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Type(s) of Cancer
Ovarian
Study Phase
Phase 3
Study Completion Date
2019-03-30
NCT00954174Uploaded 08-24-2024
Access via NCI by Request
PDS UID: nci-data-549
A Randomized Phase III Trial of Paclitaxel Plus Carboplatin Versus Ifosfamide Plus Paclitaxel in Chemotherapy-Naive Patients With Newly Diagnosed Stage I-IV, Persistent or Recurrent Carcinosarcoma (Mixed Mesodermal Tumors) of the Uterus, Fallopian Tube, Peritoneum or Ovary
Provider Information
Provider Data DescriptionThis dataset contains the data for the treatment comparison between Paclitaxel and Carboplatin Versus Paclitaxel and Ifosfamide in trial NCT00954174. NCT00954174-D2 contains quality-of-life data.
SponsorGOG Foundation
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial studies paclitaxel and carboplatin see how well they work compared with paclitaxel and ifosfamide in treating patients with fallopian tube, or peritoneal cavity cancer that is newly diagnosed, persistent, or has come back (recurrent). Drugs used in chemotherapy, such as paclitaxel, carboplatin, and ifosfamide, 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 paclitaxel is more effective when given with carboplatin or ifosfamide in treating patients with uterine, ovarian, fallopian tube, or peritoneal cavity cancer.
ConditionsMixed Mesodermal (Mullerian) Tumor
Ovarian Carcinosarcoma
Recurrent Fallopian Tube Carcinoma
Recurrent Ovarian Carcinoma
Recurrent Primary Peritoneal Carcinoma
Stage I Ovarian Cancer AJCC v6 and v7
Stage IA Fallopian Tube Cancer AJCC v6 and v7
Stage IA Ovarian Cancer AJCC v6 and v7
Stage IA Uterine Sarcoma AJCC v7
Stage IB Fallopian Tube Cancer AJCC v6 and v7
Stage IB Ovarian Cancer AJCC v6 and v7
Stage IB Uterine Sarcoma AJCC v7
Stage IC Fallopian Tube Cancer AJCC v6 and v7
Stage IC Ovarian Cancer AJCC v6 and v7
Stage IC Uterine Sarcoma AJCC v7
Stage II Ovarian Cancer AJCC v6 and v7
Stage IIA Fallopian Tube Cancer AJCC v6 and v7
Stage IIA Ovarian Cancer AJCC V6 and v7
Stage IIA Uterine Sarcoma AJCC v7
Stage IIB Fallopian Tube Cancer AJCC v6 and v7
Stage IIB Ovarian Cancer AJCC v6 and v7
Stage IIB Uterine Sarcoma AJCC v7
Stage IIC Fallopian Tube Cancer AJCC v6 and v7
Stage IIC Ovarian Cancer AJCC v6 and v7
Stage IIIA Fallopian Tube Cancer AJCC v7
Stage IIIA Ovarian Cancer AJCC v6 and v7
Stage IIIA Primary Peritoneal Cancer AJCC v7
Stage IIIA Uterine Sarcoma AJCC v7
Stage IIIB Fallopian Tube Cancer AJCC v7
Stage IIIB Ovarian Cancer AJCC v6 and v7
Stage IIIB Primary Peritoneal Cancer AJCC v7
Stage IIIB Uterine Sarcoma AJCC v7
Stage IIIC Fallopian Tube Cancer AJCC v7
Stage IIIC Ovarian Cancer AJCC v6 and v7
Stage IIIC Primary Peritoneal Cancer AJCC v7
Stage IIIC Uterine Sarcoma AJCC v7
Stage IV Fallopian Tube Cancer AJCC v6 and v7
Stage IV Ovarian Cancer AJCC v6 and v7
Stage IV Primary Peritoneal Cancer AJCC v7
Stage IVA Uterine Sarcoma AJCC v7
Stage IVB Uterine Sarcoma AJCC v7
Uterine Carcinosarcoma
Intervention TypeDrug: Carboplatin
Drug: Ifosfamide
Drug: Paclitaxel
Other: Quality-of-Life Assessment
Drug(s)Drug: Carboplatin
Drug: Paclitaxel
Drug: Ifosfamide
Total Enrolled637
RandomizationRandomized
Blinding MethodNone
Arms InterventionArm I (paclitaxel, carboplatin) - Experimental
Arm II (paclitaxel, ifosfamide) - Experimental
Secondary IDNCI-2011-01959
PubMed (PMID)35007153
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Korea, Republic of
Age Range18 Years and older (ADULT, OLDER_ADULT)
Files: NCT00954174-D1
Data DictionaryNCT00954174-D1-Data-Dictionary.pdf
DATANCT00954174-D1-Dataset.csv
OTHERREADME.pdf
Files: NCT00954174-D2
Data DictionaryNCT00954174-D2-Data-Dictionary.pdf
DATANCT00954174-D2-Dataset.csv
OTHERREADME.pdf
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