Actively Recruiting
Study to Evaluate the Non-inferiority of Low-dose HIPEC Versus High-dose HIPEC in the Treatment of PMP (HIPEC-PMP)
Led by University of Southampton · Updated on 2026-02-19
176
Participants Needed
1
Research Sites
225 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The Investigators are researching how to improve the treatment currently available for patients diagnosed with Pseudomyxoma Peritonei (PMP). This is a rare cancer that usually starts in the appendix and spreads around the abdomen. PMP is usually treated using a type of surgery called Cytoreductive Surgery (CRS). During the surgery heated chemotherapy will also be used to treat any cancer cells that cannot be seen and may be left behind. This is called Hyperthermic Intraperitoneal Chemotherapy (HIPEC). This treatment is commonly used in the UK and in Europe, however, the chemotherapy can be given at two different doses: a lower dose over 60 minutes or a higher-dose over 90 minutes. The Investigators want to understand if there is a difference between these two doses. The higher dose has been associated with a slightly increased rate of complications but may be better at killing cancer cells and preventing recurrence of cancer. In Basingstoke the lower dose over 60 minutes is used and survival results are similar to centres who use the higher dose. Previous studies have shown that both doses are effective at treating PMP, but no research has shown which is better for patients. The Investigators hope to show that the lower-dose over 60-minutes is as good as the higher-dose over 90-minutes.
CONDITIONS
Official Title
Study to Evaluate the Non-inferiority of Low-dose HIPEC Versus High-dose HIPEC in the Treatment of PMP (HIPEC-PMP)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical and/or radiological diagnosis of pseudomyxoma peritonei from primary mucinous epithelial tumors of the appendix (low and high grade)
- Intraperitoneal disease suitable for complete cytoreduction (CC0-1, residual disease less than 2.5 mm)
- Age 16 years or older and able to provide informed consent
- ECOG performance status 0-1
You will not qualify if you...
- Previous cytoreductive surgery and/or intraperitoneal chemotherapy
- Evidence or suspicion of metastases outside the peritoneum or intra-abdominal lymph nodes
- Allergy or hypersensitivity to mitomycin or its excipients (mannitol, hydrochloric acid, sodium hydroxide)
- Conditions affecting ability to understand or consent to the study
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Peritoneal Malignancy Institute Basingstoke - Hampshire Hospitals NHS Foundation Trust
Basingstoke, Hampshire, United Kingdom
Actively Recruiting
Research Team
C
Chris Wignall
CONTACT
K
Karen Martin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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