Comparing low-dose and high-dose chemotherapy for treating Pseudomyxoma Peritonei
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 From Perforated Epithelial Mucinous Tumours of the Appendix
This study is testing if a lower dose of chemotherapy given for a shorter time can work just as well as a higher dose for treating Pseudomyxoma Peritonei.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 176 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | University of Southampton Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Basingstoke, Hampshire) |
| Trial ID | NCT06513065 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 16 or older with a clinical or radiological diagnosis of Pseudomyxoma Peritonei who are eligible for complete cytoreduction.
Not a fit: Patients who have previously undergone cytoreductive surgery or have metastases outside the peritoneum may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and equally effective treatment option for patients with Pseudomyxoma Peritonei.
How similar studies have performed: While HIPEC is a standard treatment, this specific comparison of low-dose versus high-dose mitomycin C has not been directly tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Basingstoke, Hampshire
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.