NCT06513065 Study to Evaluate the Non-inferiority of Low-dose HIPEC Versus High-dose HIPEC in the Treatment of PMP (HIPEC-PMP)
| NCT ID | NCT06513065 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University of Southampton |
| Condition | Pseudomyxoma Peritonei |
| Study Type | INTERVENTIONAL |
| Enrollment | 176 participants |
| Start Date | 2024-12-04 |
| Primary Completion | 2028-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 176 participants in total. It began in 2024-12-04 with a primary completion date of 2028-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Clinical and/or radiological diagnosis of pseudomyxoma peritonei from a primary mucinous epithelial tumours of the appendix (low and high grade) 2. 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). 3. Patients aged 16 or more and capable of giving informed consent for the procedures and interventions of the current trial. 4. ECOG performance status 0-1. Exclusion Criteria: 5. Patients who have previously undergone cytoreductive surgery and/or intraperitoneal chemotherapy. 6. Clinical evidence or suspicion of metastases to sites different than peritoneum or intra-abdominal lymph nodes 7. Hypersensitivity to the active substance (mitomycin) or its excipients (mannitol, hydrochloric acid, sodium hydroxide) 8. 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 9. Women who are pregnant or breastfeeding.
Contact & Investigator
Faheez Mohamed, MBChB, MD, FRCS
PRINCIPAL INVESTIGATOR
Peritoneal Malignancy Unit Hampshire Hospitals NHS Foundation Trust
Frequently Asked Questions
Who can join the NCT06513065 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, studying Pseudomyxoma Peritonei. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06513065 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 176 participants.
Is NCT06513065 currently recruiting?
Yes, NCT06513065 is actively recruiting participants. Contact the research team at C.M.Wignall@soton.ac.uk for enrollment information.
Where is the NCT06513065 trial being conducted?
This trial is being conducted at Basingstoke, United Kingdom.
Who is sponsoring the NCT06513065 clinical trial?
NCT06513065 is sponsored by University of Southampton. The principal investigator is Faheez Mohamed, MBChB, MD, FRCS at Peritoneal Malignancy Unit Hampshire Hospitals NHS Foundation Trust. The trial plans to enroll 176 participants.