Randomized Phase III Trial Comparing in a Preoperative Schedule the Result of Two Concurrent Chemoradiation Schemes (45 Gy + Capecitabine vs 50 Gy + Capecitabine - Oxaliplatin) on the Rate of Sterilization of the Operative Specimen in Resectable Rectal Carcinomas T3-4 No-2 Mo
- Compare the efficacy of neoadjuvant chemoradiotherapy comprising radiotherapy and
capecitabine with vs without oxaliplatin followed by total mesorectal excision, in
terms of the rate of complete surgical resection, in patients with resectable stage II
or III rectal cancer.
- Compare overall and disease-free survival of patients treated with these regimens.
- Compare clinical tumor response in patients treated with these regimens.
- Compare acute and late toxicity of these regimens in these patients.
- Determine biological parameters that predict tumor response and treatment-related
toxicity in patients treated with these regimens.
- Compare sphincter preservation and function in patients treated with these regimens.
OUTLINE: This is a randomized, controlled, multicenter study. Patients are randomized to 1
of 2 treatment arms.
- Arm I: Patients undergo radiotherapy once daily 5 days a week and receive capecitabine
once daily 5 days a week in weeks 1-5.
- Arm II: Patient undergo radiotherapy and receive capecitabine as in arm I. Patients
also receive oxaliplatin once weekly in weeks 1-5.
All patients undergo total mesorectal excision 6 weeks after completion of
PROJECTED ACCRUAL: A total of 590 patients will be accrued for this study.
Allocation: Randomized, Primary Purpose: Treatment
Rate of complete surgical resection
Jean-Pierre Gerard, MD
Centre Antoine Lacassagne
United States: Federal Government