A trial looking at treatment for children and young people with low grade glioma brain tumours (SIOP - LGG 2004 CNS 2004 03)

This trial is looking at chemotherapy and radiotherapy for children and young people with a type of brain tumour called a glioma. It is recruiting children with a 'low grade' tumour, which means that it usually grows quite slowly.

This trial is for children and young people up to and including their 25th birthday. We use the term ‘you’, but of course if you are a parent, we are referring to your child.

If possible, children and teenagers with low grade gliomas will have surgery to remove their tumour. But an operation is not always possible, or the tumour sometimes grows back after surgery. In this situation, you may have either chemotherapy or radiotherapy.

This trial is trying to find the best way of treating all children and teenagers with a ‘low grade’ glioma. The researchers want to find out if

Adding another chemotherapy drug, called etoposide, to the usual chemotherapy treatment will be better at stopping the growth of the brain tumour (etoposide is a well established drug in childhood cancers, but it has not been used in this particular way before.)
Extending chemotherapy from 1 year to 18 months will prevent the tumour from regrowing

Trial doctors will collect information about any side effects you have some months, or even years after your treatment has finished. They want to improve treatment while reducing the possibility of problems in later life.

Some children have a genetic condition called neurofibromatosis type 1 (NF1). This increases your risk of developing a brain tumour. This trial will also follow those children with a low grade glioma who have NF1. The researchers will collect information about your cancer and its treatment. This greater understanding will hopefully improve treatment in the future.

Recruitment

Start 01/09/2004

End 31/01/2013

Phase

Phase 3

Who can enter

Your can enter this trial if you

Have glioma that is low grade
Are well enough to have treatment as part of this trial
Are aged between 0 and and 24 years (up to your 25th birthday)

Please note, young people between 16 and 18 years old, and some young adults between 18 and 25 years with a diagnosis of pilocytic astrocytoma are eligible for this trial. But you will not be eligible for the randomised part of the trial (see Trial design).

If you are aged between 18 and 25 years and have another type of glioma (not pilocytic glioma) you will not be eligible for this trial, but there may be another trial that is suitable for you. Your consultant will talk to you about this.

You cannot enter this trial you have certain subtypes of low grade glioma (your consultant will be able to tell you if this applies to you)

Trial design

If possible, you will have an operation to remove all the tumour, or as much of it as possible. If the tumour has been completely removed, you will not have any more treatment for now. Your progress will be followed closely by your consultant.

If you cannot have surgery and you do not have any symptoms, you may not have treatment at the moment. Your consultant will follow you closely.

If your brain tumour comes back, or it continues to grow and is causing symptoms, the consultant will discuss further treatment with you. The choice of treatment will depend on

The location of your tumour (whereabouts it is in the brain or spinal cord)
Your age
Whether you have neurofibromatosis type 1 (NF1)

Children without NF1

If you are 7 years or younger, you may have chemotherapy. This part of the trial is randomised. Children taking part are put into two different treatment 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 will have the standard treatment using the drugs vincristine and carboplatin.

If you are in group 2, you will have vincristine, carboplatin and etoposide. The treatment plans for these two groups are quite complex so your consultant will explain them to you in more detail. Overall, the chemotherapy should take about 18 months for both groups.

If you are aged 8 years or older, you may have conformal radiotherapy. Your first visit to the radiotherapy department will be for planning. The doctors will make very detailed plans for your treatment. You will have a mask specially made for you so that your head stays still during treatment. You will have treatment every day, Monday to Friday, for 6 weeks (so a total of 30 treatments).

You may also have chemotherapy, depending on the individual circumstances of your disease. You may have standard chemotherapy with vincristine and carboplatin. Or you may take part in the randomization part of this trial, so treatment in either group 1 or 2. Your consultant will explain whether chemotherapy is appropriate for you and whether you have standard chemotherapy or take part in the randomisation.

If you are aged between 16 and 18 years old, or are aged between 18 and 25 years with a diagnosis of pilocytic astrocytoma you will have treatment as described above for aged 8 years or over. But you do not take part in the randomization.

Children with NF1

If you have chemotherapy you will have standard chemotherapy treatment with vincristine and carboplatin, as for group one above. The treatment will take about 18 months in total. There is no randomisation in this group.

If you are not able to have surgery or chemotherapy, you may have conformal radiotherapy.

Hospital visits

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

An eye test
A neurological examination
An MRI of the brain and possibly spinal cord
Blood tests

Some of these tests are repeated during treatment. Whichever chemotherapy you have, you will probably be able to have this as an outpatient. So you will have your treatment during the day and go home every night.

If you have radiotherapy, you will have this as an outpatient, so you will need to travel to hospital each day, Monday to Friday, for 6 weeks. After you have finished treatment you will continue to have follow up appointments. These visits will include physical examinations, neurological examinations, eye tests and blood tests. These appointments will be

Every 3 to 6 months for the first 3 years after treatment
Every 6 months for years 4 to 5
Every 6 to 12 months for years 6 to 10

Side effects

All treatments have side effects. The most common side effects of chemotherapy include

Hair loss
A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
Feeling or being sick
Loss of appetite
Dry and sore mouth

You can read about the particular side effects of vincristine, carboplatin and etoposide by clicking on the drug names. The most common side effects of radiotherapy to the brain include

Sore skin in the area being treated
Hair loss (hair will start to grow back a few months later, but may be thinner in some areas)
Feeling or being sick
Feeling tired

You may have specific side effects, depending on the area of the brain being treated. Some of these will be long term side effects. For example, you may need extra help with schooling in the future. Your consultant will discuss this with you in detail.