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.
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.
Primary Objective:
Secondary Objective:
Tertiary Objective:
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.
In set-up
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.
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
Email: [email protected]
Phone: 023 8120 5154
Email: [email protected]
Phone: 0844 7740621
Essential trial documents coming soon.