Actively Recruiting
Individual Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Histologies
Led by National Cancer Institute (NCI) · Updated on 2026-04-14
60
Participants Needed
1
Research Sites
688 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Background: Cytoreductive surgery (CRS) removes tumors in the abdomen. HIPEC is hyperthermic (heated) chemotherapy that washes the inside of the abdomen. CRS with HIPEC may help people with peritoneal carcinomatosis. These are tumors that have spread to the lining of the abdomen from other cancers. Researchers think they can improve the results of CRS with HIPEC treatment on these tumors by choosing the chemotherapy drugs used in HIPEC. Objective: To see if HIPEC after CRS can be improved, using either a model called the SMART (Sustained Microenvironment for Analysis of Resected Tissue) System or using 3-D cell culture (organoid) models, in order to test different chemotherapy drugs on tumors that were surgically removed prior to HIPEC treatment (these models are not attached to the body) versus tumors that were treated with HIPEC while still inside the body before being immediately surgically removed. Eligibility: Adults ages 18 and older who have peritoneal carcinomatosis that cannot be fully removed safely with surgery. Design: Participants will be screened with: Medical history Physical exam Blood and urine tests Electrocardiogram (EKG) Computed tomography (CT) scan Other imaging scans, as needed Tumor biopsy, if needed Laparoscopy (small cuts are made in the abdomen, and a tube with a light and a camera is used to see the organs in the abdomen), if needed Participants will enroll in NIH protocol #13C0176. This allows their tumor samples to be used in future research. Some screening tests may be repeated in the study. Participants will have CRS. As many of their visible tumors will be removed as possible during surgery except for a few specific tumors left to receive the HIPEC treatment. Then they will receive HIPEC and the remaining tumors will be immediately removed. Participants will be in the hospital for 7-21 days after this surgery (CRS with HIPEC). Participants will give tumor, fluid samples (from the abdomen during surgery), blood, saliva, cheek swab, and stool for research. They will complete surveys about their health and quality of life. Participants with peritoneal mesothelioma (mesothelioma primary only) will have genetic (DNA) testing to determine clinical (CLIA level) germline BAP1 status for research use. Participants will have follow-up visits for up to 5 years from CRS with HIPEC. If there is disease progression, participants may have CRS with HIPEC again. Participants will then have follow-up visits for up to 5 years from the date of last CRS with HIPEC.
CONDITIONS
Official Title
Individual Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Histologies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmation of peritoneal carcinomatosis from peritoneal mesothelioma, atypical mesothelial proliferation, or appendiceal, colorectal, or ovarian cancers by pathology
- Measurable or evaluable disease based on RECIST v1.1 or peritoneal carcinomatosis index (PCI) score
- Ability to undergo optimal cytoreductive surgery with PCI score less than 20 for appendiceal, colorectal, or ovarian cancer, or PCI score up to 30 for mesothelioma or atypical mesothelial proliferation
- Age 18 years or older
- ECOG performance status 0 or 1 (Karnofsky score 80% or higher)
- Adequate organ and marrow function including neutrophils ≥ 1,000/mcL, platelets ≥ 75,000/mcL, bilirubin ≤ 1.5 times upper limit of normal, AST/ALT ≤ 3 times upper limit of normal (or ≤ 5 times if liver metastases present), and normal creatinine or creatinine clearance ≥ 60 mL/min/1.73 m²
- Agreement to use effective contraception prior to study and for 180 days after last treatment if able to have children
- Ability and willingness to provide informed consent
- Willingness to participate in tumor tissue collection protocol 13C0176
You will not qualify if you...
- Known metastatic disease outside the abdomen
- Intraperitoneal chemotherapy or other cancer therapy within 4 weeks before study treatment
- Major surgery within 12 weeks before study treatment
- Allergy to platinum-containing chemotherapy drugs
- History of dihydropyrimidine dehydrogenase deficiency (for appendiceal or colorectal cancer patients)
- Uncontrolled illnesses such as active infections, heart failure, unstable angina, arrhythmia, or psychiatric/social issues interfering with study compliance
- Pregnancy or breastfeeding
- HIV-positive with detectable viral load despite treatment; those with undetectable viral load require medical consultation before participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
S
Stephanie N Canady, R.N.
CONTACT
A
Andrew M Blakely, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
4
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here