Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Phase II multicenter randomized trial evaluating the association of PIPAC and systemic chemotherapy versus systemic chemotherapy alone as 1st-line treatment of Malignant Peritoneal Mesothelioma

This clinical trial is designed for people who have recently been diagnosed with malignant peritoneal mesothelioma, a rare cancer that affects the lining of the tummy. Researchers want to compare two ways of treating this cancer. One group will receive the usual chemotherapy treatment, while another group will have chemotherapy combined with a special procedure called PIPAC. PIPAC involves delivering chemotherapy directly into the tummy during a keyhole operation. The main goal is to see if adding PIPAC to standard chemotherapy is more effective in treating this cancer. This is a Phase II study, meaning it's exploring how well this new combination works and if it's safe for patients.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Institut Regional Du Cancer De Montpellier

Enrolment target

Start

13 Aug 2024

Malignant Peritoneal Mesothelioma

What is this study about?

This study is about a type of cancer called malignant peritoneal mesothelioma. This cancer starts in the delicate lining that covers your tummy area (abdomen) and its organs. It's quite a rare condition, and doctors are always looking for better ways to treat it and improve people's lives.

Currently, the main treatment for this cancer is chemotherapy, which uses strong medicines to kill cancer cells throughout the body. This study wants to see if we can make chemotherapy even more effective for newly diagnosed patients. They are exploring a special treatment called PIPAC, which stands for Pressurised IntraPeritoneal Aerosol Chemotherapy. This involves giving chemotherapy medicines directly into the tummy as a fine spray during a small keyhole operation.

By comparing patients who receive standard chemotherapy alone with those who get standard chemotherapy plus PIPAC, the researchers hope to understand if this combined approach works better at shrinking the cancer, controlling its spread, and helping people feel better. This is an important step in finding the best treatments for malignant peritoneal mesothelioma.

Key takeaways

Exploring a new combination treatment for malignant peritoneal mesothelioma.
Compares standard chemotherapy with chemotherapy plus PIPAC.
PIPAC involves delivering chemotherapy directly into the tummy.
Open to adults aged 18 and over, newly diagnosed.
Aims to find more effective ways to treat this rare cancer.

Who may be eligible?

This study is open to both men and women. To be considered for this study, you must be an adult, 18 years of age or older. There is no upper age limit, meaning older adults can also take part.

You would be eligible if you have been recently diagnosed with malignant peritoneal mesothelioma and your doctors believe you are well enough to undergo the treatments being investigated.

Other specific medical details will be checked by the study doctors to make sure the trial is safe and suitable for your particular health situation. These detailed checks are important to ensure the study is right for you.

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 old or older?
Do you have a diagnosis of malignant peritoneal mesothelioma?
Has your doctor confirmed you are generally well enough for cancer treatment?
Are you considering a first-line treatment for your condition?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be randomly assigned to one of two groups, like flipping a coin. One group will receive chemotherapy as standard. The other group will receive chemotherapy along with the PIPAC procedure. The PIPAC procedure involves a short keyhole operation to deliver chemotherapy directly into your tummy. You would have regular hospital visits for your chemotherapy treatments, check-ups, and to monitor how well you are doing and any side effects. There might be blood tests, scans, and other assessments at specific times during the study. The total duration of your participation would depend on your individual response to treatment and the study's protocol, which your doctor will explain fully.

Potential risks and benefits

Participating in this study might offer potential benefits, such as receiving a new treatment approach that could be more effective than standard care for your cancer. However, there's no guarantee that you will personally benefit. As with any medical treatment, there are potential risks and side effects associated with both chemotherapy and the PIPAC procedure, and these will be explained in detail by the study team. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (1)

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

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Unverified
France

Common questions

What is malignant peritoneal mesothelioma?

It's a rare cancer that starts in the lining of your tummy area. This study is exploring new ways to treat it.

What is PIPAC?

PIPAC is a way of giving chemotherapy directly into your tummy during a small keyhole operation, spraying it as a fine mist.

Will I definitely get the new PIPAC treatment?

No, you'll be randomly assigned to either receive standard chemotherapy or chemotherapy plus PIPAC. It's like drawing lots.

What are the main goals of this study?

The study aims to see if adding PIPAC to chemotherapy works better than chemotherapy alone for people with this type of cancer.

Can I leave the study if I change my mind?

Yes, you can withdraw from the study at any time, for any reason, without it affecting your medical care.