alfa, when administered with platinum-containing chemotherapy in subjects with previously untreated extensive stage small cell lung cancer (SCLC), increases survival. Secondary Objective - To evaluate whether darbepoetin alfa improves FACT-Fatigue subscale scores. Safety Objective - To assess the safety profile of darbepoetin alfa in subjects with previously untreated extensive stage SCLC. Study Design - Randomized, double-blind, placebo controlled, multicenter study. Eligible subjects will be randomized in a 1:1 ratio to treatment with darbepoetin alfa or placebo and will be stratified by region, ECOG performance status, and LDH level. Subjects will receive study drug (darbepoetin alfa or placebo) throughout the 6 cycles of chemotherapy and for 3 weeks after the last dose of chemotherapy. Subjects will be followed until death, or at the point at which all randomized subjects have completed their end of study treatment visit and 496 deaths have occurred. This will be the End of Study. Long term follow-up will run from the end of study until all subjects have died. Sample size - The planned sample size is approximately 600 subjects randomized in a 1:1 ratio Primary Endpoints - 1) change in hemoglobin concentration from baseline to the end of the chemotherapy treatment period 2) survival time Secondary endpoints - 1) change to FACT-Fatigue subscale scores from baseline to the end of study treatment Safety Endpoints - 1) incidence of adverse events (including serious and treatment related), changes in laboratory values, changes in vital signs and incidence of concomitant medications.
SponsorAmgen
Data ProviderAmgen
Partial set or SubsetOriginal Data
Patients in dataset600
# of Patients Control301
# of Patients Experimental299
DOIhttps://doi.org/10.34949/shvm-xw45
CDISC StandardADS
Study ArmsBoth comparator and experimental arm data
Clinical Trials.gov Information
Brief SummaryThe purpose of this study is to evaluate whether increasing or maintaining hemoglobin concentrations with darbepoetin alfa, when administered with platinum-containing chemotherapy in subjects with previously untreated extensive-stage small cell lung cancer (SCLC), increases survival.
ConditionsSmall Cell Lung Cancer
Intervention TypeDrug: placebo
Drug: darbepoetin alfa
Drug: darbepoetin alfa
Drug(s)Drug: darbepoetin alfa
Drug: placebo
Drug: placebo
Total Enrolled600
RandomizationRandomized
Blinding MethodQuadruple
Arms InterventionGroup 1 - darbepoetin alfa - Experimental
Group 2 - Placebo - Placebo Comparator
Group 2 - Placebo - Placebo Comparator
Secondary IDN/A
PubMed (PMID)18467726
Collaborator(s)N/A
Region(s)N/A
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Lung
Lung
Study Phase
Phase 3
Study Completion Date
June 2005
June 2005
NCT00003299Uploaded 07-30-2018
Available for Download
A Randomized Phase III Study Comparing Etoposide and Cisplatin With Etoposide, Cisplatin and Paclitaxel in Patients With Extensive Small Cell Lung Cancer
Provider Information
Provider Data DescriptionI. Determine whether the addition of paclitaxel to standard chemotherapy treatment comprising etoposide and cisplatin improves the survival of patients with extensive stage small cell lung cancer. II. Compare the tumor response rate and failure-free survival of these patients treated with these regimens. III. Describe and compare the toxic effects associated with these regimens in these patients.
SponsorAlliance for Clinical Trials in Oncology
Data ProviderAlliance for Clinical Trials in Oncology
Partial set or SubsetOriginal Data
Patients in dataset587
# of Patients Control294
# of Patients Experimental293
DOIhttps://doi.org/10.34949/bhrq-ca29
CDISC StandardADS
Study ArmsBoth comparator and experimental arm data
Clinical Trials.gov Information
Brief SummaryRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether cisplatin, etoposide, and paclitaxel are more effective than cisplatin and etoposide alone in treating patients with extensive-stage small cell lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin plus etoposide with or without paclitaxel in treating patients with extensive-stage small cell lung cancer.
ConditionsLung Cancer
Intervention TypeDrug: cisplatin
Drug: etoposide
Drug: paclitaxel
Drug: etoposide
Drug: paclitaxel
Drug(s)Drug: cisplatin
Drug: etoposide
Drug: paclitaxel
Drug: etoposide
Drug: paclitaxel
Total Enrolled587
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionCisplatin + Etoposide - Active Comparator
Cisplatin + Etoposide + Paclitaxel - Experimental
Cisplatin + Etoposide + Paclitaxel - Experimental
Secondary IDU10CA031946
PubMed (PMID)16365181
15923572
15923572
Collaborator(s)National Cancer Institute (NCI)
North Central Cancer Treatment Group
Eastern Cooperative Oncology Group
Southwest Oncology Group
North Central Cancer Treatment Group
Eastern Cooperative Oncology Group
Southwest Oncology Group
Region(s)United States
Canada
Canada
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Colorectal
Colorectal
Study Phase
Phase 3
Study Completion Date
October 2004
October 2004
NCT00003594Uploaded 07-13-2018
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A Randomized Phase III Trial of Three Different Regimens of CPT-11 Plus 5-Fluorouracil and Leucovorin Compared to 5-Fluorouracil and Leucovorin in Patients With Advanced Adenocarcinoma of the Colon and Rectum
Provider Information
Provider Data DescriptionThe NCT00003594_D4end_at dataset is one of 4 datasets associated with PubMed ID 14665611. This dataset contains information per patient regarding end of treatment timing and reason. Note: These datasets have been updated since the primary publication and may not match the exact results reported in the primary manuscript.
SponsorAlliance for Clinical Trials in Oncology
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of combination chemotherapy is most effective in treating advanced colorectal cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of various combination chemotherapy regimens in treating patients who have advanced, recurrent, or metastatic colorectal cancer that cannot be treated with surgery or radiation therapy.
ConditionsColorectal Cancer
Intervention TypeDrug: irinotecan
Drug: fluorouracil
Drug: leucovorin calcium
Drug: oxaliplatin
Drug: fluorouracil
Drug: leucovorin calcium
Drug: oxaliplatin
Drug(s)Drug: irinotecan
Drug: fluorouracil
Drug: leucovorin calcium
Drug: oxaliplatin
Drug: fluorouracil
Drug: leucovorin calcium
Drug: oxaliplatin
Total Enrolled1691
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms Interventionirinotecan + leucovorin + fluorouracil - Experimental
oxaliplatin + leucovorin + fluorouracil - Experimental
oxaliplatin + irinotecan - Experimental
oxaliplatin + leucovorin + fluorouracil - Experimental
oxaliplatin + irinotecan - Experimental
Secondary IDCDR0000066665
PubMed (PMID)22162570
21880789
18182660
11204663
21632455
21422438
20697547
20530282
19828593
19636001
19073970
19001325
17687151
16849748
15677624
15470715
14665611
31104167
21880789
18182660
11204663
21632455
21422438
20697547
20530282
19828593
19636001
19073970
19001325
17687151
16849748
15677624
15470715
14665611
31104167
Collaborator(s)National Cancer Institute (NCI)
NCIC Clinical Trials Group
NCIC Clinical Trials Group
Region(s)United States
Canada
Puerto Rico
South Africa
Canada
Puerto Rico
South Africa
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Breast
Breast
Study Phase
Phase 3
Study Completion Date
August 2007
August 2007
NCT00003855Uploaded 07-07-2018
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A Randomized Trial of Axillary Node Dissection in Women With Clinical T1-2 N0-1 M0 Breast Cancer Who Have a Positive Sentinel Node
Provider Information
Provider Data DescriptionThis dataset will allow users to reproduce the primary analysis publication (PubMed ID: 21304082) for study NCT00003855.
SponsorAlliance for Clinical Trials in Oncology
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: Surgery to remove lymph nodes in the armpit may remove cancer cells that have spread from tumors in the breast.
PURPOSE: Randomized phase III trial to determine the effectiveness of removing lymph nodes in the armpit in treating women who have stage I or stage IIA breast cancer.
ConditionsBreast Cancer
Intervention TypeProcedure: axillary lymph node dissection
Radiation: whole breast irradiation
Radiation: whole breast irradiation
Drug(s)N/A
Total Enrolled605
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionSurgery + radiotherapy - Experimental
Radiotherapy - Active Comparator
Radiotherapy - Active Comparator
Secondary IDGUMC-00153
PubMed (PMID)23290275
22820938
18640934
23338762
23037494
21327455
21304082
20739842
17485711
28898379
22820938
18640934
23338762
23037494
21327455
21304082
20739842
17485711
28898379
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Australia
Canada
Ireland
Australia
Canada
Ireland
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Prostate
Prostate
Study Phase
Phase 3
Study Completion Date
July 2012
July 2012
NCT00079001Uploaded 07-07-2018
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A Randomized Double-Blind, Placebo-Controlled Phase III Study of Early Versus Standard Zoledronic Acid to Prevent Skeletal Related Events in Men With Prostate Cancer Metastatic to Bone
Provider Information
Provider Data DescriptionNCT00079001-D3-Dataset.csv (ae) is one of 3 datasets that contain the data published in the analyses of PubMed ID 24590644. This dataset contains information that will allow you to reproduce the toxicity reported.
SponsorAlliance for Clinical Trials in Oncology
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: Zoledronate may prevent or decrease skeletal (bone)-related events (such as pain or fractures) caused by bone metastases and androgen deprivation therapy. It is not yet known whether treatment with zoledronate is effective in preventing bone-related events in patients who have prostate cancer and bone metastases.
PURPOSE: This randomized phase III trial is studying how well zoledronate works in preventing bone-related events in patients who are receiving androgen deprivation therapy for prostate cancer and bone metastases.
ConditionsMetastatic Cancer
Prostate Cancer
Prostate Cancer
Intervention TypeDrug: zoledronic acid
Other: placebo
Drug: androgen deprivation therapy
Drug: GnRH agonist
Dietary Supplement: Calcium supplement
Dietary Supplement: Vitamin D
Other: placebo
Drug: androgen deprivation therapy
Drug: GnRH agonist
Dietary Supplement: Calcium supplement
Dietary Supplement: Vitamin D
Drug(s)Drug: zoledronic acid
Drug: androgen deprivation therapy
Drug: GnRH agonist
Drug: androgen deprivation therapy
Drug: GnRH agonist
Total Enrolled645
RandomizationRandomized
Blinding MethodQuadruple
Arms InterventionZoledronic acid + androgen deprivation therapy - Experimental
Placebo + androgen deprivation therapy - Active Comparator
Placebo + androgen deprivation therapy - Active Comparator
Secondary IDU10CA031946
PubMed (PMID)24590644
33270906
33270906
Collaborator(s)National Cancer Institute (NCI)
Southwest Oncology Group
Eastern Cooperative Oncology Group
NCIC Clinical Trials Group
Novartis Pharmaceuticals
Southwest Oncology Group
Eastern Cooperative Oncology Group
NCIC Clinical Trials Group
Novartis Pharmaceuticals
Region(s)United States
Canada
Canada
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Head and Neck
Head and Neck
Study Phase
Phase 3
Study Completion Date
January 1999
January 1999
NCT03370367Uploaded 07-07-2018
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Double Blind Phase III Trial of Effects of Low Dose 13-Cisretinoic Acid on Prevention of Second Primaries in Stages I-II Head and Neck Cancer
Provider Information
Provider Data DescriptionThis dataset contains baseline, efficacy, 13-CRA toxicity, and CTC toxicity data from trial NCT03370367.
