A trial looking at stereotactic body radiotherapy for cancer that has spread (OligoRARE)

Cancer type:

All cancer types

Secondary cancers

Status:

Open

Phase:

Phase 3

This trial is looking at adding stereotactic body radiotherapy Open a glossary item to standard treatment for cancer that has spread elsewhere in the body.

It is for people who have cancer that has spread to fewer than 5 areas of the body. Your doctor can say if this applies to you.

You won’t be able to take part if you have cancer that started in the breast, prostate, lung or bowel.

More about this trial

Cancers that have spread to another part of the body are advanced cancers. They are also called:

secondary cancer
metastases
metastatic cancer

You might have standard treatment that includes chemotherapy Open a glossary item , immunotherapy or targeted cancer drugs to treat advanced cancer. Some people may have radiotherapy to help with symptoms. This is palliative radiotherapy .

Researchers are looking at ways to improve treatment for people whose cancer has spread to no more than 5 areas of the body. Cancer that has spread to fewer than 5 areas are called oligometastasis. Researchers think that adding stereotactic body radiotherapy to standard of care might help this group of people. They aren’t sure how well it will work so they are doing this trial to find out more.

Stereotactic body radiotherapy (SBRT) gives radiotherapy from many different angles around the body. The beams meet at the tumour. This means the tumour receives a high dose of radiation and the tissues around it receive a much lower dose. This lowers the risk of side effects.

The main aims of the trial are to:

find out how well adding SBRT to standard treatment works
learn more about the side effects
see if treatment affects quality of life

Who can enter

The following bullet points are a summary of the entry conditions for this trial. Talk to your doctor or the trial 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 trial if all of the following apply. You:

have cancer that has spread elsewhere in the body
have between 1 and 5 areas of cancer spread. This includes cancer spread to the brain if you are suitable to have radiosurgery or staged doses of stereotactic radiotherapy. Your doctor will know this.
have cancer that hasn’t got worse at the original (primary) area of cancer and it has been at least 4 months since you had treatment to this area
have cancer that your doctor can measure on a scan
can have stereotactic body radiotherapy to all the areas of cancer spread and are suitable to have the treatment in this trial
are well enough to be up and about for at least half the day but might not be able to work (performance status 0, 1 or 2)
are at least 18 years old

Who can’t take part

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

have cancer that started in the breast, prostate, lung or bowel (colorectal cancer)
are going to have radiotherapy to an area of the body that overlaps a lot with where you had radiotherapy in the past. Your doctor will know this.
have cancer that has only spread to the brain
have cancer cells in the fluid around the lungs or tummy, in the fluid that surround the brain and spinal cord or you have cancer in the thin membrane that surrounds the organs in the abdomen
have areas of cancer spread that measure more than 6cm across that are outside the brain. You can take part if you have cancer spread to the bone that measures more than 5cm across. This is if the radiotherapy doctor thinks it is safe for you to have radiotherapy treatment.
have spinal cord compression . You might be able to take part if you have had surgery to treat this.
have cancer that has spread into the gastrointestinal tract. This includes the food pipe (oesophagus), stomach or bowel. Or you have cancer that has spread to lymph nodes in the abdomen, cancer that has spread to the skin, or inflammation of the lymph vessels .

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

have any serious medical condition that means you can’t have radiotherapy. This includes scarring of the lungs for people who need radiotherapy to the chest. People who have Crohn’s disease or ulcerative colitis and you need radiotherapy to the bowel. People with connective tissue disease such as lupus or scleroderma.
have moderate to severe liver damage
have any other medical condition or mental health problem that could affect you taking part

Other
You are pregnant or breastfeeding.

Trial design

This phase 3 trial is taking place in Europe and the UK. The team need to find 200 people to take part including 24 from the UK.

It is a randomised trial. You are put into a group by a computer. Neither you nor your doctor will be able to decide which group you are in. There are 2 treatment groups.

You have 1 of the following:

standard treatment
standard treatment and stereotactic body radiotherapy (SBRT)

Standard treatment
Your doctor will talk to you about the type of treatment you have and how often you have it. The standard treatments for your cancer type might include:

Standard treatment and stereotactic radiotherapy
You have SBRT first. This is then followed by standard treatment as described above.

To begin with, you have a radiotherapy planning session. Once this is complete the team arrange your SBRT.

You have 1, 3, or 5 SBRT treatments to each area of cancer spread. The number of treatments you have depends on the area of the body that needs treatment. Your doctor will tell you how many treatments you’ll have.

You have it every second day if you have 3 treatments. You have it every day if you have 5 treatments. All SBRT will be completed within 2 weeks.

You then go on to have the standard treatment that your doctor has planned for you. The team can tell you more about this.

Quality of life
The trial team ask you to fill out a questionnaire:

every 3 months in the first year
every 6 months until the trial ends

The questionnaire asks 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 can take part. These include:

blood tests
a physical examination
bone scan
CT scan or MRI scan

You might also have a PET-CT scan.

Those having radiotherapy have a check up 6 weeks after it finishes. This is to see how you are and if you have any side effects from radiotherapy.

Everyone has a check up with their doctor and a CT or MRI scan:

every 3 months for the first 2 years and then
every 6 months for the next 3 years and then
once a year after that

You stop having trial scans if your cancer gets worse. The team then contact you:

every 6 months for the first 5 years of the trial and then
once a year after that

This might be at a routine hospital appointment or they might call or email you to see how you are getting on.

The team plan to collect information about:

any radiotherapy side effects
any further treatment you have had for your cancer
any new cancers you may have developed

Side effects

The trial team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.

The most common side effects of radiotherapy include: