Treatment of Newly Diagnosed Diffuse Anaplastic Wilms Tumors (DAWT) and Relapsed Favorable Histology Wilms Tumors (FHWT)
Objective
Event-free survival (EFS) [ Time Frame: From study entry to the earliest of relapse or disease progression, second malignant neoplasm, or death from any cause, assessed up to 5 years after study enrollment ] For Strata 1-3, the primary analysis of EFS will consist of a one-sample, one-sided log rank test versus a historical control cohort (or representative distribution) with stratum-specific type I error levels. For Stratum 4, the primary analysis of EFS is descriptive, but with a desired level of precision to estimate 4-year EFS at the time of the final analysis (2 years after the last patient enrolls).
