Trial Information

Nephroblastoma Clinical Trial and Study

OBJECTIVES: I. Determine the initial extension of disease, surgical procedures, gross and
histological morphology, treatments, clinical outcome, and late consequences of therapy
after treatment with neoadjuvant chemotherapy, surgery, and adjuvant chemotherapy with or
without maintenance chemotherapy in patients with intermediate risk or anaplastic stage I
Wilms' tumor. II. Determine the safety and effectiveness of reduced chemotherapy in these
patients.

OUTLINE: This is a randomized, multicenter study. Patients receive dactinomycin IV on days
1-3 and 15-17 and vincristine IV on days 1, 8, 15, and 22. Patients then undergo surgery
about a week after completion of chemotherapy. After surgery, patients receive vincristine
IV on days 1, 8, 15, and 22 and dactinomycin IV on days 8-12. Patients are then randomized
to one of two treatment arms after week 9. Arm I: Patients receive dactinomycin IV on days
1-5 of week 10 and vincristine IV on day 1 of both weeks 10 and 11. This course is repeated
during weeks 17 and 18. Arm II: Patients receive no further treatment. Patients are followed
every 3 months for 3 years, then annually thereafter. Peer Reviewed and Funded or Endorsed
by Cancer Research UK

PROJECTED ACCRUAL: A total of 350 patients (175 per treatment arm) will be accrued for this
study within 7-8 years.