[METHODS] For this international , multicentre , open-label , non-inferiority , phase 3 , randomised SIOP WT 2001 trial , we recruited children aged 6 months to 18 years at the time of diagnosis of a primary renal tumour from 251 hospitals in 26 countries who had received 4 weeks of preoperative chemotherapy with vincristine and actinomycin D. Children with stage II-III intermediate-risk Wilms ' tumours assessed after delayed nephrectomy were randomly assigned ( 1:1 ) by a minimisation technique to receive vincristine 15 mg/m ( 2 ) at weeks 1-8 , 11 , 12 , 14 , 15 , 17 , 18 , 20 , 21 , 23 , 24 , 26 , and 27 , plus actinomycin D 45 g/kg every 3 weeks from week 2 , either with five doses of doxorubicin 50 mg/m ( 2 ) given every 6 weeks from week 2 ( standard treatment ) or without doxorubicin ( experimental treatment ) .