Combination Chemotherapy With or Without Radiation Therapy in Treating Young Patients With Newly Diagnosed Stage III or Stage IV Wilms' Tumor

Completed · Phase 3

Conditions studied: Stage III Kidney Wilms Tumor, Stage IV Kidney Wilms Tumor

In brief

This 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 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.

Key facts

Study ID

NCT00379340

Run by

Children's Oncology Group

People needed

395

Starts

2007-04-30

Expected to finish

2026-03-31

Last updated by the study team

2026-07-24

Who can join

Age: any, up to 29. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must be less than 30 years of age at the time of diagnosis
• Prior to enrollment on AREN0533, all patients must have been enrolled on AREN03B2 for central pathology review. Stage III patients with LOH transferring from AREN0532 may be enrolled on this study. Eligible patients for AREN0533 must be:
• Newly diagnosed Stage IV favorable histology Wilms tumor with or without LOH 1p and 16q or
• Newly diagnosed Stage III favorable histology Wilms tumor with LOH for 1p and 16q transferring from AREN0532
• Patients with bilateral Wilms tumors (Stage V) are not eligible for AREN0533 and should be directed to AREN0534
• Patients must begin protocol therapy on AREN0533 by Day 14 after surgery or biopsy, unless medically contraindicated
• The Karnofsky performance status must be >= 50 for patients > 16 years of age and the Lansky performance status must be >= 50 for patients =< 16 years of age
• Patients cannot have had prior tumor-directed chemotherapy or radiotherapy except for patients transferring from AREN0532 or those treated for emergent issues, as medically indicated
• Total bilirubin ≤ 1.5 times upper limit of normal (ULN) for age (must be submitted for central review by Day 7)
• Serum glutamic oxaloacetic transaminase (SGOT) aspartate aminotransferase (AST) or serum glutamic pyruvic transaminase (SGPT) alanine aminotransferase (ALT) < 2.5 x ULN for age (must be submitted for central review by Day 7)
• Shortening fraction ≥ 27% by echocardiogram OR ejection fraction ≥ 50% by radionuclide angiogram
• Female patients of childbearing age must have a negative pregnancy test
• Female patients who are lactating must agree to stop breast-feeding
• Sexually active patients of childbearing potential must agree to use effective contraception

Where it is running

• Children's Oncology Group — Oakland, California, United States
• UCSF Benioff Children's Hospital Oakland — Oakland, California, United States
• Kaiser Permanente-Oakland — Oakland, California, United States
• Children's Hospital of Orange County — Orange, California, United States
• Lucile Packard Children's Hospital Stanford University — Palo Alto, California, United States
• Sutter Medical Center Sacramento — Sacramento, California, United States
• University of California Davis Comprehensive Cancer Center — Sacramento, California, United States
• Rady Children's Hospital - San Diego — San Diego, California, United States
• UCSF Medical Center-Parnassus — San Francisco, California, United States
• UCSF Medical Center-Mission Bay — San Francisco, California, United States
• Children's Hospital Colorado — Aurora, Colorado, United States
• Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center — Denver, Colorado, United States
• University of Connecticut — Farmington, Connecticut, United States
• Connecticut Children's Medical Center — Hartford, Connecticut, United States
• Yale University — New Haven, Connecticut, United States
• Alfred I duPont Hospital for Children — Wilmington, Delaware, United States
• MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Broward Health Medical Center — Fort Lauderdale, Florida, United States
• Lee Memorial Health System — Fort Myers, Florida, United States
• Golisano Children's Hospital of Southwest Florida — Fort Myers, Florida, United States
• UF Health Cancer Institute - Gainesville — Gainesville, Florida, United States
• Memorial Regional Hospital/Joe DiMaggio Children's Hospital — Hollywood, Florida, United States
• Nemours Children's Clinic-Jacksonville — Jacksonville, Florida, United States
• Valley Children's Hospital — Madera, California, United States

Full record on ClinicalTrials.gov

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