5FU/VL Vs LV5FU2 + CPT11 in Stage II-III Resected Rectal Cancer
Phase 3
- Conditions
- Cancer of the Rectum
- Registration Number
- NCT00189657
- Lead Sponsor
- Association Européenne de Recherche en Oncologie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
AERO
🇫🇷Creteil, France