Status:
RECRUITING
Study to Evaluate the Non-inferiority of Low-dose HIPEC Versus High-dose HIPEC in the Treatment of PMP (HIPEC-PMP)
Lead Sponsor:
University of Southampton
Conditions:
Pseudomyxoma Peritonei
Eligibility:
All Genders
16+ years
Phase:
PHASE3
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 a...
Detailed Description
HIPEC-PMP is a randomised, non-inferiority phase III trial with two parallel groups, designed to assess two doses of mitomycin C (MMC) for the treatment of pseudomyxoma peritonei. The trial is to be c...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Patients who have previously undergone cytoreductive surgery and/or intraperitoneal chemotherapy.
- Clinical evidence or suspicion of metastases to sites different than peritoneum or intra-abdominal lymph nodes
- Hypersensitivity to the active substance (mitomycin) or its excipients (mannitol, hydrochloric acid, sodium hydroxide)
- 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
- Women who are pregnant or breastfeeding.
Key Trial Info
Start Date :
December 4 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2029
Estimated Enrollment :
176 Patients enrolled
Trial Details
Trial ID
NCT06513065
Start Date
December 4 2024
End Date
April 1 2029
Last Update
December 11 2024
Active Locations (1)
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1
Peritoneal Malignancy Institute Basingstoke - Hampshire Hospitals NHS Foundation Trust
Basingstoke, Hampshire, United Kingdom