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

Sponsor
Hospices Civils de Lyon
Study ID
NCT02314182
Phase
PHASE3
Status
Completed

Conditions

  • Rectal Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Primary tumor resection + chemotherapy — PROCEDURE
    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 — DRUG
    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).

Study Details

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.

Key Dates

Start date
Nov 20, 2014
Status verified
Dec 2025
Primary completion
Feb 28, 2018
Completion
Feb 27, 2018

Study Design

Enrollment
5 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: A Primary tumor resection + chemotherapy
    PT resection + systemic chemotherapy +/- target therapy
  • Other: B Oxaliplatin/irinotecan + capecitabine, 5-FUI ± bevacizumab
    Chemotherapy (+/- target therapy)

Primary Outcome Measure

Overall survival [ Time Frame: up to 2 years ]

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