SponsorEastern Cooperative Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryIn this trial the investigators propose to utilize 13-cRA to prevent dysplastic changes and second malignancies in patients with squamous cell carcinoma of the head and neck regions who have a high probability of cure from their primary cancer. Comparisons between patients treated by 13-cRA and patients receiving placebo will include:
The time to diagnosis of second primary for the treatment versus control groups.
Survival time for the treatment versus control groups.
Secondarily, the cost-benefit ratio for 13-cRA will be analyzed by assessing the toxicities of 13-cis retinoic acid treated patients in comparison to those experienced by placebo treated patients.
ConditionsStage I-II Head and Neck Cancer
Intervention TypeDrug: 13-cis retinoic acid
Other: Placebo
Other: Placebo
Drug(s)Drug: 13-cis retinoic acid
Total Enrolled189
RandomizationRandomized
Blinding MethodSingle
Arms InterventionArm A - Experimental
Arm B - Placebo Comparator
Arm B - Placebo Comparator
Secondary IDN/A
PubMed (PMID)N/A
Collaborator(s)N/A
Region(s)N/A
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Colorectal
Colorectal
Study Phase
Phase 2BPhase 3
Study Completion Date
November 2009
November 2009
NCT00384176Uploaded 07-02-2018
Available for Download
Enhancing the Analytic Capacity of Colorec_AstraZe_2006_78 using a Statistical Linkage Method to Append Socioeconomic and Health Care Access Variables from the Medical Expenditure Panel Survey
Provider Information
Provider Data DescriptionThis data enhancement project seeks to further advance the mission of the PDS platform by enabling new explorations into the potential influence of health care access, socioeconomic factors, and health behaviors on the patient-level efficacy and outcomes data contained in the PDS online service. This was achieved using a statistical linkage method in which patient-level records from PDS dataset, Colorec_AstraZe_2006_78, were matched with colo-rectal cancer survivors from the nationally representative Medical Expenditure Panel Survey (MEPS). Linkage criteria were based on age, sex, race, tumor location, and a quality of life assessment called the EQ-5D index score. The use of the EQ-5D score as a linkage criterion reduces the multitude of many-to-many exact matches that would have occurred using only age, race, and sex. A sixth optional linkage criterion based on BMI category has also been provided so that users may restrict the set of linkages based on age, sex, race, tumor location, and EQ-5D further as desired. The addition of the MEPS data to the patient-level data within the PDS enclave will facilitate hypothesis-generating research efforts that explore the level of variation in patient outcomes potentially attributable to differentials in access to basic health care services and their utilization, to socioeconomic characteristics, and to health behaviors and preferences. It will support exploratory analyses designed to examine questions such as How are variations in cancer patients' access to health care and income impacting patient outcomes in specific phase III clinical trials? What variations in patient outcomes are associated with specific demographic, socioeconomic, and health-related factors? Are the demographic characteristics of those cancer patients enrolled in specific phase III clinical trials comparable to cancer patients with the same disease in the general population?
SponsorResearcher Curated
Data ProviderRTI International
Partial set or SubsetComposite
Patients in dataset690
# of Patients Control0
# of Patients ExperimentalN/A
DOIhttps://doi.org/10.34949/me3a-kj25
CDISC StandardNot Applicable
Study ArmsComparator arm data only
Clinical Trials.gov Information
Brief SummaryThe purpose of this study is to see if Cediranib in combination with FOLFOX is effective in treating metastatic colorectal cancer and to see how it compares with Avastin (Bevacizumab) in combination with FOLFOX.
ConditionsColorectal Cancer
Intervention TypeDrug: Cediranib
Drug: Bevacizumab
Drug: 5-fluorouracil ( in FOLFOX)
Drug: Leucovorin (in FOLFOX)
Drug: Oxaliplatin (in FOLFOX)
Drug: Bevacizumab
Drug: 5-fluorouracil ( in FOLFOX)
Drug: Leucovorin (in FOLFOX)
Drug: Oxaliplatin (in FOLFOX)
Drug(s)Drug: Bevacizumab
Drug: 5-fluorouracil ( in FOLFOX)
Drug: Leucovorin (in FOLFOX)
Drug: Oxaliplatin (in FOLFOX)
Drug: Cediranib
Drug: 5-fluorouracil ( in FOLFOX)
Drug: Leucovorin (in FOLFOX)
Drug: Oxaliplatin (in FOLFOX)
Drug: Cediranib
Total Enrolled1814
RandomizationRandomized
Blinding MethodQuadruple
Arms Intervention1 - Active Comparator
2 - Experimental
2 - Experimental
Secondary IDEudract Number 2005-003440-66
PubMed (PMID)31378656
30679026
19203899
30679026
19203899
Collaborator(s)N/A
Region(s)United States
Australia
Austria
Belgium
Canada
Czech Republic
Egypt
Finland
France
Germany
Hungary
India
Israel
Italy
Latvia
Malta
Philippines
Poland
Russian Federation
Slovakia
South Africa
Spain
Taiwan
Thailand
Turkey
Ukraine
United Kingdom
Vietnam
Australia
Austria
Belgium
Canada
Czech Republic
Egypt
Finland
France
Germany
Hungary
India
Israel
Italy
Latvia
Malta
Philippines
Poland
Russian Federation
Slovakia
South Africa
Spain
Taiwan
Thailand
Turkey
Ukraine
United Kingdom
Vietnam
Age Range18 Years to 130 Years (Adult, Older Adult)
Type(s) of Cancer
Colorectal
Colorectal
Study Phase
Phase 3
Study Completion Date
October 2013
October 2013
NCT00726622Uploaded 05-22-2018
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A Phase III Prospective Randomized Trial Comparing Laparoscopic-Assisted Resection Versus Open Resection for Rectal Cancer
Provider Information
Provider Data DescriptionThis dataset will allow users to reproduce the analysis for the primary publication in trial NCT00726622. This dataset is identical to NCT00726622-D1 except it also includes a patient reference (patref) field that can be tied to patient information submitted to NCTN Navigator submissions.
SponsorAlliance for Clinical Trials in Oncology
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis study is being done to compare two types of surgery currently used for rectal cancer. The two types of surgery are laparoscopic-assisted rectal resection and open laparotomy rectal resection. Although laparoscopic-assisted rectal resection is being used for rectal cancer in some medical centers, the effectiveness of this type of surgery compared to open surgery is unknown. The study will compare the safety and effectiveness of the surgeries, recovery from surgery in the hospital, overall recovery from surgery and cancer outcome.
ConditionsColorectal Cancer
Intervention TypeProcedure: Open laparotomy and rectal resection
Procedure: Laparoscopic-assisted rectal resection
Procedure: Laparoscopic-assisted rectal resection
Drug(s)N/A
Total Enrolled486
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionArm 1: Open laparotomy and rectal resection - Active Comparator
Arm 2: Laparoscopic-assisted rectal resection - Experimental
Arm 2: Laparoscopic-assisted rectal resection - Experimental
Secondary IDACOSOG-Z6051
PubMed (PMID)26441179
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Canada
Canada
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Multiple Myeloma
Multiple Myeloma
Study Phase
Phase 3
Study Completion Date
January 2014
January 2014
NCT00602641Uploaded 03-06-2018
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An Intergroup Phase III Randomized Controlled Trial Comparing Melphalan, Prednisone and Thalidomide (MPT) Versus Melphalan, Prednisone and Lenalidomide (Revlimid(TM))(MPR) in Newly Diagnosed Multiple Myeloma Patients Who Are Not Candidates for High-Dose Therapy
Provider Information
Provider Data DescriptionThere are three different submissions (each for one dataset) for trial NCT00602641. This data submission, NCT00602641-D3, contains toxicity data. The other two data submissions, NCT00602641-D1 and NCT00602641-D2, contain clinical data together with QOL data and data for treatment dose, respectively.
SponsorNational Cancer Institute
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial studies melphalan and prednisone with thalidomide to see how well it works compared to melphalan and prednisone together with lenalidomide in treating patients with newly diagnosed multiple myeloma. Drugs used in chemotherapy, such as melphalan and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Thalidomide and lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. It is not yet known whether melphalan and prednisone are more effective when given together with thalidomide or lenalidomide in treating multiple myeloma.
ConditionsPlasma Cell Myeloma
Intervention TypeOther: Laboratory Biomarker Analysis
Drug: Lenalidomide
Drug: Melphalan
Drug: Prednisone
Other: Quality-of-Life Assessment
Drug: Thalidomide
Drug: Lenalidomide
Drug: Melphalan
Drug: Prednisone
Other: Quality-of-Life Assessment
Drug: Thalidomide
Drug(s)Drug: Melphalan
Drug: Prednisone
Drug: Thalidomide
Drug: Lenalidomide
Drug: Prednisone
Drug: Thalidomide
Drug: Lenalidomide
Total Enrolled306
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionArm I (thalidomide) - Active Comparator
Arm II (lenalidomide) - Experimental
Arm II (lenalidomide) - Experimental
Secondary IDNCI-2009-00522
PubMed (PMID)26157076
Collaborator(s)N/A
Region(s)United States
Israel
Israel
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Neuroendocrine
Neuroendocrine
Study Phase
Phase 3
Study Completion Date
January 2015
January 2015
NCT00569127Uploaded 02-24-2018
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Phase III Prospective Randomized Comparison of Depot Octreotide Plus Interferon Alpha Versus Depot Octreotide Plus Bevacizumab (NSC #704865) in Advanced, Poor Prognosis Carcinoid Patients
Provider Information
Provider Data DescriptionThis dataset will allow users to reproduce toxicity analyses reported in the Journal of Clinical Oncology (Yao et al., JCO, 2017, PMID referenced above), which included adverse events among patients with advanced NETs in the SWOG Phase III trial, S0518 (NCT00569127), receiving bevacizumab + octreotide or interferon alfa-2b + octreotide.
SponsorNational Cancer Institute
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial studies octreotide acetate and recombinant interferon alfa-2b to see how well it works compared to octreotide acetate and bevacizumab in treating patients with high-risk neuroendocrine tumors that have spread to other places in the body (metastatic) or spread from where it started to nearby tissue or lymph nodes (locally advanced). Octreotide acetate and recombinant interferon alfa-2b may interfere with the growth of tumor cells and slow the growth of cancer. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving octreotide acetate together with recombinant interferon alfa-2b is more effective than giving octreotide acetate together with bevacizumab in treating patients with neuroendocrine tumor.
ConditionsAtypical Carcinoid Tumor
Carcinoid Tumor
Colorectal Neuroendocrine Tumor G1
Gastric Neuroendocrine Tumor G1
Neuroendocrine Neoplasm
Carcinoid Tumor
Colorectal Neuroendocrine Tumor G1
Gastric Neuroendocrine Tumor G1
Neuroendocrine Neoplasm
Intervention TypeBiological: Bevacizumab
Other: Laboratory Biomarker Analysis
Drug: Octreotide Acetate
Biological: Recombinant Interferon Alfa-2b
Other: Laboratory Biomarker Analysis
Drug: Octreotide Acetate
Biological: Recombinant Interferon Alfa-2b
Drug(s)Drug: Octreotide Acetate
Total Enrolled427
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionArm I (octreotide acetate and bevacizumab) - Experimental
Arm II (octreotide acetate and recombinant interferon alfa-2b) - Experimental
Arm II (octreotide acetate and recombinant interferon alfa-2b) - Experimental
Secondary IDNCI-2009-00778
PubMed (PMID)28384065
Collaborator(s)N/A
Region(s)United States
Age RangeN/A (Child, Adult, Older Adult)
Type(s) of Cancer
Lung
Lung
Study Phase
Phase 3
Study Completion Date
June 2013
June 2013
NCT00533949Uploaded 01-30-2018
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A Randomized Phase III Comparison of Standard-Dose (60 Gy) Versus High-Dose (74 Gy) Conformal Radiotherapy With Concurrent and Consolidation Carboplatin/Paclitaxel +/- Cetuximab (IND #103444) in Patients With Stage IIIA/IIIB Non-Small Cell Lung Cancer
Provider Information
Provider Data DescriptionThis dataset will allow users to reproduce adverse event tables in trial NCT00533949.
