IRIMAD Interest of postoperative reintroduction of chemotherapy in patients with colorectal liver metastases who responded well to preoperative chemotherapy with FOLFIRI with or without targeted therapy - APHP220917

Assistance Publique Hopitaux De Paris0 个研究点目标入组 254 人开始时间: 2024年2月13日最近更新: 2024年7月22日

适应症

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•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

•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

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