
"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
The trial is for men and teenage boys (14 years or older) whose germ cell tumours have come back or treatment has stopped working.
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.
There are 2 types of chemotherapy you can have if your germ cell tumour gets worse after the first treatment. These include:
high dose chemotherapy with carboplatin and etoposide followed by a stem cell transplant
But doctors aren’t sure which treatment works best. So they want to compare them to find out more.
The main aims of the trial are to:
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.
Who can take part
You may be able to join this trial if all of the following apply.
You:
Who can’t take part
You cannot join this trial if any of these apply.
Cancer related
You:
Medical conditions
You:
This phase 3 trial is taking place worldwide. It is a randomised trial. The researchers would like 420 men or teenage boys to take part.
You are put into 1 of the following treatment groups:
Neither you nor your doctor can decide which group you are in.
Standard dose chemotherapy
You have a combination of chemotherapy called TIP. This includes the drugs:
You have all your chemotherapy as a drip into a vein. Each period of treatment is 21 days. You have 4 cycles of treatment. So treatment takes 12 weeks in total. The first day of each treatment cycle is called day 1.
You have:
High dose chemotherapy
You have treatment as follows:
Before your high dose chemotherapy, your team collects your stem cells. After the treatment you have your stem cells replaced via a vein through a drip. The cells find their way back to your bone marrow. Then you can make the blood cells you need again.
The trial team can tell you more about how often you have the chemotherapy drugs. Treatment takes 13 to 16 weeks in total.
Both groups
In both treatment groups you have some injections after chemotherapy to help your blood cells regrow. These are called growth factors and you have these as injections under the skin. You have 1 of the following:
The nurse or doctor will show you or a family member or friend how to give these injections at home if you have filsgrastrim or lenograstim.
Quality of life
The trial team will ask you to fill out a questionnaire before you start treatment and at set times during treatment. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study. You only complete the questionnaires if you are 18 or older.
Research samples
The trial team will ask you to have a blood test and give a tissue sample (biopsy). The tissue sample may be from a previous biopsy or a new biopsy.
They will look at your genetic material (DNA), in your body cells such as blood and tissue cells. Knowing more about people’s genetic material might help the doctors to understand more about germ cell tumours and how treatment works. This is known as pharmacogenetic testing.
They will also ask to use any leftover samples for research purposes. You don’t have to agree to give these research samples if you don’t want to. You can still take part in the trial.
You’ll see the doctor and have some tests before you start treatment. The tests include:
You might also have a bone scan.
You have standard dose chemotherapy at the hospital usually as an inpatient for about 5 days. In the high dose chemotherapy group, you stay in the hospital for treatment. This is because you are more at high risk of developing an infection during this period so you will be in your own room. You stay in hospital for about 3 weeks.
Follow up appointments
When you finish treatment, you see the doctor after a month for a check up.
If you stop treatment but your cancer hasn’t got worse you see the doctor:
At each visit you have a check up, blood tests and an MRI scan or CT scan. The trial team follow you up for 5 years in total.
The most common side effects of high dose chemotherapy and a stem cell transplant include:
We have more information about:
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Robert Huddart
Cancer Research UK
European Organisation for Research and Treatment of Cancer (EORTC)
Institute of Cancer Research (ICR)
This is Cancer Research UK trial number CRUK/12/049
Freephone 0808 800 4040
"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”