"I now know how cancer can strike anyone whatever their situation or circumstance. I hope by taking part in a trial it will help others in my position in the future.”
A trial looking at giving a single cycle of chemotherapy for testicular cancer (111 trial)
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Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at giving a single cycle of chemotherapy for testicular cancer. This trial is supported by Cancer Research UK.
We know from research that giving a single cycle of BEP at a higher dose may be as good as giving 2 cycles of BEP at the standard dose.
The aims of this trial are to find out
- If a single cycle of BEP at a higher dose is as good as 2 cycles of BEP at the standard dose
- How safe and acceptable the higher dose of BEP is
Who can enter
You can enter this trial if
- You have a non seminoma, or mixed , germ cell cancer that is only in the testicle (stage 1)
- You have testicular cancer that has grown into the blood vessels or lymph vessels (stage T2 or T3)
- You are able to have chemotherapy
- You have satisfactory blood test results
- Your kidneys work well enough (your doctor will test for this)
- You are willing to use reliable contraception during treatment and for 6 months afterwards if there is any chance your partner could become pregnant
- You are at least 16 years old
You cannot enter this trial if you
- Have a type of testicular cancer called seminoma
- Have testicular cancer that has spread outside the testicle (stage 2, 3 or 4)
- Have had chemotherapy before
- Have had another cancer unless you have had
or germ cell cancerin the other testicle, had it removed with surgery (orchidectomy) and it has not come back for at least 3 years
- Have changes to your nerves causing problems with feeling, touch and balance
- Have scarring on your lungs (your doctor will advise you about this)
- Have another medical condition that could affect you taking part in this trial
This trial will recruit about 236 people in the UK. Everyone will have 1 cycle of bleomycin, etoposide and cisplatin (BEP). You begin BEP up to 6 weeks after surgery to remove your testicle (orchidectomy).
A cycle of BEP takes 15 days.
You have on
- Day 1 - bleomycin, etoposide and cisplatin
- Day 2 - etoposide and cisplatin
- Day 3 - etoposide
- Days 8 and 15 - bleomycin
It is unlikely that a single cycle of chemotherapy will affect your fertility. Your doctor will offer to analyse a sperm sample and count the number of healthy sperm (sperm count) you have before chemotherapy. If necessary, they can collect, freeze and store some sperm samples (sperm banking). The research team will repeat the sperm count 1, 2 and 5 years after your chemotherapy. You don’t have to agree to this if you don’t want to. You can still take part in the trial.
You will see the doctor and have some tests before taking part in this trial. These tests include
- Physical examination
- Chest X-ray
- CT scan
- Blood tests
After treatment you see the doctor
- Every 2 months to 6 months
- Every 3 months to 2 years
- Every 4 months to 4 years
- Every 6 months to 5 years
At every visit you will have a physical examination, blood tests and chest X-ray. Except at 6 months, 1 year, 2 years and 5 years when you have a CT scan instead of a chest X-ray.
The most common side effects of bleomycin, etoposide and cisplatin (BEP) are
- Feeling, or being, sick
- Loss of appetite
- Hair loss
- Shortness of breath
- Hearing changes
- Tingling or numbness in your hands or feet (peripheral neuropathy)
How to join a clinical trial
Prof Michael Cullen
Cancer Research UK
Institute of Cancer Research (ICR)
NIHR Clinical Research Network: Cancer
University Hospital Birmingham NHS Foundation Trust
This is Cancer Research UK trial number CRUK/09/011.