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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 16
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
United Kingdom
Peritoneal Malignancy Institute Basingstoke - Hampshire Hospitals NHS Foundation Trust
RECRUITING
Basingstoke
Contact Information
Primary
Chris Wignall
C.M.Wignall@soton.ac.uk
023 8120 5154
Backup
Karen Martin
K.S.Martin@soton.ac.uk
023 8120 5154
Time Frame
Start Date: 2024-12-04
Estimated Completion Date: 2029-04
Participants
Target number of participants: 176
Treatments
Active_comparator: ARM A (lower dose)
10mg/m2 MMC given intraperitoneal as one single dose at Time 0 of HIPEC
Experimental: ARM B (higher dose)
35mg/m2 MMC given in fractionated doses :50% at Time 0, 25% at T30 and 25% at T60
Related Therapeutic Areas
Sponsors
Leads: University of Southampton

This content was sourced from clinicaltrials.gov

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