A study of active surveillance for small cell lung cancer that has a risk of spreading to the brain (PRIMALung study)

Cancer type:

Lung cancer

Secondary cancers

Small cell lung cancer

Status:

Open

Phase:

Phase 3

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 standard treatment Open a glossary item for small cell lung cancer and the cancer hasn’t got worse.

Regular monitoring is also called active surveillance.

More about this trial

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 MRI scan Open a glossary item 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:

find out if regular monitoring on its own is as good as or better than regular monitoring and PCI radiotherapy
compare the 2 groups to find out more about quality of life, memory loss, slower thinking and side effects

Who can enter

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:

have small cell lung cancer that is in a single area of a lung or has spread further (limited or extensive stage small cell lung cancer)
have had standard treatment for small cell lung cancer. For those with limited stage cancer this was chemotherapy that included a platinum drug and radiotherapy or surgery. For those with extensive stage cancer this was chemotherapy that included a platinum drug. You may or may not have had radiotherapy or an immunotherapy .
started your final cycle of chemotherapy within 16 weeks of joining this study
are up and about for at least half a day but you might not be able to work (performance status 0, 1 or 2)
have satisfactory blood test results
are willing to use reliable contraception during radiotherapy if there is any chance you or your partner could become pregnant
are at least 18 years old

Who can’t take part

Cancer related
You cannot join this study if any of these apply. You:

have had radiotherapy to part of the brain or whole brain radiotherapy. You might be able to take part if you had stereotactic radiosurgery for a condition that wasn’t cancer. Your doctor will know about this.
have cancer that has spread to the brain or spinal cord or the tissues that surround them
have cancer that got worse after standard treatment
have another cancer that you are having treatment for
have moderate to severe side effects from past cancer treatments

Medical conditions
You cannot join this study if any of these apply. You:

have had a heart attack in the last 3 months or another serious heart problem that you needed to go into hospital for in the last 3 months
have a problem with how your kidneys work
have a serious breathing problem called chronic obstructive pulmonary disease or another breathing problem that the team think could affect you taking part
have moderate to severe liver damage
have any other medical condition or mental health problem that the study team think could affect you taking part

Other
You cannot join this study if any of these apply. You:

can’t have an MRI scan for any reason. For example you are allergic to the contrast dye used for an MRI scan (contrast medium) or you have metal in your body
can’t go to all the hospital study visits
are pregnant or breastfeeding

Trial design

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 (active surveillance) - group A
active surveillance and radiotherapy to the brain - group B

Regular monitoring with MRI scans alone (active surveillance)
In this group you have an MRI scan Open a glossary item 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:

when you join the study
at set times during the study

The questionnaires ask about side effects and how you’ve been feeling. This is called a quality of life study.

Hospital visits

You see the doctor and have some tests before you take part in this study. These include:

physical examination
blood tests
CT scan or MRI scan of the chest, abdomen and pelvis
MRI scan of the brain
tests to see check your memory, recall and attention (cognitive tests)

Those having radiotherapy have it at the hospital.

You have a check up with the doctor and an MRI scan of your brain:

every 3 months in the first year
every 6 months in the second year

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.

Side effects

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.