"He went through six operations and was placed on a clinical trial so he could try new treatments.”
A trial giving radiotherapy again for glioblastoma (BRIOChe)
This trial compares having radiotherapy again with chemotherapy for glioblastoma that has come back after treatment.
It is open to people who have a brain tumour called glioblastoma that has come back after initial treatment.
More about this trial
Unfortunately for some people the glioblastoma can start to grow again. Doctors in the UK usually treat this with chemotherapy.
We know from research that having radiotherapy a second time can help treat glioblastomas that have come back.
In this trial half the people will have radiotherapy again. And the other half will have
The aims of the trial are to find out:
- how well having radiotherapy again works
- how the treatments affect
quality of life.
- more about the side effects of both treatments
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 a brain tumour called glioblastoma that has come back after your initial treatment. You can also join if your glioblastoma had come back once, you had surgery to remove it and no other treatment.
- finished your initial radiotherapy at least 6 months ago
- had at least 2 weeks of temozolomide with your initial radiotherapy
- had an
MRI scanusing a contrast dyeto confirm the glioblastoma has come back within 3 weeks of going into a treatment group ( randomisation)
- can look after yourself but might not be able to do all your usual activities or active work (Karnofsky performance status 70 to 100)
- have satisfactory blood test results
- are willing to use contraception during treatment and for a time after if you or your partner could become pregnant
- can swallow tablets and capsules
- are at least 18 years old
Who can’t take part
You cannot join this trial if any of these apply. You:
- have cancer that has come back in the tissue surrounding the brain or spinal cord
- have already had
systemic treatmentsuch as chemotherapy for the glioblastoma that has come back
- have already had radiotherapy for glioblastoma that has come back
- have already had very high doses of radiotherapy to certain parts of the brain. Your doctor will know if you have.
- only have glioblastoma that has come back that the contrast dye has not highlighted on the MRI scan. Your doctor will know about this.
- have more than 3 areas where the glioblastoma has come back
- have certain gene changes (
mutations) in your glioblastoma. Your doctor will know about this.
- have had another cancer apart from
non melanoma skin cancer. You can join if you have had treatment for another cancer and there has been no sign of it for at least a year.
- are not able to have chemotherapy or radiotherapy
- have ongoing side effects from previous treatment
- are taking part in another clinical trial using an experimental drug or device
You cannot join this trial if any of these apply. You:
- are not able to have an MRI scan with the contrast dye. This could be because you have metal such as surgical clips in your body or you are allergic to the dye. There are other reasons that your doctor will know about.
- have an
inheritedcondition where your body is not able to absorb sugars such as lactose, galactose and glucogalactose. You also cannot join if you are allergic to these sugars.
- have another medical condition or mental health problem that could affect you taking part in the trial
You cannot join this trial if any of these apply. You
- have had an allergic reaction to
- are pregnant or breastfeeding
This is a phase 2 trial. The team need 70 people to join.
It is a randomised trial. A computer puts you into a treatment group. Neither you nor your doctor choose which group you are in. There are 2 groups:
You have radiotherapy once a day Monday to Friday for 2 weeks. It takes about 15 minutes each time. Before your radiotherapy starts you have a planning appointment.
Your doctor will explain which is the best chemotherapy for you. This can be one of the following standard treatments:
- lomustine, procarbazine and vincristine (PCV)
- lomustine and procarbazine
- lomustine and vincristine
You have chemotherapy once every 6 weeks. Each 6 weeks period is a
Lomustine is a capsule. You take it once at the start of each cycle of treatment. You take it at bedtime on an empty stomach. Your doctor will tell you how many to take.
Procarbazine is a capsule. You take it for 10 days at the start of each cycle of treatment. Your doctor will tell you how many to take.
You have vincristine as a drip into a vein. You have it once at the start of each cycle of treatment.
Quality of life
You fill in questionnaires at the start of the treatment and then every 6 weeks for up to 18 months.
The questions ask about:
- side effects
- general health and wellbeing
- what you are able to do
These are quality of life questionnaires.
The team will ask a small number of people and their partners or carers for an interview. A member of the team will contact you to arrange a time and place convenient to you. The interview can take place:
- at a clinic appointment
- over the phone
- using video conference
- at your home
They will ask:
- how the glioblastoma has affected your life
- how the treatment has affected your life
- what is important to you, your family and carers
The interview takes about an hour. It is tape recorded. All your details and answers are kept safe and confidential. Only members of the research team can access the recording.
You don’t have to agree to do the interview if you don’t want to.
You see the doctor for tests before taking part. These are:
- blood tests
- MRI scan of the brain
- a test to see how well your brain and nerves work – a neurological examination
You see the doctor regularly during treatment. This is to see how you are and for blood tests.
After treatment you see the doctor every 6 weeks for about 18 months.
You have an MRI scan every 12 weeks.
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 having radiotherapy again are similar to when you had radiotherapy the first time. These include:
- hair loss in patches where you have the radiotherapy
- feeling or being sick
- swelling of the brain
- skin redness and irritation on the scalp
- crustiness or blockage of the ear which could cause temporary hearing problems
- seizures (fits)
- dry mouth or taste changes
- temporary worsening of existing symptoms such as weakness and problems with talking and speech
Radiotherapy might cause damage to the brain tissue. This is radionecrosis. It can happen weeks or months after treatment. Depending on where your glioblastoma is, this may not cause any symptoms. Or it could cause symptoms similar to those listed above. In most cases you can have steroids to treat the symptoms of radionecrosis. Very rarely you might need surgery.
Your doctor, nurse or radiographer will closely monitor you for these side effects during and after treatment.
We have more information about the side effects of having radiotherapy to the brain.
We have information about the chemotherapy drugs and their side effects:
Your doctor will talk to you about the possible side effects of all the treatments before you agree to take part.
How to join a clinical trial
Dr Louise Murray
The Jon Moulton Charity Trust
University of Leeds