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

NCT00053807 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2012-09-24

No results posted yet for this study

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

Interventions

BIOLOGICAL

aldesleukin

BIOLOGICAL

recombinant interferon alfa

DRUG

fluorouracil

PROCEDURE

adjuvant therapy

Sponsors & Collaborators

  • University of Glasgow

    collaborator OTHER

  • European Organisation for Research and Treatment of Cancer - EORTC

    lead NETWORK

Principal Investigators

  • Pieter H. M. de Mulder, MD, PhD · Universitair Medisch Centrum St. Radboud - Nijmegen

  • Hein van Poppel, MD, PhD · University Hospital, Gasthuisberg

  • Paul A. Vasey, MD · Beatson Institute for Cancer Research - Glasgow

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT

Eligibility

Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1998-02-28
Primary Completion
2004-01-31

Countries

  • Austria
  • Belgium
  • Hungary
  • Israel
  • Italy
  • Netherlands
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00053807 on ClinicalTrials.gov