HIPEC PMP
Research type
Research Study
Full 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
IRAS ID
1008533
Contact name
Karen Martin
Contact email
Sponsor organisation
University of Southampton
Clinicaltrials.gov Identifier
Research summary
Pseudomyxoma peritonei (PMP) is a rare tumour that usually starts in the appendix. The tumour grows through the wall of the appendix spreading to the lining of the abdominal cavity (peritoneum). Symptoms include abdominal or pelvic pain, swelling and bowel obstruction. As PMP develops slowly it is frequently diagnosed via imaging after it has already spread beyond the appendix. Treatment involves extensive complex surgery (cytoreductive surgery; CRS) and heated chemotherapy administered directly into the abdomen, with the aim of removing all visible PMP cells and affected organs. Survival rates after surgery are good with a median survival of 16 years, but around 40% will develop recurrence of the tumour. Although surgery is currently the most effective way to remove all disease, the optimal dose of chemotherapy (mitomycin C) needs to be defined. Treating centres in the UK and worldwide use either low-dose mitomycin C (10mg/m2 for 60 minutes) or high-dose mitomycin C (35mg/m2 for a period of 90 minutes). To date there has not been a clinical trial to compare the two approaches. Given that surgery can have life changing long term outcomes (such as changes in bowel function, need for a stoma, and long-term antibiotics use after removal of the spleen), it is important to minimise the potential side effects of chemotherapy. A lower dose of mitomycin C would therefore be preferable, if it can be shown that it does not result in shorter times to, or an increase in, recurrence.
During the study 176 patients will be recruited over a 32 month period at the specialist Peritoneal Malignancy Institute, Basingstoke prior to surgery. Patients will be randomised to either low-dose or high-dose chemotherapy during surgery. Following surgery, patients will be followed up as per standard care, for a minimum of two years. The study will also compare the toxicity of each dose, impact on quality of life, and cost effectiveness.REC name
London - Westminster Research Ethics Committee
REC reference
24/LO/0692
Date of REC Opinion
31 Oct 2024
REC opinion
Further Information Favourable Opinion