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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 : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief 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.

Condition or disease Intervention/treatment Phase
Rectal Adenocarcinoma Procedure: Primary tumor resection + chemotherapy Drug: Oxaliplatin/irinotecan + capecitabine, 5-FUI ± bevacizumab Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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 2014
Actual Primary Completion Date : February 2018
Actual Study Completion Date : February 27, 2018

Arm Intervention/treatment
Experimental: A Primary tumor resection + chemotherapy
PT resection + systemic chemotherapy +/- target therapy
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

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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

  5. 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)

  6. 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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Non-complicated primary tumor (i.e. tumor without obstruction, bleeding, abscess or perforation requiring emergency surgery and/or contra-indicating first-line chemotherapy)
  • 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:

  • Rectal tumor operated before inclusion
  • 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.

Information from the National Library of Medicine

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


Locations
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France
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
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Eddy COTTE Service de Chirurgie Générale et Digestive, Centre hospitalier Lyon Sud, HCL

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02314182     History of Changes
Other Study ID Numbers: 2014.847
First Posted: December 11, 2014    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
Keywords provided by Hospices Civils de Lyon:
Rectal adenocarcinoma
unresectable
surgery
chemotherapy
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Bevacizumab
Capecitabine
Oxaliplatin
Irinotecan
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors