Actively Recruiting
Individualized Response Assessment to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Peritoneal Carcinomatosis From Mesothelioma, Ovarian, Colorectal, or Appendiceal Cancers
Led by National Cancer Institute (NCI) · Updated on 2026-04-14
60
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating ways to improve treatment for peritoneal carcinomatosis, a condition where tumors spread to the lining of the abdomen, using a combination of cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC). This study evaluates whether testing chemotherapy drugs on tumor samples outside the body, using the SMART System or 3-D organoid models, can better predict responses compared to treating tumors inside the body during surgery. The goal is to understand how these methods relate to tumor tissue changes after treatment. Participants will undergo CRS to remove as many visible tumors as possible, leaving some to be treated with HIPEC directly in the abdomen. They will be randomly assigned to one of four HIPEC chemotherapy regimens involving drugs like oxaliplatin, mitomycin C, cisplatin, doxorubicin, and intravenous sodium thiosulfate or 5-fluorouracil. Tumor tissues will be collected before and after HIPEC, and some will be tested in the lab using the SMART System or organoid models to assess treatment effects. During the study, participants will provide various biological samples for research and complete health and quality-of-life surveys. Follow-up visits will occur for up to five years after surgery to monitor disease progression and survival. If the disease returns, participants may have additional CRS with HIPEC. The study will measure tumor response using percent necrosis and Ki-67 levels approximately four days post-treatment, along with long-term outcomes like quality of life and survival.
CONDITIONS
Brief 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...
- Confirmed peritoneal carcinomatosis from peritoneal mesothelioma, atypical mesothelial proliferation, appendiceal, colorectal, or ovarian cancers by the NCI Laboratory of Pathology
- Measurable or evaluable disease by RECIST v1.1 or peritoneal carcinomatosis index (PCI) score
- Able to undergo optimal cytoreductive surgery with PCI score below specified cutoffs (less than 20 for appendiceal/colorectal/ovarian; 30 or less for mesothelioma)
- Age 18 years or older
- ECOG performance status 0 or 1 (Karnofsky 80% or higher)
- Adequate organ and marrow function meeting specified blood count and chemistry levels
- Agree to use contraception if able to conceive or father a child before and for 180 days after treatment
- Willing and able to provide informed consent and participate in tumor tissue collection protocol
You will not qualify if you...
- Known spread of cancer outside the abdomen
- Received intraperitoneal chemotherapy or other cancer treatment within 4 weeks before study start
- Major surgery within 12 weeks before study start
- Allergic reactions to platinum-based chemotherapy
- History of dihydropyrimidine dehydrogenase deficiency (for appendiceal or colorectal cancer patients)
- Uncontrolled illnesses including active infections, heart failure, unstable angina, arrhythmias, or psychiatric/social issues affecting participation
- Pregnancy or nursing during treatment
- HIV-positive with detectable viral load despite treatment; those with undetectable viral load require special evaluation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo cytoreductive surgery (CRS) to remove visible tumors followed immediately by hyperthermic intraperitoneal chemotherapy (HIPEC) to target residual microscopic disease.
1 surgical procedure (in-person)
Duration - Approximately 4 days post-HIPEC
Tumor biopsies collected before and after intra-operative HIPEC treatment are analyzed using SMART System or 3-D cell culture models to assess response to chemotherapy.
No additional visits; tissue analysis performed on collected samples
Duration - Up to 5 years
Participants are monitored for quality of life, progression-free survival, and overall survival with periodic assessments and questionnaires.
Visits every 3 months for 2 years, then every 6 months for up to 5 years
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.
A
Andrew M Blakely, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
4
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