MedTrace Logo

Study to Evaluate the Non-inferiority of Low-dose HIPEC Versus High-dose HIPEC in the Treatment of PMP (HIPEC-PMP)

NCT06513065 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 176

Last updated 2026-02-19

No results posted yet for this study

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.

Conditions

  • Pseudomyxoma Peritonei

Interventions

DRUG

Mitomycin c

Mitomycin is a tumour antibiotic isolated from the broth of Streptomyces species. It has alkylating properties, which results in DNA cross-linking. Once MMC enters the tumour cell, it needs microsomal modification by various enzymes to be transformed into active state; free radicals constituted of semiquinones of MMC are responsible for its cytotoxic effects. Mitomycin is licenced in the UK and recommended by NICE for intraperitoneal chemotherapy.

Sponsors & Collaborators

  • University of Southampton

    lead OTHER

Principal Investigators

  • Faheez Mohamed, MBChB, MD, FRCS · Peritoneal Malignancy Unit Hampshire Hospitals NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-04
Primary Completion
2028-09-30
Completion
2029-04-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06513065 on ClinicalTrials.gov