Cancer of the Rectum Clinical Trial
| NCT number | NCT00189657 |
| Other study ID # | AERO-R98 |
| Secondary ID | |
| Status | Recruiting |
| Phase | Phase 3 |
| First received | September 12, 2005 |
| Last updated | September 12, 2005 |
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.
| Status | Recruiting |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| France | AERO | Creteil |
| Lead Sponsor | Collaborator |
|---|---|
| Association Européenne de Recherche en Oncologie | Aventis Pharmaceuticals, Pfizer |
France,
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