Pseudomyxoma PeritoneiPhase 3HIPEC-PMPNCT06513065
Study to Evaluate the Non-inferiority of Low-dose HIPEC Versus High-dose HIPEC in the Treatment of PMP (HIPEC-PMP)
A Phase 3 study testing Mitomycin c in people with Pseudomyxoma Peritonei, run by University of Southampton at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Pseudomyxoma Peritonei
- What is being tested?
- Mitomycin c
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Dec 2024to Apr 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Peritoneal Malignancy Institute Basingstoke - Hampshire Hospitals NHS Foundation Trust
Basingstoke, Hampshire
Faheez Mohamed, Faheez.Mohamed@hhft.nhs.uk
Sophia Stanford, sophia.stanford@hhft.nhs.uk
About this study
Official title: 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
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).
Read more
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.
Read the detailed description
HIPEC-PMP is a randomised, non-inferiority phase III trial with two parallel groups, designed to assess two doses of mitomycin C (MMC) for the treatment of pseudomyxoma peritonei. The trial is to be carried out in a single specialist centre.
The low and high doses within the trial are used routinely across the world, but to date they have not been compared directly. As the lead site use low dose MMC, the trial has been designed to assess whether this has comparable performance to high dose with respect to clinical outcomes (primarily disease-free survival; DFS), hence the non-inferiority design. The trial uses a Bayesian design to incorporate existing information on the two treatments (given they are used routinely, and various studies have reported DFS rates in cohort studies). The design allows for discounting the prior information through data-driven weighting of different prior distributions, if the observed data is observed to be markedly different to prior data.
Cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) represent the standard of care for Pseudomyxoma Peritonei (PMP) of appendiceal origin. Although Mitomycin C is used as standard of care HIPEC treatment, the optimal dose of Mitomycin C (MMC) and duration of HIPEC following cytoreductive surgery remains to be defined.
This study therefore aims to evaluate the non-inferiority of HIPEC with mitomycin C 10 mg/m2 for 60 minutes versus HIEPC with mitomycin C 35 mg/m2 for 90 minutes. There is a small risk of higher toxicity with 35 mg/m2 of Mitomycin C, however Kuijpers et al found that morbidity was tolerable and convincing survival.
There is limited evidence on the quality of life in patients with PMP, therefore assessing quality of life will provide information that could be used to improve patient care and well-being. In addition, furthering understanding of the genetics of the disease could improve prognostication and targeted treatments for patient benefit could be explored and will therefore be investigated in this study. Translational blood samples including tissue (normal, primary and metastatic), serum, plasma, DNA, RNA and buffy coat will be collected for genetic analysis.
- Conditions
- Pseudomyxoma Peritonei
- Being tested
- Mitomycin c
- Keywords
- Psuedomyxoma Peritonei, Mitomycin C, Hyperthermic Intraperitoneal Chemotherapy, Appendix
- Medical subject headings
- Pseudomyxoma Peritonei
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitomycin cDrug
Also called HIPEC
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.
| Study group | Role | What they receive |
|---|---|---|
| ARM A (lower dose) | Active comparator | 10mg/m2 MMC given intraperitoneal as one single dose at Time 0 of HIPEC Receives: 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 Receives: Drug: Mitomycin c |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Free Survival
To compare disease free survival between low- and high-dose mitomycin C (MMC).
Measured: 24 Months
Secondary outcomes (6)
Adverse Events using Common Terminology Criteria for Adverse Events
To compare short- and long-term toxicity between arms.
Measured: 24 Months
EQ-5D-5L Quality of Life Questionnaire
To compare short- and long-term quality of life between arms.
Measured: 24 Months
QLQ-C30 Quality of Life Questionnaire
To compare short- and long-term quality of life between arms.
Measured: 24 Months
MODRUM Healthcare Resource Use Questionnaire
To compare the cost-effectiveness of high dose with low dose mitomycin. Participants will document how often they have used healthcare services over a period of 2 years following surgery. The number of uses of healthcare services reported by participants will be compared between the two arms.
Measured: 24 Months
Healthcare Cost
To compare the cost-effectiveness of high dose with low dose mitomycin. Participants will document how often they have used healthcare services over a period of 2 years following surgery using the MODRUM questionnaire. The number of reported uses of healthcare services and associated costs of using these services will be compared between the two arms.
Measured: 24 Months
Quality-adjusted Life Years
Results from the EQ-5D-5L Quality of Life Questionnaire, QLQ-C30 Quality of Life Questionnaire, and MODRUM Healthcare Resource Use Questionnaire as reported by participants will be used to calculate quality-adjusted life years for participants. The results will be compared between the two arms.
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start4 Dec 2024
- Primary completionSep 2028 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pseudomyxoma PeritoneiStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southampton
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Faheez Mohamed, MBChB, MD, FRCS, Principal investigator, Peritoneal Malignancy Unit Hampshire Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06513065
- Sponsor's protocol ID
- 83709
- Acronym
- HIPEC-PMP
- Status last verified
- Feb 2026
- First submitted
- 25 Jun 2024
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: In order to meet our ethical obligation to responsibly share data generated by interventional clinical trials, SCTU operate a transparent data sharing request process. As a minimum, anonymous data will be available for request from three months after publication of an article, to researchers who provide a completed Data Sharing request form that describes a methodologically sound proposal, for the purpose of the approved proposal and if appropriate a signed Data Sharing Agreement. Data will be shared once all parties have signed relevant data sharing documentation.
