Clinical Trial on HIPEC With Mitomycin C in Colon Cancer Peritoneal Metastases (GECOP-MMC)

Korábbi kezelés

• Concurrent or previously treated extraperitoneal disease.
• Disease progression during preoperative chemotherapy, if received.
• Patients previously treated with HIPEC.

Más betegség

• Peritoneal carcinomatosis of any other origin, particularly rectal cancer or appendicular adenocarcinoma, or signet ring cell colon cancer on histology.
• No intraoperative confirmation of peritoneal disease (PCI 0). Likewise, cases of perianastomotic (local) or lymph node (locoregional) recurrences will be excluded.
• High volume peritoneal disease with a PCI> 20 (intraoperative evaluation).
• History of other cancers (except cutaneous basal cell carcinoma or cervix carcinoma in situ) in the 5 years prior to entry into the study.
• Patients included in another first-line clinical trial for the studied disease.
• Emergency surgical intervention for obstruction or perforation of a primary tumour with synchronous PM (although rescue and secondary CRS + HIPEC after emergency surgery of the primary tumour are acceptable if inclusion criteria are fulfilled).

Egyéb

• Pregnancy (or suspicion of it) or lactation period.
• Persons deprived of liberty or under legal or administrative supervision.
• 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.

• Histologically confirmed colon adenocarcinoma, except signet ring cell carcinomas (those with > 50% of the tumor composed of these cells, which comprise only 1% of all colon adenocarcinomas).
• Absence of previously treated or current extraperitoneal metastases, including distant lymphadenopathy (retroperitoneal, mediastinal, etc), liver metastases, or lung metastases (ruled out by PET-scan in case of doubt).
• Synchronous or metachronous peritoneal metastasis of mild to moderate volume, with a PCI ≤ 20 (Appendix 2) (intraoperative confirmation).
• Macroscopically complete surgical cytoreduction CCS-0 (intraoperative confirmation).
• Treatment with perioperative systemic chemotherapy (SCT), before and/or after surgical procedure.
• Age> 18 years.
• Acceptable anesthetic/surgical risk: ASA 1-3 (Appendix 3), ECOG 0-1 (Appendix 4). No severe alterations in hematological, renal, cardiac, pulmonary or hepatic function (operable patients).
• Information to the patient and signing of a study-specific informed consent.