drugset / Trial / NCT03073694

Comparing Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (CRS-HIPEC) Using Mitomycin-C Versus Melphalan for Colorectal Peritoneal Carcinomatosis

NCT03073694

Phase 2 Unknown 100 enrolled University of Kansas Medical Center
RandomizedParallel-groupSingle-blindTreatment

Summary

The purpose of this trial is to compare the morbidity and mortality of CRS-HIPEC using mitomycin-C versus melphalan for colorectal peritoneal carcinomatosis. Morbidity and mortality will measured using the Comprehensive Complication Index (CCI) score, Common terminology criteria for adverse events (CTCAE version 4.03), and the Clavien-Dindo Classification.

Timeline

Start
2017-07-14
Primary completion
2024-07
Completion
2025-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Melphalan Small molecule 60 mg/m2 Intravenous
Comparator Mitomycin C Other / unclassified 5 mg/m2 Intravenous

Indications