Interleukin-2, Interferon Alfa, and Fluorouracil Compared With Observation in Treating Patients Who Have Undergone Surgery for Kidney Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00053807
Recruitment Status : Completed
First Posted : February 6, 2003
Last Update Posted : September 24, 2012
University of Glasgow
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Kidney Cancer Biological: aldesleukin Biological: recombinant interferon alfa Drug: fluorouracil Procedure: adjuvant therapy Phase 3

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
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
Actual Primary Completion Date : January 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Cancer
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 75 and under

Performance status

  • WHO 0-1

Life expectancy

  • Not specified


  • WBC at least 3,500/mm^3
  • Platelet count at least 100,000/mm^3


  • Liver function tests no greater than 1.25 times upper limit of normal (ULN)


  • Creatinine less than 1.5 times ULN


  • No myocardial infarction within the past 6 months
  • No unstable angina pectoris


  • 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


Biologic therapy

  • No other concurrent immunotherapy


  • No prior chemotherapy

Endocrine therapy

  • No concurrent corticosteroids
  • No concurrent hormonal therapy


  • No prior radiotherapy


  • See Disease Characteristics
  • No prior major organ allografts


  • No other concurrent investigational drugs, agents, or devices

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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
U.Z. Gasthuisberg
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
United Kingdom
Beatson Institute for Cancer Research - Glasgow
Glasgow, Scotland, United Kingdom, G61 1BD
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
University of Glasgow
Study Chair: Pieter H. M. de Mulder, MD, PhD Universitair Medisch Centrum St. Radboud - Nijmegen
Study Chair: Hein van Poppel, MD, PhD University Hospital, Gasthuisberg
Study Chair: Paul A. Vasey, MD Beatson Institute for Cancer Research - Glasgow

Publications of Results:
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.

Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC Identifier: NCT00053807     History of Changes
Other Study ID Numbers: EORTC-30955
First Posted: February 6, 2003    Key Record Dates
Last Update Posted: September 24, 2012
Last Verified: September 2012

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
stage III renal cell cancer
stage IV renal cell cancer

Additional relevant MeSH terms:
Kidney Neoplasms
Carcinoma, Renal Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents