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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2005 by Association Européenne de Recherche en Oncologie.
Recruitment status was:  Recruiting
Aventis Pharmaceuticals
Information provided by:
Association Européenne de Recherche en Oncologie Identifier:
First received: September 12, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
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.

Condition Intervention Phase
Cancer of the Rectum
Procedure: 5FU/LV Mayo Clinic or LV5FU2
Procedure: LV5FU2 + irinotecan
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Association Européenne de Recherche en Oncologie:


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00189657

Contact: Annie JOUHAUD + 33 1 43 77 72 10

AERO Recruiting
Creteil, France, 94000
Contact: Pascal Piedbois, MD    + 33 1 49 81 25 82   
Sponsors and Collaborators
Association Européenne de Recherche en Oncologie
Aventis Pharmaceuticals
Principal Investigator: Pascal Piedbois, MD Association Europeenne de Recherche en Oncologie
Principal Investigator: Thierry Andre, MD Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Principal Investigator: Alain Piolot, MD Association Europeenne de Recherche en Oncologie
Principal Investigator: Emmanuel Achille, MD Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Principal Investigator: Iradj Bobhani, MD Fondation Française de Cancérologie Digestive
Principal Investigator: Jean-Yves Douillard, MD UNICANCER
  More Information Identifier: NCT00189657     History of Changes
Other Study ID Numbers: AERO-R98
Study First Received: September 12, 2005
Last Updated: September 12, 2005

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors processed this record on May 22, 2017