Clinical Trial on HIPEC With Mitomycin C in Colon Cancer Peritoneal Metastases (GECOP-MMC)
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital Universitario de Fuenlabrada
About this trial
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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- complete cytoreductive surgery plus HIPEC with Mytomicin C for 90 minutes
- complete cytoreductive surgery without HIPEC
Treatment groups
216 Participants
are divided into 2 treatment groupsSponsors and collaborators
Hospital Universitario de Fuenlabrada
Lead sponsor
Instituto de Investigación Hospital Universitario La Paz
Collaborator
Source ClinicalTrials.gov