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Intensified Chemotherapy in CRC After Resection of Liver Metastases

NCT00208260 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2026-02-05

No results posted yet for this study

Summary

Randomized, open label, multicentre phase II trial followed by phase III comparing overall survival after having selected the best experimental arm.

Conditions

Interventions

DRUG

FOLFIRI

FOLFIRI : Irinotecan : 180 mg/m² 90 min continuous perfusion during levorin d1 every 2 weeks

DRUG

FOLFOX-4

FOLFOX 4 : Oxaliplatine : 85 mg/m² 2h continuous perfusion during levorin d1 every 2weeks

DRUG

FOLFIRI-HD

High Dose FOLFIRI : Irinotecan : 260 mg/m² in 90min continuous perfusion during levorin d1 every 2 weeks

DRUG

FOLFOX-7

FOLFOX 7 : Oxaliplatine : 130 mg/m² in 2h continuous perfusion during levorin d1 every 2 weeks

DRUG

FOLFIRINOX

FOLFIRINOX : Oxaliplatine : 85 mg/m² 2h continuous perfusion followed by 1H rest followed by 90 min continuous perfusion of irinotecan : 180 mg/m² during levorin d1 every 2 weeks

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Sanofi

    collaborator INDUSTRY

  • Chugai Pharmaceutical

    collaborator INDUSTRY

  • Institut du Cancer de Montpellier - Val d'Aurelle

    lead OTHER

Principal Investigators

  • Marc YCHOU, MD, PhD · CRLC Val d'Aurelle

  • Michel RIVOIRE, MD · CRLC Leon Berard - Lyon

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-04-30
Completion
2007-08-31

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 NCT00208260 on ClinicalTrials.gov