GRECCAR 8: Primary Tumor Resection in Rectal Cancer With Unresectable Metastasis

PHASE3CompletedINTERVENTIONAL
Enrollment

5

Participants

Timeline

Start Date

November 20, 2014

Primary Completion Date

February 28, 2018

Study Completion Date

February 27, 2018

Conditions
Rectal Adenocarcinoma
Interventions
PROCEDURE

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"

DRUG

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)."

Trial Locations (3)

59067

Service de Chirurgie Générale et Digestive, CHRU Claude Huriez, Lille

69495

Service de Chirurgie Générale et Digestive, Centre hospitalier Lyon Sud, HCL, Pierre-Bénite

83500

Service d'Oncologie Médicale, Clinique du Cap-d'Or, La Seyne-sur-Mer

All Listed Sponsors
lead

Hospices Civils de Lyon

OTHER

NCT02314182 - GRECCAR 8: Primary Tumor Resection in Rectal Cancer With Unresectable Metastasis | Biotech Hunter | Biotech Hunter