Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
A trial looking at radiotherapy to prevent spread of mesothelioma after chest wall operation (SMART trial)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Doctors sometimes give a few radiotherapy treatments to the area where you have a small tissue sample (
We know from recent research that spreading of mesothelioma to the chest wall may not be as common as doctors thought. And other studies suggest that having radiotherapy soon after a chest wall operation may not reduce the chances of mesothelioma spreading to the chest wall.
The researchers want to compare giving radiotherapy very soon after a chest wall operation with giving it only if the mesothelioma spreads within the scar tissue.
The aims of this study are to find out
- The best time to give radiotherapy to lower the risk of mesothelioma spreading to the chest wall
- The side effects of giving radiotherapy soon after the procedure and how it affects quality of life
Who can enter
You may be able to enter this trial if you have mesothelioma in the covering of your lung (pleural mesothelioma), are at least 18 years and in the last 35 days have had one of the following
- An operation to take a small piece of tissue (biopsy) from the lining of your lungs (pleura)
- Surgery to your lungs
- An examination of the lining of your lung using a thin tube with a small camera, put into your chest wall
- A large tube put into your chest wall to drain fluid from around your lung
- A tube tunnelled under your skin to allow regular drainage of the fluid around the lung (indwelling pleural catheter)
You cannot enter this trial if you
- Have already had radiotherapy to the same area of your chest
- Have a lump of at least 1cm near the site of the procedure
- Do not have access to a telephone
This is a phase 3 trial. It will recruit 203 people. It is a randomised trial. You will be put into 1 of 2 groups.
People in group1 have radiotherapy to the area on the chest wall where they had their operation or procedure. You have this within 35 days.
People in group 2 will have radiotherapy to the area at a later date, only if they develop signs that the cancer has spread.
You have radiotherapy 3 days in a row. Each visit takes about 30 minutes.
A nurse will phone you monthly to find out if anything has changed around the area where you had your operation. They will explain to you what to look for. If you feel a lump in the area, the nurse will make an appointment for you to see the doctor. If necessary the doctor will arrange for you to have radiotherapy. For people in group 1 who had immediate radiotherapy, the doctor will talk to you about whether you need more radiotherapy.
Each month the research team will ask you to fill in a score sheet. This is to find out how much pain you have (if any). You fill it in at home and the team will provide you with a pre paid envelope to return the score sheet.
The researchers will also ask some people who are in the trial and live in Oxford or Bristol to take part in a short interview at their 6 month follow up. They will ask you about your experiences of being in the trial and your treatment so far.
You see the doctor and have some tests before taking part in this trial. These include
- A physical examination
- Recording the place and size of the site of your operation on the chest
- Recording how much pain you feel at the site
You then see the doctor at 1, 3, 6, 9 and 12 months for the same tests.
Before having radiotherapy you see the doctor to have your radiotherapy planned. This is so the doctor can work out where to give radiotherapy and how much to give. To have radiotherapy you go to hospital on 3 days in a row. It takes 30 minutes for each treatment.
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Nick Maskell
NIHR Clinical Research Network: Cancer
NIHR Research for Patient Benefit (RfPB) Programme
North Bristol NHS Trust