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

NCT02314182 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2025-12-19

No results posted yet for this study

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

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).

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Principal Investigators

  • Eddy COTTE · Service de Chirurgie Générale et Digestive, Centre hospitalier Lyon Sud, HCL

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-20
Primary Completion
2018-02-28
Completion
2018-02-27

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02314182 on ClinicalTrials.gov