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This dataset is available to Authorized Users of the Project Data Sphere Cancer Research Platform through an initiative with the National Cancer Institute (NCI) of the U.S. National Institutes of Health (NIH). To gain access to this dataset, you must complete the following steps:

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Kidney

Treatment for Very Low and Standard Risk Favorable Histology Wilms Tumor

Unique Dataset IDnci-data-427ClinicalTrial.gov IDNCT00352534
DownloadableNo
SponsorChildren's Oncology Group ; National Cancer Institute (NCI)Data ProviderNational Cancer InstituteTotal Study Enrolled Patients808RandomizationNoPubMed (PMID)27811504.0
Study PhaseClinical Study Phase IIIBlinding MethodOpen Label StudyType(s) of dataN/AIntervention TypeN/ADataset TypeOther

Clinical Trial Title

Treatment for Very Low and Standard Risk Favorable Histology Wilms Tumor

Trial Summary and Conditions

This 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.

Data Summary

See Data Dictionary.

Study Objectives

Primary: Evaluate the overall and event-free survival of younger patients with newly diagnosed stage I favorable histology Wilms' tumor (< 2 years of age and < 550gms) treated with nephrectomy only (very low risk), or with newly diagnosed stage III favorable histology Wilms tumor with possible nephrectomy followed by vincristine, dactinomycin, doxorubicin hydrochloride, and radiotherapy (standard risk). Secondary: Determine the effects of adding doxorubicin hydrochloride to the regimen for patients with stage I or II favorable histology found to have a high-risk biological marker; Determine whether the omission of adjuvant therapy increases the incidence of contralateral kidney lesions in patients with very low-risk disease treated by nephrectomy and observation only; Determine whether the omission of adjuvant therapy increases the incidence of renal failure in patients with very low-risk disease who have metachronous relapse; Correlate study outcomes in patients with standard-risk disease with biological data from tissue collections on protocol study COG-AREN03B2

Outcome Measures

Primary: Event Free Survival Probability [Time Frame: 4 years] Probability of no relapse, secondary malignancy, or death after 4 year in the study; Overall Survival (OS) Probability [Time Frame: 4 years] Probability of being alive after 4 years in the study. Secondary: Incidence of Contralateral Kidney Lesions [Time Frame: During follow-up] Number of contralateral kidney lesions during follow-up; Incidence of Renal Failure [Time Frame: During follow-up] Number of renal failures defined as requiring dialysis or renal transplant as determined by low GFR during follow-up

ClinicalTrial.gov

Below are the clinical trial(s) associated with this dataset (all links are to ClinicalTrials.Gov):

NCI Description

NCT00352534-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.?

Available Downloads: NCT00352534-D1

To gain access to the data and analytic tools click here.

Data Dictionary: NCT00352534-D1-Data-Dictionary_6.pdf

DATA: NCT00352534-D1-Dataset_5.csv

OTHER: README.pdf

Available Downloads: NCT00352534-D2

To gain access to the data and analytic tools click here.

Data Dictionary: NCT00352534-D2-Data-Dictionary_7.pdf

DATA: NCT00352534-D2-Dataset_2.csv

OTHER: README.pdf

Available Downloads: NCT00352534-D3

To gain access to the data and analytic tools click here.

Data Dictionary: NCT00352534-D3-Data-Dictionary_4.pdf

DATA: NCT00352534-D3-Dataset_3.csv

OTHER: README.pdf