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Assessing HIPEC with Mitomycin C for Colon Cancer with Peritoneal Metastases

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

Phase 4 Interventional Hospital Universitario de Fuenlabrada · NCT05250648

This study is testing if a heated chemotherapy treatment called HIPEC with Mitomycin C can help people with colon cancer that has spread to the abdominal lining do better after surgery.

Quick facts

PhasePhase 4
Study typeInterventional
Enrollment216 (estimated)
Ages18 Years and up
SexAll
SponsorHospital Universitario de Fuenlabrada Academic / other
Drugs / interventionschemotherapy
Locations31 sites (Elche, Alicante and 30 other locations)
Trial IDNCT05250648 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of Hyperthermic IntraPEritoneal Chemotherapy (HIPEC) with Mitomycin C in patients with colon cancer that has spread to the peritoneum. Participants will undergo complete cytoreductive surgery followed by either HIPEC or no HIPEC, allowing researchers to compare peritoneal recurrence rates between the two groups. The study addresses previous uncertainties regarding the role of HIPEC in improving patient outcomes, particularly in light of conflicting evidence from earlier studies. By focusing on a specific patient population with mild to moderate peritoneal metastases, the trial seeks to clarify the potential benefits of this treatment approach.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 with histologically confirmed colon adenocarcinoma and mild to moderate peritoneal metastases who are eligible for cytoreductive surgery.

Not a fit: Patients with severe extraperitoneal metastases or those with significant comorbidities that affect surgical risk may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into the effectiveness of HIPEC with Mitomycin C, potentially improving treatment outcomes for patients with colon cancer peritoneal metastases.

How similar studies have performed: While previous studies have raised questions about HIPEC's benefits, this trial aims to address methodological flaws and could provide new insights into its effectiveness.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Elche, Alicante and 30 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Peritoneal CarcinomatosisColon CancerHIPECMitomycinColon NeoplasmsPeritoneal metastasis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.