{ "abstract": "Introduction: Pseudomyxoma peritonei (PMP) is a rare malignancy usually originating from a perforated appendix tumour. Potentially curative treatment involves cytoreductive surgery (CRS) with heated intraperitoneal chemotherapy, commonly mitomycin-C (MMC). Different regimens of MMC are used across the world, with little convincing evidence for which regimen best balances favourable clinical outcomes against side effects and cost. The aim of this trial is to compare two dosing regimens of MMC during CRS.\n\nMethods and analysis: The HIPEC-PMP trial is an individually randomised, parallel group, single-blind, non-inferiority trial that will randomise patients (1:1) with PMP who are amenable to complete cytoreduction to one of two established regimens, either low-dose MMC (10 mg/m2 for 60 min) or high-dose MMC (35 mg/m2 for 90 min) to test the non-inferiority of low-dose MMC. A Bayesian design is used to incorporate prior information on each dose, with a principled approach to discount historical data if it is markedly different from the trial data. Participants must have a clinical and/or radiological diagnosis of PMP from a primary mucinous epithelial tumour of the appendix that is amenable to complete cytoreduction and will be recruited from a single specialist centre. Participants will be followed up for a minimum of 2 years. The primary endpoint is disease-free survival at 2 years, and secondary endpoints are overall survival, adverse events, quality of life and cost-effectiveness. A Bayesian analysis will be used to determine the probability that 2-year recurrence rates are within 10% to determine non-inferiority. The trial has a target sample size of 176.\n\nEthics and dissemination: The study is sponsored by the University of Southampton, coordinated by the Cancer Research UK Southampton Clinical Trials Unit, and open to recruitment at the Peritoneal Malignancy Unit at the Hampshire Hospitals Foundation Trust. The trial protocol has received the favourable opinion of the London-Westminster Research Ethics Committee (REC 24/LO/0692), as well as the necessary approvals from the Medicines and Healthcare products Regulatory Agency and NHS Health Research Authority. Informed consent is required before any trial specific procedures are undertaken. It is intended that the results of the study will be disseminated via publication in peer-reviewed scientific journals, conference presentations and submission to regulatory authorities.\n\nTrial registration number: NCT06513065.", "abstract_shown": true, "affiliations": [ "Cancer Research UK Southampton Clinical Trials Unit, University of Southampton, Southampton, Hampshire, UK", "University Hospital Southampton NHS Foundation Trust, Southampton, UK", "Peritoneal Malignancy Institute, Hampshire Hospitals NHS Foundation Trust, Winchester, UK", "MRC Biostatistics Unit, University of Cambridge, Cambridge, UK", "Southampton Health Technologies Assessment Centre, University of Southampton, Southampton, UK" ], "article_type": "research article", "arxiv": null, "author_total": 17, "authors": [ { "affs": [ 0, 1 ], "name": "Sean Ewings", "orcid": "0000-0001-7214-4917" }, { "affs": [ 2 ], "name": "Sophia Stanford" }, { "affs": [ 0, 1 ], "name": "Chris Wignall" }, { "affs": [ 0, 1 ], "name": "Karen Martin" }, { "affs": [ 3 ], "name": "Pavel Mozgunov" }, { "affs": [ 3 ], "name": "Gianmarco Caruso" }, { "affs": [ 0, 1 ], "name": "Louise Holmes" }, { "affs": [ 0, 1 ], "name": "Paul Smith" }, { "affs": [ 4 ], "name": "David Scott" }, { "affs": [ 0, 1 ], "name": "Gareth Griffiths" }, { "affs": [ 2 ], "name": "Alexios Tzivanakis" }, { "affs": [ 2 ], "name": "Sanjeev Dayal" }, { "affs": [ 2 ], "name": "Vasanth Mark Samuel" }, { "affs": [ 2 ], "name": "Gui Han Lee" }, { "affs": [ 2 ], "name": "Brendan Moran" }, { "affs": [ 2 ], "name": "Faheez Mohamed" }, { "affs": [ 2 ], "name": "Tom Cecil" } ], "bibtex": "https://research.draconitic.com/paper/5xb8277tyckcz.bib", "cited_by": 0, "doi": "10.1136/bmjgast-2025-002187", "fulltext_url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC13735369/", "id": "5xb8277tyckcz", "issns": [ "2054-4774" ], "landing_url": "https://doi.org/10.1136/bmjgast-2025-002187", "language": "en", "licence": "CC-BY-NC-4.0", "licence_label": "CC BY-NC 4.0", "licence_source": "article", "licence_url": "https://creativecommons.org/licenses/by-nc/4.0/", "metadata_licence": null, "native_subjects": [ [ "heading", "1506" ], [ "heading", "Cancer" ], [ "openalex", "2746|Intraperitoneal and Appendiceal Malignancies" ] ], "openalex": "W7225157187", "pdf_url": "https://bmjopengastro.bmj.com/content/13/1/e002187.full.pdf", "pmcid": "PMC13735369", "pmid": "42977327", "published": "2026-11-03", "publisher": "BMJ Publishing Group", "ris": "https://research.draconitic.com/paper/5xb8277tyckcz.ris", "sources": [ { "first_seen": "2026-11-09T12:21:04Z", "native_id": "PMC13735369", "source": "pmc", "url": "https://doi.org/10.1136/bmjgast-2025-002187" } ], "subjects": [ { "field": "medicine", "origin": "heading:Cancer", "subfield": "oncology" } ], "title": "Evaluating the non-inferiority of HIPEC with mitomycin C 10 mg/m2 for 60 min versus HIPEC with mitomycin C 35 mg/m2 for 90 min in the treatment of pseudomyxoma peritonei from perforated epithelial mucinous tumours of the appendix (HIPEC-PMP): protocol for a single-blinded, randomised controlled trial", "title_text": "Evaluating the non-inferiority of HIPEC with mitomycin C 10 mg/m2 for 60 min versus HIPEC with mitomycin C 35 mg/m2 for 90 min in the treatment of pseudomyxoma peritonei from perforated epithelial mucinous tumours of the appendix (HIPEC-PMP): protocol for a single-blinded, randomised controlled trial", "type": "peer-reviewed", "updated_at": "2026-11-09T12:21:04Z", "url": "https://research.draconitic.com/paper/5xb8277tyckcz", "venue": "BMJ Open Gastroenterology", "versions": [] }