RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Phase II Single-Blind Randomized Trial Comparing Morbidity of Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (CRS-HIPEC) Using Mitomycin-C Versus Melphalan for Colorectal Peritoneal Carcinomatosis

Quick Facts

Study Start:2017-07-14
Study Completion:2025-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03073694

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Mazin Al-kasspooles, MD
CONTACT
913-588-6568
mal-kasspooles@kumc.edu
Ashley Shores
CONTACT
913-588-1897
ashores@kumc.edu

Principal Investigator

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

Study Locations (Sites)

The University of Kansas Medical Center
Westwood, Kansas, 66205
United States

Collaborators and Investigators

Sponsor: University of Kansas Medical Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-07-14
Study Completion Date2025-07

Study Record Updates

Study Start Date2017-07-14
Study Completion Date2025-07

Terms related to this study

Keywords Provided by Researchers

  • Peritoneal Surface Disease
  • mitomycin-c
  • melphalan
  • Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (CRS-HIPEC)
  • Peritoneal Carcinomatosis

Additional Relevant MeSH Terms

  • Cancer, Appendiceal
  • ColoRectal Cancer