Title:
Treatment for Very Low, Low and Standard Risk Favorable Histology Wilms Tumor
Protocol Number:
PAREN0532
Phase:
Phase III
Physician:
Alan Friedman
Purpose:
This phase III trial is studying vincristine and dactinomycin with or without doxorubicin and radiation therapy or observation only to see how well they work in treating patients undergoing surgery for newly diagnosed stage I, stage II, or stage III Wilms' tumor.
Eligibility:
Ages Eligible for Study: up to 29 Years, Genders Eligible for Study: Both Criteria Histologically confirmed Wilms' tumor Newly diagnosed stage I-III disease Must be enrolled on protocol COG-AREN03B2 Good Health Normal Labs
Treatment:
Stratum I (very low-risk disease): Patients undergo nephrectomy only. If they meet criteria, they are then observed periodically for 5 years. Stratum II (low-risk disease): Patients undergo nephrectomy. Between 9 and 14 days post-nephrectomy, patients receive vincristine and dactinomycin.Treatment continues for up to 19 weeks. Stratum III (standard-risk, stage I or II disease with adverse biological marker): Patients undergo nephrectomy. Between 9 and 14 days post-nephrectomy, patients receive vincristine IV beginning on day 1, every week for 10 weeks then every 3 weeks for a total of 15 doses. Patients receive dactinomycin IV beginning day 1, alternating every 3 weeks with doxorubicin hydrochloride IV for a total of 5 doses of dactinomycin and 4 doses of doxorubicin. Treatment continues for up to 25 weeks. Stratum IV (standard-risk, stage III disease): Patients undergo nephrectomy, if feasible or biopsy. For patients who undergo biopsy only, definitive surgery is undertaken at week 7 or 13. Between 9 and 14 days post-nephrectomy, patients receive vincristine IV beginning on day 1 every week for 10 weeks then every 3 weeks for a total of 15 doses. Patients receive dactinomycin IV beginning day 1, alternating every 3 weeks with doxorubicin hydrochloride IV for a total of 5 doses of dactinomycin and 4 dose of doxorubicin hydrochloride. Patients undergo radiotherapy over 5-7 days after nephrectomy. Treatment continues for up to 25 weeks.
Population:
Pediatric
Last Update
05/25/2013 04:02 AM