SponsorRadiation Therapy Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as paclitaxel, carboplatin work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether high-dose radiation therapy is more effective than standard-dose radiation therapy when given together with combination chemotherapy with or without cetuximab in treating patients with non-small cell lung cancer.
PURPOSE: This randomized phase III trial is studying high-dose or standard-dose radiation therapy given together with chemotherapy with or without cetuximab to see how well they work in treating patients with newly diagnosed stage III non-small cell lung cancer that cannot be removed by surgery.
ConditionsLung Cancer
Radiation Toxicity
Radiation Toxicity
Intervention TypeBiological: Cetuximab
Drug: Carboplatin
Drug: Paclitaxel
Radiation: 60 Gy RT
Radiation: 74 Gy RT
Drug: Carboplatin
Drug: Paclitaxel
Radiation: 60 Gy RT
Radiation: 74 Gy RT
Drug(s)Drug: Carboplatin
Drug: Paclitaxel
Drug: Paclitaxel
Total Enrolled544
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms Intervention60 Gy RT - Active Comparator
74 Gy RT - Experimental
60 Gy RT + Cetuximab - Experimental
74 Gy RT + Cetuximab - Experimental
74 Gy RT - Experimental
60 Gy RT + Cetuximab - Experimental
74 Gy RT + Cetuximab - Experimental
Secondary IDCDR0000564240
PubMed (PMID)31841363
26606200
25601342
26606200
25601342
Collaborator(s)National Cancer Institute (NCI)
North Central Cancer Treatment Group
Cancer and Leukemia Group B
NRG Oncology
North Central Cancer Treatment Group
Cancer and Leukemia Group B
NRG Oncology
Region(s)United States
Canada
Canada
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Lung
Lung
Study Phase
Phase 2BPhase 3
Study Completion Date
April 2012
April 2012
NCT00409188Uploaded 01-19-2018
Available for Download
Enhancing the Analytic Capacity of LungNo_MerckKG_2007_145 using a Statistical Linkage Method to Append Socioeconomic and Health Care Access Variables from the Medical Expenditure Panel Survey
Provider Information
Provider Data DescriptionThis data enhancement project seeks to further advance the mission of the PDS platform by enabling new explorations into the potential influence of health care access, socioeconomic factors, and health behaviors on the patient-level efficacy and outcomes data contained in the PDS online service. This was achieved using a statistical linkage method in which patient-level records from PDS dataset, LungNo_MerckKG_2007_145, were matched with lung cancer survivors from the nationally representative Medical Expenditure Panel Survey (MEPS). Linkage criteria were based on age, sex, race, and a quality of life assessment called the EQ-5D index score. The use of the EQ-5D score as a linkage criterion reduces the multitude of many-to-many exact matches that would have occurred using only age, race, and sex.
The addition of the MEPS data to the patient-level data within the PDS enclave will facilitate hypothesis-generating research efforts that explore the level of variation in patient outcomes potentially attributable to differentials in access to basic health care services and their utilization, to socioeconomic characteristics, and to health behaviors and preferences. It will support exploratory analyses designed to examine questions such as How are variations in cancer patients' access to health care and income impacting patient outcomes in specific phase III clinical trials? What variations in patient outcomes are associated with specific demographic, socioeconomic, and health-related factors? Are the demographic characteristics of those cancer patients enrolled in specific phase III clinical trials comparable to cancer patients with the same disease in the general population?
SponsorResearcher Curated
Data ProviderRTI International
Partial set or SubsetComposite
Patients in dataset507
# of Patients Control0
# of Patients ExperimentalN/A
DOIhttps://doi.org/10.34949/tn3n-w544
CDISC StandardNot Applicable
Study ArmsComparator arm data only
Clinical Trials.gov Information
Brief SummaryThe purpose of this study is to determine whether the cancer vaccine tecemotide (L-BLP25) in addition to best supportive care is effective in prolonging the lives of subjects with unresectable stage III non-small cell lung cancer, compared to best supportive care alone.
A local ancillary (sub) study in European centers will evaluate the immune response in peripheral blood after tecemotide (L-BLP25) or placebo vaccination.
ConditionsNon-small Cell Lung Cancer
Intervention TypeBiological: Tecemotide (L-BLP25)
Drug: Single low dose cyclophosphamide
Drug: Placebo
Drug: Single low dose cyclophosphamide
Drug: Placebo
Drug(s)Drug: Single low dose cyclophosphamide
Drug: Placebo
Drug: Placebo
Total Enrolled1513
RandomizationRandomized
Blinding MethodQuadruple
Arms InterventionTecemotide (L-BLP25) - Experimental
Placebo - Placebo Comparator
Placebo - Placebo Comparator
Secondary IDN/A
PubMed (PMID)24331154
24976972
34870327
25722382
24976972
34870327
25722382
Collaborator(s)Merck KGaA, Darmstadt, Germany
Region(s)United States
Argentina
Australia
Austria
Belgium
Brazil
Canada
China
Czech Republic
Denmark
France
Germany
Greece
Hong Kong
Hungary
India
Ireland
Israel
Italy
Korea, Republic of
Mexico
Netherlands
Poland
Portugal
Romania
Russian Federation
Singapore
Slovakia
Spain
Sweden
Switzerland
Taiwan
United Kingdom
Argentina
Australia
Austria
Belgium
Brazil
Canada
China
Czech Republic
Denmark
France
Germany
Greece
Hong Kong
Hungary
India
Ireland
Israel
Italy
Korea, Republic of
Mexico
Netherlands
Poland
Portugal
Romania
Russian Federation
Singapore
Slovakia
Spain
Sweden
Switzerland
Taiwan
United Kingdom
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Prostate
Prostate
Study Phase
Phase 2BPhase 3
Study Completion Date
January 2012
January 2012
NCT00988208Uploaded 01-19-2018
Available for Download
Enhancing the Analytic Capacity of Prostate_Celgene_2009_90 using a Statistical Linkage Method to Append Socioeconomic and Health Care Access Variables from the Medical Expenditure Panel Survey
Provider Information
Provider Data DescriptionThis data enhancement project seeks to further advance the mission of the PDS platform by enabling new explorations into the potential influence of health care access, socioeconomic factors, and health behaviors on the patient-level efficacy and outcomes data contained in the PDS online service. This was achieved using a statistical linkage method in which patient-level records from PDS dataset, Prostate_Celgene_2009_90, were matched with prostate cancer survivors from the nationally representative Medical Expenditure Panel Survey (MEPS). Linkage criteria were based on age, sex, race, and a quality of life assessment called the EQ-5D index score. The use of the EQ-5D score as a linkage criterion reduces the multitude of many-to-many exact matches that would have occurred using only age, race, and sex. A fifth optional linkage criterion based on BMI category has also been provided so that users may restrict the set of linkages based on age, sex, race, and EQ-5D further as desired.
The addition of the MEPS data to the patient-level data within the PDS enclave will facilitate hypothesis-generating research efforts that explore the level of variation in patient outcomes potentially attributable to differentials in access to basic health care services and their utilization, to socioeconomic characteristics, and to health behaviors and preferences. It will support exploratory analyses designed to examine questions such as How are variations in cancer patients' access to health care and income impacting patient outcomes in specific phase III clinical trials? What variations in patient outcomes are associated with specific demographic, socioeconomic, and health-related factors? Are the demographic characteristics of those cancer patients enrolled in specific phase III clinical trials comparable to cancer patients with the same disease in the general population?
SponsorResearcher Curated
Data ProviderRTI International
Partial set or SubsetComposite
Patients in dataset526
# of Patients Control0
# of Patients ExperimentalN/A
DOIhttps://doi.org/10.34949/r1zh-ph85
CDISC StandardNot Applicable
Study ArmsComparator arm data only
Clinical Trials.gov Information
Brief SummaryThe purpose of the study is to determine whether lenalidomide is safe and effective for use in combination with docetaxel and prednisone for the treatment of subjects with metastatic Castrate-Resistant Prostate Cancer.
The addition of lenalidomide to docetaxel and prednisone is proposed to increase the life expectancy of these subjects.
ConditionsProstate Cancer
Intervention TypeDrug: Lenalidomide
Drug: Docetaxel
Drug: Prednisone
Drug: Placebo
Drug: Docetaxel
Drug: Prednisone
Drug: Placebo
Drug(s)Drug: Lenalidomide
Drug: Docetaxel
Drug: Prednisone
Drug: Placebo
Drug: Docetaxel
Drug: Prednisone
Drug: Placebo
Total Enrolled1059
RandomizationRandomized
Blinding MethodQuadruple
Arms InterventionDocetaxel, Prednisone, Lenalidomide (DPL) - Experimental
Docetaxel and Prednisone (DP) - Experimental
Docetaxel and Prednisone (DP) - Experimental
Secondary IDEudraCT Number 2008-007969-23
PubMed (PMID)27522164
25743937
27560549
25743937
27560549
Collaborator(s)N/A
Region(s)United States
Australia
Austria
Belgium
Canada
Czechia
Denmark
France
Germany
Greece
Hungary
Israel
Italy
Mexico
Netherlands
Poland
Russian Federation
South Africa
Spain
Sweden
United Kingdom
Australia
Austria
Belgium
Canada
Czechia
Denmark
France
Germany
Greece
Hungary
Israel
Italy
Mexico
Netherlands
Poland
Russian Federation
South Africa
Spain
Sweden
United Kingdom
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Breast
Breast
Study Phase
Phase 3
Study Completion Date
January 2014
January 2014
NCT00068601Uploaded 12-23-2017
Access via NCI by Request
Phase III Trial of LHRH Analog Administration During Chemotherapy to Reduce Ovarian Failure Following Chemotherapy in Early Stage, Hormone-Receptor Negative Breast Cancer
Provider Information
Provider Data DescriptionThis dataset will allow users to reproduce the results reported in the New England Journal of Medicine (Moore et al., NEJM, 2015, PMID referenced above) for trial NCT00068601.
SponsorSouthwest Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: Goserelin blocks hormone production in the ovaries. It is not yet known whether ovarian suppression using goserelin will prevent ovarian failure (early menopause) in women receiving chemotherapy for breast cancer.
PURPOSE: This randomized phase III trial is studying how well giving goserelin together with chemotherapy works compared with chemotherapy alone in preventing early menopause in women with stage I, stage II, or stage IIIA breast cancer.
