NCT05250648 Clinical Trial on HIPEC With Mitomycin C in Colon Cancer Peritoneal Metastases (GECOP-MMC)
| NCT ID | NCT05250648 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Hospital Universitario de Fuenlabrada |
| Condition | Peritoneal Carcinomatosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 216 participants |
| Start Date | 2022-03-02 |
| Primary Completion | 2029-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 216 participants in total. It began in 2022-03-02 with a primary completion date of 2029-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: 1. 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). 2. 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). 3. Synchronous or metachronous peritoneal metastasis of mild to moderate volume, with a PCI ≤ 20 (Appendix 2) (intraoperative confirmation). 4. Macroscopically complete surgical cytoreduction CCS-0 (intraoperative confirmation). 5. Treatment with perioperative systemic chemotherapy (SCT), before and/or after surgical procedure. 6. Age\> 18 years. 7. 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). 8. Information to the patient and signing of a study-specific informed consent. Exclusion Criteria: 1. Peritoneal carcinomatosis of any other origin, particularly rectal cancer or appendicular adenocarcinoma, or signet ring cell colon cancer 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 disease with a PCI\> 20 (intraoperative evaluation). 4. Concurrent or previously treated extraperitoneal disease. 5. Disease progression during preoperative chemotherapy, if received. 6. Patients previously treated with HIPEC. 7. History of other cancers (except cutaneous basal cell carcinoma or cervix carcinoma in situ) in the 5 years prior to entry into the study. 8. Patients included in another first-line clinical trial for the studied disease. 9. Pregnancy (or suspicion of it) or lactation period. 10. 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). 11. Persons deprived of liberty or under legal or administrative supervision. 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.
Contact & Investigator
Fernando Pereira, PhD
PRINCIPAL INVESTIGATOR
Hospital Universitario de Fuenlabrada, Madrid, Spain
Frequently Asked Questions
Who can join the NCT05250648 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Peritoneal Carcinomatosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05250648 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05250648 currently recruiting?
Yes, NCT05250648 is actively recruiting participants. Contact the research team at fernando.pereira@salud.madrid.org for enrollment information.
Where is the NCT05250648 trial being conducted?
This trial is being conducted at Elche, Spain, Almería, Spain, Badajoz, Spain, Sant Joan Despí, Spain and 11 additional locations.
Who is sponsoring the NCT05250648 clinical trial?
NCT05250648 is sponsored by Hospital Universitario de Fuenlabrada. The principal investigator is Fernando Pereira, PhD at Hospital Universitario de Fuenlabrada, Madrid, Spain. The trial plans to enroll 216 participants.