RECRUITING

Flat Dose Vs. Weight-based IP Chemotherapy for CRS/HIPEC

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

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.

Official Title

A Randomized Phase 2 Trial of Flat Dose Vs. Weight-based Dose of Intra-peritoneal (IP) Chemotherapy for Patients Undergoing Cytoreductive Surgery and Heated Intra-peritoneal Chemotherapy (CRS/HIPEC) for Advanced Gastrointestinal Malignancy

Quick Facts

Study Start:2021-06-04
Study Completion:2026-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04779554

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
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients diagnosed with one of the following: low-grade appendiceal mucinous neoplasm, appendiceal cancer with peritoneal carcinomatosis, colorectal cancer with peritoneal carcinomatosis
  2. * ECOG performance status \< 3
  3. * Candidate for grossly complete cytoreductive surgery
  4. * Life expectancy greater than 3 months
  5. * Adequate organ and marrow function
  6. * Ability to understand and the willingness to sign a written informed consent document
  1. * Any extra-abdominal metastases
  2. * Untreated lung metastases
  3. * Liver metastases not amenable to resection or ablation
  4. * Known brain metastases
  5. * Chemotherapy or radiotherapy within 4 weeks prior to entering the study
  6. * Presence of residual significant adverse events attributed to prior cancer treatment
  7. * Currently receiving any other investigational therapeutic agents
  8. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to Mitomycin C.
  9. * Pregnant or breast-feeding women
  10. * Uncontrolled ongoing illness

Contacts and Locations

Study Contact

Prakash Pandalai, MD
CONTACT
859-323-8920
Prakash.Pandalai@uky.edu

Principal Investigator

Prakash Pandalai, MD
PRINCIPAL_INVESTIGATOR
University of Kentucky

Study Locations (Sites)

University of Kentucky
Lexington, Kentucky, 40536
United States
University of Vermont Medical Center
Burlington, Vermont, 05401
United States

Collaborators and Investigators

Sponsor: Prakash Pandalai

  • Prakash Pandalai, MD, PRINCIPAL_INVESTIGATOR, University of Kentucky

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 Date2021-06-04
Study Completion Date2026-02

Study Record Updates

Study Start Date2021-06-04
Study Completion Date2026-02

Terms related to this study

Keywords Provided by Researchers

  • cytoreductive surgery
  • colorectal cancer
  • pseudomyxoma peritonei
  • appendiceal mucinous neoplasm
  • mitomycin C
  • pharmacokinetics
  • CRS/HIPEC
  • HIPEC
  • Appendix cancer
  • LAMN

Additional Relevant MeSH Terms

  • Peritoneal Carcinomatosis