Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.
A study to understand more about tissue damage and treatment resistance in people having radiotherapy for lung cancer (RADAR)
This study is looking at blood and tissue samples and scans in people who are having, or have had, radiotherapy for lung cancer.
If you have radiotherapy for lung cancer, you will usually have a number of CT scans after you finish treatment. By measuring changes in the size and shape of the cancer in these scans, your doctor may be able to tell how well the treatment has worked.
More about this trial
Researchers want to develop better tests to work out who will respond to radiotherapy before they start treatment. And to find out who is at greatest risk of side effects. In this study, they will look at genes and proteins (biomarkers) in blood and cancer tissue of people who are having radiotherapy for lung cancer or who have already finished it. They will also use special PET scans and MRI scans to look at how radiotherapy affects healthy and cancerous lung tissue. The main aim of this study is to develop better tests to
- Work out in advance who will respond to radiotherapy treatment
- See who is at greatest risk of side effects
You will not have any direct benefit from taking part in this study, and it is unlikely to change your treatment plan in any way. But the results of the study will be used to help people with cancer in the future.
Who can enter
You can enter this study if you have lung cancer and are in one of the following situations
- You are due to start a course of radiotherapy aimed to cure your lung cancer, and the dose and treatment plan are approved by the study team – you can check this with your doctor OR
- You have had radiotherapy aimed to cure or control symptoms of lung cancer, and you have developed side effects
AND you are
- Well enough to take part in any tests and scans you need you to have for the study
- Able to understand written and spoken information about the study
- Willing to use reliable contraception during the study if there is any chance you or your partner could become pregnant
You cannot enter this study if you
- Are already taking part in another clinical trial, unless that study team is happy for you to join this study, and share any clinical information needed
- Are pregnant or breastfeeding
You cannot join group B in this study if you
- Are having chemotherapy at the same time as your radiotherapy
- Have cancer that measures less than 2 cm across
- Are too unwell to carry out normal, light, activities (performance status of more than 0 or 1)
- Cannot lie comfortably on your back for 2 hours
- Are allergic to the tracer injection 18F FLT, or any drugs like this – you can check this with your doctor
You cannot join group C in this study if
- You are having chemotherapy at the same time as your radiotherapy
- You are too unwell to carry out normal, light activities (performance status of more than 0 or 1)
- You cannot have MRI scans (for example you have metal or a
pacemakerin your body, or you cannot cope in small spaces)
- You are allergic to a contrast dye used for the MRI scans, called gadolinium
- Your kidneys do not work well enough to flush out the gadolinium
This study aims to recruit at least 300 people into 3 groups. The group you are in depends on your treatment plan. Everyone will give permission for the team to use information from their medical notes. And to study samples of any cancer tissue you have already had removed. Everyone will also give some blood samples – the number you give and when will depend on your situation.
If you are in group A, this is all you will need to do.
If you are in group B, you will also have 3 PET scans during the study. Each scan will last about 65 minutes. Before each scan, the team will put a small plastic tube (cannula) into a vein in each of your arms, and take a blood sample from one of these. After the start of the PET scan, the staff will inject a very small amount of radioactive tracer called FLT into the other tube. You then rest on your back on the couch in the PET scanner, and stay as still as you can. The team will take more small samples of blood throughout the rest of the scan.
If you are in group C, you will have 4 MRI scans during the study. Each scan will last around 60 minutes. Before each scan the team will put a small plastic tube into a vein in your arm. You then lie in the scanner, and keep as still as possible. The scanner is very noisy, but you will be able to listen to music. During your scan, the team will inject some dye into the tube in your arm. The dye shows up blood vessels in your cancer. The staff may also give you an oxygen mask during the scan. You breathe normal air through this for most of the scan, but the team will change this to pure oxygen for a few minutes part way through.
After your scans, the team will offer you some refreshments.
If you are in group B or C, you will have 2 study scans about 12 days apart before you start radiotherapy. You have a 3rd scan in the first 2 weeks of your radiotherapy course. People in group C will have a 4th MRI scan shortly after they finish their course of radiotherapy.
If you had not started radiotherapy when you joined the study, you will give a blood sample
- Twice before you start radiotherapy
- On days 2, 3 and 8 of your radiotherapy course
- Weekly for the rest of your radiotherapy course
- 1, 3 and 6 months after you finish radiotherapy
- If your cancer comes back, or you have a severe reaction to your radiotherapy
If you have already started radiotherapy when you join the study, you will give a blood sample when you join.
If you are in groups B or C, you give some of these samples on the same days as your study scans. The rest of the blood tests should be timed for when you are already at the hospital for a routine visit.
If you have a PET scan, you may find lying still for the length of the scan uncomfortable. The staff will try to make it as comfortable as possible. If you become too uncomfortable to carry on, the team will stop the scan.
If you are having the study PET scan, you will be exposed to a little extra radiation from the injection. We are all exposed to a very small amount of radiation during the course of a normal day (background radiation). The amount of radiation you have from the extra PET scan is about the same as 15 years of background radiation, and is thought to be low risk. The team advise that after your scan, you keep away from children and pregnant women until the next morning.
MRI scans are very safe. You may feel sick for a few minutes when you have the contrast injection. Very rarely, you may have an allergic reaction to the contrast injection, but staff will be able to treat this if this happens to you.
How to join a clinical trial
Dr Fiona Blackhall
Dr Corinne Faivre Finn
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
The Christie Lung Cancer Research Fund