A trial comparing treatments for a brain tumour called medulloblastoma (HR-MB)
Cancer type:
Status:
Phase:
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.
More about 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:
- which is the best treatment for high risk medulloblastoma
- what the long term side effects are
- what affect the treatments have on
quality of life
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 high risk medulloblastoma, your doctor will be able to tell you if yours is high risk
- have not had any treatment for your medulloblastoma apart from surgery or 1
cycle of carboplatin and etoposide if you needed to start treatment straightaway - have satisfactory blood test results
- are willing to use contraception during treatment and for a time after if you are sexually active and you or your partner could become pregnant
- are at least 3 years old
Who can’t take part
You cannot join this trial if any of these apply. You:
- have a tumour that has or very likely to have a change in a
gene that repairs DNA , your doctor will know this - have a tumour that has spread to another part of the body outside the brain and spinal cord
- have a large amount of tumour left in the brain after surgery but no other high risk factors. Your doctor will know how large the amount is and if you have no other high risk factors.
- have had treatment for a brain tumour or another cancer
- have another
primary tumour in another part of the brain - can’t have had radiotherapy or chemotherapy to the brain or spine
- are allergic to any of the treatments used in this trial or any of their ingredients
- have another medical condition, mental health problem or any other issue that the doctor or the trial team think could affect you taking part
- are pregnant or breastfeeding
Trial design
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:
- standard radiotherapy
- hyperfractionated accelerated radiotherapy (HART)
- high dose chemotherapy and standard radiotherapy
In the second randomisation people in the standard radiotherapy group and the HART group go into 1 of 2 treatment groups:
- standard chemotherapy
- temozolomide
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:
- standard chemotherapy
- temozolomide
The standard chemotherapy you have is a combination of:
- vincristine
- CCNU (lomustine)
- cisplatin or carboplatin
- cyclophosphamide
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:
- after surgery but before starting radiotherapy
- 2 years after diagnosis
- 5 years after diagnosis
- at 18 years of age
The questions ask about:
- side effects from treatment
- symptoms
- your general health
- what you can do
- your ability to think and reason such as concentration, learning, remembering, speaking and understanding
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.
Hospital visits
You see the doctor to have tests before joining the trial. These tests include:
- a physical examination
- blood tests
- MRI scan
- lumbar puncture
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:
- every 4 months during the first year after treatment and then
- every 6 months for a year and then
- every year till 5 years after treatment
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.
Radiotherapy has short term and long term side effects. The short term side effects include:
- hair loss
- slight swelling of the brain which is usually not noticed, you have small doses of steroids to help with this
- sore throat
- feeling or being sick
- skin rash or redness
After treatment has finished you might:
- feel very tired
- have occasional headaches
- occasional bouts of being sick
These side effects can be worrying but usually settle down between 6 and 9 months after treatment.
The long term side effects include:
- stunted growth
- early onset of puberty
- not being able to or difficulty getting pregnant
- problems with learning
- cataracts
- heart problems
We have more information about:
The most common side effects of chemotherapy can include:
- a drop in blood cells causing an increased risk of infection, bruising and bleeding
- feeling or being sick
- feeling tired and weak (fatigue)
- hair loss or thinning
- sore mouth and throat
- diarrhoea or constipation
- skin changes such as redness and rash
- numbness and tingling in the hands and feet
- changes to the way the kidneys and liver works
The side effects of high dose thiotepa can also include:
- hearing problems
- eye problems
- high levels of sugar in the blood
- headaches, dizziness, confusion, memory problems and fits
- high blood pressure
- muscle and joint pain
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.
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 Simon Bailey
Supported by
Cancer Research UK
The Brain Tumour Charity
University of Birmingham
Other information
This is Cancer Research UK trial number CRUK/17/019.
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
