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Rectal AdenocarcinomaPhase 3GRECCAR8NCT02314182

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

A Phase 3 study testing Primary tumor resection + chemotherapy and Oxaliplatin/irinotecan + capecitabine, 5-FUI ± bevacizumab in people with Rectal Adenocarcinoma, run by Hospices Civils de Lyon at 3 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Rectal Adenocarcinoma
What is being tested?
Primary tumor resection + chemotherapy and Oxaliplatin/irinotecan + capecitabine, 5-FUI ± bevacizumab
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
3 sitesFrance
Study dates
20 Nov 2014to 27 Feb 2018
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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);
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  • 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

Who cannot join

  • 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)
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  • 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.

Trial locations and contacts

3 sites in 1 country.

France3 sites

  • Service d'Oncologie Médicale, Clinique du Cap-d'Or

    La Seyne-sur-Mer, 83500

  • Service de Chirurgie Générale et Digestive, CHRU Claude Huriez

    Lille, 59067

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

    Pierre-Bénite, France, 69495

Other trials in France

About this study

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

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.
Being tested
Primary tumor resection + chemotherapy, Oxaliplatin/irinotecan + capecitabine, 5-FUI ± bevacizumab
Keywords
Rectal adenocarcinoma, unresectable, surgery, chemotherapy
Medical subject headings
Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Primary tumor resection + chemotherapyProcedure or surgery

    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 ± bevacizumabDrug

    Also called EGFR antibodies panitumumad and cetuxiamb in case of KRAS wild-type tumors.

    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).

Study groups in NCT02314182
Study groupRoleWhat they receive
A Primary tumor resection + chemotherapyExperimentalPT resection + systemic chemotherapy +/- target therapy
Receives: Procedure: Primary tumor resection + chemotherapy
B Oxaliplatin/irinotecan + capecitabine, 5-FUI ± bevacizumabOtherChemotherapy (+/- target therapy)
Receives: Drug: Oxaliplatin/irinotecan + capecitabine, 5-FUI ± bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

    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.

    Measured: up to 2 years

Secondary outcomes (6)

  1. Progression free survival

    Progression free survival will be assessed every 3 months during follow-up and will be estimated at 24 months.

    Measured: up to 2 years

  2. Quality of life

    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.

    Measured: Up to 2 years

  3. Toxicity of chemotherapy (Common Toxicity Criteria for Adverse Events (NCI-CTC-AE V4.0)

    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

    Measured: Up to 2 years

  4. Response of the metastatic disease to systemic chemotherapy (RECIST 1.1 criteria)

    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

    Measured: up to2 years

  5. Time to disease progression

    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)

    Measured: up to 2 years

  6. Post-operative morbidity

    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.

    Measured: within 30 days after surgical intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2014 (estimated)
  2. Study start20 Nov 2014
  3. Primary completionFeb 2018
  4. Study completion27 Feb 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02314182
Sponsor's protocol ID
2014.847
Acronym
GRECCAR8
Status last verified
Dec 2025
First submitted
12 Nov 2014
Last updated
19 Dec 2025
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 25849254

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Primary tumor resection + chemotherapy and Oxaliplatin/irinotecan + capecitabine, 5-FUI ± bevacizumab in people with Rectal Adenocarcinoma, run by Hospices Civils de Lyon at 3 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02314182, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.

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