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High-Dose Fluorouracil With or Without Leucovorin Compared With Standard Fluorouracil Plus Leucovorin Following Surgery in Treating Patients With Stage III Colon Cancer

NCT00004150 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2013-11-06

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which chemotherapy regimen is more effective for colon cancer.

PURPOSE: This randomized phase III trial is studying high-dose fluorouracil with or without leucovorin to see how well it works compared to standard-dose fluorouracil and leucovorin in treating patients who have undergone surgery for stage III colon cancer.

Conditions

Interventions

DRUG

fluorouracil

DRUG

leucovorin calcium

PROCEDURE

adjuvant therapy

Sponsors & Collaborators

  • European Organisation for Research and Treatment of Cancer - EORTC

    collaborator NETWORK

  • Federation Francophone de Cancerologie Digestive

    collaborator OTHER

  • Grupo Espanol Tratamiento Tumores Digestivos

    collaborator OTHER

  • Robert Roessle Klinik

    lead INDIV

Principal Investigators

  • Claus-Henning Koehne, MD · Klinikum Oldenburg

  • G. Leam · Saint Laurentius Ziekenhuis

  • Laurent Bedenne, MD · Hopital Du Bocage

  • Alfredo Carrato-Mena, MD · Hospital Universitario de Elche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-03-31
Completion
2007-04-30

Countries

  • Belgium
  • France
  • Germany
  • Netherlands
  • Serbia
  • Spain

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 NCT00004150 on ClinicalTrials.gov