A trial looking at different ways of giving radiotherapy for children and young people with medulloblastoma (HIT - SIOP PNET 4) (CNS 2003 05)

Please note this trial is no longer recruiting patients.

This trial will compare standard radiotherapy with hyperfractionated radiotherapy (HFRT) for children and young people with medulloblastoma.

This trial is for children from 4 years old and young people up to and including the age of 21. We use the term 'you' in this summary, but of course if you are a parent, we are referring to your child.

Medulloblastom is a type of brain tumour called a primitive neuroectodermal tumour (PNET). It grows in the hind brain (the cerebellum). It is the most common brain tumour in children.

In some children, the medulloblastoma has not spread to the rest of the brain or spinal cord. Doctors call this ‘standard risk’. The main treatment for standard risk medulloblastoma is surgery to remove as much of the cancer as possible. But there may be cancer cells left behind. So children have radiotherapy and chemotherapy after surgery.

This trial is trying to find the best way of giving radiotherapy to children with medulloblastoma. It will compare the standard treatment of daily radiotherapy with hyperfractionated radiotherapy (HFRT). Children will have HFRT twice a day instead of once. They have smaller doses, but the dose of radiotherapy overall is bigger. The researchers think HFRT may kill more cancer cells than standard radiotherapy. The aim of the trial is to find out which method

Is better at stopping the cancer from coming back
Has the fewest side effects

Recruitment

Start 01/12/2003

End 31/12/2006

Phase

Phase 3

Who can enter

You can enter this trial if you

Have been diagnosed with medulloblastoma
Have had an operation to remove all or most of your cancer and the cancer has not spread to the spinal cord or elsewhere in the brain
Are well enough to start radiotherapy no more than 40 days after surgery
Have satisfactory blood tests
Are aged between 4 and 21 years
Are willing to use adequate contraception if there is a chance that you or your partner could become pregnant

You cannot enter this trial if you

Have a medulloblastoma that has spread elsewhere in the brain or to the spinal cord
Would need an anaesthetic to have radiotherapy
Are not able to tolerate radiotherapy twice a day
Have any other medical condition or illness that prevents you from having radiotherapy or chemotherapy
Have previously had treatment for a brain tumour or any other type of cancer
Have any of the following types of neuroectodermal tumours - atypical teratoid, rhabdoid tumour, medulloepithelioma, ependymoblastoma or a brainstem or supratentorial primitive neuroectodermal tumour
Have Gorlin’s syndrome

Trial design

This trial is randomised and there are two treatment groups. If you take part, you are put into one of two different groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

If you are in group 1, you have standard radiotherapy, once a day from Monday to Friday, for a total of 31 days.

If you are in group 2, you have HFRT. You have radiotherapy twice a day from Monday to Friday, for at total of 34 days. The treatments will usually be at about 9am and 5pm.

All patients will also have chemotherapy during radiotherapy treatment. You have vincristine once a week for 7 weeks. You have this drug into a vein through a drip, or through a central line, sometimes called a ‘wiggly line’.

Six weeks after radiotherapy has finished, all patients will have a combination of chemotherapy drugs called ‘maintenance chemotherapy’. You have

CCNU (lomustine) as a tablet
Cisplatin and vincristine into a drip or through a central line.

You have CCNU and cisplatin in week 1 and vincristine once a week in weeks 1, 2 and 3, followed by 3 weeks with no treatment. This 6 week period is called a ‘cycle’ of chemotherapy. You have 8 cycles of chemotherapy, so the treatment will take about a year in total.

Your doctors will ask if they can keep a small sample of your tumour. Using this in other research will help the doctors to find out more about medulloblastoma. This will not directly benefit you but will help children with cancer in the future.

Hospital visits

You will see a doctor and have various tests before you start treatment. These tests include

A full neurological examination
MRI of your brain and spinal cord
Lumbar puncture
Blood tests
Hearing test (audio gram)

You may need to repeat some of these tests during and after treatment.

If possible, you have your radiotherapy treatment as a day patient. This may depend on your individual circumstances. Your consultant will discuss this with you.

You have your weekly vincristine as a day patient. You will need to stay in hospital for 2 days while you have maintenance chemotherapy.

After the treatment has finished you will see the doctor regularly. These will be arranged on an individual basis.

Side effects

Radiotherapy and chemotherapy both have side effects. Early side effects of radiotherapy to the brain include

Sore and red skin
Feeling or being sick
A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness

Late side effects include

You may have these side effects whether you have standard radiotherapy or HFRT. There is more information about the side effects of radiotherapy to the brain in the Brain Tumours section of CancerHelp UK.

You will probably have chemotherapy whether you are part of this trial or not. The most common side effects of chemotherapy include