GRECCAR 8: Primary Tumor Resection in Rectal Cancer With Unresectable Metastasis
NCT ID: NCT02314182
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
5 participants
INTERVENTIONAL
2014-11-20
2018-02-27
Brief Summary
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* 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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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A Primary tumor resection + chemotherapy
PT resection + systemic chemotherapy +/- target therapy
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
B Oxaliplatin/irinotecan + capecitabine, 5-FUI ± bevacizumab
Chemotherapy (+/- target therapy)
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).
Interventions
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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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Unresectable synchronous metastases
* ECOG performance status 0-1
* Rectal adenocarcinoma (\<15 cm from the anal verge) with few or no symptoms and unresectable metastasis (assessed by the investigator) unsuitable for curative treatment
* No known unresectable primary tumor (with clear margin \>1mm) on CT-scan and MRI
* No disease progression under chemotherapy (for at least 4 cycles);
* Assessment of KRAS status before randomization (wild type or mutated);
* Life expectancy without cancer \>2 years
* White blood cell count ≥ 3 x 109/L, with neutrophils ≥ 1,5 x 109/L, platelet count ≥ 100 x 109/L, hemoglobin°≥ 9 g/dL (5,6 mmol/l)
* Total bilirubin ≤ 1.5 x ULN (upper limit of normal), ASAT and ALAT ≤ 2.5 x ULN, alkaline phosphatase°≤°1.5°x ULN, serum creatinine ≤ 1.5 x ULN;
* Age ≥ 18 years ≤ 75 years
* Patients with childbearing potential should use effective contraception during the study and up 6 months after the end of chemotherapy
* Covered by a Health System where applicable, and/or in compliance with the recommendations of the national laws in force relating to biomedical research;
* Signed written informed consent obtained prior to any study-specific screening procedures
Exclusion Criteria
* Symptoms related to the rectal tumor requiring first intention rectal surgery (appreciated by investigator)
* Contra-indication for surgery
* Resectable metastases
* Complicated (obstruction, bleeding, abscess, perforation) primary tumor requiring emergency surgery and/or contra-indicating first line-chemotherapy
* Non-resectable primary tumor (with wild margin)
* Age \> 75 years \< 18 years
* ECOG performance status \> 2
* Under nutrition (albumin \< 30 g/l)
* Peritoneal carcinomatosis
* Disease progression under chemotherapy (RECIST 1.1 criteria)
* Known hypersensitivity reaction or specific contraindications to any of the components of study treatments
* Clinically relevant coronary artery disease or history of myocardial infarction in the last 12 months, or high risk of uncontrolled arrhythmia
* Pregnancy (absence to be confirmed by ß-hCG test) or breast-feeding;
* Previous malignancy in the last 5 years
* Medical, geographical, sociological, psychological or legal conditions that would prevent the patient from completing the study or signing the informed consent; in the investigator's opinion
* Any significant disease which, in the investigator's opinion, excludes the patient from the study
* Under an administrative or legal supervision.
18 Years
75 Years
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Principal Investigators
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Eddy COTTE
Role: PRINCIPAL_INVESTIGATOR
Service de Chirurgie Générale et Digestive, Centre hospitalier Lyon Sud, HCL
Locations
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Service de Chirurgie Générale et Digestive, Centre hospitalier Lyon Sud, HCL
Pierre-Bénite, France, France
Service d'Oncologie Médicale, Clinique du Cap-d'Or
La Seyne-sur-Mer, , France
Service de Chirurgie Générale et Digestive, CHRU Claude Huriez
Lille, , France
Countries
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References
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Cotte E, Villeneuve L, Passot G, Boschetti G, Bin-Dorel S, Francois Y, Glehen O; French Research Group of Rectal Cancer Surgery (GRECCAR). GRECCAR 8: impact on survival of the primary tumor resection in rectal cancer with unresectable synchronous metastasis: a randomized multicentre study. BMC Cancer. 2015 Feb 12;15:47. doi: 10.1186/s12885-015-1060-0.
Other Identifiers
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2014.847
Identifier Type: -
Identifier Source: org_study_id