Flat Dose vs. Weight-based IP Chemotherapy for CRS/HIPEC
Status:
Recruiting
Trial end date:
2024-02-01
Target enrollment:
Participant gender:
Summary
Peritoneal carcinomatosis from advanced gastro-intestinal malignancy has historically been
associated with poor overall survival (≤ 12 months) with few treatment options. Cytoreductive
surgery (CRS), which involves removal of all macroscopic tumor nodules, combined with direct
administration of heated intra-peritoneal (IP) chemotherapy (HIPEC) to the affected
peritoneal surfaces, has been shown to be an effective treatment option that extends overall
survival among certain cases of peritoneal carcinomatosis. IP chemotherapy allows delivery of
a high dose of cytostatic drug directly onto the peritoneal surfaces at risk for microscopic
residual disease while systemic exposure remains limited. Additionally, hyperthermia is known
to enhance the cytotoxicity of several agents (including Mitomycin C) and improves the depth
of peritoneal penetration.
This trial will be a randomized phase 2 comparison of flat dose versus weight-based dose
Mitomycin C. The hypothesis of this study is that HIPEC weight-based dosing may result in
similarly effective peritoneal Mitomycin C concentrations with less systemic absorption and
potential systemic toxicity, compared with the HIPEC flat dosing approach in patients
undergoing CRS/HIPEC.