Adjuvant Interleukin-2, Interferon-alpha and 5-Fluorouracil for Patients With High Risk of Relapse After Surgical Treatment for Renal Cell Carcinoma
- Compare the effect of adjuvant combination therapy comprising interleukin-2, interferon
alfa, and fluorouracil vs observation only on disease-free survival or overall survival
of patients with renal cell carcinoma at high risk of relapse after radical surgery.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2
- Arm I: Patients receive interleukin-2 subcutaneously (SC) on days 3, 4, and 5 of weeks
1 and 4 and on days 1, 3, and 5 of weeks 2 and 3. Patients also receive interferon alfa
SC once weekly during weeks 1 and 4 and 3 times weekly during weeks 2, 3, 5, 6, 7, and
8. Patients then receive fluorouracil IV on day 1 of weeks 5, 6, 7, and 8.
- Arm II (control arm): Patients receive no adjuvant treatment before disease
Quality of life is assessed at baseline and at 2 and 6 months after randomization.
Patients are followed monthly for 3 months (arm I only), every 3 months for 1 year, every 6
months for 4 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 550 patients (275 per treatment arm) will be accrued for this
study within 3 years.
Allocation: Randomized, Primary Purpose: Treatment
Pieter H. M. de Mulder, MD, PhD
Universitair Medisch Centrum St. Radboud - Nijmegen
United States: Federal Government