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5FU/VL Vs LV5FU2 + CPT11 in Stage II-III Resected Rectal Cancer

NCT00189657 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2005-09-19

No results posted yet for this study

Summary

The main objective of this randomized trial is to compare 5FU/LV (Mayo-Clinic regimen or LV5FU2) to LV5FU2 + irinotécan in patients with resected B2 and C rectal cancer. Preoperative radiotherapy is recommended but not mandatory. Main endpoint is disease free survival. Secondary endpoint are overall survival, time to local recurrence, time to distant metastases, and tolerance. A total of 600 patients will be included in the trial.

Conditions

  • Cancer of the Rectum

Interventions

PROCEDURE

5FU/LV Mayo Clinic or LV5FU2

PROCEDURE

LV5FU2 + irinotecan

Sponsors & Collaborators

  • Aventis Pharmaceuticals

    collaborator INDUSTRY

  • Pfizer

    collaborator INDUSTRY

  • Association Européenne de Recherche en Oncologie

    lead OTHER

Principal Investigators

  • Pascal Piedbois, MD · Association Europeenne de Recherche en Oncologie

  • Thierry Andre, MD · GERCOR - Multidisciplinary Oncology Cooperative Group

  • Alain Piolot, MD · Association Europeenne de Recherche en Oncologie

  • Emmanuel Achille, MD · GERCOR - Multidisciplinary Oncology Cooperative Group

  • Iradj Bobhani, MD · Fondation Française de Cancérologie Digestive

  • Jean-Yves Douillard, MD · UNICANCER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • France

Study Locations

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Entities

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 NCT00189657 on ClinicalTrials.gov