Interleukin-2, Interferon Alfa, and Fluorouracil Compared With Observation in Treating Patients Who Have Undergone Surgery for Kidney Cancer
NCT ID: NCT00053807
Last Updated: 2012-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
96 participants
INTERVENTIONAL
1998-02-28
Brief Summary
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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.
Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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aldesleukin
recombinant interferon alfa
fluorouracil
adjuvant therapy
Eligibility Criteria
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Inclusion Criteria
* 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
75 Years
ALL
No
Sponsors
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University of Glasgow
OTHER
European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Responsible Party
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Principal Investigators
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Pieter H. M. de Mulder, MD, PhD
Role: STUDY_CHAIR
Universitair Medisch Centrum St. Radboud - Nijmegen
Hein van Poppel, MD, PhD
Role: STUDY_CHAIR
University Hospital, Gasthuisberg
Paul A. Vasey, MD
Role: STUDY_CHAIR
Beatson Institute for Cancer Research - Glasgow
Locations
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Kaiser Franz Josef Hospital
Vienna, , Austria
Onze Lieve Vrouw Ziekenhuis Aalst
Aalst, , Belgium
Universitair Ziekenhuis Gent
Ghent, , Belgium
AZ Groeninge - Campus St. Maarten
Kortrijk, , Belgium
U.Z. Gasthuisberg
Leuven, , Belgium
National Institute of Oncology
Budapest, , Hungary
Rambam Medical Center
Haifa, , Israel
Ospedale di Circolo e Fondazione Macchi
Varese, , Italy
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, , Netherlands
Onze Lieve Vrouwe Gasthuis
Amsterdam, , Netherlands
Akademisch Medisch Centrum
Amsterdam, , Netherlands
University Medical Center Nijmegen
Nijmegen, , Netherlands
Daniel Den Hoed Cancer Center at Erasmus University Medical Center
Rotterdam, , Netherlands
Academisch Ziekenhuis Utrecht
Utrecht, , Netherlands
Marmara University Hospital
Istanbul, , Turkey (Türkiye)
Dokuz Eylul University School of Medicine
Izmir, , Turkey (Türkiye)
Beatson Institute for Cancer Research - Glasgow
Glasgow, Scotland, United Kingdom
Countries
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References
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Aitchison M, Bray CA, Van Poppel H, et al.: Final results from an EORTC (GU Group)/NCRI randomized phase III trial of adjuvant interleukin-2, interferon alpha, and 5-fluorouracil in patients with a high risk of relapse after nephrectomy for renal cell carcinoma (RCC). [Abstract] J Clin Oncol 29 (Suppl 15): A-4505, 2011.
Other Identifiers
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EORTC-30955
Identifier Type: -
Identifier Source: secondary_id
EORTC-30955
Identifier Type: -
Identifier Source: org_study_id