
"I am glad that taking part in a trial might help others on their own cancer journey.”
This trial is comparing treatments after surgery for high risk medulloblastoma. It is for children and adults.
It is for people who have a higher risk of their tumour coming back after treatment.
Medulloblastoma is most commonly diagnosed in children. Teenagers and adults can also get it.
We use the term ‘you’ in this summary but if you are a parent we are referring to your child.
Cancer Research UK supports this trial.
After surgery to remove the medulloblastoma everyone has radiotherapy. You have it to the brain and spinal cord. You might also have before radiotherapy. This is because doctors aren’t sure what is the best treatment for high risk medulloblastoma.
In this trial researchers are looking at different treatments to try and find what is the best treatment and which has the least side effects. After surgery everyone has chemotherapy. Then you go into 1 of 3 different treatment groups.
The aims of this trial are to compare these treatments 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
You cannot join this trial if any of these apply. You:
After surgery everyone has chemotherapy. You have carboplatin and etoposide. You have them through a long line such as a central line. You have 2 3 weeks apart.
After the chemotherapy you have an and you might need a
. This is to find out how well the chemotherapy worked.
If your tumour has got worse, you can’t take part in the trial any further. In this case your doctor will talk to you about what other treatment options there are.
This is an international phase 3 trial. The trial team need 850 people to join the study with 250 people from the UK.
It is a randomised trial. Neither you nor your doctor can choose which group you are in. There are 2 randomisations.
In the first randomisation everyone goes into 1 of 3 treatment groups:
In the second randomisation people in the standard radiotherapy group and the HART group go into 1 of 2 treatment groups:
People in the high dose chemotherapy and standard radiotherapy group go on to have temozolomide afterwards.
Radiotherapy
Before your radiotherapy you have a planning appointment. This is so the doctor and radiotherapist can work out where to give the radiotherapy and how much to give. The appointment can take up to 2 hours.
When you have radiotherapy you must lie very still. To help with this you have a facemask made. The radiographer places the mask over your head when you have treatment to keep you head still.
You have radiotherapy to the whole brain and spine.
You have the standard radiotherapy once a day Monday to Friday for 6 weeks.
For hyperfractionated accelerated radiotherapy (HART) you have more than 1 treatment each day. You have it Monday to Friday for no more than 5 weeks. You have the first treatment in the morning and the other in the evening. There is at least 6 hours between each treatment.
High dose chemotherapy and standard radiotherapy
Before starting your high dose chemotherapy you need to have collected.
To do this you have an injection of a growth factor called G-CSF. This makes the stem cells move out of your in the bones to the blood in the veins.
A few days after you have this injection. You have some blood taken over 1 or 2 days at the hospital. It takes a few hours each time. This is to collect the stem cells which are stored till you have your high dose chemotherapy.
You have 2 cycles of high dose thiotepa. You have the chemotherapy through a long line such as a central line. You have thiotepa once a day for 4 days.
On the 4th day you also have the stem cells. This is like having a blood transfusion. You have the stem cells after each cycle of thiotepa.
After the chemotherapy you have another MRI scan to see how well the treatment worked. If it has worked well enough you then have radiotherapy.
You have radiotherapy once a day Monday to Friday for 6 weeks.
Before your radiotherapy you have a planning appointment.
After your radiotherapy you have temozolomide. You have it once a day for 5 days and then you don’t take it for 23 days. Each 28 day period is a cycle of treatment. You have 6 cycles of temozolomide.
Second randomisation for people in the standard radiotherapy group and HART group
After your radiotherapy you go into 1 of 2 treatment groups at random. The groups are:
The standard chemotherapy you have is a combination of:
You have vincristine, cisplatin (or carboplatin) and cyclophosphamide through your central line. CCNU is a capsule. You have treatment in cycles. You have 8 cycles of treatment (about 9 months). Your doctor will tell you how many weeks there are in each cycle of treatment.
Temozolomide is a tablet. Your doctor will tell you how many to take. You take temozolomide once a day for 5 days and then you don’t take it for 23 days. Each 28 day period is a cycle of treatment. You have 6 cycles of temozolomide.
Quality of life
You fill in a few questionnaires:
The questions ask about:
These are quality of life questionnaires.
Research samples
When you join the trial and during the trial you give tissue samples and blood samples. The trial team will also ask for samples of the fluid that circulates around the brain and spinal cord.
Researchers will use these samples to find out more about medulloblastoma and the treatments for it.
You see the doctor to have tests before joining the trial. These tests include:
During treatment you see the doctor regularly for blood tests and to see how you are. You have MRI scans during treatment your doctor will tell when and how often.
You see the doctor 6 weeks after finishing all your treatment and then regularly for 5 years after joining the trial.
You have an MRI scan:
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.
Radiotherapy has short term and long term side effects. The short term side effects include:
After treatment has finished you might:
These side effects can be worrying but usually settle down between 6 and 9 months after treatment.
The long term side effects include:
We have more information about:
The most common side effects of chemotherapy can include:
The side effects of high dose thiotepa can also include:
We have more information about thiotepa and its side effects.
We have information about the side effects of:
Your doctor or a member of the trial team 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.
Professor Simon Bailey
Cancer Research UK
The Brain Tumour Charity
University of Birmingham
This is Cancer Research UK trial number CRUK/17/019.
Freephone 0808 800 4040
"I am glad that taking part in a trial might help others on their own cancer journey.”