Study to Evaluate the Non-inferiority of Low-dose HIPEC Versus High-dose HIPEC in the Treatment of PMP (HIPEC-PMP)
NCT Number: NCT06513065
Acronym: HIPEC-PMP
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Pseudomyxoma Peritonei
Interventions: DRUG: Mitomycin c
Sponsor: University of Southampton
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 176
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2029-04
Locations: Peritoneal Malignancy Institute Basingstoke - Hampshire Hospitals NHS Foundation Trust, Basingstoke, Hampshire, United Kingdom

Summary:
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.

Primary Outcome Measures: Disease Free Survival, To compare disease free survival between low- and high-dose mitomycin C (MMC)., 24 Months
Secondary Outcome Measures: Adverse Events using Common Terminology Criteria for Adverse Events, To compare short- and long-term toxicity between arms., 24 Months|EQ-5D-5L Quality of Life Questionnaire, To compare short- and long-term quality of life between arms., 24 Months|QLQ-C30 Quality of Life Questionnaire, To compare short- and long-term quality of life between arms., 24 Months|MODRUM Healthcare Resource Use Questionnaire, To compare the cost-effectiveness of high dose with low dose mitomycin. Participants will document how often they have used healthcare services over a period of 2 years following surgery. The number of uses of healthcare services reported by participants will be compared between the two arms., 24 Months|Healthcare Cost, To compare the cost-effectiveness of high dose with low dose mitomycin. Participants will document how often they have used healthcare services over a period of 2 years following surgery using the MODRUM questionnaire. The number of reported uses of healthcare services and associated costs of using these services will be compared between the two arms., 24 Months|Quality-adjusted Life Years, Results from the EQ-5D-5L Quality of Life Questionnaire, QLQ-C30 Quality of Life Questionnaire, and MODRUM Healthcare Resource Use Questionnaire as reported by participants will be used to calculate quality-adjusted life years for participants. The results will be compared between the two arms., 24 Months