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

Primary Purpose

Kidney Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
aldesleukin
recombinant interferon alfa
fluorouracil
adjuvant therapy
Sponsored by
European Organisation for Research and Treatment of Cancer - EORTC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Cancer focused on measuring stage III renal cell cancer, stage IV renal cell cancer

Eligibility Criteria

undefined - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kaiser Franz Josef Hospital
  • Onze Lieve Vrouw Ziekenhuis Aalst
  • Universitair Ziekenhuis Gent
  • AZ Groeninge - Campus St. Maarten
  • U.Z. Gasthuisberg
  • National Institute of Oncology
  • Rambam Medical Center
  • Ospedale di Circolo e Fondazione Macchi
  • Onze Lieve Vrouwe Gasthuis
  • Akademisch Medisch Centrum
  • Jeroen Bosch Ziekenhuis
  • University Medical Center Nijmegen
  • Daniel Den Hoed Cancer Center at Erasmus University Medical Center
  • Academisch Ziekenhuis Utrecht
  • Marmara University Hospital
  • Dokuz Eylul University School of Medicine
  • Beatson Institute for Cancer Research - Glasgow

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 5, 2003
Last Updated
September 20, 2012
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Collaborators
University of Glasgow
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1. Study Identification

Unique Protocol Identification Number
NCT00053807
Brief Title
Interleukin-2, Interferon Alfa, and Fluorouracil Compared With Observation in Treating Patients Who Have Undergone Surgery for Kidney Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
February 1998 (undefined)
Primary Completion Date
January 2004 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Collaborators
University of Glasgow

4. Oversight

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Cancer
Keywords
stage III renal cell cancer, stage IV renal cell cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
aldesleukin
Intervention Type
Biological
Intervention Name(s)
recombinant interferon alfa
Intervention Type
Drug
Intervention Name(s)
fluorouracil
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy

10. Eligibility

Sex
All
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pieter H. M. de Mulder, MD, PhD
Organizational Affiliation
Universitair Medisch Centrum St. Radboud - Nijmegen
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hein van Poppel, MD, PhD
Organizational Affiliation
University Hospital, Gasthuisberg
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Paul A. Vasey, MD
Organizational Affiliation
Beatson Institute for Cancer Research - Glasgow
Official's Role
Study Chair
Facility Information:
Facility Name
Kaiser Franz Josef Hospital
City
Vienna
ZIP/Postal Code
A-1100
Country
Austria
Facility Name
Onze Lieve Vrouw Ziekenhuis Aalst
City
Aalst
ZIP/Postal Code
B-9300
Country
Belgium
Facility Name
Universitair Ziekenhuis Gent
City
Ghent
ZIP/Postal Code
B-9000
Country
Belgium
Facility Name
AZ Groeninge - Campus St. Maarten
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Facility Name
U.Z. Gasthuisberg
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Facility Name
National Institute of Oncology
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
30196
Country
Israel
Facility Name
Ospedale di Circolo e Fondazione Macchi
City
Varese
ZIP/Postal Code
21100
Country
Italy
Facility Name
Onze Lieve Vrouwe Gasthuis
City
Amsterdam
ZIP/Postal Code
1091 HA
Country
Netherlands
Facility Name
Akademisch Medisch Centrum
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Jeroen Bosch Ziekenhuis
City
Hertogenbosch
ZIP/Postal Code
5211 NL
Country
Netherlands
Facility Name
University Medical Center Nijmegen
City
Nijmegen
ZIP/Postal Code
6500 HB
Country
Netherlands
Facility Name
Daniel Den Hoed Cancer Center at Erasmus University Medical Center
City
Rotterdam
ZIP/Postal Code
3075 EA
Country
Netherlands
Facility Name
Academisch Ziekenhuis Utrecht
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Facility Name
Marmara University Hospital
City
Istanbul
ZIP/Postal Code
81190
Country
Turkey
Facility Name
Dokuz Eylul University School of Medicine
City
Izmir
ZIP/Postal Code
35340
Country
Turkey
Facility Name
Beatson Institute for Cancer Research - Glasgow
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G61 1BD
Country
United Kingdom

12. IPD Sharing Statement

Citations:
Citation
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.
Results Reference
result

Learn more about this trial

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

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