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

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

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.