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

Recruiting now · Phase 4

Conditions studied: Peritoneal Carcinomatosis, Colon Cancer

In brief

The aim of this study is to assess whether there are differences in PERITONEAL RECURRENCE in patients with Colon Cancer Peritoneal Metastases treated with complete surgical resection and systemic chemotherapy, with (Group 1) or without (Group 2) HIPEC with Mitomycin-C.

Key facts

Study ID

NCT05250648

Run by

Hospital Universitario de Fuenlabrada

People needed

216

Starts

2022-03-02

Expected to finish

2029-10-01

Last updated by the study team

2024-10-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).
• Concurrent or previously treated extraperitoneal disease.
• Disease progression during preoperative chemotherapy, if received.
• Patients previously treated with HIPEC.
• 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.
• Pregnancy (or suspicion of it) or lactation period.
• 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).
• 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.

Where it is running

• Hospital Clínico Universitario "Lozano Blesa" — Zaragoza, Zaragoza, Spain (enrolling)
• Hospital Universitario Torrecárdenas — Almería, Almería, Spain (enrolling)
• Complejo Hospitalario Universitario de Badajoz — Badajoz, Badajoz, Spain (enrolling)
• Hospital Sant Joan Despi Moises Broggi — Sant Joan Despí, Barcelona, Spain (enrolling)
• Hospital General Universitario de Castellón — Castellon, Castellón, Spain (enrolling)
• Consorcio Hospitalario Provincial de Castellón — Castellon, Castellón, Spain (enrolling)
• Hospital General Universitario de Ciudad Real — Ciudad Real, Ciudad Real, Spain (enrolling)
• Hospital Universitario Reina Sofía — Córdoba, Córdoba, Spain (enrolling)
• Hospital Universitario Y Politécnico La Fe — Valencia, Valencia, Spain (enrolling)
• Hospital Universitario Río Hortega — Valladolid, Valladolid, Spain (enrolling)
• Hospital General Universitario de Elche — Elche, Alicante, Spain (enrolling)
• Hospital Universitario de Gran Canaria Doctor Negrín — Las Palmas de Gran Canaria, Gran Canaria, Spain (enrolling)
• Hospital Universitario Principe de Asturias — Alcalá de Henares, Madrid, Spain (enrolling)
• Hospital Universitario Fundación Alcorcón — Alcorcón, Madrid, Spain (enrolling)
• HOSPITAL UNIVERSITARIO DE FUENLABRADA (Coordinating Centre) — Fuenlabrada, Madrid, Spain (enrolling)
• Hospital General Universitario Gregorio Marañón — Madrid, Madrid, Spain (enrolling)
• Hospital Universitario Ramón Y Cajal — Madrid, Madrid, Spain (enrolling)
• Fundación Jiménez Díaz — Madrid, Madrid, Spain (enrolling)
• Hospital Universitario La Paz — Madrid, Madrid, Spain (enrolling)
• Hospital Universitario Infanta Elena — Valdemoro, Madrid, Spain (enrolling)
• Hospital Universitario Son Espases — Palma de Mallorca, Mallorca, Spain (enrolling)
• Hospital Universitario Virgen de La Arrixaca — El Palmar, Murcia, Spain (enrolling)
• Hospital General Universitario Reina Sofía — Murcia, Murcia, Spain (enrolling)
• Hospital Regional Universitario de Málaga — Málaga, MÁLAGA, Spain (enrolling)
• Hospital Universitario Central de Asturias — Oviedo, Principality of Asturias, Spain (enrolling)

Full record on ClinicalTrials.gov

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