This trial is active, not recruiting.

Condition kidney cancer
Treatments dactinomycin, vincristine sulfate, conventional surgery
Phase phase 3
Sponsor University of Leicester
Start date July 1993
Trial size 350 participants
Trial identifier NCT00003804, CDR0000066948, EU-98064, SIOP-93-01


RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known which regimen of chemotherapy is more effective for stage I Wilms' tumor.

PURPOSE: Randomized phase III trial to study the effectiveness of chemotherapy and surgery in treating children who are at risk of or who have stage I Wilms' tumor.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Primary purpose treatment

Eligibility Criteria

Male or female participants up to 17 years old.

DISEASE CHARACTERISTICS: Initial diagnosis of a unilateral tumor with clinical and radiological characteristics of a nephroblastoma Histologically proven stage I Wilms' tumor after neoadjuvant treatment and surgery Intermediate risk or anaplastic No detectable distant metastases 4 weeks after adjuvant chemotherapy PATIENT CHARACTERISTICS: Age: 0.5 to 17 Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified PRIOR CONCURRENT THERAPY: See Disease Characteristics

Additional Information

Official title Nephroblastoma Clinical Trial and Study
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2014.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).