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

Launched by UNIVERSITY OF SOUTHAMPTON · Jul 18, 2024

Keywords

ClinConnect Summary

This clinical trial, called HIPEC-PMP, is looking at how effective two different doses of chemotherapy are for treating Pseudomyxoma Peritonei (PMP), a rare type of cancer that often starts in the appendix and spreads in the abdomen. During surgery to remove the cancer, heated chemotherapy is used to target any remaining cancer cells. The trial will compare a lower dose given over 60 minutes with a higher dose given over 90 minutes to see if the lower dose is just as effective without increasing risks of complications.

To be eligible for this trial, participants must be at least 16 years old, have a confirmed diagnosis of PMP, and have disease that can be completely removed during surgery. They should also be in good health with no major other illnesses. Participants can expect to undergo surgery and receive one of the chemotherapy doses while being closely monitored for their health and recovery. This study aims to provide valuable information about which chemotherapy dose works better for patients with PMP, which could lead to improved treatment options in the future.

Gender

ALL

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.