Assessing HIPEC with Mitomycin C for Colon Cancer with Peritoneal Metastases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Hospital General Universitario de Elche
  Elche, Alicante, Spain Recruiting
• Hospital Universitario Torrecárdenas
  Almería, Almería, Spain Recruiting
• Complejo Hospitalario Universitario de Badajoz
  Badajoz, Badajoz, Spain Recruiting
• Hospital Sant Joan Despi Moises Broggi
  Sant Joan Despí, Barcelona, Spain Recruiting
• Hospital General Universitario de Castellón
  Castellon, Castellón, Spain Recruiting
• Consorcio Hospitalario Provincial de Castellón
  Castellon, Castellón, Spain Recruiting

Study contacts

• Principal investigator: Fernando Pereira, PhD — Hospital Universitario de Fuenlabrada, Madrid, Spain
• Study coordinator: Fernando Pereira, PhD
• Email: fernando.pereira@salud.madrid.org
• Phone: +34916006455

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.