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

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ClinicalTrials.gov Identifier: NCT00189657
Recruitment Status : Unknown
Verified September 2005 by Association Européenne de Recherche en Oncologie.
Recruitment status was:  Recruiting
First Posted : September 19, 2005
Last Update Posted : September 19, 2005
Information provided by:

Study Description
Brief 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.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

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U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00189657

Contact: Annie JOUHAUD + 33 1 43 77 72 10 annie.jouhaud@aero-eu.org

AERO Recruiting
Creteil, France, 94000
Contact: Pascal Piedbois, MD    + 33 1 49 81 25 82    pascal.piedbois@hmn.aphp.fr   
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 GERCOR - Multidisciplinary Oncology Cooperative Group
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
More Information

ClinicalTrials.gov Identifier: NCT00189657     History of Changes
Other Study ID Numbers: AERO-R98
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: September 19, 2005
Last Verified: September 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
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs