Cancer of the Rectum
Conditions
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.
Interventions
PROCEDURE5FU/LV Mayo Clinic or LV5FU2
PROCEDURELV5FU2 + irinotecan
Sponsors
Aventis Pharmaceuticals
Pfizer
Association Européenne de Recherche en Oncologie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Countries
France
Contacts
Primary ContactAnnie JOUHAUD
Outcome results
None listed