
"He went through six operations and was placed on a clinical trial so he could try new treatments.”
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.
Glioblastoma is a type of brain tumour. Doctors can treat glioblastoma with:
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:
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:
Who can’t take part
Cancer related
You cannot join this trial if any of these apply. You:
Medical conditions
You cannot join this trial if any of these apply. You:
Other
You cannot join this trial if any of these apply. You
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:
Radiotherapy
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.
Chemotherapy
Your doctor will explain which is the best chemotherapy for you. This can be one of the following standard treatments:
You have chemotherapy once every 6 weeks. Each 6 weeks period is a . You have up to 6 cycles of treatment as long as it is working and the side effects aren’t too bad.
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:
These are quality of life questionnaires.
Interview
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:
They will ask:
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:
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:
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.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Louise Murray
The Jon Moulton Charity Trust
University of Leeds
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
"He went through six operations and was placed on a clinical trial so he could try new treatments.”