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Phase 3
18 Years
Open (Enrolling)
Cancer of the Rectum

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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:


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


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

Completion Date:

Related Keywords:

  • Cancer of the Rectum
  • Rectal Neoplasms