NCT02314182

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

GRECCAR 8 : Impact on Survival of the Primary Tumor Resection in Rectal Cancer With Unresectable Synchronous Metastasis a Randomized Multicenter Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A prospective, open, multicenter, randomized III trial with two arms: * Arm A: Primary tumor resection , followed by chemotherapy * Arm B: Chemotherapy alone. Compare overall 2-year survival rates in patients treated for resectable rectal adenocarcinoma with unresectable metastasis, treated either with the primary tumor resection with chemotherapy +/- target therapy, or with chemotherapy (+/- target therapy) alone.

Conditions

• Rectal Adenocarcinoma

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2014-11-20
• Primary completion: 2018-02-01
• Completion: 2018-02-27
• First posted: 2014-12-11
• Last updated: 2025-12-19

Locations

3 sites across 1 country: France