Phase 3
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Cancer of the Rectum
Both
Cancer of the Rectum
Trial Information
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Pascal Piedbois, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Association Europeenne de Recherche en Oncologie
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
AERO-R98
NCT ID:
NCT00189657
Start Date:
Completion Date:
Related Keywords:
- Cancer of the Rectum
- Rectal Neoplasms
Name | Location |
|---|
