Clinical Trial on HIPEC with Mitomycin C in Colon Cancer Peritoneal Metastases (GECOP-MMC)
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
Hospital Universitario de Fuenlabrada
216 participants
Mar 2, 2022
INTERVENTIONAL
Conditions
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
Inclusion Criteria10
- 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).
- Treatment with perioperative systemic chemotherapy (SCT), before and/or after surgical procedure.
- Age\> 18 years.
- 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).
- Information to the patient and signing of a study-specific informed consent.
- Persons deprived of liberty or under legal or administrative supervision.
- 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.
Exclusion Criteria9
- 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.
- Disease progression during preoperative chemotherapy, if received.
- Patients previously treated with HIPEC.
- History of other cancers (except cutaneous basal cell carcinoma or cervix carcinoma in situ) in the 5 years prior to entry into the study.
- Patients included in another first-line clinical trial for the studied disease.
- Pregnancy (or suspicion of it) or lactation period.
Interventions
In the arm with HIPEC, this will be performed with Mytomicin C, at a dose of 35 mg/m2 in peritoneal dialysis solution (2 liter/m2) for 90 minutes, with dose fractionation: 50% min 0, 25% min 30, 25% min 60
in the arm without HIPEC, only complete cytoreductive surgery will be performed
Locations(31)
View Full Details on ClinicalTrials.gov
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NCT05250648