A trial looking at treatment for children and young people with non pineal supratentorial primitive neuroectodermal brain tumours (CNS 2004 01)

This trial is looking at radiotherapy and chemotherapy for children and young people with non-pineal supratentorial primitive neuroectodermal tumour (PNET).

This trial is for children and young people from 3 years up to and including the age of 18. We use the term ‘you’, but of course if you are a parent, we are referring to your child.

PNET is a type of brain tumour. Some children have what is called a ‘non-pineal supratentorial’ primitive neuroectodermal brain tumour. This just means that the PNET tumour is not in the hindbrain, brain stem or pineal gland.

This type of brain tumour is usually treated with surgery, radiotherapy and chemotherapy. First of all, you have an operation to remove as much of the brain tumour as possible. Then you have radiotherapy, followed by chemotherapy.

The doctors running this trial want to find out if they can improve on standard radiotherapy treatment so that more children are cured. If you have standard radiotherapy you have one treatment every day (Monday to Friday) for about 6 weeks. In this trial, you have radiotherapy in smaller doses twice a day over about 5 weeks. This is called Hyperfractionated Accelerated Radiotherapy, or HART for short. You will then have chemotherapy with standard drugs that have been used for many years.

The aims of this trial are to find out

If HART is better than standard radiotherapy at stopping the cancer from coming back
More about the short and long term side effects of HART

Please note this trial is no longer recruiting patients.

Recruitment

Start 01/02/2004

End 25/11/2008

Phase

Phase 2

Who can enter

You can enter this trial if you

Have been diagnosed with non-pineal supratentorial primitive neuroectodermal (PNET) brain tumour and your cancer may or may not have spread to other areas of the brain, or to the spinal cord
Are well enough to take part in this trial
Have satisfactory blood test results
Are aged between 3 and 18 years (inclusive)

You cannot enter this trial if you

Have a type of neuroectodermal tumour called supratentorial atypical teratoid or rhabdoid tumour, or medulloepithelioma
Have a PNET tumour that is in the pineal gland, hindbrain or brain stem
Have already had chemotherapy or radiotherapy
Have an infection that needs treatment
Have had another cancer in the past

Trial design

This trial will recruit 30 children and teenagers in the UK who have already had an operation to remove as much of their brain tumour as possible.

If you take part, you will have radiotherapy twice a day from Monday to Friday, with about 7 or 8 hours in between each treatment. You will have 50 treatments in total over 25 days, so treatment will last for about 5 weeks.

About 6 weeks after radiotherapy, you will have chemotherapy with the drugs

You have treatment every 6 weeks, this is called a ‘cycle’ of chemotherapy. You will have 8 cycles, so the chemotherapy will take about a year in total.

Hospital visits

You will see a doctor for examinations and tests before treatment starts. Tests include

MRI scan of the brain tumour
Blood tests
Lumbar puncture
Hearing test (audiogram)

You will probably have radiotherapy as an out patient, so you will be visiting hospital twice a day, or once a day and waiting between treatments. During radiotherapy, you will have regular blood tests and see a doctor or nurse twice a week. These appointments will be combined with your radiotherapy treatments.

You may have some of your chemotherapy as an in patient, so you will stay in hospital overnight once every 6 weeks. And you will have some of your chemotherapy as a day patient. You may have extra appointments in between these visits to see a doctor and for blood tests.

When your chemotherapy has finished, you will continue to visit the out patient clinic to see a doctor and have tests every

Two months for the first year
Three months for the next two years
Six months for two years after that

You will have further MRI scans after you finish radiotherapy and 3 months after you finish chemotherapy. You may have other appointments to see the doctor and have tests and these will be arranged with you individually.

The researchers want to collect information about the possible long term side effects of treatment in children. They will ask you to complete a questionnaire. This will ask questions about side effects and how these affect daily life. This will take place after surgery and before radiotherapy. Then after one year, 3 years, 5 years and also when you are about 20 years old.

Side effects

All treatments have side effects. Early side effects of radiotherapy include

Sore and red skin in the area treated
Difficulty swallowing
Hair loss in the area treated
A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness

You may have these side effects whether you have HART as part of this trial, or whether you have standard radiotherapy. But doctors think that HART may possibly cause an increase in the above side effects.

Doctors already know that radiotherapy to the brain has long term side effects that may affect your growth and development. For example, it may cause problems with memory or learning difficulties in very young children. It is not yet known if HART will have the same effect, make the side effects worse, or reduce the side effects. The doctors will monitor you closely during and after treatment.

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

The most common side effects of chemotherapy include