RecruitingPHASE2INTERVENTIONAL

Technical Feasibility of Modified Early Post-Operative Intraperitoneal Chemotherapy (mEPIC)

This study is looking at a new way to give chemotherapy directly into the tummy after a big surgery to remove cancer. This surgery is called cytoreductive surgery and is often followed by a hot chemotherapy wash called HIPEC. The study focuses on cancers that have spread to the lining of the tummy, specifically from the appendix or bowel. The new chemotherapy method, called mEPIC, is shorter (two days instead of five) and changes how the medicine is given, aiming to be more effective and simpler to manage. Researchers want to make sure it's safe and practical for hospitals to use, while also helping patients recover better.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Ciusss de L'Est de l'Île de Montréal

Enrolment target

Start

01 May 2026

Estimated completion

01 Sep 2028

Peritoneal Carcinomatosis Appendiceal Neoplasms Colorectal Cancer Metastatic

What is this study about?

This study is exploring a new approach to treating certain cancers that have spread to the lining of the tummy, known as peritoneal carcinomatosis. These cancers often originate from the bowel or appendix. When this happens, patients usually undergo a major operation called cytoreductive surgery, where as much of the cancer as possible is removed. This is often followed by a special treatment called HIPEC, which involves washing the inside of the tummy with heated chemotherapy.

After these treatments, sometimes doctors give more chemotherapy directly into the tummy, called early post-operative intraperitoneal chemotherapy (EPIC). This is done to try and kill any tiny cancer cells that might still be left behind, helping to stop the cancer from coming back. The aim is to deliver strong chemotherapy without it affecting the rest of the body too much.

However, the original EPIC treatment can be quite long and challenging. This study is testing a modified, shorter version (mEPIC), which is given over two days instead of five. Researchers want to see if this new, shorter method is still safe, and practical for both patients and hospital staff, and if it can offer the same benefits as the longer treatment. They will closely watch for any side effects and how easily the treatment can be given in a hospital setting.

Key takeaways

Tests a shorter, new way to give chemotherapy directly into the tummy.
For bowel and appendix cancers that have spread to the tummy lining.
Given for two days after major surgery, instead of five.
Aims to be easier for patients and hospital staff.
Safety and practicality are key things being checked.
Part of a larger treatment plan including surgery and HIPEC.

Who may be eligible?

To be considered for this study, you would need to be 18 years or older and generally in good health. Your cancer would need to be in the lining of your tummy, coming from either your appendix or bowel. Doctors would also need to have carefully checked your cancer spread using scans. Importantly, a team of expert doctors would need to agree that this specific surgery and treatment plan, including the new mEPIC, is suitable for you.

There are also some health requirements. For example, your blood tests for platelets and a type of white blood cell called neutrophils need to be at a certain level. Your kidneys and liver also need to be working well. You also need to be able to understand and sign the consent form and be willing to follow all the study instructions.

However, some things would mean you couldn't join. For instance, if you have other types of cancer, are too unwell for the surgery, or have a known allergy to the chemotherapy drug (fluorouracil). If you are pregnant or have certain heart conditions or enzyme deficiencies, you also wouldn't be able to take part. The surgeons would also need to check there aren't too many adhesions (scar tissue) inside your tummy before the main surgery.

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.

Are you 18 years or older?
Do you have cancer that has spread to the lining of your tummy, from your appendix or bowel?
Are you generally in good health and able to have surgery?
Do you have good kidney and liver function as shown by blood tests?
Are you able to agree to take part and follow study instructions?
Are you NOT pregnant and don't have any severe allergies to fluorouracil?

Answer every question to see your result.

What does participation involve?

If you join this study, you will first undergo the usual surgery (cytoreductive surgery) and hot chemotherapy wash (HIPEC). After this, instead of the standard five-day chemotherapy directly into your tummy, you would receive the new, modified chemotherapy (mEPIC) for two days. This involves getting a dose of chemotherapy medicine (fluorouracil) directly into your tummy on day 1 and day 2 after your surgery. Each day, you'll receive an initial amount as a quick dose, followed by a slower infusion of the medicine over 24 hours.

Throughout your hospital stay, the doctors and nurses will closely monitor your health and any side effects you might experience. They will also look at how easy it is to give this new treatment. We don't have information about follow-up appointments after you leave the hospital, but typically, there would be scheduled check-ups to monitor your recovery and health over time.

Potential risks and benefits

This study aims to find a safer and more convenient way to provide important post-operative chemotherapy, potentially making treatment easier for patients and hospitals. While the chemotherapy drug used is known, this modified schedule is new, so there's a chance of unexpected side effects or it might not work as well as the standard treatment. As with any medical study, there's always a risk of side effects from the treatments given, and these will be carefully monitored. You have the right to withdraw from the study at any time without affecting your medical care.

Locations (1)

Hôpital Maisonneuve-Rosemont
Verified postcode
Montreal, Canada· Recruiting

Common questions

What kind of cancer is this study for?

This study is for cancers that have spread to the lining of the tummy, specifically those that started in the appendix or bowel.

What does mEPIC mean?

mEPIC stands for modified early post-operative intraperitoneal chemotherapy. It's a new, shorter way to give chemotherapy directly into your tummy after surgery.

How is mEPIC different from the usual treatment?

The main difference is that mEPIC is given over two days after surgery, compared to the standard five days. The way the chemotherapy medicine is given each day is also slightly different.

Will I still get regular surgery with this study?

Yes, you will still have the standard surgery to remove the cancer (cytoreductive surgery) and usually a hot chemotherapy wash (HIPEC) before the mEPIC treatment begins.

What will doctors be looking for in this study?

They want to see if the two-day mEPIC treatment is safe, practical for hospitals to manage, and to check for any side effects.

How to find out more

Mikael Soucisse, MD, FRCSC

mikael.lefebvre.soucisse@umontreal.ca 514-252-3400 Official trial record

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