
"I am glad that taking part in a trial might help others on their own cancer journey.”
This study is looking at chemotherapy, radiotherapy and stem cell transplants for people with high risk neuroblastoma.
It is open to children and young people with a high risk that:
Please note, we use the term ‘you’ in this summary, but of course if you are a parent of a child with cancer, we are referring to your child.
Doctors can treat high risk neuroblastoma with:
In this study you have all parts of the treatment. The study team are looking at the following parts of treatment:
Induction chemotherapy
The is a combination of drugs called RAPID COJEC. Researchers think that another combination of chemotherapy called GOPH might be better. Doctors in Germany already use GOPH.
In this part of the study half the children have RAPID COJEC. The other half have GOPH.
High dose chemotherapy and stem cell transplant
High dose chemotherapy can damage the which makes your blood cells. So to help with this, before having high dose chemotherapy the doctor takes blood to get stem cells (
). You have a stem cell transplant after you have the high dose chemotherapy.
The standard treatment is to give one treatment of high dose chemotherapy and a stem cell transplant. Researchers think that giving an extra treatment of high dose chemotherapy with 2 stem cell transplants might be better.
In this part of the study half the children have the standard treatment. The other half have an extra treatment of high dose chemotherapy and 2 stem cell transplants.
Radiotherapy
Researchers are also looking at adding an extra treatment of radiotherapy to the standard treatment. This is a booster dose. They think it might be better than the standard treatment.
In this part of the study half the children have the standard radiotherapy. The other half have the standard radiotherapy and a booster dose.
The aims of this study are to find out whether:
The following bullet points are a summary of the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.
There are a number of parts in this study. To go into each part there are different entry conditions. At each part your doctor will know what the entry conditions are. They will go through them with you to see if you are able to join that part. The entry conditions below are for when you join the study from the start. |
Who can take part
You may be able to join this study if have high risk neuroblastoma that has spread to nearby tissue or to another part of the body. One of the following apply, you are:
or
or
And both of the following apply. You:
Who can’t take part
Cancer related
You cannot join this study if any of these apply. You:
Medical conditions
You cannot join this study if any of these apply. You:
Other
You cannot join this study if any of these apply. You are:
This is an international phase 3 study. The team need 800 people worldwide to take part with 206 people in the UK.
There are 5 parts to the study. After each part your doctor will examine you again. This is to make sure you are able to go on to the next part.
Part 1 – Induction
In this part a computer puts you into a treatment group. This is randomisation. Neither you nor your doctor chooses which group you are in. The 2 chemotherapy treatment groups are:
RAPID COJEC
In this group you have the following chemotherapy:
GPOH
In this group you have the following chemotherapy:
In each group you have all the chemotherapy as a drip into a vein through a or a
.
Everyone has as an injection under the skin. This is a growth factor that helps your bone marrow make blood cells.
Your doctor will tell you when and how often you have the treatment.
Everyone has stem cells collected through a drip into a vein. This can be either during or just after this treatment. Your doctor will talk to you about this before you have the stem cells taken.
After the induction chemotherapy you might not be able to continue in this study. In this case your doctor might suggest you go into a trial called VERITAS.
Part 2 - Surgery
Whether you take part in the study or not you will probably have surgery to remove the neuroblastoma after chemotherapy. You will be in hospital for 1 to 3 weeks. Your doctor will tell more about the surgery.
Part 3 – High dose chemotherapy and stem cell transplant
In this part a computer puts you into a treatment group. This is randomisation. Neither you nor your doctor chooses which group you are in. The 2 high dose chemotherapy treatment groups are:
After the high dose chemotherapy everyone has their own stem cells put back into their blood stream.
You have all these treatments as a drip into a vein through a central line or a PICC line.
Your doctor can tell you more about the treatments, how long they take and how often you have them.
Part 4 – Radiotherapy
Everyone has radiotherapy.
The 2 radiotherapy treatment groups are:
A computer puts you into a treatment group. Your doctor will talk to you about this.
Before your radiotherapy you have a planning appointment. This is to make sure the radiotherapy goes exactly where it is needed.
You have radiotherapy once a day Monday to Friday for 2½ weeks.
Part 5 – Maintenance treatment
After radiotherapy everyone has treatment to prevent the neuroblastoma coming back. This is a standard treatment.
Your doctor will tell about:
You see the doctor to have tests before taking part. These include:
You are in hospital for most of your treatment.
Your doctor sees your regularly during treatment.
After treatment you see the doctor:
Your doctor will then tell you how often they want to see you.
The study team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.
We have information about the side effects of:
We also have information about the side effects of radiotherapy.
Your doctor will talk to you about the possible side effects of all the treatments before you agree to take part.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Martin Elliot
Cancer Research UK Clinical Trials Unit, Birmingham
International Society of Paediatric Oncology (SIOP)
Solving Kids Cancer (SKC)
Gustave Roussy
SIOPEN
Neuroblastoma UK
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
"I am glad that taking part in a trial might help others on their own cancer journey.”