A trial looking at the long term effects of treatment for children and young people who had a germ cell tumour

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:

Other

This trial is to find out about the long term side effects of treatment for germ cell tumours. It will recruit children and young people who finished their treatment at least 5 years ago and who have no sign of their cancer remaining (are in remission). We use the term ‘you’ in this summary, but of course if you are a parent, we are referring to your child.

Germ cells are the cells that produce eggs in females and sperm in males. Rarely these cells become cancerous. Germ cell tumours usually develop in the testicles or ovaries, but can be found in other parts of the body. Doctors usually treat germ cell tumours with chemotherapy. And some people will have surgery. These treatments generally work very well and most children and young people are cured.

As more children get better after treatment for germ cell tumours, researchers want to look at the long term effects. Doctors know that the chemotherapy drugs they use might affect how well certain parts of the body work, such as the lungs and the kidneys. They want to understand more about how the cancer and treatment affects quality of life years later.

The aim of this trial is to find out what the late effects of treatment are, and to understand more about how germ cell cancer and its treatment affect quality of life. The doctors will use the information from this trial to improve how they follow up children’s progress after treatment.

Who can enter

You can enter this trial if you were diagnosed with a germ cell tumour and

  • Had treatment with carboplatin, etoposide and bleomycin chemotherapy (JEB) as part of the UKCCSG GC 8901 (GC 2) trial OR
  • Had treatment with cisplatin, vinblastine and bleomycin chemotherapy (PVB) or etoposide, cisplatin and bleomycin chemotherapy (BEP) as part of the UKCCSG GC 7901 (GC 1) trial
  • Finished treatment at least 5 years ago
  • Have no signs of cancer following treatment (you are ‘in remission’)
  • Your doctor thinks that it is appropriate that you take part in this study
  • Are still going to outpatients at one of the CCLG children’s cancer centres, or you are still in contact with one of these centres, and your doctor asks you to take part (if you had treatment for a tumour on the tailbone (coccyx) and have been discharged from follow up at the hospital, your GP may still contact you about the study)

You cannot enter this trial if you were diagnosed with a germ cell tumour that started in your brain.

Trial design

If you can take part in this study, one of the research team will send your parents a letter about it 2 weeks before your routine follow up appointment. If you are over 18 years old, the research team will send the letter directly to you.

With your permission, the research team would like to look at your medical notes to get precise information about the results of any tests you had before and after treatment. These tests are to see if there are any long term effects from treatment. You may need to have some tests repeated. This will depend on what tests and treatment you have had, and how you are.

Everyone taking part will fill in a questionnaire. This will ask about how you are feeling and what side effects you are having from the cancer and treatment. It is called a quality of life questionnaire. If you are older you may want to help your parent fill in the questionnaire, or fill in the questionnaire yourself.

Hospital visits

You will see the doctor at your routine follow up appointment. So you won’t have to make any extra trips to the hospital as part of this trial. You may need to have some tests at this appointment. The doctor will tell you more about this. These tests may include

  • Breathing tests (lung function tests)
  • Tests to see how well kidneys are working (kidney function test)
  • Blood test
  • Ultrasound of the bladder

Your doctor will ask you and your parents to fill in the quality of life questionnaire. You can do this at the hospital or at home.

Side effects

As there are no treatments involved in this trial, there are no side effects.

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. Adam Glaser

Supported by

Children's Cancer and Leukaemia Group (CCLG)
NIHR Clinical Research Network: Cancer

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 1099

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

Katie took part in a new clinical trial

A picture of Katie cycling

"We believed that with the clinical trial, Katie had the best chance of recovery. Without these trials, amazing new treatments may never be found."

Last reviewed:

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