A trial looking at Intensity Modulated Arc Therapy for people with neuroblastoma (IMAT)

Cancer type:

Children's cancers
Neuroblastoma

Status:

Open

Phase:

Phase 1/2

This trial is comparing a higher dose of radiotherapy with the standard dose for people with neuroblastoma. It is also looking at using a type of radiotherapy called Intensity Modulated Arc Therapy (IMAT). 

This trial is for children older than 18 months as well as adults. We use the term ‘you’ in this summary, but of course if you are a parent, we are referring to your child. 

Cancer Research UK supports this trial. 

More about this trial

Neuroblastoma is a cancer that usually starts in nerve cells of the tummy (abdomen). It mainly affects children and young people but it can also affect adults.   

Neuroblastoma is often treated with radiotherapy. This uses high energy x-rays to kill cancer cells. 

Doctors plan radiotherapy treatment so that cancer cells get a high dose of radiation and healthy cells receive a lower dose. But this can be hard to do using conventional radiotherapy. 

Researchers have developed a new type of radiotherapy called Intensity Modulated Arc Therapy (IMAT). This allows radiotherapy to be directed more accurately at the cancer. 

Doctors think that using IMAT means a higher dose of radiotherapy can be given so the treatment might be better at killing the cancer cells. 

In this trial you have 1 of the following:

  • normal (standard) dose of radiotherapy 
  • higher dose of radiotherapy 

You might also have either conventional radiotherapy or IMAT. This depends on which type of radiotherapy the doctor thinks is better for you. 

The main aims of this trial are to: 

  • find the highest and safest dose of IMAT 
  • find how well IMAT works as a treatment 
  • learn more about the side effects of IMAT

Who can enter

The following bullet points list 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. 

You may be able to join this trial if all of the following apply. 

  • You have neuroblastoma that started in the tummy or the area between your hip bones (abdominal neuroblastoma)
  • Your doctor thinks that you have a high risk neuroblastoma and that you are well enough to have radiotherapy to try to cure your cancer (radical radiotherapy)     
  • You were at least 18 months at the time of diagnosis
  • You are willing to use effective contraception during treatment if there is any possibility you could become pregnant

You cannot join this trial if you are pregnant.   

Trial design

This is a phase 1/2 trial. Researchers need around 50 people from the UK to take part. 

This trial is randomised. People taking part are put into 1 of the following treatment groups by computer:

  • standard dose of radiotherapy 
  • higher dose of radiotherapy

Neither you nor your doctor will be able to decide which group you are. 
 
study diagram

Standard dose of radiotherapy
You have a radiotherapy planning scan. The scan helps doctors know how much radiation you need and exactly where you need it. After a couple of weeks you start radiotherapy.

Your doctors will decide whether you should have conventional radiotherapy or IMAT. They decide this depending on which treatment they think will cause the least damage to healthy tissue and so have less side effects. 

You have radiotherapy every day, Monday to Friday, with a break at weekends. Each treatment takes about 15 to 20 minutes. You have around 15 treatments (3 weeks).  

Higher dose of radiotherapy 
You have a radiotherapy planning scan and start radiotherapy a couple of weeks later. 

Your doctor will tell you if you have conventional radiotherapy or IMAT. It depends on which treatment doctors think is better for you. 

You have radiotherapy every weekday. Each treatment takes about 15 to 20 minutes. You have around 25 treatments (5 weeks).

Hospital visits

You see a doctor and have some tests (such as blood tests) before taking part. Your doctor can tell you which tests you have. They are the same as the standard treatment. 

During treatment you see the trial doctor every week. This is for 3 weeks if you are in the standard dose of radiotherapy group. And 5 weeks if you are in the higher dose of radiotherapy group.

After you finish radiotherapy you see or speak to the doctor every week for a month. You then see the doctor as part of your regular follow up.

Side effects

Radiotherapy has short term (or acute) side effects that usually start a few days after the radiotherapy begins. And side effects that can start some months or years later (long term or late side effects). 
 
The most common short term side effects of radiotherapy include:

  • tiredness or weakness 
  • feeling or being sick 
  • diarrhoea or constipation 
  • skin problems such as skin rashes and sore skin 
  • loss of appetite 

We have more information about short term side effects of radiotherapy

And information about long term side effects of radiotherapy.

The trial team will tell you about all the possible side effects before you start the trial. 

Location

Belfast
Birmingham
Cambridge
Cardiff
Glasgow
Leeds
London
Manchester
Newcastle upon Tyne
Nottingham
Oxford
Sheffield
Southampton
Sutton
Wirral

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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr Mark Gaze

Supported by

Cancer Research UK
University of Birmingham

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

12055

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Cara took part in a clinical trial

A picture of Cara

"I am glad that taking part in a trial might help others on their own cancer journey.”

Last reviewed:

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