
"I am glad that taking part in a trial might help others on their own cancer journey.”
This study is comparing regular monitoring with immediate radiotherapy to the brain to reduce the risk of cancer spreading there.
It is for people who have had for small cell lung cancer and the cancer hasn’t got worse.
Regular monitoring is also called active surveillance.
Small cell lung cancer can spread to the brain. Your doctor might suggest that you have radiotherapy to the brain to reduce this risk. This is called prophylactic cranial irradiation (PCI). Radiotherapy kills any cancer cells that might have spread into the brain but are too small to see. This is a standard treatment.
Radiotherapy to the brain can cause side effects, such as memory loss. So doctors don’t want to give treatments that people might not need. Instead of having PCI radiotherapy, doctors want to find out if monitoring the cancer with an is just as good. This regular monitoring is also called active surveillance. This means you don’t have treatment straight away. Your doctor keeps a close eye on you to check for any signs that the cancer is growing. If it does, you and your doctor can decide which treatment is best for you.
In this study, some people have regular MRI scans to monitor for cancer spread to the brain. And some people have regular MRI scans and PCI radiotherapy.
The main aims of the study are to:
The following bullet points are a summary of the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.
Who can take part
You may be able to join this study if all of the following apply. You:
Who can’t take part
Cancer related
You cannot join this study if any of these apply. You:
Medical conditions
You cannot join this study if any of these apply. You:
Other
You cannot join this study if any of these apply. You:
This phase 3 study is taking place in Europe and the UK. The team need about 600 people to take part.
It is a randomised study. A computer puts you into a group. Neither you nor your doctor can decide which group you are in. There are 2 groups. You have 1 of the following:
Regular monitoring with MRI scans alone (active surveillance)
In this group you have an of your brain every few months. You have these scans for up to 2 years.
Regular monitoring with MRI scans alongside radiotherapy
In this group you have the MRI scans as described above. You also have prophylactic cranial irradiation (radiotherapy) to the brain. You have a radiotherapy planning session before starting radiotherapy. Your doctor will tell you when this takes place.
You have radiotherapy every day, Monday to Friday for 2 weeks. Each treatment lasts for a few minutes.
Both groups
The team will talk to you about treatment options if your cancer starts to grow during the study.
Quality of life
The study team ask you to fill out some questionnaires:
The questionnaires ask about side effects and how you’ve been feeling. This is called a quality of life study.
You see the doctor and have some tests before you take part in this study. These include:
Those having radiotherapy have it at the hospital.
You have a check up with the doctor and an MRI scan of your brain:
The check up includes a physical examination and some cognitive tests. For this you do some small tasks on paper. You also do some tasks linked to following instructions, understanding and thinking. This helps the doctors measure your memory, recall and attention. So they can understand and find out how each might be affected.
After 2 years of being in the study, the team check how you are getting on every 6 months for up to 3 years. They might see you at the hospital or they might call you to see how you are getting on.
The study team monitor you during the study and afterwards. Contact your advice line or tell your doctor or nurse if any side effects of PCI radiotherapy are bad or not getting better.
An MRI scan is a safe test and doesn’t use radiation. There is a small chance that your skin will feel warmer and you might feel a twitching sensation during the scan. This is because of the energy used during the scan,
We have more information about prophylactic cranial irradiation (PCI) to the brain and its side effects.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Corinne Faivre-Finn
European Organisation for Research and Treatment of Cancer (EORTC)
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
"I am glad that taking part in a trial might help others on their own cancer journey.”