5
Participants
Start Date
November 20, 2014
Primary Completion Date
February 28, 2018
Study Completion Date
February 27, 2018
Primary tumor resection + chemotherapy
"Step 1: Primary Tumor (PT) resection~* Within 3 weeks after randomization~* Immunonutrition given 7 days prior to PT resection~* Mechanical bowel preparation performed before surgery according to the local practices~* Performed by laparoscopy (recommended) or by laparotomy (at the investigator's discretion)~Step 2: postoperative CT-scan~* Must be performed within 4 weeks after surgery~* CT-scan/MRI with the same criteria as pre-treatment evaluation~Step 3: Chemotherapy +/- target therapy~* Within 4 weeks after the surgery~* Chemotherapy administered according to the usual scheme for the chosen protocol~* All validated and/or registered perioperative rectal cancer treatments authorized~* The duration of one treatment cycle depending on the type of treatment administered~* Radiotherapy is allowed after randomization if indicated"
Oxaliplatin/irinotecan + capecitabine, 5-FUI ± bevacizumab
"Treatment will start within 3 weeks after randomization; Chemotherapy will be administered according to the regimen in the chosen protocol and validated by the MDOC of each center.~If complications occur, emergency surgery can be performed according to the local practices of each investigator center.~Radiotherapy is allowed after randomization if indicated (MDOC)."
Service de Chirurgie Générale et Digestive, CHRU Claude Huriez, Lille
Service de Chirurgie Générale et Digestive, Centre hospitalier Lyon Sud, HCL, Pierre-Bénite
Service d'Oncologie Médicale, Clinique du Cap-d'Or, La Seyne-sur-Mer
Hospices Civils de Lyon
OTHER