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Trial Comparing Two Strategies of Chemotherapy for Metastatic Colorectal Cancer

NCT00126256 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 570

Last updated 2015-08-13

No results posted yet for this study

Summary

The standard treatment of metastatic colorectal cancer is based on systemic chemotherapy. Several effective drugs are currently available and can be administered either sequentially or in combination. Most patients receive 2 or 3 lines of chemotherapy. The aim of this randomized trial is to evaluate the potential benefit of a bitherapy with 5-fluorouracil (5-FU) and oxaliplatin as first line chemotherapy compared with a sequential chemotherapy with 5-FU alone as first line chemotherapy followed by the combination of 5-FU with oxaliplatin in case of progressive disease, in terms of progression-free survival and overall survival in patients with advanced colorectal cancer.

Conditions

Interventions

DRUG

5-fluorouracil

DRUG

leucovorin

DRUG

irinotecan

DRUG

oxaliplatin

Sponsors & Collaborators

  • Fondation Francaise de Cancerologie Digestive

    collaborator OTHER

  • Sanofi

    collaborator INDUSTRY

  • Gustave Roussy, Cancer Campus, Grand Paris

    lead OTHER

Principal Investigators

  • Michel Ducreux, Pr · Gustave Roussy, Cancer Campus, Grand Paris

  • Jean-Pierre F Pignon, MD, PhD · Gustave Roussy, Cancer Campus, Grand Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-02-28
Primary Completion
2006-02-28
Completion
2006-02-28

Countries

  • France

Study Locations

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Entities

Drugs
Diseases
Companies

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 NCT00126256 on ClinicalTrials.gov