A trial looking at giving a single cycle of chemotherapy for testicular cancer (111 trial)

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

Cancer type:

Testicular cancer





This trial is looking at giving a single cycle of chemotherapy for testicular cancer. This trial is supported by Cancer Research UK.

Doctors often treat testicular cancer with bleomycin, etoposide and cisplatin. Doctors call this BEP chemotherapy. They usually give 2 cycles of BEP.

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 carcinoma in situ Open a glossary item or germ cell cancer Open a glossary item in 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

Trial design

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

You have all 3 drugs through a drip into a vein (intravenous). On days 8 and 15, you may have the bleomycin as an injection into a muscle instead of through a drip into a vein.

It is unlikely that a single cycle of chemotherapy will affect your fertility Open a glossary item. Your doctor will offer to analyse a sperm sample and count the number of healthy sperm (sperm count Open a glossary item) you have before chemotherapy. If necessary, they can collect, freeze and store some sperm samples (sperm banking Open a glossary item). 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.

Hospital visits

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.

Side effects

The most common side effects of bleomycin, etoposide and cisplatin (BEP) are

You can find more about bleomycin, etoposide and cisplatin on CancerHelp UK.

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

Prof Michael Cullen

Supported by

Cancer Research UK
Institute of Cancer Research (ICR)
NIHR Clinical Research Network: Cancer
University Hospital Birmingham NHS Foundation Trust

Other information

This is Cancer Research UK trial number CRUK/09/011.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 2413

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

Ashley was diagnosed with testicular cancer when he was 28

A picture of Ashley

"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.”

Last reviewed:

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