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

September 12, 2005 updated by: Association Européenne de Recherche en Oncologie
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • rectal adenocarcinoma
  • R0 surgery
  • T3, N0, M0 or T4, N0, M0 or N1,2, M0
  • chemotherapy can be started within 8 weeks after surgery
  • Age > 18
  • Performance status ECOG < 3
  • preoperative radiotherapy allowed
  • preoperative chemotherapy with 5FU +/- LV allowed
  • Neutrophiles > 1 500/mm3; Pl. > 100 000/mm3
  • Transaminases < 2 x UNL; Alcalines Phosphatases < 2 x UNL; Bili < 1.1 UNL
  • creatininemia < 120 µmol/l and/or clearance of creatininemia > 60 ml/mn
  • Written informed consent before inclusion

Exclusion Criteria:

  • postoperative radiotherapy
  • Distant metastases
  • Contraindication to any drug contained in the chemotherapy regimens
  • Any serious active disease or co-morbid medical condition including digestive inflammatory disease
  • Gilbert disease
  • severe toxicity of radiotherapy
  • Pregnancy or breast feeding
  • Absence of contraception in non menopausal women
  • Adult patient unable to give informed consent because of intellectual impairment
  • Concomitant participation to another trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Association Européenne de Recherche en Oncologie

Collaborators

Pfizer
Aventis Pharmaceuticals

Investigators

  • Principal Investigator: Thierry Andre, MD, GERCOR - Multidisciplinary Oncology Cooperative Group
  • Principal Investigator: Pascal Piedbois, MD, Association Europeenne de Recherche en Oncologie
  • Principal Investigator: Alain Piolot, MD, Association Europeenne de Recherche en Oncologie
  • Principal Investigator: Emmanuel Achille, MD, GERCOR - Multidisciplinary Oncology Cooperative Group
  • Principal Investigator: Iradj Bobhani, MD, Fondation Française de Cancérologie Digestive
  • Principal Investigator: Jean-Yves Douillard, MD, UNICANCER

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 19, 2005

Study Record Updates

Last Update Posted (Estimate)

September 19, 2005

Last Update Submitted That Met QC Criteria

September 12, 2005

Last Verified

September 1, 2005

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AERO-R98

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cancer of the Rectum

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uganda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe