Study to Evaluate the Non-inferiority of Low-dose HIPEC Versus High-dose HIPEC in the Treatment of PMP (HIPEC-PMP)

NCT06513065 | Recruiting Phase 3 DMC

• 1 other identifier: 83709
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

Brief Summary

The Investigators are researching how to improve the treatment currently available for patients diagnosed with Pseudomyxoma Peritonei (PMP). This is a rare cancer that usually starts in the appendix and spreads around the abdomen. PMP is usually treated using a type of surgery called Cytoreductive Surgery (CRS). During the surgery heated chemotherapy will also be used to treat any cancer cells that cannot be seen and may be left behind. This is called Hyperthermic Intraperitoneal Chemotherapy (HIPEC). This treatment is commonly used in the UK and in Europe, however, the chemotherapy can be given at two different doses: a lower dose over 60 minutes or a higher-dose over 90 minutes. The Investigators want to understand if there is a difference between these two doses. The higher dose has been associated with a slightly increased rate of complications but may be better at killing cancer cells and preventing recurrence of cancer. In Basingstoke the lower dose over 60 minutes is used and survival results are similar to centres who use the higher dose. Previous studies have shown that both doses are effective at treating PMP, but no research has shown which is better for patients. The Investigators hope to show that the lower-dose over 60-minutes is as good as the higher-dose over 90-minutes.

Conditions

Pseudomyxoma Peritonei

Keywords

Psuedomyxoma Peritonei; Mitomycin C; Hyperthermic Intraperitoneal Chemotherapy; Appendix

Outcome Measures

Primary Outcomes (1)

• Disease Free Survival

  To compare disease free survival between low- and high-dose mitomycin C (MMC).

  24 Months

Secondary Outcomes (6)

• Adverse Events using Common Terminology Criteria for Adverse Events

  24 Months

• EQ-5D-5L Quality of Life Questionnaire

  24 Months

• QLQ-C30 Quality of Life Questionnaire

  24 Months

• MODRUM Healthcare Resource Use Questionnaire

  24 Months

• Healthcare Cost

  24 Months

Study Arms (2)

ARM A (lower dose)

ACTIVE COMPARATOR

10mg/m2 MMC given intraperitoneal as one single dose at Time 0 of HIPEC

Drug: Mitomycin c

ARM B (higher dose)

EXPERIMENTAL

35mg/m2 MMC given in fractionated doses :50% at Time 0, 25% at T30 and 25% at T60

Drug: Mitomycin c

Interventions

Mitomycin c DRUG

Mitomycin is a tumour antibiotic isolated from the broth of Streptomyces species. It has alkylating properties, which results in DNA cross-linking. Once MMC enters the tumour cell, it needs microsomal modification by various enzymes to be transformed into active state; free radicals constituted of semiquinones of MMC are responsible for its cytotoxic effects. Mitomycin is licenced in the UK and recommended by NICE for intraperitoneal chemotherapy.

Also known as: HIPEC

ARM A (lower dose); ARM B (higher dose)

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients who have previously undergone cytoreductive surgery and/or intraperitoneal chemotherapy.
• Clinical evidence or suspicion of metastases to sites different than peritoneum or intra-abdominal lymph nodes
• Hypersensitivity to the active substance (mitomycin) or its excipients (mannitol, hydrochloric acid, sodium hydroxide)
• 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
• Women who are pregnant or breastfeeding.

Sponsors & Collaborators

• University of Southampton: lead

Study Sites (1)

Peritoneal Malignancy Institute Basingstoke - Hampshire Hospitals NHS Foundation Trust

Basingstoke, Hampshire, United Kingdom

RECRUITING

MeSH Terms

Conditions

Pseudomyxoma Peritonei

Interventions

Mitomycin; Hyperthermic Intraperitoneal Chemotherapy

Condition Hierarchy (Ancestors)

Adenocarcinoma, Mucinous; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Cystic, Mucinous, and Serous

Intervention Hierarchy (Ancestors)

Mitomycins; Indolequinones; Quinones; Organic Chemicals; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Chemotherapy, Adjuvant; Combined Modality Therapy; Therapeutics; Drug Therapy; Hyperthermia, Induced

Study Officials

• Faheez Mohamed, MBChB, MD, FRCS

  Peritoneal Malignancy Unit Hampshire Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chris Wignall

CONTACT

023 8120 5154; C.M.Wignall@soton.ac.uk

Karen Martin

CONTACT

023 8120 5154; K.S.Martin@soton.ac.uk

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: July 22, 2024
• Study Start: December 4, 2024
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): April 1, 2029
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: As a minimum, anonymous data will be available for request from three months after publication of an article and up to a maximum of 25 years.
• Access Criteria: Researchers interested in our data are asked to complete the Request for Data Sharing form (CTU/FORM/5219) \[template located on the SCTU web site, www.southampton.ac.uk/ctu\] to provide a brief research proposal on how they wish to use the data. It will include; the objectives, what data are requested, timelines for use, intellectual property and publication rights, data release definition in the contract and participant informed consent etc. If considered necessary, a Data Sharing Agreement from Sponsor may be required.

Locations

GB (1)