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GRECCAR 8: Primary Tumor Resection in Rectal Cancer With Unresectable Metastasis (GRECCAR8)

Civil Hospices of Lyon logo

Civil Hospices of Lyon

Status and phase

Completed
Phase 3

Conditions

Rectal Adenocarcinoma

Treatments

Procedure: Primary tumor resection + chemotherapy
Drug: Oxaliplatin/irinotecan + capecitabine, 5-FUI ± bevacizumab

Study type

Interventional

Funder types

Other

Identifiers

NCT02314182
2014.847

Details and patient eligibility

About

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.

Enrollment

5 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

5 participants in 2 patient groups

A Primary tumor resection + chemotherapy
Experimental group
Description:
PT resection + systemic chemotherapy +/- target therapy
Treatment:
Procedure: Primary tumor resection + chemotherapy
B Oxaliplatin/irinotecan + capecitabine, 5-FUI ± bevacizumab
Other group
Description:
Chemotherapy (+/- target therapy)
Treatment:
Drug: Oxaliplatin/irinotecan + capecitabine, 5-FUI ± bevacizumab

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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