ConditionsBreast Cancer
Infertility
Menopausal Symptoms
Infertility
Menopausal Symptoms
Intervention TypeDrug: cyclophosphamide
Drug: goserelin acetate
Drug: goserelin acetate
Drug(s)Drug: cyclophosphamide
Drug: goserelin acetate
Drug: goserelin acetate
Total Enrolled257
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionStandard Chemotherapy - Active Comparator
Chemotherapy Plus Goserelin - Experimental
Chemotherapy Plus Goserelin - Experimental
Secondary IDS0230
PubMed (PMID)25738668
Collaborator(s)National Cancer Institute (NCI)
Cancer and Leukemia Group B
Eastern Cooperative Oncology Group
ETOP IBCSG Partners Foundation
Cancer and Leukemia Group B
Eastern Cooperative Oncology Group
ETOP IBCSG Partners Foundation
Region(s)Australia
Belgium
Hungary
Italy
New Zealand
Switzerland
Belgium
Hungary
Italy
New Zealand
Switzerland
Age Range18 Years to 49 Years (Adult)
Type(s) of Cancer
Breast
Breast
Study Phase
Phase 3
Study Completion Date
March 2015
March 2015
NCT00053898Uploaded 11-17-2017
Access via NCI by Request
A Clinical Trial Comparing Anastrozole With Tamoxifen in Postmenopausal Patients With Ductal Carcinoma in Situ (DCIS) Undergoing Lumpectomy With Radiation Therapy
Provider Information
Provider Data DescriptionThe dataset will allow users to view descriptions of SUMP75_ANALYSIS file for B-35 primary results paper.
SponsorNSABP Foundation Inc
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: Estrogen can stimulate the growth of breast cancer cells. Tamoxifen may fight breast cancer by blocking the use of estrogen. Anastrozole may fight breast cancer by decreasing estrogen production. It is not yet known whether anastrozole is more effective than tamoxifen in preventing the recurrence of breast cancer.
PURPOSE: This randomized phase III trial is studying anastrozole to see how well it works compared to tamoxifen in preventing the recurrence of breast cancer in postmenopausal women with ductal carcinoma in situ who are undergoing lumpectomy and radiation therapy.
ConditionsBreast Cancer
Intervention TypeDrug: anastrozole
Drug: tamoxifen citrate
Radiation: Radiation Therapy
Drug: tamoxifen citrate
Radiation: Radiation Therapy
Drug(s)Drug: tamoxifen citrate
Drug: anastrozole
Drug: anastrozole
Total Enrolled3104
RandomizationRandomized
Blinding MethodQuadruple
Arms InterventionGroup 1 - Active Comparator
Group 2 - Experimental
Group 2 - Experimental
Secondary IDNSABP-B-35
PubMed (PMID)17991930
26686957
26686960
23984897
26686957
26686960
23984897
Collaborator(s)National Cancer Institute (NCI)
North Central Cancer Treatment Group
Southwest Oncology Group
American College of Surgeons
North Central Cancer Treatment Group
Southwest Oncology Group
American College of Surgeons
Region(s)United States
Canada
Puerto Rico
Canada
Puerto Rico
Age RangeN/A (Child, Adult, Older Adult)
Type(s) of Cancer
Prostate
Prostate
Study Phase
Phase 3
Study Completion Date
April 2010
April 2010
NCT00004054Uploaded 11-15-2017
Access via NCI by Request
A Phase III Protocol of Androgen Suppression (AS) and Radiation Therapy (RT) vs AS and RT Followed by Chemotherapy With Paclitaxel, Estramustine, and Etoposide (TEE) for Localized, High-Risk, Prostate Cancer
Provider Information
Provider Data DescriptionThis dataset contains data from trial NCT00004054 to reproduce the results in 26209502.
SponsorRadiation Therapy Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: Hormones can stimulate the production of prostate cancer cells. Hormone therapy may fight prostate cancer by reducing the production of androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether hormone therapy plus radiation therapy is more effective with or without combination chemotherapy for prostate cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of hormone therapy plus radiation therapy with or without combination chemotherapy in treating patients who have prostate cancer.
ConditionsProstate Cancer
Intervention TypeDrug: bicalutamide
Drug: estramustine phosphate sodium
Drug: etoposide
Drug: flutamide
Drug: paclitaxel
Drug: Luteinizing hormone releasing hormone [LHRH] agonist
Radiation: Radiation therapy
Drug: warfarin
Drug: estramustine phosphate sodium
Drug: etoposide
Drug: flutamide
Drug: paclitaxel
Drug: Luteinizing hormone releasing hormone [LHRH] agonist
Radiation: Radiation therapy
Drug: warfarin
Drug(s)Drug: bicalutamide
Drug: flutamide
Drug: Luteinizing hormone releasing hormone [LHRH] agonist
Drug: estramustine phosphate sodium
Drug: etoposide
Drug: paclitaxel
Drug: warfarin
Drug: flutamide
Drug: Luteinizing hormone releasing hormone [LHRH] agonist
Drug: estramustine phosphate sodium
Drug: etoposide
Drug: paclitaxel
Drug: warfarin
Total Enrolled397
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionHormones and RT - Experimental
Hormones and RT plus Chemotherapy - Experimental
Hormones and RT plus Chemotherapy - Experimental
Secondary IDCDR0000067250
PubMed (PMID)18990504
26209502
26209502
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Canada
Canada
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Breast
Breast
Study Phase
Phase 3
Study Completion Date
August 2012
August 2012
NCT00265759Uploaded 10-23-2017
Available for Download
A Randomized Phase III Trial Comparing 16 to 18 Weeks of Neoadjuvant Exemestane (25 mg Daily), Letrozole (2.5 mg), or Anastrozole (1 mg) in Postmenopausal Women With Clinical Stage II and III Estrogen Receptor Positive Breast Cancer
Provider Information
Provider Data DescriptionPrimary: To determine whether anastrozole, exemestane or letrozole administered for 16 to 18 weeks as neoadjuvant endocrine treatment for postmenopausal patients with stage II or stage III ER+ breast cancer should be chosen as the aromatase inhibitor arm of a future study that will compare neoadjuvant aromatase inhibitor treatment with neoadjuvant chemotherapy.
Secondary: To compare the neoadjuvant treatment regimens relative to the rates of improvement in surgical outcome. To compare and confirm the radiological response rates (mammography by central radiological analysis) between these three neoadjuvant treatment regimens. To compare the relative safety of the neoadjuvant treatment regimens in terms of reported adverse events. See protocol for further details.
SponsorAlliance for Clinical Trials in Oncology
Data ProviderAlliance for Clinical Trials in Oncology
Partial set or SubsetOriginal Data
Patients in dataset622
# of Patients Control0
# of Patients Experimental377
DOIhttps://doi.org/10.34949/gg2g-wg21
CDISC StandardADS
Study ArmsBoth comparator and experimental arm data
Clinical Trials.gov Information
Brief SummaryRATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using exemestane, letrozole, or anastrozole, may fight breast cancer by lowering the amount of estrogen the body makes. Giving exemestane, letrozole, or anastrozole before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known whether exemestane, letrozole, or anastrozole is more effective in treating breast cancer.
PURPOSE: This randomized phase III trial is studying exemestane, letrozole, and anastrozole to compare how well they work in treating postmenopausal women who are undergoing surgery for stage II or stage III breast cancer.
ConditionsBreast Cancer
Intervention TypeDrug: anastrozole
Drug: exemestane
Drug: letrozole
Procedure: Therapeutic Conventional Surgery
Drug: exemestane
Drug: letrozole
Procedure: Therapeutic Conventional Surgery
Drug(s)Drug: exemestane
Drug: letrozole
Drug: anastrozole
Drug: letrozole
Drug: anastrozole
Total Enrolled622
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionArm I - Experimental
Arm II - Experimental
Arm III - Experimental
Arm II - Experimental
Arm III - Experimental
Secondary IDACOSOG-Z1031
PubMed (PMID)21555689
28045625
34011995
28045625
34011995
Collaborator(s)National Cancer Institute (NCI)
Cancer and Leukemia Group B
Cancer and Leukemia Group B
Region(s)United States
Age RangeN/A (Child, Adult, Older Adult)
Type(s) of Cancer
Lung
Lung
Study Phase
Phase 2B
Study Completion Date
June 2013
June 2013
NCT00453154Uploaded 10-23-2017
Available for Download
Combination Chemotherapy With or Without Maintenance Sunitinib Malate (NSC 736511) for Untreated Extensive Stage Small Cell Lung Cancer: A Phase IB/Randomized Phase II Study
Provider Information
Provider Data DescriptionPhase IB: To determine the phase II dose for sunitinib combined with cisplatin
and etoposide.
Phase II: To compare the progression-free survival of patients with extensive
stage small cell lung cancer treated with cisplatin or carboplatin and etoposide
followed by maintenance sunitinib to patients receiving the same chemotherapy
followed by placebo.
See protocol for further details.
SponsorAlliance for Clinical Trials in Oncology
Data ProviderAlliance for Clinical Trials in Oncology
Partial set or SubsetOriginal Data
Patients in dataset144
# of Patients Control46
# of Patients Experimental49
DOIhttps://doi.org/10.34949/zbwg-ef42
CDISC StandardADS
Study ArmsBoth comparator and experimental arm data
Clinical Trials.gov Information
Brief SummaryThis partially randomized phase I/II trial studies the side effects and best dose of sunitinib malate and to see how well it works when given together with cisplatin or carboplatin and etoposide in treating patients with extensive-stage small cell lung cancer. Drugs used in chemotherapy, such as cisplatin, carboplatin, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether cisplatin or carboplatin and etoposide are more effective when given with or without sunitinib malate in treating small cell lung cancer.
ConditionsExtensive Stage Lung Small Cell Carcinoma
Recurrent Lung Small Cell Carcinoma
Recurrent Lung Small Cell Carcinoma
Intervention TypeDrug: Carboplatin
Drug: Cisplatin
Drug: Etoposide
Other: Laboratory Biomarker Analysis
Other: Placebo Administration
Drug: Sunitinib Malate
Drug: Cisplatin
Drug: Etoposide
Other: Laboratory Biomarker Analysis
Other: Placebo Administration
Drug: Sunitinib Malate
Drug(s)Drug: Carboplatin
Drug: Cisplatin
Drug: Etoposide
Drug: Sunitinib Malate
Drug: Cisplatin
Drug: Etoposide
Drug: Sunitinib Malate
Total Enrolled156
RandomizationRandomized
Blinding MethodDouble
Arms InterventionArm I (Combination Chemotherapy + Sunitinib Maintenance) - Experimental
Arm II (Combination Chemotherapy + Placebo Maintenance) - Active Comparator
Arm II (Combination Chemotherapy + Placebo Maintenance) - Active Comparator
Secondary IDNCI-2009-00465
PubMed (PMID)25732163
Collaborator(s)N/A
Region(s)United States
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Prostate
Prostate
Study Phase
Phase 3
Study Completion Date
August 2015
August 2015
NCT00002874Uploaded 10-20-2017
Access via NCI by Request
A PHASE III TRIAL OF RADIATION THERAPY WITH OR WITHOUT CASODEX IN PATIENTS WITH PSA ELEVATION FOLLOWING RADICAL PROSTATECTOMY FOR pT3N0 CARCINOMA OF THE PROSTATE
Provider Information
Provider Data DescriptionThis dataset will allow users to reproduce the treatment comparison in trial NCT00002874.
