Heated mitomycin C chemotherapy during surgery for colon cancer spread to abdomen
Tests adding heated mitomycin C to surgery for spread colon cancer.
Plain-language title generated from the registry record
Registry title: Clinical Trial on HIPEC With Mitomycin C in Colon Cancer Peritoneal Metastases (GECOP-MMC)
Key facts
- Where
- Alcalá de Henares, Alcorcón, Almería, Badajoz, Barcelona, Castello De La Plana, Ciudad Real, Córdoba, Donostia, Elche, Fuenlabrada, Las Palmas De Gran Canaria, Madrid, Málaga, Murcia, Oviedo, Palma, Sevilla, Valencia, Valladolid, and Zaragoza, SpainSee the 31 sites
- Phase
- Phase 4
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with colon cancer that has spread only to the lining of the belly (peritoneum), and whose visible tumour was fully removed by surgery. It compares surgery with and without heated chemotherapy (HIPEC with Mitomycin C).
- Age
- Older than 18 years.
- Sex
- All sexes can join.
- Disease stage
- Colon adenocarcinoma with peritoneal metastases of mild to moderate volume (PCI 20 or less), seen during surgery. No metastases outside the peritoneum. Signet ring cell carcinoma is not accepted.
- Earlier treatment
- Must have had chemotherapy for the whole body (systemic) before and/or after the operation. Must not have had HIPEC before.
Main reasons for not taking part
- Peritoneal cancer from another origin, such as rectal or appendix cancer
- Peritoneal disease with PCI above 20
- Cancer outside the peritoneum, now or treated before
- Disease got worse during chemotherapy before surgery
- Pregnancy or breastfeeding
Read by machine on 12 November 2026.
Where in Spain
- Hospital Universitario Principe de AsturiasAlcalá de Henares, SpainTaking people
- Hospital Universitario Fundación AlcorcónAlcorcón, SpainTaking people
- Hospital Universitario TorrecárdenasAlmería, SpainTaking people
- Hospital Universitario de BadajozBadajoz, SpainTaking people
- Hospital de Sant Joan Despí - Moises BroggiBarcelona, SpainTaking people
- Consorcio Hospitalario Provincial De CastellonCastello De La Plana, SpainTaking people
- Hospital General Universitario De CastellonCastello De La Plana, SpainTaking people
- Hospital General Universitario de Ciudad RealCiudad Real, SpainTaking people
- Hospital General Universitario Reina SofiaCórdoba, SpainTaking people
- Hospital Universitario DonostiaDonostia, SpainTaking people
- Hospital General Universitario de ElcheElche, SpainTaking people
- Hospital Universitario de FuenlabradaFuenlabrada, SpainTaking people
- El Hospital Universitario De Gran Canaria Dr. NegrinLas Palmas De Gran Canaria, SpainTaking people
- Hospital General Universitario Gregorio MarañónMadrid, SpainTaking people
- Hospital Universitario Fundación Jiménez DíazMadrid, SpainTaking people
- Hospital Universitario Infanta ElenaMadrid, SpainTaking people
- Hospital Universitario La PazMadrid, SpainTaking people
- Hospital Universitario Ramón y CajalMadrid, SpainTaking people
- MD Anderson Cancer CenterMadrid, SpainTaking people
- Hospital Quironsalud MalagaMálaga, SpainTaking people
- Hospital Universitario Regional de MálagaMálaga, SpainTaking people
- Hospital General Universitario Reina SofíaMurcia, SpainTaking people
- University Clinical Hospital Virgen De La ArrixacaMurcia, SpainTaking people
- Hospital Universitario Central De AsturiasOviedo, SpainTaking people
- University Hospital Son EspasesPalma, SpainTaking people
- University Hospital Virgen Del Rocio S.L.Sevilla, SpainTaking people
- Fundación Instituto Valenciano de OncologíaValencia, SpainTaking people
- Hospital Clinico Universitario de ValenciaValencia, SpainTaking people
- Hospital Universitario Y Politecnico La FeValencia, SpainTaking people
- Hospital Universitario Rio HortegaValladolid, SpainTaking people
- Hospital Clinico Universitario Lozano BlesaZaragoza, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Hospital Universitario de Fuenlabrada
- Trial code
- NCT05250648EU 2024-512726-28-00
- Record updated
- 9 October 2024
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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.
Exclusion: Concurrent or previously treated extraperitoneal disease; Disease progression during preoperative chemotherapy, if received; Patients previously treated with HIPEC; 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); 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.