A trial looking at treatment for germ cell tumours (AGCT1531)
Cancer type:
Status:
Phase:
This trial is looking at follow up and different treatment options for people with germ cell tumours to help improve treatment results and 
.
Germ cell tumours are a type of cancer that mainly affects children, teenagers and young adults. This trial is open to all of them.
We use the term ’you’ but if you are a parent we are referring to your child.
More about this trial
Surgery and chemotherapy are the main treatment for germ cell tumours. You usually have surgery first to remove the germ cell tumour. You might then have chemotherapy.
In this trial the team want to look at substances in the blood called . Some tumours and cancers make substances that are found in the blood. These are called tumour markers.
The team have identified new tumour markers that could tell:
- whether the germ cell tumour is coming back
- how well treatment is working
This new tumour marker is microRNA. They think that microRNA might be a better tumour marker than the substances that doctors currently measure. They want to find out if doctors might be able to use these new tumour markers to help with the treatment of people with germ cell tumours.
In this trial you have surgery as planned to remove the germ cell tumour. After surgery everyone has regular blood tests to check for tumour markers.
You have chemotherapy if your tumour was not completely removed by surgery or it may have spread to another part of the body.
The chemotherapy you usually have is a combination of bleomycin, etoposide and cisplatin (BEP).
In this trial researchers are looking at bleomycin, etoposide and carboplatin (BEC). Carboplatin is a chemotherapy drug that is similar to cisplatin. It might work just as well but have fewer side effects. The team will compare BEP and BEC.
For people who don’t have chemotherapy after surgery you see the doctor regularly. This is called active watching. If the tumour markers show that your tumour may be coming back your doctor will talk to you about treatment options. This might include having treatment as part of this trial.
The aims of this trial are to find out:
- how well active watching after having the tumour completely removed by surgery works
- how well BEC compares to BEP
- more about the side effects of these chemotherapy combinations
- how these treatments affect
quality of life
Who can enter
The following bullet points are a summary of 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.
Who can take part
You may be able to join this trial if you are 25 years old or younger and you have a germ cell tumour of the:
You need to be up and about for some of the day but might need help looking after yourself (performance score 0, 1,2 or 3).
Those who are to have chemotherapy
All of the following must also apply. You:
- are well enough to have treatment
- have satisfactory blood test results
- are willing to use reliable contraception during the trial if you are sexually active and you or your partner might become pregnant
Who can’t take part
You cannot join this trial if any of the following apply. You have:
- stage 1 testicular cancer and you have had the
lymph nodes at the back of your tummy removed by surgery - a pure dysgerminoma
- a pure mature
teratoma - a pure immature teratoma
- a poor risk germ cell tumour
- a germ cell tumour that started in the brain or spinal cord
- a germ cell tumour with somatic malignant transformation
- a spermatocytic seminoma
- have already had treatment for your current cancer
- have had radiotherapy. This is apart from radiotherapy to your brain, spinal cord or both for cancer that has spread there.
Your doctor will know about all of the above.
Those who are having chemotherapy
You cannot join this trial if any of the following apply. You:
- have a lung problem that could affect you having bleomycin
- are pregnant
- are breastfeeding or planning to breastfeed
Trial design
This is an international phase 3 trial. You have surgery as planned by your doctor.
There are 2 different parts in this trial. The observation part and the treatment part.
Observation part
People whose tumour has been completely removed by surgery go into this part.
The team need about 700 people worldwide to take part with 155 people from the UK.
You have:
- regular hospital appointments
- blood tests for
tumour markers - tests and scans
They use these to monitor your tumour to see whether it is coming back or starting to grow.
If your tumour is coming back or growing your doctor will talk to you about what treatment options you have. This might include having treatment as part of the trial.
Treatment part
People whose tumour has not been completely removed by surgery or has spread to another part of the body go into this part.
The team need about 1,000 people worldwide to take part with 181 people from the UK.
This part is randomised. A computer puts you into a group. Neither you nor your doctor can choose which group you are in. The 2 groups are:
- bleomycin, etoposide and carboplatin (BEC)
- bleomycin, etoposide and cisplatin (BEP)
You have all these drugs as a drip into a vein. You have treatment in cycles. Each is 3 weeks. You have 3 or 4 cycles. Your doctor will tell how many you have.
Samples for research
You give several blood samples in both parts of the trial. Where possible the team take these samples when you give blood samples as part of your routine care.
Doctors use substances in the blood called to monitor what is happening to the tumour.
The team will use these samples to look for a substance in the blood called microRNA. They think that microRNA might be a better tumour marker than what is currently used.
Quality of life for people in the treatment part
The team ask you to fill in questionnaires:
- when you agree to take part in the trial
- when you finish treatment
- a year after finishing treatment
The questions ask about:
- your general health
- what daily activities you can do
- side effects
These are quality of life questionnaires.
Hospital visits
You see the doctor for tests before taking part. These tests include:
- a
physical examination - blood tests
- scans such as a CT scan, an MRI scan or an ultrasound scan. Your doctor will tell you which scan or scans you have.
You will also have a hearing test if you are having chemotherapy. You might also have a breathing test (). Your doctor will let you know if you need one.
Treatment part
While having chemotherapy you see the doctor at regularly. This is to see how you are and for blood tests.
Everyone
As part of the trial you see the doctor every:
- month for the 1st year
- 3 months for the 2nd year
- 6 months for the 3rd, 4th and 5th year
- then every year to the 10th year
You have tests and scans regularly to see how you are. Your doctor will tell you how often you have these.
Side effects
Observation part
The trial team don’t expect any side effects for people in this part of the trial.
Treatment part
The trial 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.
The most common side effects of chemotherapy include:
- hair loss
- a drop in blood cells causing an increased risk of infection, breathlessness, tiredness, bruising and bleeding
- feeling or being sick
We have more information about:
- bleomycin, etoposide and cisplatin (BEP)
- cisplatin
- carboplatin
- etoposide
- bleomycin
- possible problems after cancer surgery
Your doctor will talk to you about the possible side effects of the treatments and answer any questions you have before you agree to take part in the trial.
Location
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.
Chief Investigator
Dr Sara Stoneham
Supported by
Cancer Research UK
Children’s Oncology Group (COG)
Japan Children’s Cancer Group (JCCG)
National Cancer Institute (NCI)
University of Birmingham
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
