NCT06513065RecruitingPhase 3
Study to Evaluate the Non-inferiority of Low-dose HIPEC Versus High-dose HIPEC in the Treatment of PMP (HIPEC-PMP)
A Single Blinded Randomised Controlled Study to Evaluate the Non-inferiority of HIPEC With Mitomycin C 10 mg/m2 for 60 Minutes Versus HIPEC With Mitomycin C 35mg/m2 for 90 Minutes in the Treatment of Pseudomyxoma Peritonei From Perforated Epithelial Mucinous Tumours of the Appendix
Source: ClinicalTrials.gov · Last updated 19 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 176 (estimated)
- First submitted
- 25 Jun 2024
- Start date
- 4 Dec 2024
- Primary completion date
- 30 Sept 2028
- Lead sponsor
- University of Southampton
- Diseases
- Childhood cancers
- NCT number
- NCT06513065
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 176
- From 4 Dec 2024 to the primary completion date, 30 Sept 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have previously undergone cytoreductive surgery and/or intraperitoneal chemotherapy.
Other illness
- Patients with conditions which may affect their ability to understand, retain and weigh up the information related to the requirements and consenting process of the study
Lab values
- Hypersensitivity to the active substance (mitomycin) or its excipients (mannitol, hydrochloric acid, sodium hydroxide)
Other
- Clinical evidence or suspicion of metastases to sites different than peritoneum or intra-abdominal lymph nodes
- Women who are pregnant or breastfeeding.
Who the study is looking for
- Clinical and/or radiological diagnosis of pseudomyxoma peritonei from a primary mucinous epithelial tumours of the appendix (low and high grade)
- The extent of intraperitoneal disease must be deemed to be amenable to complete cytoreduction (CC0-1, i.e. residual disease of \< 2.5mm in diameter).
- Patients aged 16 or more and capable of giving informed consent for the procedures and interventions of the current trial.
- ECOG performance status 0-1.
Age in the registry: 16 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peritoneal Malignancy Institute Basingstoke - Hampshire Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Basingstoke | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.