MedTrace Logo

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

NCT03073694 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-06-09

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Mitomycin c

Mitomycin-c will be given to participants in Treatment Arm 1 as a one-time, intraoperative, intravenous administration for a duration of 90 minutes. 45 minutes into the perfusion, a maintenance dose will be administered.

DRUG

Melphalan

Melphalan will be given to participants in Treatment Arm 2 as a one-time, intraoperative, intravenous administration for a duration of 90 minutes.

Sponsors & Collaborators

  • University of Kansas Medical Center

    lead OTHER

Principal Investigators

  • Mazin Al-kasspooles, MD · The University of Kansas - Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-14
Primary Completion
2024-07-31
Completion
2025-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03073694 on ClinicalTrials.gov