SponsorRadiation Therapy Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using bicalutamide may fight prostate cancer by reducing the production of androgens. It is not yet known if radiation therapy is more effective with or without bicalutamide for prostate cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without bicalutamide in treating patients who have stage II or stage III prostate cancer and elevated prostate-specific antigen (PSA) levels following radical prostatectomy.
ConditionsProstate Cancer
Intervention TypeDrug: bicalutamide
Radiation: radiation therapy
Drug: placebo
Radiation: radiation therapy
Drug: placebo
Drug(s)Drug: bicalutamide
Drug: placebo
Drug: placebo
Total Enrolled840
RandomizationRandomized
Blinding MethodQuadruple
Arms InterventionBicalutamide - Experimental
Placebo - Placebo Comparator
Placebo - Placebo Comparator
Secondary IDCDR0000065158
PubMed (PMID)28146658
35790016
35737923
33570548
32215583
35790016
35737923
33570548
32215583
Collaborator(s)National Cancer Institute (NCI)
Southwest Oncology Group
NRG Oncology
Southwest Oncology Group
NRG Oncology
Region(s)United States
Canada
Canada
Age RangeN/A (Child, Adult, Older Adult)
Type(s) of Cancer
Esophageal
Esophageal
Study Phase
Phase 3
Study Completion Date
June 2012
June 2012
NCT00052910Uploaded 10-13-2017
Available for Download
Phase III Intergroup Trial of Adjuvant Chemoradiation After Resection of Gastric or Gastroesophageal Adenocarcinoma
Provider Information
Provider Data DescriptionOBJECTIVES:
Compare overall survival in patients with resected gastric adenocarcinoma treated with epirubicin, cisplatin, and infusional fluorouracil (5-FU) vs 5-FU bolus and leucovorin calcium before and after 5-FU plus radiotherapy.
Compare disease-free survival and local and distant recurrence rates in these patients treated with these regimens.
SponsorAlliance for Clinical Trials in Oncology
Data ProviderAlliance for Clinical Trials in Oncology
Partial set or SubsetOriginal Data
Patients in dataset546
# of Patients Control280
# of Patients Experimental266
DOIhttps://doi.org/10.34949/05b2-5q20
CDISC StandardADS
Study ArmsBoth comparator and experimental arm data
Clinical Trials.gov Information
Brief SummaryRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy after surgery may kill any remaining tumor cells following surgery. It is not yet known which chemotherapy and radiation therapy regimen is more effective in treating stomach or esophageal cancer.
PURPOSE: Randomized phase III trial to compare two different chemotherapy and radiation therapy regimens in treating patients who have undergone surgery for stomach or esophageal cancer.
ConditionsEsophageal Cancer
Gastric Cancer
Gastric Cancer
Intervention TypeDrug: cisplatin
Drug: epirubicin hydrochloride
Drug: fluorouracil
Drug: leucovorin calcium
Radiation: radiation therapy
Drug: epirubicin hydrochloride
Drug: fluorouracil
Drug: leucovorin calcium
Radiation: radiation therapy
Drug(s)Drug: fluorouracil
Drug: leucovorin calcium
Drug: cisplatin
Drug: epirubicin hydrochloride
Drug: leucovorin calcium
Drug: cisplatin
Drug: epirubicin hydrochloride
Total Enrolled546
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionArm I - Active Comparator
Arm II - Experimental
Arm II - Experimental
Secondary IDU10CA031946
PubMed (PMID)34149004
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Canada
Canada
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Leukemia/Lymphoma
Leukemia/Lymphoma
Study Phase
Phase 2B
Study Completion Date
October 2008
October 2008
NCT00301821Uploaded 08-28-2017
Available for Download
A Phase II Study of Epratuzumab, Rituximab (ER)-CHOP for Patients With Previously Untreated Diffuse Large B-Cell Lymphoma
Provider Information
Provider Data DescriptionTo prospectively assess the efficacy of combination of CHOP with epratuzumab and
rituximab (ER-CHOP), as measured by 12-month, event-free survival (EFS12),
in patients with previously untreated stages II, III, and IV diffuse large B-cell
lymphoma.
To assess the use of PET scan routinely early in treatment and post-completion of
chemotherapy and thereby assess the functional CR rate (CR/PR or stable by CT
scan and PET negative).
To assess the safety of ER-CHOP.
SponsorAlliance for Clinical Trials in Oncology
Data ProviderAlliance for Clinical Trials in Oncology
Partial set or SubsetOriginal Data
Patients in dataset107
# of Patients ControlN/A
# of Patients Experimental107
DOIhttps://doi.org/10.34949/vtkf-jr80
CDISC StandardADS
Study ArmsExperimental arm data only
Clinical Trials.gov Information
Brief SummaryRATIONALE: Monoclonal antibodies, such as epratuzumab and rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving monoclonal antibody therapy together with chemotherapy may kill more cancer cells.> PURPOSE: This phase II trial is studying how well giving monoclonal antibody therapy together with combination chemotherapy works in treating patients with stage II, stage III, or stage IV diffuse large B-cell lymphoma.
ConditionsLymphoma
Intervention TypeBiological: epratuzumab
Biological: rituximab
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: prednisone
Drug: vincristine sulfate
Biological: rituximab
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: prednisone
Drug: vincristine sulfate
Drug(s)Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: prednisone
Drug: vincristine sulfate
Drug: doxorubicin hydrochloride
Drug: prednisone
Drug: vincristine sulfate
Total Enrolled107
RandomizationN/A
Blinding MethodNone (Open Label)
Arms InterventionEpratuzumab + Rituximab + CHOP - Experimental
Secondary IDNCI-2012-02685
PubMed (PMID)17099879
21383282
21673350
27282998
21383282
21673350
27282998
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Breast
Breast
Study Phase
Phase 3
Study Completion Date
April 2003
April 2003
NCT00003088Uploaded 08-24-2017
Access via NCI by Request
A Randomized Phase III Trial of Sequential Chemotherapy Using Doxorubicin, Paclitaxel, and Cyclophosphamide or Concurrent Doxorubicin and Cyclophosphamide Followed by Paclitaxel at 14 or 21 Day Intervals in Women With Node Positive Stage II/IIIA Breast Cancer
Provider Information
Provider Data DescriptionThe NCT00003088_D10_(treated) dataset is one of 5 datasets associated with PubMed ID 12668651. This dataset contains one record for treated patients only (N=1973). The dataset contains the primary and secondary endpoint survival data.
Dataset NCT00003088-D5 and NCT00003088-D10 each contain the same clinical data. NCT00003088-D10 also contains a patient reference (patid) that can be tied to patient information submitted to NCTN Navigator submissions.
SponsorAlliance for Clinical Trials in Oncology
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving drugs at different times or combining more than one drug may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective for breast cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy consisting of either doxorubicin, cyclophosphamide, or paclitaxel given at different times with that of combination chemotherapy consisting of doxorubicin plus cyclophosphamide followed by paclitaxel in treating women with stage II or stage IIIA breast cancer.
ConditionsBreast Cancer
Intervention TypeDrug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: paclitaxel
Drug: doxorubicin hydrochloride
Drug: paclitaxel
Drug(s)Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: paclitaxel
Drug: doxorubicin hydrochloride
Drug: paclitaxel
Total Enrolled2005
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionSequential chemotherapy 21 days - Experimental
Concurrent chemotherapy 14 days - Experimental
Sequential chemotherapy 14 days - Experimental
Concurrent chemotherapy 21 days - Experimental
Concurrent chemotherapy 14 days - Experimental
Sequential chemotherapy 14 days - Experimental
Concurrent chemotherapy 21 days - Experimental
Secondary IDU10CA031946
PubMed (PMID)17704418
16609087
16039867
16381623
15743513
15668278
12668651
16609087
16039867
16381623
15743513
15668278
12668651
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Canada
Canada
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Kidney
Kidney
Study Phase
Phase 3
Study Completion Date
August 2015
August 2015
NCT00326898Uploaded 08-19-2017
Access via NCI by Request
ASSURE: Adjuvant Sorafenib or Sunitinib for Unfavorable Renal Carcinoma
Provider Information
Provider Data DescriptionAs of November 6, 2017, there are four different datasets available for NCT00326898. This is NCT00326898-D4. NCT00326898-D1 and NCT00326898-D3 each contain the same clinical data. NCT00326898-D2 and NCT00326898-D4 each contain the same toxicity data. NCT00326898-D1 and NCT00326898-D2 were the original two submissions. NCT00326898-D3 and NCT00326898-D4 updated the original data submissions to include a new blinded ID that will allow for the future linking to non-clinical data (e.g., genomic data). Other than the IDs, the datasets are identical. We recommend that NCT00326898-D3 and NCT00326898-D4 be used.
SponsorNational Cancer Institute
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial studies sunitinib malate to see how well it works compared to sorafenib tosylate or placebo in treating patients with kidney cancer that has been removed by surgery. Sunitinib malate and sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving sunitinib malate or sorafenib tosylate after surgery may kill any tumor cells that remain after surgery. It is not yet known whether sunitinib malate is more effective than sorafenib tosylate or placebo in treating kidney cancer.
ConditionsClear Cell Renal Cell Carcinoma
Stage I Renal Cell Cancer AJCC v6 and v7
Stage II Renal Cell Cancer AJCC v7
Stage III Renal Cell Cancer AJCC v7
Stage I Renal Cell Cancer AJCC v6 and v7
Stage II Renal Cell Cancer AJCC v7
Stage III Renal Cell Cancer AJCC v7
Intervention TypeOther: Laboratory Biomarker Analysis
Other: Placebo
Other: Quality-of-Life Assessment
Drug: Sorafenib Tosylate
Drug: Sunitinib Malate
Other: Placebo
Other: Quality-of-Life Assessment
Drug: Sorafenib Tosylate
Drug: Sunitinib Malate
Drug(s)Drug: Sunitinib Malate
Drug: Sorafenib Tosylate
Drug: Sorafenib Tosylate
Total Enrolled1943
RandomizationRandomized
Blinding MethodDouble
Arms InterventionArm A (sunitinib malate, placebo) - Experimental
Arm B (sorafenib tosylate, placebo) - Experimental
Arm C (placebo) - Placebo Comparator
Arm B (sorafenib tosylate, placebo) - Experimental
Arm C (placebo) - Placebo Comparator
Secondary IDNCI-2009-00534
PubMed (PMID)34480522
34405965
31703971
28945839
28278333
26969090
34405965
31703971
28945839
28278333
26969090
Collaborator(s)Cancer and Leukemia Group B
NCIC Clinical Trials Group
Southwest Oncology Group
NCIC Clinical Trials Group
Southwest Oncology Group
Region(s)United States
Canada
Puerto Rico
Canada
Puerto Rico
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Breast
Breast
Study Phase
Phase 3
Study Completion Date
January 2015
January 2015
NCT00070564Uploaded 08-12-2017
Access via NCI by Request
Phase III Trial of Continuous Schedule AC + G vs. Q 2 Week Schedule AC, Followed by Paclitaxel Given Either Every 2 Weeks or Weekly for 12 Weeks as Post-Operative Adjuvant Therapy in Node-Positive or High-Risk Node-Negative Breast Cancer
Provider Information
Provider Data DescriptionThere are 2 datasets associated with this publication: NCT00070564-D1 and NCT00070564-D2. This dataset contains adverse event data from trial NCT00070564 to reproduce results in PMID 25422488.
SponsorSouthwest Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel, use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them after surgery may kill any remaining tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating resected breast cancer.
