Comparing low-dose and high-dose chemotherapy for treating Pseudomyxoma Peritonei

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of low-dose versus high-dose hyperthermic intraperitoneal chemotherapy (HIPEC) using mitomycin C in patients with Pseudomyxoma Peritonei (PMP). The study is designed as a randomized, non-inferiority trial to determine if the lower dose administered over 60 minutes is as effective as the higher dose given over 90 minutes. The primary outcome measure is disease-free survival, and the trial incorporates a Bayesian design to analyze existing data on treatment outcomes. Conducted at a single specialist center, this research aims to refine treatment protocols for this rare cancer.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Clinical and/or radiological diagnosis of pseudomyxoma peritonei from a primary mucinous epithelial tumours of the appendix (low and high grade)
2. 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).
3. Patients aged 16 or more and capable of giving informed consent for the procedures and interventions of the current trial.
4. ECOG performance status 0-1.

   Exclusion Criteria:
5. Patients who have previously undergone cytoreductive surgery and/or intraperitoneal chemotherapy.
6. Clinical evidence or suspicion of metastases to sites different than peritoneum or intra-abdominal lymph nodes
7. Hypersensitivity to the active substance (mitomycin) or its excipients (mannitol, hydrochloric acid, sodium hydroxide)
8. Patients with conditions which may affect their ability to understand, retain and weigh up the information related to the requirements and consenting process of the study
9. Women who are pregnant or breastfeeding.

Where it's running

• Peritoneal Malignancy Institute Basingstoke - Hampshire Hospitals NHS Foundation Trust
  Basingstoke, Hampshire, United Kingdom Recruiting

Study contacts

• Principal investigator: Faheez Mohamed, MBChB, MD, FRCS — Peritoneal Malignancy Unit Hampshire Hospitals NHS Foundation Trust
• Study coordinator: Chris Wignall
• Email: C.M.Wignall@soton.ac.uk
• Phone: 023 8120 5154

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Appendix Cancer and PMP Patient Registry and Natural History Study

  This global, patient-powered registry tests how appendix cancer and pseudomyxoma peritonei progress over time by collecting real-world data from patients and caregivers.

  Recruiting Appendix Cancer Pseudomyxoma Peritonei Research Foundation · Springfield, Pennsylvania · NCT07769346

• Metformin in PMP from appendiceal mucinous neoplasms

  This pilot study tests whether metformin is feasible to use in adults with pseudomyxoma peritonei caused by appendiceal mucinous tumors who have recurrent or unresected disease.

  Recruiting Phase 2 University of California, Irvine · Orange, California · NCT07693452

• Pseudovax: a vaccine for people with pseudomyxoma peritonei

  This trial will test whether the Pseudovax peptide vaccine with GM‑CSF plus the PD‑1 drug tislelizumab can boost anti‑tumor immunity in adults with GNAS‑mutated pseudomyxoma peritonei.

  Recruiting Early Phase 1 Oslo University Hospital · Oslo, Oslo · NCT07341360

• One versus three HIPEC cycles after cytoreductive surgery for pseudomyxoma peritonei

  This study will see if giving three HIPEC sessions instead of one after cytoreductive surgery helps people with pseudomyxoma peritonei live longer, delay disease progression, and keep a better quality of life.

  Recruiting Beijing Tsinghua Chang Gung Hospital · Beijing, Changping · NCT07328737

• Neoadjuvant treatment for patients with advanced Pseudomyxoma peritonei

  This study is testing a new combination of medications to see if it can help patients with advanced Pseudomyxoma peritonei have better surgery results.

  Recruiting Phase 2 Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Milan · NCT06800391

• Using cardiac coherence to reduce anxiety in patients with peritoneal carcinosis before surgery

  This study is testing if teaching patients with peritoneal carcinosis some breathing techniques can help reduce their anxiety before surgery.

  Recruiting Institut du Cancer de Montpellier - Val d'Aurelle · Montpellier, Hérault · NCT04024917

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.