Not yet recruitingPHASE2INTERVENTIONAL

The Efficacy of PIPAC and Minimally Invasive Radical Resection in High-risk Gastric Cancer Patients.

Doctors are studying a new treatment for stomach cancer that has a high chance of spreading to the lining of the tummy. After keyhole surgery to remove the cancer, patients in this study will either receive standard chemotherapy, or a new approach. The new approach involves standard chemotherapy along with a special treatment called PIPAC. PIPAC uses a fine spray to deliver chemotherapy drugs directly inside the tummy cavity, then this is repeated 6-8 weeks later. The aim is to see if this combined treatment reduces the risk of cancer returning in the tummy lining after 12 months, compared to standard care. This study is for people aged 18-80 years. It will help doctors understand the best way to prevent the cancer from spreading.

At a glance

Status

Not yet recruiting

Phase

PHASE2

Sponsor

Odense University Hospital

Enrolment target

264

Start

01 Sep 2024

Estimated completion

01 Jan 2028

Gastric Cancer Chemotherapy, Adjuvant Peritoneal Metastases Minimally Invasive Surgical Procedures

What is this study about?

Stomach cancer, also known as gastric cancer, is a serious condition. While there have been improvements in how we treat early stomach cancer, many patients are diagnosed when the cancer is more advanced. This means that even after surgery to remove the cancer, there's a higher chance it could come back, especially in the lining of the tummy. Doctors are always looking for better ways to prevent this.

This study is exploring a new treatment option for people with stomach cancer that is considered high-risk for spreading. The main surgery for this type of cancer is called a D2 gastrectomy, which involves removing part of the stomach and nearby lymph nodes. This surgery is now often done using keyhole (minimally invasive) techniques, which means smaller cuts and often a quicker recovery.

After keyhole surgery, patients in this study will be split into two groups. One group will receive the usual follow-up treatment, which often includes chemotherapy given into the bloodstream. The other group will receive the usual follow-up treatment PLUS a new procedure called PIPAC (Pressurised Intraperitoneal Aerosol Chemotherapy). During PIPAC, chemotherapy drugs are gently sprayed as a fine mist directly inside the tummy cavity through small cuts, immediately after the main surgery, and then again 6-8 weeks later. The idea is that delivering chemotherapy drugs directly to the tummy lining might be more effective at killing any tiny cancer cells remaining there and stopping the cancer from returning.

Key takeaways

This study investigates a new treatment option for high-risk stomach cancer.
It combines standard chemotherapy with a special procedure called PIPAC.
PIPAC involves spraying chemotherapy drugs directly inside the tummy to prevent cancer recurrence.
Participation includes random assignment to either standard care or standard care plus PIPAC.
The goal is to see if the new treatment improves how long patients stay cancer-free in their tummy lining.
The study involves people having keyhole stomach surgery between 18 and 80 years old.

Who may be eligible?

This study is looking for patients aged between 18 and 80 years old who have been diagnosed with a specific type of stomach cancer (gastric adenocarcinoma or a similar cancer at the junction of the food pipe and stomach, called Siewert type III). Your cancer must be at a certain stage (called clinical T2, T3 or T4a). If your cancer is T2, it needs to be of a type that is harder to treat with chemotherapy.

You might also be eligible if your doctor found cancer cells in the fluid around your tummy (abdominal lavage cytology positive) but these cells disappeared after your first round of chemotherapy. You need to be well enough to undergo the treatment, meaning your general health and fitness, as scored by a system called ECOG, should be 0 or 1. You also need to be having keyhole surgery (robot-assisted or laparoscopic) to remove your stomach cancer.

However, you won't be able to join if you've had a bad reaction to certain chemotherapy drugs in the past (like cisplatin or doxorubicin), or if you have significant problems with your kidneys, heart, or liver. Your blood tests also need to be within a healthy range. If you are a woman who can get pregnant, you'll need to have a negative pregnancy test and use reliable contraception during the study.

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 between 18 and 80 years old?
Do you have gastric (stomach) or GEJ (food pipe junction) adenocarcinoma of specific types/stages?
Are you having keyhole surgery (robotic or laparascopic D2 gastrectomy)?
Are your kidney, heart, and liver functions generally healthy?
Have you not had a serious allergic reaction to cisplatin or doxorubicin before?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will first go through checks to make sure the study is right for you. If you meet the criteria, you will be randomly assigned to one of two groups: either the standard treatment group or the group receiving standard treatment plus PIPAC. Your surgery will be a keyhole D2 gastrectomy. If you are in the PIPAC group, the first PIPAC treatment will happen during your surgery. You will then have a second PIPAC treatment 6-8 weeks later. This will involve another short hospital stay for the procedure. You will also have follow-up appointments and tests over a certain period to check how you are doing and see if the treatment has been successful. The full duration of your participation will depend on the follow-up schedule designed for the trial, but the primary results will be assessed after 12 months.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as receiving a new and potentially more effective treatment that could reduce the chance of your cancer returning, especially in the tummy lining. However, as with any medical treatment, there are potential risks and side effects associated with chemotherapy drugs and surgical procedures. The PIPAC procedure itself carries risks, similar to other abdominal surgeries. All treatments will be carefully monitored by your medical team. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (5)

City of Hope
Verified postcode
Duarte, United States
Odense University Hospital
Verified postcode
Odense C, Denmark
University Hospital Lille
Verified postcode
Lille, France
Charité, University of Berlin
Verified postcode
Berlin, Germany
Karolinska University Hospital
Verified postcode
Stockholm, Sweden

Common questions

What is PIPAC?

PIPAC stands for Pressurised Intraperitoneal Aerosol Chemotherapy. It's a way of spraying chemotherapy drugs directly inside your tummy as a fine mist during a short keyhole procedure.

Why is this study important for stomach cancer?

It's important because it aims to find a better way to stop stomach cancer from coming back, especially in the lining of the tummy, which is a common problem after surgery for high-risk cases.

Will I definitely receive the new PIPAC treatment if I join?

No, you will be randomly assigned to either receive the standard care or the standard care plus PIPAC. This is to fairly compare the two approaches.

What are Cisplatin and Doxorubicin?

These are chemotherapy drugs commonly used to treat various cancers, including stomach cancer. They work by killing cancer cells.

How long will I be involved in the study?

You will be involved throughout your treatment and follow-up period. The main aim is to see the results after 12 months, but longer-term follow-up may be part of the study plan.

How to find out more

Jonas Sanberg, PhD

jonas.sanberg@rsyd.dk +45 20546466 Official trial record

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