PURPOSE: This randomized phase III trial is comparing 2 different regimens of combination chemotherapy to see how well they work in treating patients who have undergone surgery for stage I, stage II, or stage III breast cancer.
ConditionsBreast Cancer
Intervention TypeBiological: pegfilgrastim
Drug: AC regimen
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: paclitaxel
Drug: AC regimen
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: paclitaxel
Drug(s)Drug: AC regimen
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: paclitaxel
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: paclitaxel
Total Enrolled3294
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionArm I - Active Comparator
Arm II - Experimental
Arm III - Active Comparator
Arm IV - Experimental
Arm V - Experimental
Arm VI - Experimental
Arm II - Experimental
Arm III - Active Comparator
Arm IV - Experimental
Arm V - Experimental
Arm VI - Experimental
Secondary IDS0221
PubMed (PMID)25422488
21766209
21766209
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Canada
Puerto Rico
Canada
Puerto Rico
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Colorectal
Colorectal
Study Phase
Phase 3
Study Completion Date
November 2012
November 2012
NCT00079274Uploaded 08-10-2017
Available for Download
A Randomized Phase III Trial of Oxaliplatin (OXAL) Plus 5-Fluorouracil (5-FU)/Leucovorin (CF) With or Without Cetuximab (C225) After Curative Resection for Patients With Stage III Colon Cancer
Provider Information
Provider Data DescriptionPrimary Objective: To compare the disease-free survival (DFS) in patients with stage III
(TxN1-2M0) colon cancer who are KRAS wild-type randomized to 24
weeks of adjuvant chemotherapy with either: (1) Oxaliplatin (OXAL) +
5-fluorouracil/leucovorin (5-FU/LV) (FOLFOX) or (2) FOLFOX + C225.
Secondary Objectives:
I. To compare the DFS in unselected patients with stage III (TxN1-2M0)
colon cancer randomized to 24 weeks of adjuvant chemotherapy with
either: (1) Oxaliplatin (OXAL) + 5-fluorouracil/leucovorin (5-FU/LV)
(FOLFOX) or (2) FOLFOX + C225.
II. To compare the overall survival (OS) in patients with KRAS wildtype
tumors, and in unselected patients with stage III (Tx, N1-2, M0)
colon cancer randomized to 24 weeks of adjuvant chemotherapy
with FOLFOX with or without C225.
III. To assess toxicities resulting from the addition of C225 to chemotherapy.
IV. To compare the quality of life, measures of patient satisfaction,
nutrition, and cancer risk in patients treated with FOLFOX with
or without C225, using four patient-completed questionnaires.
SponsorAlliance for Clinical Trials in Oncology
Data ProviderAlliance for Clinical Trials in Oncology
Partial set or SubsetOriginal Data
Patients in dataset3397
# of Patients Control1337
# of Patients Experimental1631
DOIhttps://doi.org/10.34949/zywx-9253
CDISC StandardADS
Study ArmsBoth comparator and experimental arm data
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial was originally designed to compare three different combination chemotherapy regimens to see how well they work. As of September 1, 2004, the study was expanded to a total of 6 arms (the original 3 arms (A, B, C) and 3 additional arms which were the same as the first 3 but with cetuximab) in treating patients who have undergone surgery for stage III colon cancer. Drugs used in chemotherapy, such as irinotecan hydrochloride, fluorouracil, leucovorin calcium, and oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining more than one chemotherapy drug with monoclonal antibody therapy and giving them after surgery may kill any remaining tumor cells. It was not known at the time this study was developed which combination chemotherapy regimen is more effective after surgery in treating colon cancer. This study had several key changes, based on the results of other phase III trials. As of 6/1/2005, patients no longer received irinotecan on this study and treatment arms B, C, E, and F were discontinued. Patients on arms B and C crossed to arm A. Patients on arms E and F crossed to arm D. Patients on arms C and F who had not gotten to irinotecan continued on arms A and D, respectively. As of 8/18/2008, pre-screening for Kirsten rat sarcoma (KRAS) status was added with mutant KRAS (or KRAS not evaluable) patients put on arm G and wild-type KRAS patients randomized between arm A and arm D. Patients on arm G were treated per physician discretion and followed for disease and survival status. KRAS was determined in a central laboratory and was process for all patients on this study. The primary endpoint of this study was modified on 8/18/2008 to focus on patients having wild-type KRAS tumors. All modifications were approved by the Central Institution Review Board, local Institutional Review Boards, NCI, and the NCCTG Data Safety Monitoring Board.
ConditionsAdenocarcinoma of the Colon
Stage III Colon Cancer
Stage III Colon Cancer
Intervention TypeDrug: irinotecan hydrochloride
Drug: oxaliplatin
Drug: leucovorin calcium
Drug: fluorouracil
Biological: cetuximab
Drug: Locally Directed Therapy
Drug: oxaliplatin
Drug: leucovorin calcium
Drug: fluorouracil
Biological: cetuximab
Drug: Locally Directed Therapy
Drug(s)Drug: oxaliplatin
Drug: leucovorin calcium
Drug: fluorouracil
Drug: irinotecan hydrochloride
Drug: Locally Directed Therapy
Drug: leucovorin calcium
Drug: fluorouracil
Drug: irinotecan hydrochloride
Drug: Locally Directed Therapy
Total Enrolled3397
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionArm A (combination chemotherapy) - Experimental
Arm B (combination chemotherapy) - Experimental
Arm C (combination chemotherapy) - Experimental
Arm D (combination chemotherapy, monoclonal antibody) - Experimental
Arm E (combination chemotherapy, monoclonal antibody) - Experimental
Arm F (combination chemotherapy, monoclonal antibody) - Experimental
Arm G (Locally directed therapy) - Other
Arm B (combination chemotherapy) - Experimental
Arm C (combination chemotherapy) - Experimental
Arm D (combination chemotherapy, monoclonal antibody) - Experimental
Arm E (combination chemotherapy, monoclonal antibody) - Experimental
Arm F (combination chemotherapy, monoclonal antibody) - Experimental
Arm G (Locally directed therapy) - Other
Secondary IDN0147
PubMed (PMID)36306483
35963480
33863713
33356421
33203692
32165096
31811950
31268130
28983557
28006055
23623224
22474202
35963480
33863713
33356421
33203692
32165096
31811950
31268130
28983557
28006055
23623224
22474202
Collaborator(s)Eastern Cooperative Oncology Group
Region(s)United States
Canada
Puerto Rico
Canada
Puerto Rico
Age Range18 Years to 99 Years (Adult, Older Adult)
Type(s) of Cancer
Colorectal
Colorectal
Study Phase
Phase 3
Study Completion Date
May 2004
May 2004
NCT00002575Uploaded 08-07-2017
Available for Download
A PHASE III PROSPECTIVE RANDOMIZED TRIAL COMPARING LAPAROSCOPIC-ASSISTED COLECTOMY VERSUS OPEN COLECTOMY FOR COLON CANCER
Provider Information
Provider Data DescriptionOBJECTIVES:
-Compare the disease-free and overall survival rates of patients with colon cancer treated with laparoscopic-assisted colectomy vs open colectomy.
-Compare the safety of these regimens in terms of early and late morbidity and 30-day mortality of these patients.
-Compare the differences in costs and cost effectiveness between these treatments in this patient population.
-Compare the differences in quality of life of patients treated with these regimens. (closed as of 4/30/99)
SponsorAlliance for Clinical Trials in Oncology
Data ProviderAlliance for Clinical Trials in Oncology
Partial set or SubsetOriginal Data
Patients in dataset871
# of Patients Control0
# of Patients Experimental871
DOIhttps://doi.org/10.34949/6jmv-jr51
CDISC StandardADS
Study ArmsBoth comparator and experimental arm data
Clinical Trials.gov Information
Brief SummaryRATIONALE: Less invasive types of surgery may help reduce the number of side effects and improve recovery. It is not yet known which type of surgery is more effective for colon cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of laparoscopic-assisted colectomy with open colectomy in treating patients who have colon cancer.
ConditionsColorectal Cancer
Intervention TypeProcedure: conventional surgery
Procedure: laparoscopic surgery
Procedure: laparoscopic surgery
Drug(s)N/A
Total Enrolled810
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionConventional surgery - Experimental
Laparoscopic-assisted colectomy - Experimental
Laparoscopic-assisted colectomy - Experimental
Secondary IDNCI-2012-02234
PubMed (PMID)21452066
18948801
15141043
11790211
18948801
15141043
11790211
Collaborator(s)National Cancer Institute (NCI)
NCIC Clinical Trials Group
NCIC Clinical Trials Group
Region(s)United States
Canada
Puerto Rico
Canada
Puerto Rico
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Lung
Lung
Study Phase
Phase 3
Study Completion Date
July 2006
July 2006
NCT00033592Uploaded 08-07-2017
Available for Download
Phase III Trial Comparing Nicotine Inhaler Versus Bupropion Versus Nicotine Inhaler Plus Bupropion For Smoking Cessation Efficacy And Relapse Prevention
Provider Information
Provider Data DescriptionOBJECTIVES: I. Compare the effectiveness of nicotine inhaler vs bupropion vs nicotine inhaler plus bupropion on smoking cessation and prevention of relapse in participants who currently smoke. II. Compare the reduction in the rate of relapse to smoking after initial abstinence in participants treated long term with these regimens.
SponsorAlliance for Clinical Trials in Oncology
Data ProviderAlliance for Clinical Trials in Oncology
Partial set or SubsetOriginal Data
Patients in dataset1708
# of Patients Control470
# of Patients Experimental1238
DOIhttps://doi.org/10.34949/02nc-0h74
CDISC StandardADS
Study ArmsBoth comparator and experimental arm data
Clinical Trials.gov Information
Brief SummaryRATIONALE: Use of a nicotine inhaler and/or bupropion may be effective in helping people stop smoking and prevent them from starting smoking again. It is not yet known whether a nicotine inhaler or bupropion are more effective alone or combined for stopping smoking.
PURPOSE: Randomized phase III trial to compare the effectiveness of the nicotine inhaler or bupropion alone to that of the nicotine inhaler combined with bupropion in helping people to stop smoking and prevent starting smoking again.
