Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
A trial looking at radiotherapy for melanoma that has spread to the brain
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Cancer spread to the brain
Melanoma
Secondary cancers
Skin cancer
Status:
Closed
Phase:
Phase 3
This trial is looking at treating melanoma that has spread to the brain with radiotherapy to the whole brain (whole brain radiotherapy). This trial is supported by Cancer Research UK.
More about this trial
If melanoma spreads to your brain, you may have surgery or a type of radiotherapy that targets the tumour very precisely called stereotactic radiotherapy, or both. After having this treatment, you may have whole brain radiotherapy. But doctors do not know if this is helpful or not. So in this trial, they will recruit people who have had surgery or stereotactic radiotherapy for melanoma that has spread to the brain, into 2 groups. Half the people will have radiotherapy to their whole brain, and half will not.
The trial team will also look at the costs and effects of having whole brain radiotherapy for both you and the healthcare system.
The main aims of this trial are to find out
- If having whole brain radiotherapy after surgery or stereotactic radiotherapy (or both) helps to delay melanoma from coming back
- About the side effects of whole brain radiotherapy
Who can enter
You may be able to enter this trial if you
- Have between 1 and 3 areas of melanoma spread to your brain, which have been treated with surgery, stereotactic radiotherapy or both in the last 6 weeks
- Are able to have radiotherapy to the brain in the next 8 weeks
- Are able to have an MRI scan
- Are well enough to be up and about for at least half the day (performance status of 0, 1 or 2)
- Have had a CT scan or PET scan in the last 12 weeks
- Have satisfactory blood test results
- Are at least 18 years old
You cannot enter this trial if you
- Had treatment more than 6 weeks ago for melanoma that has spread to your brain
- Have any medical problem that the doctors think may affect your taking part in the study
- Have had any other cancer within the last five years, apart from carcinoma in situ of the cervix or non melanoma skin cancer
- Are pregnant or breastfeeding
Trial design
This is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. After having surgery or stereotactic radiotherapy, people in one group have whole brain radiotherapy. People in the other group don't.
The trial team will ask you to fill out a questionnaire before you start treatment and then every 2 months. The questionnaire will ask about any side effects you have had and how you have been feeling. This is called a quality of life study. You will also be asked a number of questions about your memory and attention span (mental ability tests). And, about your healthcare use and any employment or income you may have. The trial team will treat all this information 
, so no one will be able to link the results to you.
If you are in the group not having whole brain radiotherapy and your cancer starts to grow, then you may have whole brain radiotherapy. Your doctor will discuss this with you.
Hospital visits
You will see the doctors and have some tests before you start treatment. The tests include
- Physical examination
- Urine test
- Blood tests
- Blood tests to see how well your kidneys work
- Mental ability tests
You have the mental ability tests and physical examination every 2 months for 2 years then every 3 months until your cancer starts to grow again.
You will have an MRI scan of your brain before you start treatment and then every 3 months for 2 years. After 2 years you will have an MRI scan every 6 months until your cancer starts to grow again.
If your cancer starts to grow again, you will continue to see the doctors every 2 months and may need to continue completing the quality of life (QOL) questionnaires, mental ability tests and healthcare use and employment questionnaires until you do not wish to, or you start new treatment.
Side effects
The most common side effects of whole brain radiotherapy are
- Tiredness
- Hair loss
- Sickness
- Skin reaction such as your skin going red or darker in the treatment area
We have more information about surgery and stereotactic radiotherapy.
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.
Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.
Chief Investigator
Professor Mark Middleton
Supported by
Australia and New Zealand Melanoma Trials Group (ANZMTG)
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
University of Oxford
Other information
This is Cancer Research UK trial number CRUK/10/008.
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
Last review date
CRUK internal database number:
4164
Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.
Around 1 in 5 people take part in clinical trials
