Adjuvant Interleukin-2, Interferon-alpha and 5-Fluorouracil for Patients With High Risk of Relapse After Surgical Treatment for Renal Cell Carcinoma
N/A
75 Years
Both
Kidney Cancer
Trial Information
Adjuvant Interleukin-2, Interferon-alpha and 5-Fluorouracil for Patients With High Risk of Relapse After Surgical Treatment for Renal Cell Carcinoma
OBJECTIVES:
- 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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed primary renal cell carcinoma meeting 1 of the following
criteria:
- Stage T3b, T3c, or T4 tumor
- Any pT stage and nodal status pN 1 or 2
- Any pT stage and microscopic positive margins
- Presence of any microscopic vascular invasion
- Underwent surgical resection of primary tumor within the past month
- Removal of clinical N+ disease required
- No evidence of metastatic disease
- No evidence of macroscopic residual disease
PATIENT CHARACTERISTICS:
Age
- 75 and under
Performance status
- WHO 0-1
Life expectancy
- Not specified
Hematopoietic
- WBC at least 3,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Liver function tests no greater than 1.25 times upper limit of normal (ULN)
Renal
- Creatinine less than 1.5 times ULN
Cardiovascular
- No myocardial infarction within the past 6 months
- No unstable angina pectoris
Other
- Not pregnant or nursing
- No prior or other concurrent malignancies that would preclude study therapy or
comparisons
- No other concurrent illness that would preclude study therapy
- No concurrent active infections requiring antibiotic therapy
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No other concurrent immunotherapy
Chemotherapy
- No prior chemotherapy
Endocrine therapy
- No concurrent corticosteroids
- No concurrent hormonal therapy
Radiotherapy
- No prior radiotherapy
Surgery
- See Disease Characteristics
- No prior major organ allografts
Other
- No other concurrent investigational drugs, agents, or devices
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Principal Investigator
Pieter H. M. de Mulder, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Universitair Medisch Centrum St. Radboud - Nijmegen
Authority:
United States: Federal Government
Study ID:
EORTC-30955
NCT ID:
NCT00053807
Start Date:
February 1998
Completion Date:
Related Keywords:
- Kidney Cancer
- stage III renal cell cancer
- stage IV renal cell cancer
- Carcinoma, Renal Cell
- Kidney Neoplasms
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