ConditionsLung Cancer
Intervention TypeOther: placebo
Drug: bupropion hydrochloride
Drug: nicotine
Drug: bupropion hydrochloride
Drug: nicotine
Drug(s)Drug: nicotine
Drug: bupropion hydrochloride
Drug: bupropion hydrochloride
Total Enrolled1708
RandomizationRandomized
Blinding MethodDouble
Arms InterventionArm I: nicotine inhaler cartridges - Experimental
Arm II: bupropion - Experimental
Arm III: nicotine inhaler cartridges - Experimental
Arm IV: bupropion - Experimental
Arm V: placebo - Placebo Comparator
Arm VI: nicotine inhaler cartridges - Experimental
Arm VII: placebo inhaler - Placebo Comparator
Arm VIII: nicotine inhaler cartridges - Experimental
Arm IX: placebo inhaler cartridges - Placebo Comparator
Arm X: bupropion - Experimental
Arm XI: placebo - Placebo Comparator
Arm XII: nicotine inhaler cartridges - Experimental
Arm XIII: placebo inhaler cartridges - Placebo Comparator
Arm XIV: nicotine inhaler cartridges - Experimental
Arm XV: placebo inhaler cartridges - Placebo Comparator
Arm II: bupropion - Experimental
Arm III: nicotine inhaler cartridges - Experimental
Arm IV: bupropion - Experimental
Arm V: placebo - Placebo Comparator
Arm VI: nicotine inhaler cartridges - Experimental
Arm VII: placebo inhaler - Placebo Comparator
Arm VIII: nicotine inhaler cartridges - Experimental
Arm IX: placebo inhaler cartridges - Placebo Comparator
Arm X: bupropion - Experimental
Arm XI: placebo - Placebo Comparator
Arm XII: nicotine inhaler cartridges - Experimental
Arm XIII: placebo inhaler cartridges - Placebo Comparator
Arm XIV: nicotine inhaler cartridges - Experimental
Arm XV: placebo inhaler cartridges - Placebo Comparator
Secondary IDCDR0000069303
PubMed (PMID)N/A
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Canada
Canada
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Breast
Breast
Study Phase
Phase 3
Study Completion Date
April 2012
April 2012
NCT00041119Uploaded 07-28-2017
Available for Download
Cyclophosphamide And Doxorubicin (CA) (4 VS 6 Cycles) Versus Paclitaxel (4 VS 6 Cycles) As Adjuvant Therapy For Breast Cancer in Women With 0-3 Positive Axillary Lymph Nodes:A 2X2 Factorial Phase III Randomized Study
Provider Information
Provider Data DescriptionTo determine the equivalence of paclitaxel given every two weeks with cyclophosphamide and doxorubicin hydrochloride (CA) given every two weeks as adjuvant therapy for women with 0-3 positive axillary lymph nodes, for disease-free survival.
To determine if longer therapy, 12 weeks, is superior to shorter therapy, 8 weeks, of either CA or paclitaxel for disease-free survival for women with primary breast cancer with 0-3 positive axillary lymph nodes.
To determine the equivalence of paclitaxel given every two weeks with CA given every two weeks, and the potential superiority of longer vs. shorter therapy, in relation to overall survival, local control (regardless of metastatic status) and time to distant metastases (regardless of local recurrence status).
To compare toxicities of short and long course CA and paclitaxel as adjuvant therapy for women with 0-3 positive axillary lymph node breast cancer.
To determine the effect of long and short course CA and paclitaxel on the induction of menopause for pre-menopausal patients.
SponsorAlliance for Clinical Trials in Oncology
Data ProviderAlliance for Clinical Trials in Oncology
Partial set or SubsetOriginal Data
Patients in dataset3871
# of Patients Control1142
# of Patients Experimental2729
DOIhttps://doi.org/10.34949/ksa0-vq66
CDISC StandardADS
Study ArmsBoth comparator and experimental arm data
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial studies cyclophosphamide and doxorubicin hydrochloride compared with paclitaxel as adjuvant therapy in treating breast cancer in women with 0-3 positive axillary lymph nodes. Giving additional cancer treatment after surgery may help to lower the risk that the cancer will come back (adjuvant therapy). Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether the standard adjuvant therapy of cyclophosphamide and doxorubicin hydrochloride is more effective than paclitaxel in treating women with breast cancer
ConditionsBreast Cancer
Intervention TypeDrug: AC regimen
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: paclitaxel
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: paclitaxel
Drug(s)Drug: AC regimen
Drug: doxorubicin hydrochloride
Drug: cyclophosphamide
Drug: paclitaxel
Drug: doxorubicin hydrochloride
Drug: cyclophosphamide
Drug: paclitaxel
Total Enrolled3871
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionArm I (CA for 4 courses) - Active Comparator
Arm II (CA for 6 courses [closed to accrual 12/15/2007]) - Experimental
Arm III (paclitaxel for 4 courses) - Experimental
Arm IV (paclitaxel for 6 courses [closed 12/15/2007]) - Experimental
Arm II (CA for 6 courses [closed to accrual 12/15/2007]) - Experimental
Arm III (paclitaxel for 4 courses) - Experimental
Arm IV (paclitaxel for 6 courses [closed 12/15/2007]) - Experimental
Secondary IDCDR0000069444
PubMed (PMID)22843789
22826271
30409792
24934787
22826271
30409792
24934787
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
South Africa
South Africa
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
CNS
CNS
Study Phase
Phase 3
Study Completion Date
October 2001
October 2001
NCT03015701Uploaded 07-26-2017
Access via NCI by Request
Double Blind Randomized Trial of the Anti-Progestational Agent Mifepristone In The Treatment of Unresectable Meningioma
Provider Information
Provider Data DescriptionNCT03015701-D3-Dataset.csv provides adverse event data from both the blinded and open label treatment epochs.
SponsorSouthwest Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryTo compare daily oral mifepristone vs placebo with respect to time to treatment failure in patients with unresectable meningioma.
ConditionsMeningioma
Intervention TypeDrug: Mifepristone
Other: Placebo
Other: Placebo
Drug(s)Drug: Mifepristone
Total Enrolled193
RandomizationRandomized
Blinding MethodQuadruple
Arms InterventionArm 1 - Experimental
Arm 2 - Placebo Comparator
Arm 2 - Placebo Comparator
Secondary IDU10CA032102
PubMed (PMID)N/A
Collaborator(s)National Cancer Institute (NCI)
Region(s)N/A
Age Range18 Years to 120 Years (Adult, Older Adult)
Type(s) of Cancer
Head and Neck
Head and Neck
Study Phase
Phase 2BPhase 3
Study Completion Date
November 2014
November 2014
NCT00656513Uploaded 07-26-2017
Access via NCI by Request
A Phase II/III Study Comparing Acupuncture-like Transcutaneous Electrical Nerve Stimulation (ALTENS) Versus Pilocarpine in Treating Early Radiation-Induced Xerostomia
Provider Information
Provider Data DescriptionThis dataset contains quality of life (QOL) data from trial NCT00656513 to reproduce the results in PubMed ID = 25841622.
SponsorRadiation Therapy Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) and pilocarpine may help to relieve chronic xerostomia (dry mouth). It is not yet known which remedy is more effective in treating chronic dry mouth caused by radiation therapy in patients with head and neck cancer.
PURPOSE: This randomized phase II/III trial is studying ALTENS to see how well it works compared with pilocarpine in treating chronic dry mouth caused by radiation therapy in patients with head and neck cancer.
ConditionsHead and Neck Cancer
Xerostomia
Xerostomia
Intervention TypeDrug: Pilocarpine
Procedure: ALTENS
Procedure: ALTENS
Drug(s)Drug: Pilocarpine
Total Enrolled196
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionPilocarpine: Phase III - Active Comparator
ALTENS: Phase III - Experimental
ALTENS: Phase II - Experimental
ALTENS: Phase III - Experimental
ALTENS: Phase II - Experimental
Secondary IDCDR0000592644
PubMed (PMID)22252927
Collaborator(s)National Cancer Institute (NCI)
NRG Oncology
NRG Oncology
Region(s)United States
Canada
Canada
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Breast
Breast
Study Phase
Phase 3
Study Completion Date
April 2012
April 2012
NCT00041119Uploaded 07-20-2017
Available for Download
Cyclophosphamide And Doxorubicin (CA) (4 VS 6 Cycles) Versus Paclitaxel (4 VS 6 Cycles) As Adjuvant Therapy For Breast Cancer in Women With 0-3 Positive Axillary Lymph Nodes:A 2X2 Factorial Phase III Randomized Study
Provider Information
Provider Data Description-To determine the equivalence of paclitaxel given every two weeks as adjuvant therapy for women with 0-3 positive axillary lymph nodes, for disease-free survival.
-To determine the potential superiority of longer vs. shorter therapy, in relation to overall survival, local control and time to distant metastases.
-To compare toxicities of short and long course CA and paclitaxel as adjuvant therapy for women with 0-3 positive axillary lymph node breast cancer.
-To determine the effect of long and short course CA and paclitaxel on the induction of menopause for pre-menopausal patients.
SponsorAlliance for Clinical Trials in Oncology
Data ProviderAlliance for Clinical Trials in Oncology
Partial set or SubsetOriginal Data
Patients in dataset3871
# of Patients Control1142
# of Patients Experimental2729
DOIhttps://doi.org/10.34949/290c-k254
CDISC StandardADS
Study ArmsBoth comparator and experimental arm data
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial studies cyclophosphamide and doxorubicin hydrochloride compared with paclitaxel as adjuvant therapy in treating breast cancer in women with 0-3 positive axillary lymph nodes. Giving additional cancer treatment after surgery may help to lower the risk that the cancer will come back (adjuvant therapy). Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether the standard adjuvant therapy of cyclophosphamide and doxorubicin hydrochloride is more effective than paclitaxel in treating women with breast cancer
ConditionsBreast Cancer
Intervention TypeDrug: AC regimen
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: paclitaxel
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: paclitaxel
Drug(s)Drug: AC regimen
Drug: doxorubicin hydrochloride
Drug: cyclophosphamide
Drug: paclitaxel
Drug: doxorubicin hydrochloride
Drug: cyclophosphamide
Drug: paclitaxel
Total Enrolled3871
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionArm I (CA for 4 courses) - Active Comparator
Arm II (CA for 6 courses [closed to accrual 12/15/2007]) - Experimental
Arm III (paclitaxel for 4 courses) - Experimental
Arm IV (paclitaxel for 6 courses [closed 12/15/2007]) - Experimental
Arm II (CA for 6 courses [closed to accrual 12/15/2007]) - Experimental
Arm III (paclitaxel for 4 courses) - Experimental
Arm IV (paclitaxel for 6 courses [closed 12/15/2007]) - Experimental
Secondary IDCDR0000069444
PubMed (PMID)22843789
22826271
30409792
24934787
22826271
30409792
24934787
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
South Africa
South Africa
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Prostate
Prostate
Study Phase
Phase 3
Study Completion Date
December 2013
December 2013
NCT00309985Uploaded 06-21-2017
Access via NCI by Request
CHAARTED: ChemoHormonal Therapy Versus Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer
Provider Information
Provider Data DescriptionAs of November 6, 2017, there are four different datasets available for NCT00309985. This is NCT00309985-D4. NCT00309985-D1 and NCT00309985-D3 each contain the same clinical data. NCT00309985-D2 and NCT00309985-D4 each contain the same toxicity data. NCT00309985-D1 and NCT00309985-D2 were the original two submissions. NCT00309985-D3 and NCT00309985-D4 updated the original data submissions to include a new blinded ID that will allow for the future linking to non-clinical data (e.g., genomic data). Other than the IDs, the datasets are identical. We recommend that NCT00309985-D3 and NCT00309985-D4 be used.
Data submissions NCT00309985-D3 and -D4 can be used to reproduce the results from E3805?s primary publication 26244877. Data submissions NCT00309985-D7, D8, D9, D10, D11, and D12 contain additional data collected on the trial that were not published. Patients in the NCT00309985-D3, -D4, -D7, D8, D9, D10, D11, and D12 data submissions have the same deidentified patient IDs.
SponsorECOG-ACRIN Cancer Research Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen ablation therapy may stop the adrenal glands from making androgens. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether androgen-ablation therapy is more effective with or without docetaxel in treating metastatic prostate cancer.
PURPOSE: This randomized phase III trial is studying androgen-ablation therapy and chemotherapy to see how well they work compared to androgen-ablation therapy alone in treating patients with metastatic prostate cancer.
