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

NCT00189657 | Unknown Phase 3

• 1 other identifier: AERO-R98
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer of the Rectum

Interventions

5FU/LV Mayo Clinic or LV5FU2 PROCEDURE

LV5FU2 + irinotecan PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Association Européenne de Recherche en Oncologie: lead
• Aventis Pharmaceuticals: collaborator
• Pfizer: collaborator

Study Sites (1)

AERO

Créteil, 94000, France

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Irinotecan

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Annie JOUHAUD

CONTACT

+ 33 1 43 77 72 10; annie.jouhaud@aero-eu.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 19, 2005
• Last Updated: September 19, 2005

Record last verified: 2005-09

Locations

FR (1)