Interleukin-2, Interferon Alfa, and Fluorouracil Compared With Observation in Treating Patients Who Have Undergone Surgery for Kidney Cancer
RATIONALE: Interferon alfa may interfere with the growth of tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining interferon alfa and interleukin-2 with fluorouracil may kill any remaining tumor cells following surgery. It is not yet known whether combining interferon alfa and interleukin-2 with fluorouracil is more effective than observation after surgery for kidney cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of combining interleukin-2, interferon alfa, and fluorouracil to that of observation alone in treating patients who have undergone surgery for kidney cancer and are at high risk of relapse.
Biological: recombinant interferon alfa
Procedure: adjuvant therapy
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||Adjuvant Interleukin-2, Interferon-alpha and 5-Fluorouracil for Patients With High Risk of Relapse After Surgical Treatment for Renal Cell Carcinoma|
|Study Start Date:||February 1998|
|Primary Completion Date:||January 2004 (Final data collection date for primary outcome measure)|
- 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 treatment arms.
- 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 progression.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00053807
|Kaiser Franz Josef Hospital|
|Vienna, Austria, A-1100|
|Onze Lieve Vrouw Ziekenhuis Aalst|
|Aalst, Belgium, B-9300|
|Universitair Ziekenhuis Gent|
|Ghent, Belgium, B-9000|
|AZ Groeninge - Campus St. Maarten|
|Kortrijk, Belgium, 8500|
|Leuven, Belgium, B-3000|
|National Institute of Oncology|
|Budapest, Hungary, 1125|
|Rambam Medical Center|
|Haifa, Israel, 30196|
|Ospedale di Circolo e Fondazione Macchi|
|Varese, Italy, 21100|
|Onze Lieve Vrouwe Gasthuis|
|Amsterdam, Netherlands, 1091 HA|
|Akademisch Medisch Centrum|
|Amsterdam, Netherlands, 1105 AZ|
|Jeroen Bosch Ziekenhuis|
|Hertogenbosch, Netherlands, 5211 NL|
|University Medical Center Nijmegen|
|Nijmegen, Netherlands, 6500 HB|
|Daniel Den Hoed Cancer Center at Erasmus University Medical Center|
|Rotterdam, Netherlands, 3075 EA|
|Academisch Ziekenhuis Utrecht|
|Utrecht, Netherlands, 3584 CX|
|Marmara University Hospital|
|Istanbul, Turkey, 81190|
|Dokuz Eylul University School of Medicine|
|Izmir, Turkey, 35340|
|Beatson Institute for Cancer Research - Glasgow|
|Glasgow, Scotland, United Kingdom, G61 1BD|
|Study Chair:||Pieter H. M. de Mulder, MD, PhD||Universitair Medisch Centrum St. Radboud - Nijmegen|
|Study Chair:||Hein van Poppel, MD, PhD||U.Z. Gasthuisberg|
|Study Chair:||Paul A. Vasey, MD||Beatson Institute for Cancer Research - Glasgow|