ConditionsMetastatic Hormone-sensitive Prostate Cancer
Intervention TypeDrug: androgen-deprivation therapy
Drug: docetaxel
Drug: docetaxel
Drug(s)Drug: androgen-deprivation therapy
Drug: docetaxel
Drug: docetaxel
Total Enrolled790
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionAndrogen-Deprivation Therapy and Docetaxel - Experimental
Androgen-Deprivation Therapy alone - Active Comparator
Androgen-Deprivation Therapy alone - Active Comparator
Secondary IDE3805
PubMed (PMID)26244877
34007017
32313142
29522362
29384722
29261442
28159490
34007017
32313142
29522362
29384722
29261442
28159490
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
CNS, Germ Cell, Head and Neck, Liver, Neuroblastoma, Ototoxicity, Ovarian, Sarcoma
CNS, Germ Cell, Head and Neck, Liver, Neuroblastoma, Ototoxicity, Ovarian, Sarcoma
Study Phase
Phase 3
Study Completion Date
April 2015
April 2015
NCT00716976Uploaded 06-07-2017
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A Randomized Phase III Study of Sodium Thiosulfate for the Prevention of Cisplatin-Induced Ototoxicity in Children
Provider Information
Provider Data DescriptionNCT00716976-D3
One row for each of the 194 serious adverse events detailed on manuscript page 69. These events are reported through the National Cancer Institute, Cancer Therapy Evaluation Program, Adverse Event Reporting System (CTEP-AERS).
SponsorChildren's Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: Sodium thiosulfate may reduce or prevent hearing loss in young patients receiving cisplatin for cancer. It is not yet known whether sodium thiosulfate is more effective than no additional treatment in preventing hearing loss.
PURPOSE: This randomized phase III trial is studying sodium thiosulfate to see how well it works in preventing hearing loss in young patients receiving cisplatin for newly diagnosed germ cell tumor, hepatoblastoma, medulloblastoma, neuroblastoma, osteosarcoma, or other malignancy.
ConditionsBrain Tumor
Central Nervous System Tumor
Childhood Germ Cell Tumor
Extragonadal Germ Cell Tumor
Liver Cancer
Neuroblastoma
Ototoxicity
Ovarian Cancer
Sarcoma
Central Nervous System Tumor
Childhood Germ Cell Tumor
Extragonadal Germ Cell Tumor
Liver Cancer
Neuroblastoma
Ototoxicity
Ovarian Cancer
Sarcoma
Intervention TypeDrug: sodium thiosulfate
Procedure: examination
Procedure: examination
Drug(s)Drug: sodium thiosulfate
Total Enrolled131
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionSTS Arm (sodium thiosulfate treatment) - Experimental
Observation Arm (No sodium thiosulfate treatment) - Experimental
Observation Arm (No sodium thiosulfate treatment) - Experimental
Secondary IDCOG-ACCL0431
PubMed (PMID)27914822
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Australia
Canada
Australia
Canada
Age Range1 Year to 18 Years (Child, Adult)
Type(s) of Cancer
Prostate
Prostate
Study Phase
Phase 3
Study Completion Date
July 2015
July 2015
NCT00331773Uploaded 06-07-2017
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A Phase III Randomized Study of Hypofractionated 3D-CRT/MRT Versus Conventionally Fractionated 3D-CRT/MRT in Patients With Favorable-Risk Prostate Cancer
Provider Information
Provider Data DescriptionThis dataset will allow users to reproduce the treatment comparison between arms in trial NCT00331773.
SponsorRadiation Therapy Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: Giving radiation therapy that uses a 3-dimensional (3-D) image of the tumor to help focus thin beams of radiation directly on the tumor, and giving hypofractionated radiation therapy (higher doses over a shorter period of time), may be less costly with fewer side effects and just as effective in treating prostate cancer.
PURPOSE: This randomized phase III trial is studying several different radiation therapy regimens to compare how well they work in treating patients with stage II prostate cancer.
ConditionsProstate Cancer
Intervention TypeRadiation: Conventional 3D-CRT or IMRT
Radiation: Hypofractionated 3D-CRT or IMRT
Radiation: Hypofractionated 3D-CRT or IMRT
Drug(s)N/A
Total Enrolled1116
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionConventional 3D-CRT - Active Comparator
Hypofractionated 3D-CRT - Experimental
Hypofractionated 3D-CRT - Experimental
Secondary IDCDR0000481119
PubMed (PMID)27044935
35776901
30763425
35776901
30763425
Collaborator(s)National Cancer Institute (NCI)
NRG Oncology
NRG Oncology
Region(s)United States
Canada
Canada
Age Range18 Years to 120 Years (Adult, Older Adult)
Type(s) of Cancer
Pancreas
Pancreas
Study Phase
Phase 3
Study Completion Date
November 2012
November 2012
NCT01124786Uploaded 05-17-2017
Available for Download
A Phase II Randomized, Open-Label, Multicenter Study Comparing CO-1.01 With Gemcitabine as First-Line Therapy in Patients With Metastatic Pancreatic Adenocarcinoma
Provider Information
Provider Data DescriptionSee outcome measures
SponsorClovis Oncology
Data ProviderClovis
Partial set or SubsetOriginal Data
Patients in dataset232
# of Patients Control118
# of Patients Experimental114
DOIhttps://doi.org/10.34949/q15p-en76
CDISC StandardADS
Study ArmsBoth comparator and experimental arm data
Clinical Trials.gov Information
Brief SummaryThe purpose of this study is to determine whether CO-1.01 is safe and effective in the treatment of patients with metastatic pancreatic cancer and low hENT1 expression compared with gemcitabine.
ConditionsMetastatic Pancreatic Adenocarcinoma
Intervention TypeDrug: CO-1.01
Drug: Gemcitabine
Drug: Gemcitabine
Drug(s)Drug: CO-1.01
Drug: Gemcitabine
Drug: Gemcitabine
Total Enrolled367
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionCO-1.01 - Experimental
gemcitabine - Active Comparator
gemcitabine - Active Comparator
Secondary IDN/A
PubMed (PMID)N/A
Collaborator(s)N/A
Region(s)United States
Argentina
Australia
Belgium
Brazil
Canada
France
Germany
Italy
Netherlands
Norway
Russian Federation
Sweden
Ukraine
United Kingdom
Argentina
Australia
Belgium
Brazil
Canada
France
Germany
Italy
Netherlands
Norway
Russian Federation
Sweden
Ukraine
United Kingdom
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Colorectal
Colorectal
Study Phase
Phase 3
Study Completion Date
July 2003
July 2003
NCT00002968Uploaded 05-01-2017
Available for Download
Phase III Randomized Study of Adjuvant Immunotherapy With Monoclonal Antibody 17-1A Versus No Adjuvant Therapy Following Resection for State II (Modified Astler-Coller B2) Adenocarcinoma of the Colon
Provider Information
Provider Data DescriptionI. To determine whether adjuvant treatment with MoAb 17-1A will improve the probability of overall and disease-free survival, and increase disease-free intervals in patients who have undergone resection of a Stage II colon cancer. II. To determine whether alterations in the expression of cell cycle related genes (thymidylate synthase, p53, and the cyclin-dependent kinase inhibitors p21 and p27) predict the risk of survival and recurrence in this patient population. III. To determine whether alterations in markers of metastatic potential-expression of DCC and measures of tumor angiogenesis (microvascular density and vascular endothelial growth factor expression)-predict the risk of survival and recurrence in this patient population. IV. To determine whether a marker of cellular differentiation-sucrase isomaltase-predicts the risk of survival and recurrence in this patient population. V. To determine whether DNA ploidy and cell proliferation are prognostic of tumor recurrence and overall survival in Stage II colon cancer. VI. To determine whether interactions among these tumor markers identify subsets of patients with significantly altered outcome. VII. To determine whether pathologic features including tumor grade; tumor mitotic (proliferation) index; tumor border configuration; host lymphoid response to tumor; and lymphatic vessel, venous vessel and perineural invasion predict outcome in this patient population.
SponsorAlliance for Clinical Trials in Oncology
Data ProviderAlliance for Clinical Trials in Oncology
Partial set or SubsetOriginal Data
Patients in dataset1738
# of Patients ControlN/A
# of Patients Experimental865
DOIhttps://doi.org/10.34949/57rt-nr42
CDISC StandardExcel
Study ArmsExperimental arm data only
Clinical Trials.gov Information
Brief SummaryRandomized phase III trial to compare the effectiveness of surgery with or without monoclonal antibody therapy in treating patients who have stage II colon cancer. Monoclonal antibodies such as edrecolomab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether surgery to remove colon cancer is more effect with or without monoclonal antibody therapy.
ConditionsMucinous Adenocarcinoma of the Colon
Signet Ring Adenocarcinoma of the Colon
Stage IIA Colon Cancer
Stage IIB Colon Cancer
Stage IIC Colon Cancer
Signet Ring Adenocarcinoma of the Colon
Stage IIA Colon Cancer
Stage IIB Colon Cancer
Stage IIC Colon Cancer
Intervention TypeBiological: edrecolomab
Other: laboratory biomarker analysis
Other: laboratory biomarker analysis
Drug(s)N/A
Total Enrolled2100
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionArm I (edrecolomab) - Experimental
Arm II (no treatment) - No Intervention
Arm II (no treatment) - No Intervention
Secondary IDNCIC CTG CO.14
PubMed (PMID)N/A
Collaborator(s)N/A
Region(s)United States
Age Range18 Years and older (Adult, Older Adult)
Type(s) of Cancer
Breast
Breast
Study Phase
Phase 2B
Study Completion Date
August 2014
August 2014
NCT00861705Uploaded 04-14-2017
Available for Download
Randomized Phase II 2 x 2 Factorial Trial of the Addition of Carboplatin +/- Bevacizumab to Neoadjuvant Weekly Paclitaxel Followed by Dose-Dense AC in Hormone Receptor-Poor/HER2-Negative Resectable Breast Cancer
Provider Information
Provider Data DescriptionPRIMARY OBJECTIVES:
I. To determine whether adding bevacizumab to neoadjuvant weekly paclitaxel (+/- carboplatin) and subsequent dose-dense doxorubicin and cyclophosphamide (ddAC) significantly increases the rate of pathologic complete response (pCR) in the breast in patients with HR-poor/HER2 (-), resectable breast cancer.
II. To determine whether adding carboplatin every 3 weeks to neoadjuvant weekly paclitaxel followed by ddAC (+/- bevacizumab) significantly raises the rate of pCR in the breast in patients with HR-poor/HER2(-), resectable breast cancer.
III. To determine whether adding bevacizumab every 2 weeks to neoadjuvant weekly paclitaxel (+/- carboplatin) and subsequent ddAC significantly raises the rate of pCR in the breast in patients with basal-like breast cancers, as defined by gene expression array.
IV. To determine whether adding carboplatin every 3 weeks to neoadjuvant weekly paclitaxel followed by ddAC (+/- bevacizumab) significantly raises the rate of pCR in the breast in patients with basal-like breast cancers, as defined by gene expression array.
SECONDARY OBJECTIVES:
Please see the protocol for more details.
SponsorAlliance for Clinical Trials in Oncology
Data ProviderAlliance for Clinical Trials in Oncology
Partial set or SubsetOriginal Data
Patients in dataset454
# of Patients Control115
# of Patients Experimental339
DOIhttps://doi.org/10.34949/hpp1-ws07
CDISC StandardADS
Study Arms