A trial looking at treatment for children and teenagers with germ cell tumours (GC 2005 04)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Children's cancers

Status:

Closed

Phase:

Phase 3

This trial is trying to improve the treatment for children and teenagers with germ cell tumours.

This trial is for children and young people up to their 18th birthday. We use the term ‘you’ in this summary, but of course if you are a parent, we are referring to your child.

Germ cell tumours are quite rare, but are most common in children and young adults. The tumours begin in the reproductive cells of the body, the eggs and sperm. Because they begin in the eggs and sperm most germ cell tumours develop in the ovaries or testicles. But during development of a baby in the womb the cells can also travel to other parts of the body. So tumours may develop elsewhere, for example in the stomach.

In the UK, germ cell tumours are usually treated with surgery alone, or with surgery followed by chemotherapy. The treatment works well in most children and 9 out of 10 are cured of their cancer. But of course doctors want to improve on this.

Doctors recognise that chemotherapy has side effects and want to find out if some of the children can have less chemotherapy or none at all, while still being cured.

Germ cell tumours produce substances called markers and these are measured by a blood test. These markers are AFP (alpha feta protein) and HCG (human chorionic gonadotropin). Doctors follow the marker levels to find out if treatment is working. In a previous trial for germ cell tumours, children had chemotherapy until their marker levels had returned to normal. They then had 2 more course of chemotherapy. So children had about 5 or 6 courses of chemotherapy in total.

The doctors recruiting patients into this trial want to decide on the amount of chemotherapy in a slightly different way. They will look at

  • Where the tumour started
  • Whether it has spread or not
  • The level of AFP in the blood

This will mean that some children will have less chemotherapy than they would have done in the past. If this is found to be a better way or as good a way of treating germ cell tumours, while reducing side effects, it will be used for children and teenagers in the future.

Who can enter

You can enter this trial if you

  • Have recently been diagnosed with extracranial (outside the brain) germ cell tumour, or mature or immature teratoma
  • Have satisfactory blood test results
  • Are aged between 0 years up to your 18th birthday

You cannot enter this trial if you

  • Have a germ cell tumour that is intracranial (inside the brain)
  • Have already had chemotherapy
  • Are pregnant or breastfeeding

Trial design

This national trial aims to recruit about 100 children and teenagers with germ cell tumours over 5 years.

You may have already had an operation to remove as much of your tumour as possible by the time you are recruited on to this trial. If not, the doctors will decide whether it is possible for you to have an operation.

There are 3 treatment groups. Your doctor will decide which group you are in depending on

  • Where the tumour started
  • Whether it has spread or not
  • The level of AFP in your blood

The groups are called ‘low risk’, ‘intermediate risk’ and ‘high risk’. This is to do with the risk of your tumour coming back (recurring).

Low risk

If you are in this group, you will not have chemotherapy following your surgery. You will be closely monitored. If a scan shows that the cancer has come back, or if the level of AFP rises, your doctor will then consider chemotherapy. In that case, you will become part of the intermediate or high risk group.

Intermediate risk

If you are in this group, you have chemotherapy every day for 3 days into your central line. You have etoposide over about 4 hours every day. On day two, you also have carboplatin over about 1 hour. On day three, you also have bleomycin over about 30 minutes. This will be repeated every 3 weeks.

This 3 week period is called a ‘cycle’ of chemotherapy. You have 4 cycles, over about 3 months.

After chemotherapy you will have a scan. If this shows that there is still some cancer left behind, your doctor may talk to you about the possibility of further surgery to remove it.

High risk

If you are in this group, you have the same chemotherapy as the intermediate risk group. But you have 6 cycles of chemotherapy, over about 4 and a half months.

After chemotherapy you will have a scan. If this shows that there is still some cancer left behind, your doctor may talk to you about the possibility of surgery to remove it.

Hospital visits

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

You have some of these tests again during and after treatment.

The treatment for your germ cell tumour is very intensive, whether you take part in this trial or not. You will not have extra tests or treatment as a result of taking part in this trial.

After treatment has finished, you will continue to see the doctor regularly for many years. These appointments will be arranged with you individually and will probably become less frequent as time passes.

Side effects

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

If you would like to read more about the side effects of carboplatin, etoposide and bleomycin, click on the drug names.

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 J. Hale

Supported by

Cancer Research UK Children's Cancer Trials Team
University of Birmingham
NIHR Clinical Research Network: Cancer

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 657

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

Rhys was only four years old when he was diagnosed with a brain tumour

A picture of Rhys

"He went through six operations and was placed on a clinical trial so he could try new treatments.”

Last reviewed:

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