Status:
UNKNOWN
5FU/VL Vs LV5FU2 + CPT11 in Stage II-III Resected Rectal Cancer
Lead Sponsor:
Association Européenne de Recherche en Oncologie
Collaborating Sponsors:
Aventis Pharmaceuticals
Pfizer
Conditions:
Cancer of the Rectum
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 r...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00189657
Last Update
September 19 2005
Active Locations (1)
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1
AERO
Créteil, France, 94000