A trial looking at treatment for children and young people with medulloblastoma (CNS 2001 06)

Please note this trial is no longer recruiting patients.

This trial is looking at radiotherapy and chemotherapy for children and young people with medulloblastoma that has spread (metastasised).

This trial is for children and young people from 3 years up to and including the age of 21. We use the term ‘you’, but of course if you are a parent, we are referring to your child.

Medulloblastoma is a type of brain tumour called a primitive neuro-ectodermal tumour (PNET). It is the most common brain tumour in children, and is usually treated with surgery, radiotherapy and chemotherapy.

After surgery, children usually have radiotherapy once a day for 4 to 6 weeks. In this trial you will have radiotherapy twice a day instead of once a day. This is called hyperfractionated accelerated radiotherapy, or HART.

There are two phases in this trial and the first phase has now finished. In the first phase children had HART on its own. In the second phase you have a combination of HART and vincristine chemotherapy.

The aim of this trial is to see if having radiotherapy twice a day, and alongside chemotherapy, is a better treatment for medulloblastoma. Doctors also want to find out if there are any serious side effects of

HART on its own
HART and chemotherapy together

Recruitment

Start 01/01/2002

End 02/06/2008

Phase

Phase 2

Who can enter

You can enter this trial if you

Have been diagnosed with medulloblastoma that has spread to another area of the brain or to the spinal cord
Are between 3 and 21 years old
Have satisfactory blood test results
Are well enough to have treatment

You cannot enter this trial if you

Have had any other cancer
Have had radiotherapy or chemotherapy in the past
Are not able to tolerate radiotherapy twice a day
Would need an anaesthetic to be able to have radiotherapy
Have an infection that needs treating with antibiotics
Are pregnant or breastfeeding

Trial design

Phase 1 (no longer recruiting)

The first phase of the trial recruited 7 patients. All the patients had radiotherapy twice a day (HART) from Monday to Friday for 5 weeks (25 days of treatment).

About 8 weeks after the radiotherapy finished patients then had 'maintenance' chemotherapy. The chemotherapy drugs given were CCNU (lomustine), cisplatin and vincristine. Patients had treatment once every 6 weeks, for a total of 8 times.

Phase 2 (currently recruiting)

The second phase of this trial will recruit about 22 children and young people. If you take part you have radiotherapy twice a day (HART) from Monday to Friday for 5 weeks (25 days of treatment). You have vincristine chemotherapy once a week for 8 weeks, starting during the first week of radiotherapy.

About 6 weeks after the radiotherapy has finished you have CCNU, cisplatin and vincristine chemotherapy. You have chemotherapy treatment once every 6 weeks, for a total of 8 times. This is called ‘maintenance chemotherapy’.

You will be asked if the doctors can keep a small sample of your tumour. This will not be used straight away but will be stored. This sample may help the doctors to find out more about medulloblastoma in the future.

Hospital visits

You will see the doctors and have some tests before taking part in this trial. The tests include

A full neurological examination
Height, weight and head circumference
MRI scan or CT scan
Lumbar puncture
Blood tests
Hearing test (audiogram)

You have radiotherapy twice a day and the 2 treatments need to be 8 hours apart. So this will mean either going to the hospital twice a day, or waiting around between treatments. You will see the doctor or nurse twice a week when you are having radiotherapy. This is to see how you are, to check for any side effects and have blood tests done.

You have Vincrisitine as an injection into a vein and this takes a few minutes. You have Cisplatin as a drip into a vein, which takes about 6 hours. You also have some fluid in a drip for a few hours before and after you have cisplatin. CCNU (lomustine) is a tablet and you have this on the first day of each chemotherapy cycle.

After the treatment has finished, you will see the doctor

Every 2 months for the first year
Every 3 months for the second and third years
Every 6 months for the fourth and fifth years.

Side effects

Radiotherapy and chemotherapy both have side effects. It is possible that the side effects of HART may be slightly worse than the side effects of standard radiotherapy. These side effects include

Sore skin
Discomfort when swallowing
Hair loss
A drop in the number of blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness

There is more information about the side effects of radiotherapy to the brain on CancerHelp UK.

The side effects of chemotherapy include

Hair loss
A drop in the number of blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
Feeling or being sick
Tummy pain
Sore mouth (mucositis)

There is more information about the side effects of vincristine, CCNU and cisplatin on CancerHelp UK.