Clinical Trial on HIPEC with Mitomycin C in Colon Cancer Peritoneal Metastases (GECOP-MMC)

Launched by HOSPITAL UNIVERSITARIO DE FUENLABRADA · Feb 20, 2022

Keywords

ClinConnect Summary

This clinical trial, called GECOP-MMC, is studying a treatment for patients with colon cancer that has spread to the lining of the abdomen, known as peritoneal metastases. The researchers want to find out if adding a specific type of treatment called HIPEC (Hyperthermic Intraperitoneal Chemotherapy) with a drug called Mitomycin C can help reduce the chances of cancer returning in patients who have already had surgery to remove the tumors and received standard chemotherapy. Participants will be divided into two groups: one will receive the HIPEC treatment and the other will not.

To be eligible for the trial, participants must be adults with confirmed colon cancer that meets certain criteria, including having no other significant cancer spread outside the abdomen and having specific levels of disease volume. They should also be in good overall health to tolerate surgery and anesthesia. If you join the trial, you’ll receive close medical care and regular check-ups to monitor your health and the effects of the treatment. This study is currently recruiting participants, and it aims to provide valuable information that could help improve treatment options for colon cancer patients in the future.

Gender

ALL

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.