Phase IV multicentric clinical trial to evaluate the efficacy of hyperthermic intraperitoneal chemotherapy (HIPEC) with Mytomicin-C after complete surgical cytoreduction in patients with Colon Cancer Peritoneal Metastases - Phase IV Clinical Trial on HIPEC with Mytomicin-C in Colon Cancer Peritoneal Metastases

Hospital Universitario de Fuenlabrada0 个研究点目标入组 216 人开始时间: 2024年4月23日最近更新: 2024年4月29日

适应症

试验速览

暂无简介。

•1) Histologically confirmed colon cancer, except those with signet ring cells (> 50% of the tumor composed of these cells, only 1% of CRCs)
•2) Absence of extraperitoneal metastases, including distant lymphadenopathy, liver and lung metastases (ruled out by PET in case of doubt).
•3) Mild or moderate extent synchronous or metachronous peritoneal carcinomatosis with a PCI = 20 (intraoperative confirmation)
•4) Obtaining a macroscopically complete surgical cytoreduction CCS-0 (intraoperative confirmation)
•5) Treatment with perioperative systemic chemotherapy (before and/or after surgical procedure).
•6) Age> 18 years
•7) Acceptable anesthetic/surgical risk: ASA 1-3, ECOG 0-1. No severe alterations in hematological, renal and hepatic function (operable patients)
•8) Information to the patient and signing of a study-specific informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 108
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 108

•1) Carcinomatosis of any other origin, particularly rectal cancer or appendicular adenocarcinoma, or signet ring cell CC on histology.
•2) No intraoperative confirmation of peritoneal disease (PCI 0). Likewise, cases of perianastomotic (local) or lymph node (locoregional) recurrences will be excluded.
•3) High volume peritoneal carcinomatosis, with a PCI> 20 (intraoperative evaluation).
•4) Concurrent or previously treated extraperitoneal disease.
•5) Progression during preoperative chemotherapy, if received.
•6) Patients previously treated with HIPEC.
•7) History of other cancers (except cutaneous basal cell carcinoma or cervical carcinoma in situ) in the 5 years prior to entry into the study.
•8) Patient included in another first-line clinical trial for the disease studied.
•9) Pregnancy (or suspected of it) or lactation period.
•10) Urgent intervention for obstruction or perforation.
•11) Persons deprived of liberty or under guardianship.
•12) Inability to understand the nature of the intervention, the risks, benefits, expected evolution and the need to undergo periodic medical examinations, either for geographical, social or psychological reasons.

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