Combination Chemotherapy With or Without Radiation Therapy in Treating Young Patients With Newly Diagnosed Stage III or Stage IV Wilms Tumor
RATIONALE: 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.
PURPOSE: 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.
Drug: doxorubicin hydrochloride
Drug: vincristine sulfate
Procedure: therapeutic conventional surgery
Radiation: radiation therapy
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Treatment of Newly Diagnosed Higher Risk Favorable Histology Wilms Tumors|
- Event-free survival as measured by Woolson and an O'Brien-Fleming Boundary at 4 years [ Designated as safety issue: No ]
|Study Start Date:||February 2007|
|Estimated Primary Completion Date:||July 2016 (Final data collection date for primary outcome measure)|