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

This trial is looking at giving a single cycle of chemotherapy for testicular cancer.

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

Recruitment

Start 18/03/2010

End 18/03/2013

Phase

Other

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 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 or germ cell cancer 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.

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.