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NCT Number: NCT02314182

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

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.

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Key information

Conditions

Rectal Adenocarcinoma Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Service de Chirurgie Générale et Digestive, Centre hospitalier Lyon Sud, HCL, Pierre-Bénite, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Other names: EGFR antibodies panitumumad and cetuxiamb in case of KRAS wild-type tumors.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

GRECCAR 8 : Impact on Survival of the Primary Tumor Resection in Rectal Cancer With Unresectable Synchronous Metastasis a Randomized Multicenter Study

Acronym: GRECCAR8

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Dec 11, 2014
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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