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06513065
- Acronym / sponsor ID
- HIPEC-PMP / 83709
- Conditions
- Pseudomyxoma Peritonei
- Keywords
- Psuedomyxoma Peritonei, Mitomycin C, Hyperthermic Intraperitoneal Chemotherapy, Appendix
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- University of SouthamptonUniversity, hospital or other
- Study start
- 4 Dec 2024 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 22 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
HIPEC-PMP is a randomised, non-inferiority phase III trial with two parallel groups, designed to assess two doses of mitomycin C (MMC) for the treatment of pseudomyxoma peritonei. The trial is to be carried out in a single specialist centre.
The low and high doses within the trial are used routinely across the world, but to date they have not been compared directly. As the lead site use low dose MMC, the trial has been designed to assess whether this has comparable performance to high dose with respect to clinical outcomes (primarily disease-free survival; DFS), hence the non-inferiority design. The trial uses a Bayesian design to incorporate existing information on the two treatments (given they are used routinely, and various studies have reported DFS rates in cohort studies). The design allows for discounting the prior information through data-driven weighting of different prior distributions, if the observed data is observed to be markedly different to prior data.
Cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) represent the standard of care for Pseudomyxoma Peritonei (PMP) of appendiceal origin. Although Mitomycin C is used as standard of care HIPEC treatment, the optimal dose of Mitomycin C (MMC) and duration of HIPEC following cytoreductive surgery remains to be defined.
This study therefore aims to evaluate the non-inferiority of HIPEC with mitomycin C 10 mg/m2 for 60 minutes versus HIEPC with mitomycin C 35 mg/m2 for 90 minutes. There is a small risk of higher toxicity with 35 mg/m2 of Mitomycin C, however Kuijpers et al found that morbidity was tolerable and convincing survival.
There is limited evidence on the quality of life in patients with PMP, therefore assessing quality of life will provide information that could be used to improve patient care and well-being. In addition, furthering understanding of the genetics of the disease could improve prognostication and targeted treatments for patient benefit could be explored and will therefore be investigated in this study. Translational blood samples including tissue (normal, primary and metastatic), serum, plasma, DNA, RNA and buffy coat will be collected for genetic analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARM A (lower dose) | Active comparator | Drug: Mitomycin c10mg/m2 MMC given intraperitoneal as one single dose at Time 0 of HIPEC |
| ARM B (higher dose) | Experimental | Drug: Mitomycin c35mg/m2 MMC given in fractionated doses :50% at Time 0, 25% at T30 and 25% at T60 |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mitomycin cAlso: HIPECMitomycin 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. | Drug | ARM A (lower dose), ARM B (higher dose) |
Primary outcome
Disease Free Survival
Time frame: 24 Months
To compare disease free survival between low- and high-dose mitomycin C (MMC).
6 secondary outcomes
Adverse Events using Common Terminology Criteria for Adverse Events
Time frame: 24 Months
EQ-5D-5L Quality of Life Questionnaire
Time frame: 24 Months
QLQ-C30 Quality of Life Questionnaire
Time frame: 24 Months
MODRUM Healthcare Resource Use Questionnaire
Time frame: 24 Months
Healthcare Cost
Time frame: 24 Months
Quality-adjusted Life Years
Time frame: 24 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Individual participant dataSharing planned: Yes. In order to meet our ethical obligation to responsibly share data generated by interventional clinical trials, SCTU operate a transparent data sharing request process. As a minimum, anonymous data will be available for request from three months after publication of an article, to researchers who provide a completed Data Sharing request form that describes a methodologically sound proposal, for the purpose of the approved proposal and if appropriate a signed Data Sharing Agreement. Data will be shared once all parties have signed relevant data sharing documentation.
Related trials for Pseudomyxoma Peritonei
RecruitingPhase 3
Phase 3 Study of Fibrinogen Concentrate (CSL511) in Subjects With Pseudomyxoma Peritonei Undergoing Cytoreductive Surgery
Acquired Fibrinogen Deficiency
Not yet recruitingPhase 2
Intestinal & Multivisceral Transplantation for Unresectable Mucinous Carcinoma Peritonei (TRANSCAPE)
Secondary Malignant Neoplasm of Retroperitoneum, Secondary Malignant Neoplasm of Peritoneum
RecruitingObservational study
Register With Patients in Which Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) Was Performed
Peritoneal Carcinomatosis, Pseudomyxoma Peritonei
RecruitingObservational study
The Appendix Cancer PMP Research Foundation Natural History Study/Patient Registry
Appendix Cancer, Pseudomyxoma Peritonei
RecruitingPhase 2
Metformin in Pseudomyxoma Peritonei Secondary to Appendiceal Mucinous Neoplasms
Appendiceal Mucinous Neoplasm, Pseudomyxoma Peritonei
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Faheez Mohamed, MBChB, MD, FRCS principal investigator
Peritoneal Malignancy Unit Hampshire Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mitomycin c in people with Pseudomyxoma Peritonei, run by University of Southampton at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chris Wignall (023 8120 5154, C.M.Wignall@soton.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Free Survival (time frame: 24 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.