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

NCT00053807 | Completed Phase 3

• 1 other identifier: EORTC-30955
• Study Type: interventional
• Target: 96
• Locations: 8 countries
• Sites: 17

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.

Conditions

Kidney Cancer

Keywords

stage III renal cell cancer; stage IV renal cell cancer

Interventions

aldesleukin BIOLOGICAL

recombinant interferon alfa BIOLOGICAL

fluorouracil DRUG

adjuvant therapy PROCEDURE

Eligibility Criteria

• Age: Up to 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead
• University of Glasgow: collaborator

Study Sites (17)

Kaiser Franz Josef Hospital

Vienna, A-1100, Austria

Location

Onze Lieve Vrouw Ziekenhuis Aalst

Aalst, B-9300, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, B-9000, Belgium

Location

AZ Groeninge - Campus St. Maarten

Kortrijk, 8500, Belgium

Location

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

National Institute of Oncology

Budapest, 1125, Hungary

Location

Rambam Medical Center

Haifa, 30196, Israel

Location

Ospedale di Circolo e Fondazione Macchi

Varese, 21100, Italy

Location

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, 5211 NL, Netherlands

Location

Onze Lieve Vrouwe Gasthuis

Amsterdam, 1091 HA, Netherlands

Location

Akademisch Medisch Centrum

Amsterdam, 1105 AZ, Netherlands

Location

University Medical Center Nijmegen

Nijmegen, 6500 HB, Netherlands

Location

Daniel Den Hoed Cancer Center at Erasmus University Medical Center

Rotterdam, 3075 EA, Netherlands

Location

Academisch Ziekenhuis Utrecht

Utrecht, 3584 CX, Netherlands

Location

Marmara University Hospital

Istanbul, 81190, Turkey (Türkiye)

Location

Dokuz Eylul University School of Medicine

Izmir, 35340, Turkey (Türkiye)

Location

Beatson Institute for Cancer Research - Glasgow

Glasgow, Scotland, G61 1BD, United Kingdom

Location

Related Publications (1)

• 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.

  RESULT

MeSH Terms

Conditions

Kidney Neoplasms; Carcinoma, Renal Cell

Interventions

aldesleukin; Interferon-alpha; Fluorouracil; Chemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2003
• First Posted: February 6, 2003
• Study Start: February 1, 1998
• Primary Completion: January 1, 2004
• Last Updated: September 24, 2012

Record last verified: 2012-09

Locations

AU (1); TU (2); HU (1); NL (6); IL (1); IT (1); BE (4); GB (1)