metastatic colorectal cancer

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 254

Inclusion Criteria

Histologically proven resected metachronous CLM with curative intent that could not be treated with perioperative oxaliplatin-based chemotherapy for oncologic or tolerability reasons. For this study, metachronous CLM is defined as liver recurrence occurring more than 12 months after treatment of the primary colorectal cancer, Patients must be 18 years old or older, A WHO performance status of 0 or 1, Participants must be affiliated to a social security scheme, No more than 10 treated CLM at surgery, At least 2 cycles and no more than 8 cycles of preoperative FOLFIRI based chemotherapy ± targeted therapy, Preoperative FOLFIRI based chemotherapy ± targeted therapy administered no more than 12 weeks before surgery, R0/R1resection ± radiofrequency ablation with curative intent of all liver deposits with no macroscopic residual liver disease, Objective response to preoperative therapy defined as complete or partial radiological response and/or major or complete pathologic response, No extrahepatic or residual liver disease on baseline work-up including thoraco-abdominal CT scan within 6 weeks after surgery. 1 non-specific lung nodule of less than 10 mm in maximum diameter is not considered as extra-hepatic metastases, Primary tumor (or liver metastasis) of CRC must be characterized for RAS and BRAF status, No contraindication to FOLFIRI based chemotherapy

Exclusion Criteria

Palliative/R2 resection of CLM, 10 lesions or more treated at the time of surgery, Patients undergoing only radiofrequency ablation of all liver deposit (this situation precludes the assessment of pathologic response to preoperative chemotherapy), Extra-hepatic or residual metastasis of CRC, Absence of objective response to therapy (radiological or pathological response ), Inflammatory bowel disease, Known UGT1A1*28 allele homozygosity, Contraindications to investigational medicinal products (irinotecan, 5-FU, folinic acid) and to auxiliary medicinal products (ondansetron, methylprednisolone), Known pregnancy (pregnancy test for women of childbearing) or breastfeeding women

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Demonstrate an improvement of disease-free survival rate at 3 years;Secondary Objective: To compare the overall survival rates between the two treatment arms, To compare liver free survival between the two groups, To compare extra -hepatic recurrence rate between the two groups, To assess toxicity of postoperative treatment, To assess compliance of postoperative treatment, To assess the rate of further curative treatment of recurrence;Primary end point(s): Disease-free survival rate at 3 years

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Overall survival at 3 years;Secondary end point(s):Liver-free survival at 3 years;Secondary end point(s):Extra -hepatic recurrence rate;Secondary end point(s):Safety including chemotherapy associated toxicity assessed by International Common Terminology Criteria for Adverse Events (CTCAE) grading system;Secondary end point(s):Compliance defined as the ability to administrate a total of 12 cycles of FOLFIRI-based chemotherapy including preoperative treatment;Secondary end point(s):Rate of treatment of recurrence with curative intent