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Kidney

Treatment for Patients With Bilateral, Multicentric, or Bilaterally-Predisposed Unilateral Wilms Tumor

Unique Dataset IDnci-data-389ClinicalTrial.gov IDNCT00945009
DownloadableNo
SponsorChildren's Oncology GroupData ProviderNational Cancer InstituteTotal Study Enrolled Patients249RandomizationNoPubMed (PMID)28795993.0
Study PhaseClinical Study Phase IIIBlinding MethodOpen Label StudyType(s) of dataN/AIntervention TypeBiological, Drug, Radiation, SurgeryDataset TypeOther

Clinical Trial Title

Treatment for Patients With Bilateral, Multicentric, or Bilaterally-Predisposed Unilateral Wilms Tumor

Trial Summary and Conditions

This 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.

Data Summary

See data dictionary for more details.

Study Objectives

OBJECTIVES: I. To improve 4-year event-free survival (EFS) to 73% for young patients with bilateral Wilms tumor (BWT). II. To prevent complete removal of at least one kidney in 50% of patients with BWT by using prenephrectomy 3-drug chemotherapy induction with vincristine (vincristine sulfate), dactinomycin, and doxorubicin (doxorubicin hydrochloride). III. To evaluate the efficacy of chemotherapy in preserving renal units in children with diffuse hyperplastic perilobar nephroblastomatosis (DHPLN) and preventing Wilms tumor development. IV. To facilitate partial nephrectomy in lieu of nephrectomy in 25% of children with unilateral tumors and aniridia, Beckwith-Wiedemann syndrome (BWS), hemihypertrophy or other overgrowth syndromes, by using prenephrectomy 2-drug chemotherapy induction with vincristine and dactinomycin. V. To have 75% of patients with BWT undergo definitive surgical treatment by 12 weeks after initiation of chemotherapy. OUTLINE: Patients are assigned to 1 of 3 arms. ARM 1 (Bilateral Wilms Tumors) ARM 2 (Unilateral High Risk tumors bilaterally predisposed) ARM 3 (DHPLN)

Outcome Measures

Primary: Event-Free Survival (EFS) [ Time Frame: 4 years from study enrollment ] Kidney Preservation After Preoperative Chemotherapy [ Time Frame: 12 weeks from study entry ] Number of Patients Without Complete Removal of at Least One Kidney [ Time Frame: 12 weeks from the study entry ] Percentage of Patients Who Experienced Partial Nephrectomy After Preoperative Chemotherapy [ Time Frame: 12 weeks from study entry ] Percentage of Patients Who Had Definitive Surgical Treatment [ Time Frame: 12 weeks from study entry ]

ClinicalTrial.gov

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

NCI Description

There 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.?

Available Downloads: NCT00945009-D1

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

Data Dictionary: NCT00945009-D1-Data-Dictionary_2.pdf

DATA: NCT00945009-D1-Dataset_1.csv

OTHER: README.pdf