GRECCAR 8: Primary Tumor Resection in Rectal Cancer With Unresectable Metastasis (GRECCAR8)
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|ClinicalTrials.gov Identifier: NCT02314182|
Recruitment Status : Completed
First Posted : December 11, 2014
Last Update Posted : November 1, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Rectal Adenocarcinoma||Procedure: Primary tumor resection + chemotherapy Drug: Oxaliplatin/irinotecan + capecitabine, 5-FUI ± bevacizumab||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||GRECCAR 8 : Impact on Survival of the Primary Tumor Resection in Rectal Cancer With Unresectable Synchronous Metastasis a Randomized Multicenter Study|
|Actual Study Start Date :||November 20, 2014|
|Actual Primary Completion Date :||February 2018|
|Actual Study Completion Date :||February 27, 2018|
Experimental: A Primary tumor resection + chemotherapy
PT resection + systemic chemotherapy +/- target therapy
Procedure: Primary tumor resection + chemotherapy
Step 1: Primary Tumor (PT) resection
Step 2: postoperative CT-scan
Step 3: Chemotherapy +/- target therapy
B Oxaliplatin/irinotecan + capecitabine, 5-FUI ± bevacizumab
Chemotherapy (+/- target therapy)
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).
Other Name: EGFR antibodies panitumumad and cetuxiamb in case of KRAS wild-type tumors.
- Overall survival [ Time Frame: up to 2 years ]Overall survival, defined as the time interval between the date of randomization and the date of death, with a 24 months' follow-up, in both treatment arms.
- Progression free survival [ Time Frame: up to 2 years ]Progression free survival will be assessed every 3 months during follow-up and will be estimated at 24 months.
- Quality of life [ Time Frame: Up to 2 years ]Quality of life will be assessed at the time of randomization and then every 3 months in both treatment arms. The EORTC QLQ-C30, QLQ-CR29 questionnaires will be used.
- Toxicity of chemotherapy (Common Toxicity Criteria for Adverse Events (NCI-CTC-AE V4.0) [ Time Frame: Up to 2 years ]Chemotherapy toxicity will be graded according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTC-AE V4.0) in both treatment arms
- Response of the metastatic disease to systemic chemotherapy (RECIST 1.1 criteria) [ Time Frame: up to2 years ]The response rate of the metastatic disease will be evaluated in both treatment arms by CT scan and analyzed using the RECIST 1.1 criteria
- Time to disease progression [ Time Frame: up to 2 years ]Time to disease progression is defined as the lapse of time between the date of randomization and the first date of progression (clinical or imaging) of the metastatic disease in both treatment arms, or of the primary rectal tumor in the chemotherapy arm (Arm B)
- Post-operative morbidity [ Time Frame: within 30 days after surgical intervention ]The evaluation of post-operative morbidity and mortality will be assessed in the primary tumor resection arm (Arm A) and in the chemotherapy arm (Arm B) for patients who require emergency surgery. The post-operative complications will be evaluated according to the Clavien-Dindo Classification of Surgical Complication and graded 0 to V.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02314182
|Service d'Oncologie Médicale, Clinique du Cap-d'Or|
|La Seyne-sur-Mer, France, 83500|
|Service de Chirurgie Générale et Digestive, CHRU Claude Huriez|
|Lille, France, 59067|
|Service de Chirurgie Générale et Digestive, Centre hospitalier Lyon Sud, HCL|
|Pierre Benite, France, 69495|
|Principal Investigator:||Eddy COTTE||Service de Chirurgie Générale et Digestive, Centre hospitalier Lyon Sud, HCL|