A trial looking at when to give radiotherapy for cancer that has spread to the brain (USZ-STRIKE)
Cancer type:
Status:
Phase:
This trial is looking at the best time to give radiotherapy to people whose 
has spread to the brain.
It is open to people with:
- melanoma with a cancer spread to the brain
- newly diagnosed non small cell lung cancer (NSCLC) that has spread to the brain
Cancer that has spread to the brain is also called brain metastases.
More about this trial
The for people whose melanoma or NSCLC has spread to the brain is usually one or more of the following:
chemotherapy immunotherapy - a
targeted drug
Doctors usually use radiotherapy later. This is when the brain metastases grow or when the symptoms of brain metastases get worse while having standard treatment or afterwards.
It isn’t known when the best time is to have radiotherapy. In this trial, the team are looking at giving radiotherapy with the standard treatment instead of waiting until later. Half the people who join the trial will have the standard treatment only. The other half will have the standard treatment with radiotherapy.
The radiotherapy used in this trial is stereotactic radiotherapy (SRT). It is also called stereotactic radiosurgery (SRS). This targets the area of cancer in the brain. The cancer receives a high dose of radiotherapy while the surrounding area gets a much lower dose. This means there are fewer side effects.
The main aims of this trial are to find out:
- how well giving radiotherapy with the standard treatment works for people with brain metastases
- what the side effects are
- how radiotherapy affects
quality of life - how radiotherapy affects your ability to think, reason, concentrate, remember things, speak and understand
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 melanoma diagnosed at any time but has just spread to the brain (brain metastases). Or you have newly diagnosed NSCLC that has spread to the brain and you have had no treatment.
- have no symptoms, few symptoms or minor symptoms of brain metastases. You might be able to join if you are taking medication to control symptoms.
- have brain metastases that are a certain size. The size depends on the number of metastases you have. Your doctor will know about this.
- must be able to have treatment that reaches your whole body (systemic treatment)
- are able to have stereotactic radiosurgery. Your doctor will know if you can.
- must be willing to use reliable contraception during the trial and for a certain time after if you or your partner could become pregnant
- might need help from time to time but you can mostly look after yourself (Karnofsky performance scale 60 or more)
- are at least 18 years old
Who can’t take part
You cannot join this trial if any of these apply. You:
- have or might have cancer spread to the tissue surrounding the brain (leptomeningeal spread). Your doctor will know this.
- have already had radiotherapy to the brain
- have already had systemic treatment for your brain metastases
- have any other medical condition or mental health problem that could affect you taking part
For people with NSCLC you cannot join if you have had certain treatments for your cancer already. Your doctor will know which treatments these are.
Trial design
This is an international phase 3 trial. The team need 190 people to take part with 45 from the UK.
Everyone has the standard treatment for their cancer.
This is a randomised trial. Neither you nor your doctor can choose which group you are in. The 2 groups are:
- radiotherapy and standard treatment
- standard treatment only
If you are in the first group, you start your standard treatment at about the same time as you have radiotherapy.
If you are in the second group, you have standard treatment. You may have radiotherapy to your brain at a later time if your brain metastases grow. Or symptoms from the brain metastases get worse while having standard treatment or afterwards.
Radiotherapy
You have the radiotherapy within 2 weeks of being randomised.
You will have either 1 treatment (fraction) or 5 treatments of radiotherapy. This depends on the number and size of your brain metastases. Your doctor will explain this to you.
If you have 5 treatments you have it over 5 days. That is 1 treatment a day Monday to Friday.
Before starting radiotherapy you have a planning appointment. This is so the doctor can work out where to give the radiotherapy and how much to give.
As part of the planning appointment you might also have a radiotherapy mask or mould made.
Standard treatment
Depending on your cancer and whether there are certain gene changes () you might have one or more of following:
- chemotherapy
- immunotherapy
- targeted drugs
You usually have chemotherapy and immunotherapy as a drip into a vein. You usually have targeted drugs as tablets or capsules.
Your doctor will explain which treatment you are going to have. And they can answer any questions you might have.
You continue to have the standard treatment as long as it is helpful and the side effects aren’t too bad.
Quality of life
You fill in questionnaires before starting treatment then at:
- 3 months
- 6 months
- 1 year
- 2 years
The questions ask about:
- your general health and wellbeing
- what daily activities you can do
- your memory, ability to think, concentrate, learn, speak and understand things
- any side effects or symptoms
These are quality of life questionnaires. If these questions make you feel uncomfortable, you can stop at any time. You can leave a question unanswered if you want. The answers will help the trial team understand how treatment affects your daily life.
Samples for research
The trial team will take tissue samples (biopsies) and blood samples as part of the trial. Your doctor will explain when they take the samples and how often.
They will use these samples to find out more about melanoma or NSCLC and brain metastasis.
The team will also ask if you are willing to have these samples stored so future researchers can use them. You don’t have to agree to this.
Hospital visits
You see the doctor to have tests before taking part. These include:
- a
physical examination - blood tests
- urine test
- MRI scan of the brain
- CT scan
- amino acid PET scan – if available at the hospital
- tests to see how well you can remember, concentrate and understand
You see the doctor after treatment at:
- 3 weeks
- 6 weeks
- 3 months
- then every 3 months for about 2½ years
At each visit you have an MRI scan. If you had the amino acid PET scan at the start you might also have another one at each of these appointments as well.
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.
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Some of the standard treatments doctors use to treat melanoma and NSCLC can affect the These side effects could happen during treatment or months after treatment has finished. Rarely, these side effects could be life threatening. Your doctor or nurse can explain what these side effects are, the risk of them happening and what to look out for. |
The most common side effects of radiotherapy to the brain are:
- tiredness (fatigue)
- seizures (fits)
- hair loss
- symptoms getting worse such as headaches, problems with your eyesight, hearing and taste or problems with moving around (coordination) and balance
- your attention, memory and talking getting worse
We have more information about the side effects of having radiotherapy to the brain.
We have information about:
Your doctor will talk to you about the side effects of all the treatments and answer any questions you have before you agree to take part in the trial.
Location
Recruitment start:
Recruitment end:
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.
Chief Investigator
Professor Mary O’Brien
Supported by
ETOP IBCSG Partners Foundation
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
