RecruitingNAINTERVENTIONAL

Hemithoracic Irradiation With Proton Therapy in Malignant Pleural Mesothelioma

This study is for people in the UK with a specific type of lung cancer called malignant pleural mesothelioma that affects only one side of their chest. It aims to find out if a new type of radiation treatment, called proton beam therapy, can help people live longer and stop their cancer from growing, compared to just carefully watching the cancer (known as 'watch and wait'). Participants will be randomly put into one of two groups: one group will receive proton beam therapy, and the other will have their condition monitored closely. The study will also look at how safe the proton therapy is and if it affects people's quality of life. This is an important study to see if this advanced treatment can make a real difference.

At a glance

Status

Recruiting

Phase

Sponsor

University College, London

Enrolment target

148

Start

28 Mar 2024

Estimated completion

30 Sep 2029

Malignant Pleural Mesothelioma

What is this study about?

This study is for people who have malignant pleural mesothelioma, a type of cancer that starts in the lining of the lungs and affects only one side of the chest. The main goal of this research is to see if a newer, more focused type of radiation treatment, called proton beam therapy (PBT), can help people live longer and keep their cancer from growing. Currently, for some people with this cancer, doctors might suggest a 'watch and wait' approach, meaning they monitor the cancer closely without immediate treatment.

In this study, some people will receive proton beam therapy, which is designed to target the cancer more precisely than traditional radiation, potentially reducing damage to healthy tissues nearby. Others will be in the 'watch and wait' group, where their health will be closely monitored. If the cancer in the 'watch and wait' group starts to grow, they will then be given standard treatments like immunotherapy or chemotherapy, as decided by their doctor.

By comparing these two approaches, doctors hope to understand if proton beam therapy is a better option for treating this type of mesothelioma. The study will also carefully check how safe the proton therapy is and how it affects people's daily lives and overall well-being. This information will help doctors make better decisions about treatment for future patients with this condition.

Key takeaways

It's a study for people with mesothelioma affecting one side of the chest.
Compares proton beam therapy to a 'watch and wait' approach.
Aims to see if proton therapy helps people live longer and controls cancer growth.
Will look at treatment safety and impact on quality of life.
Participants will be randomly assigned to one of two treatment groups.
Follow-up will continue for two years after starting the study.

Who may be eligible?

To be part of this study, you need to be at least 18 years old and have been diagnosed with malignant pleural mesothelioma that affects only one side of your chest. Your doctors should agree that it's safe for you to consider a 'watch and wait' approach before starting active treatment. It's also important that your lungs are working well enough and that you're generally fit and active.

You'll also need to agree to travel to either UCLH or The Christie hospitals if you are chosen for the proton beam therapy group, and be happy to have follow-up appointments at your local trial centre. Your cancer cannot have spread to other parts of your body, and you shouldn't have had previous major treatments like surgery, radiotherapy, chemotherapy, or immunotherapy for your mesothelioma.

There are also some reasons why you might not be able to join, such as if you are pregnant or breastfeeding, have other serious health conditions that might shorten your life expectancy, or have a pacemaker. The study doctors will carefully check all these details to make sure the study is right for you.

Quick self-check

Are you at least 18 years old?
Does your mesothelioma affect only one side of your chest?
Do you have a diagnosis of epithelioid or non-epithelioid mesothelioma?
Are your lungs working well enough?
Is your cancer not causing severe symptoms (WHO Performance Status 0-1)?
Are you willing to travel to UCLH or The Christie if you get proton therapy?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you will be randomly placed into one of two groups, like flipping a coin. You have an equal chance of being in either group. One group will receive proton beam therapy, which involves daily treatments from Monday to Friday for about five weeks. This treatment aims to target the cancer directly.

The other group will be carefully monitored without immediate active treatment; this is often called 'watch and wait'. If your cancer starts to grow while you are in the 'watch and wait' group, your doctors will then give you standard treatments like immunotherapy or chemotherapy, as they would normally. No matter which group you are in, you will be followed up by the study team at your local hospital for two years from when you start the study. There will be regular check-ups to see how you are doing, monitor your cancer, and assess your general health and quality of life. The study will also involve regular scans and tests to keep track of your condition.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as receiving a new and potentially more effective type of radiation treatment (proton beam therapy) that targets cancer more precisely. However, like all treatments, proton beam therapy can have side effects, which the study will carefully monitor. Those in the 'watch and wait' group will avoid immediate treatment side effects, but might feel anxious about not actively treating their cancer from the start. You might also benefit from closer monitoring than usual. You are free to withdraw from the study at any time without giving a reason, and this will not affect your future medical care.

Locations (25)

East Sussex Healthcare NHS Trust - Eastbourne Hospital
Eastbourne, United Kingdom· Recruiting
East Sussex Healthcare NHS Trust - Conquest Hospital
Saint Leonards-on-Sea, United Kingdom· Recruiting
Royal Berkshire Hospital
Reading, United Kingdom· Recruiting
Southend University Hospital
Southend, United Kingdom· Recruiting
Queen Alexandra Hospital
Portsmouth, United Kingdom· Recruiting
Queen Elizabeth Hospital, King's Lynn
Kings Lynn, United Kingdom· Recruiting
Furness General Hospital
Barrow in Furness, United Kingdom· Recruiting
Betsi Cadwaladr University Health Board -Glan Clwyd Hospital
Bodelwyddan, United Kingdom· Recruiting
Southmead Hospital
Bristol, United Kingdom· Recruiting
Addenbrooke's Hospital
Cambridge, United Kingdom· Recruiting
Velindre Cancer Centre
Cardiff, United Kingdom· Recruiting
Broomfield Hospital
Chelmsford, United Kingdom· Recruiting

+13 more sites — see the official record for the full list.

Common questions

What is malignant pleural mesothelioma?

It's a rare and serious type of cancer that affects the lining of the lungs and chest wall. It is often linked to asbestos exposure.

What is proton beam therapy?

It's a highly advanced type of radiation treatment that uses protons (tiny particles) to deliver radiation directly to the cancer, aiming to reduce damage to healthy tissues around it.

Why is this study being done?

Doctors want to find out if proton beam therapy is a more effective and safer treatment option for this type of cancer compared to closely watching the cancer and treating it later if it grows.

Will I definitely get the proton beam therapy?

No, you'll be randomly assigned to either receive proton beam therapy or be in the 'watch and wait' group. You have an equal chance of being in either group.

What does 'watch and wait' mean?

It means your medical team will carefully monitor your condition with regular check-ups and scans, but you won't receive active cancer treatment straight away. Treatment will start if the cancer shows signs of growing.

How to find out more

Klara Sinalova

ctc.hit-meso@ucl.ac.uk 020 7679 9826 Official trial record

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