RecruitingPHASE3INTERVENTIONAL

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

Doctors are studying a rare cancer called Pseudomyxoma Peritonei (PMP), which usually starts in the appendix. The standard treatment involves surgery to remove the cancer, followed by heated chemotherapy washed inside the tummy, called HIPEC. There are two common ways to give this chemotherapy: a lower dose for 60 minutes or a higher dose for 90 minutes. This study aims to find out if the lower dose, which might cause fewer side effects, is just as effective as the higher dose. Currently, both doses are used, but we don't know which is better for patients. This research hopes to show that the lower, shorter dose is equally good, potentially making treatment safer while still preventing the cancer from returning.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

University of Southampton

Enrolment target

176

Start

04 Dec 2024

Estimated completion

01 Apr 2029

Pseudomyxoma Peritonei

What is this study about?

Pseudomyxoma Peritonei, often shortened to PMP, is a very rare type of cancer that typically begins in the appendix. From there, it can spread to other areas inside the tummy. The main treatment for PMP involves a special surgery to remove as much of the cancer as possible. Immediately after this surgery, another treatment called HIPEC is given. This stands for Hyperthermic Intraperitoneal Chemotherapy, which means heated chemotherapy is washed around inside your tummy. The idea is to kill any tiny cancer cells that might have been left behind and can't be seen.

While this treatment is quite common in the UK and Europe, there are two main ways the chemotherapy drug, Mitomycin C, is given during HIPEC. One way is a lower dose for 60 minutes, and the other is a higher dose for 90 minutes. Both have been shown to be effective, but doctors don't yet know if one is better than the other, especially when it comes to balancing how well they kill cancer cells versus how many side effects they cause. Some studies suggest the higher dose might lead to slightly more complications, even though it aims to be more effective at preventing the cancer from coming back.

This study, called HIPEC-PMP, wants to specifically compare these two approaches. The researchers believe that the lower dose, given for a shorter time, is just as good as the higher dose. If this is proven true, it could mean that patients receive equally effective treatment with potentially fewer problems or side effects. This research will also look at the impact on patients' quality of life and explore the genetics of PMP to help improve future treatments.

Key takeaways

Compares two chemotherapy doses for rare cancer PMP.
Aims to prove lower dose is as effective as higher dose.
Might lead to treatments with fewer side effects.
Participation involves standard surgery plus one of two chemo doses.
Will track long-term health and quality of life.

Who may be eligible?

To be considered for this study, you would need to have been diagnosed with Pseudomyxoma Peritonei (PMP) that started in your appendix. Doctors would need to believe that surgery could remove most, if not all, of your cancer, leaving very small or no remaining disease. You must be at least 16 years old and able to understand and agree to take part in the study. Your general health and fitness, as assessed by your doctor, should also be good enough for you to undergo the treatment.

There are also some reasons why you wouldn't be able to join. For example, if you've already had surgery for your PMP or received chemotherapy directly into your tummy before. You also couldn't take part if the cancer has spread beyond your tummy or to distant parts of your body. If you have an allergy to the chemotherapy drug, Mitomycin C, or if you have any conditions that would make it difficult for you to understand the study information or give your consent, you wouldn't be eligible. Lastly, if you are pregnant or breastfeeding, you would not be able to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do I have PMP that started in my appendix?
Do my doctors believe most of my cancer can be removed by surgery?
Am I 16 years old or older?
Have I NOT had PMP surgery or chemotherapy in my tummy before?
Is my general health good enough for major surgery and chemotherapy?
Am I NOT pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be randomly assigned to receive either the lower dose of heated chemotherapy (Mitomycin C for 60 minutes) or the higher dose (Mitomycin C for 90 minutes) during your surgery. This means neither you nor your doctor will get to choose which dose you receive. All other aspects of your surgery and care will be standard. You will have regular check-ups and scans after your treatment to monitor your recovery and the success of the treatment. The study will also involve questions about your quality of life to understand how the treatment impacts you. The total duration of your participation will involve follow-up appointments over several years, as is typical for cancer care, to track how well the treatment works in the long term and whether the cancer returns.

Potential risks and benefits

Taking part in this study could potentially offer the benefit of helping to find the safest and equally effective treatment for PMP, which could improve care for future patients. For you personally, you would receive the current standard-of-care treatment, and the study aims to confirm if a potentially less toxic dose is just as effective. However, there are potential risks, as with any medical treatment, including side effects from chemotherapy. While the aim is to find an equally effective and potentially safer option, there's always a possibility that one dose might be slightly better or worse for certain individuals. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Peritoneal Malignancy Institute Basingstoke - Hampshire Hospitals NHS Foundation Trust
Verified postcode
Basingstoke, United Kingdom· Recruiting

Common questions

What is PMP therapy?

PMP stands for Pseudomyxoma Peritonei, a rare cancer. The therapy involves surgery and heated chemotherapy inside your tummy.

What is HIPEC?

HIPEC is Hyperthermic Intraperitoneal Chemotherapy. It's when heated chemotherapy is washed around your tummy after surgery to kill cancer cells.

Why are there two different doses of chemotherapy?

Doctors use two different doses of chemotherapy for HIPEC, but they don't know which is best for patients. This study aims to find out.

Will I get to choose which dose I receive?

No, you will be randomly assigned to either the lower or higher dose, like drawing lots, to make the comparison fair.

What will happen after my treatment?

You will have regular check-ups and scans to see how you are recovering and to monitor the cancer over time.

How to find out more

Chris Wignall

c.m.wignall@soton.ac.uk 023 8120 5154 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.