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Lower dose of heated chemo may be just as effective for rare abdominal cancer

NCT ID NCT06513065

Disease control Sponsor: University of Southampton Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a lower dose of heated chemotherapy given during surgery works as well as a higher dose for people with pseudomyxoma peritonei, a rare cancer that spreads in the abdomen. About 176 participants will be randomly assigned to receive either the lower dose over 60 minutes or the higher dose over 90 minutes. The goal is to see if the lower dose can control the cancer just as well while causing fewer side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Mitomycin C (heated chemotherapy given during surgery)
What this could lead to
If the lower dose works as well, it could mean fewer complications for patients while still controlling the cancer effectively.
What could go wrong
This is a single study with 176 participants, so results may not apply to everyone. The lower dose might be less effective at preventing cancer return.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 176 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Apr 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

16 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

pseudomyxoma peritonei

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pseudomyxoma peritonei

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Peritoneal Malignancy Institute Basingstoke - Hampshire Hospitals NHS Foundation Trust

    RECRUITING

    Basingstoke, Hampshire, United Kingdom

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