Active not recruitingNAINTERVENTIONAL

A Feasibility Study Evaluating Surgery for Mesothelioma After Radiation Therapy Using Extensive Pleural Resection

This study is exploring a new way to treat mesothelioma, a type of cancer affecting the lining of the lungs. It combines surgery with different levels of radiation therapy, including a special 'boost' radiation that aims high doses at specific tumour areas. Researchers want to find the highest but safest dose of this 'boost' radiation when given alongside other radiation, and then followed by surgery. They believe this special radiation might also help activate the body's immune system to fight the cancer more effectively. The study will gradually increase the radiation dose for small groups of patients to carefully monitor for side effects and determine the best approach.

At a glance

Status

Active not recruiting

Phase

Sponsor

University Health Network, Toronto

Enrolment target

Start

05 Sep 2019

Estimated completion

01 Apr 2027

Mesothelioma; Lung

What is this study about?

This study is looking into a new treatment for mesothelioma, a type of cancer that develops in the lining of your lungs. Often mesothelioma is treated with surgery, and sometimes with chemotherapy or standard radiation. This study is trying a new approach by combining surgery with a special type of radiation therapy. They are specifically interested in something called 'boost radiation', which delivers a strong dose directly to larger parts of the tumour.

The main aim is to find the safest but most effective dose of this 'boost' radiation when it's given along with other, more general radiation. The doctors will slowly increase the radiation dose for small groups of patients, watching carefully for any difficult side effects. If the side effects are manageable, they will offer a slightly higher dose to the next group, until they reach a point where too many side effects occur, or a pre-determined maximum dose. The surgery will happen a short time after the radiation treatment.

The researchers also think that this specific type of radiation might encourage your body's immune system to fight the cancer better. They hope this combined approach could lead to more effective ways to control the disease for people with mesothelioma.

Key takeaways

This study combines surgery with a new type of radiation therapy for mesothelioma.
It aims to find the safest and most effective dose of this special radiation.
Researchers hope it might also boost your body's immune system to fight cancer.
Participation involves radiation treatment followed by surgery, then follow-up care.
You must have a recent diagnosis of malignant pleural mesothelioma and certain health conditions to join.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old. Your general health and fitness, as measured by something called an ECOG score, should be good – generally meaning you are able to look after yourself and do light activities. Your lung function also needs to be healthy enough to safely receive radiation treatment.

You must have been recently diagnosed with a specific type of mesothelioma called malignant pleural mesothelioma. Even if your cancer has certain cell types (sarcomatoid or biphasic), you might still be included, though your results will be looked at separately. The study is for early to mid-stage mesothelioma where the cancer has not spread significantly.

There are also reasons why you wouldn't be able to join. These include if you are under 18, if your cancer has spread to certain lymph nodes or to distant parts of your body, or if your general health or lung function is not good enough. You also can't have had previous radiation treatment to your chest, or other serious health conditions that would make radiation treatment risky. Having certain other cancers, or being pregnant or breastfeeding, would also exclude 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?
Have you been recently diagnosed with malignant pleural mesothelioma?
Is your general health and lung function good enough for surgery and radiation?
Has your cancer not spread to distant parts of your body or certain lymph nodes?
Have you not had previous radiation treatment to your chest?
Are you able to give your informed consent to participate?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will first receive radiation treatment. This will involve a background dose of radiation, and some patients will also receive the special 'boost' radiation to specific areas. The amount of background radiation will start at a very low level for the first three patients and will gradually increase for every new group of three patients, as long as the previous group handled the treatment well. This careful approach helps doctors find the safest dose.

About one to two weeks after you finish your radiation therapy, you will have surgery. Following the surgery, the study team will continue to monitor your health and recovery according to a set schedule. The total duration of your participation will depend on the follow-up plan, which the study team will explain in detail.

Potential risks and benefits

Participating in this study might offer you access to a new treatment approach for mesothelioma that isn't widely available yet, which could potentially improve your outcome. The researchers hope that activating your immune system with this radiation might help control the cancer better. However, there are risks involved; radiation therapy and surgery can have side effects, and some people may experience more severe reactions. The study is designed to carefully monitor these effects to find the safest dose. You are always free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Princess Margaret Hospital, University Health Network
Verified postcode
Toronto, Canada

Common questions

What is mesothelioma?

Mesothelioma is a type of cancer that develops in the thin layer of tissue covering your lungs (the pleura).

What is 'boost radiation'?

It's a special type of radiation therapy that delivers a focused, high dose of radiation specifically to bigger areas of the cancer within the lung lining.

What does 'maximum tolerated dose' mean?

It's the highest dose of a treatment that causes side effects that are manageable and not too serious for patients.

Will I definitely have surgery as part of this study?

Yes, if you join this study, surgery is planned approximately one to two weeks after you complete the radiation therapy.

What is an 'immunologic abscopal effect'?

This is a scientific idea that radiation treatment in one part of the body might also help the immune system fight cancer in other, untreated parts of the body.