Multicentre Phase IV clinical trial to evaluate the efficacy of hyperthermic intraoperative chemotherapy (HIPEC) with Mitomycin-C after complete surgical debulking in patients with peritoneal metastases of colon cancer. - GECOP-MMC

Hospital Universitario De Fuenlabrada0 个研究点目标入组 216 人开始时间: 2024年4月30日最近更新: 2024年8月21日

适应症

试验速览

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•Histologically proven colon cancer, except those with signet ring cells (those with > 50% of the tumor composed of such cells, which only account for 1% of CRC)., Absence of current or previously treated extraperitoneal metastases, including distant adenopathies (retroperitoneal, mediastinal,...), liver metastases, or pulmonary metastases (ruled out by PET in case of doubt)., Synchronous or metachronous peritoneal carcinomatosis of mild or moderate extension, with a PCI = 20 (APPENDIX I) (intraoperative evaluation)., Obtaining a macroscopically complete surgical cytoreduction CCS-0 (intraoperative evaluation)., Treatment with perioperative systemic chemotherapy (before and/or after the surgical procedure)., Age > 18 years., Acceptable anesthetic/surgical risk: ASA 1-3 (APPENDIX II), ECOG 0-1 (APPENDIX III), hematological, renal and hepatic function without severe alterations (operable patients)., Information to the patient and signature of the study-specific Informed Consent.

•Peritoneal carcinomatosis of any other origin, in particular rectal cancer or appendiceal adenocarcinoma, or signet ring cell colon cancer on histology., Urgent intervention for obstruction or perforation of a primary tumor with synchronous MP (although salvage or secondary CR + HIPEC after emergency surgery of the primary tumor are acceptable if the inclusion criteria are met)., Persons deprived of liberty or under guardianship., Inability to understand the nature of the intervention, the risks, benefits, expected evolution and need to undergo periodic medical examinations, either for geographical, social or psychological reasons., No intraoperative confirmation of peritoneal disease (PCI 0). Cases of perianastomotic (local) or lymph node (locoregional) recurrence will also be excluded., High volume peritoneal carcinomatosis, with a PCI > 20 (APPENDIX I), or incomplete cytoreduction (intraoperative evaluation)., Concurrent or previously treated extraperitoneal disease., Progression during preoperative chemotherapy, if received., Patients previously treated with HIPEC., History of other cancers (except cutaneous basal cell carcinoma or carcinoma in situ of the cervix) in the 5 years prior to study entry., Patient included in another first-line clinical trial for the disease studied., Pregnancy (or suspected pregnancy) or lactation period.

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