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Fluorouracil and Leucovorin With or Without Irinotecan in Treating Patients With Metastatic Colorectal Cancer

NCT00004885 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 430

Last updated 2012-09-24

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 whether fluorouracil and leucovorin plus irinotecan is more effective than fluorouracil and leucovorin alone for colorectal cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of fluorouracil and leucovorin with or without irinotecan in treating patients who have metastatic colorectal cancer.

Conditions

Interventions

DRUG

FOLFIRI regimen

DRUG

fluorouracil

DRUG

irinotecan hydrochloride

DRUG

leucovorin calcium

Sponsors & Collaborators

  • European Organisation for Research and Treatment of Cancer - EORTC

    lead NETWORK

Principal Investigators

  • Claus-Henning Koehne, MD · Klinik und Poliklinik fuer Innere Medizin - Universitaet Rostock

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-07-31
Primary Completion
2001-07-31

Countries

  • Austria
  • Belgium
  • Egypt
  • France
  • Germany
  • Italy
  • Netherlands
  • Russia
  • South Africa

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 NCT00004885 on ClinicalTrials.gov