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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Association Européenne de Recherche en Oncologie.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Aventis Pharmaceuticals
Pfizer
Information provided by:
Association Européenne de Recherche en Oncologie
ClinicalTrials.gov Identifier:
NCT00189657
First received: September 12, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

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 ClinicalTrials.gov identifier: NCT00189657

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

Locations
France
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
Pfizer
Investigators
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

No publications provided

ClinicalTrials.gov Identifier: NCT00189657     History of Changes
Other Study ID Numbers: AERO-R98
Study First Received: September 12, 2005
Last Updated: September 12, 2005
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

ClinicalTrials.gov processed this record on September 16, 2014