Title

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 (PMP) from perforated epithelial mucinous tumours of the appendix.

Description

Cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) represent the standard of care for Pseudomyxoma Peritonei (PMP) of appendiceal origin. However, the optimal dose of Mitomycin C (MMC) and duration of HIPEC following cytoreductive surgery remains to be defined. The low and high doses within the trial are used routinely across the world, but to date they have not been compared directly.

Objectives

Primary Objective:

• To compare disease free survival between low- and high-dose mitomycin C (MMC)

Secondary Objective:

• To compare short- and long-term toxicity and quality of life between arms. To evaluate cost effectiveness.

Tertiary Objective:

• Collection of material for genetic analysis/translational research.

Trial Design

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 carried out in a single specialist centre.

Trial Status

Open to recruitment

Population

Patients aged 16 and above with clinical and/or radiological diagnosis of pseudomyxoma peritonei (PMP) who are suitable for treatment with cytoreductive surgery and HIPEC chemotherapy.

Patients who have previously undergone cytoreductive surgery and/or intraperitoneal chemotherapy will not be considered eligible.

Funder

Self-funded by Hampshire Hospitals NHS Foundation Trust - Basingstoke Peritoneal Malignancy Institute.

Senior Trial Manager

Karen Martin

Trial Manager

Chris Wignall

Data Manager

Becci Brotherwood

Contact Information for trial queries:

Email: pmp@soton.ac.uk

Phone: 023 8120 5154

SAE Reporting

Email: ctu@soton.ac.uk

Phone: 0844 7740621