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

Association Européenne de Recherche en Oncologie

Status and phase

Unknown

Phase 3

Conditions

Cancer of the Rectum

Treatments

Procedure: 5FU/LV Mayo Clinic or LV5FU2

Procedure: LV5FU2 + irinotecan

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00189657

AERO-R98

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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