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A trial looking at chemotherapy for testicular cancer (TE3)

Please note this trial is no longer recruiting patients.

This trial is comparing 2 different ways of having a drug called bleomycin for testicular cancer.

The standard chemotherapy for testicular cancer is a combination of bleomycin, etoposide and cisplatin. This is usually called BEP chemotherapy.

BEP works very well for testicular cancer, and many patients are cured. But bleomycin can cause serious side effects in a small number of patients. It can damage the lung tissue and cause shortness of breath. If this happens the doctors may need to lower the dose of bleomycin, or even change to another drug.

Researchers think that giving bleomycin more slowly may reduce the risk of it causing lung damage. In this trial, they will compare bleomycin given over half an hour on 3 separate days (standard treatment), to a slow continuous infusion of bleomycin 24 hours a day, for 3 days.

The aim of this trial is to find out if giving bleomycin continuously for 3 days causes fewer side effects than giving the same dose over a shorter time on 3 separate days. And to see which treatment works better.

Recruitment

Start 01/07/2003
End 02/03/2011

Phase

Phase 3

Who can enter

You can enter this trial if you

  • Have testicular cancer that doctors expect to be cured with chemotherapy (‘good risk’ testicular cancer)
  • Have not had radiotherapy or chemotherapy for your testicular cancer yet
  • Are well enough to have chemotherapy
  • Have satisfactory blood test results
  • Are aged 16 to 50 years

You cannot enter this trial if you

  • Have had radiotherapy or chemotherapy already
  • Have poor lung function
  • Have poor kidney function
  • Have had another cancer, except for basal cell skin cancer
  • Have any other serious medical condition

Trial design

This is a randomised trial. It will recruit 210 patients. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

Group 1 have ‘standard’ BEP chemotherapy. Each 3 weeks of chemotherapy is one cycle of treatment. You have

  • Etoposide through a drip into a vein on the first 3 days of each cycle. This takes about 2 hours each day.
  • Cisplatin through a drip into a vein on the first 2 days of each cycle. This takes about 4 hours each day.
  • Bleomycin through a drip into a vein on one day each week of the 3 week cycle (day 2, day 8 and day 15). This takes about half and hour each time.

Group 2 will also have BEP chemotherapy, but with continuous bleomycin. Each 3 weeks of chemotherapy is one cycle of treatment. You have

  • Etoposide through a drip into a vein on the first 3 days of each cycle. This takes about 2 hours each day.
  • Cisplatin through a drip into a vein on the first 2 days of each cycle. This takes about 4 hours each day.
  • Bleomycin into a vein continuously (24 hours a day) for the first 3 days of each cycle.

Both groups will have the same dose of bleomycin overall. And have 3 cycles of treatment over 9 weeks.

You will fill out a questionnaire before you start treatment, after your first cycle of chemotherapy, and then a few weeks and a year after you finish treatment. It will ask you how you have been feeling and about any side effects you have had. This is called a ‘quality of life’ questionnaire.

Hospital visits

You will see the doctors and have some tests before you take part in this trial. The tests include

You will be in hospital for 3 days at the start of each 3 week cycle of chemotherapy. If you are in group 1, you will go to the outpatient department for bleomycin on day 8 and day 15 of each cycle. If you are in group 2, you will go to the hospital on days 8 and 15 for blood tests. But you will not have any treatment on these days.

You have blood tests and possibly a chest X-ray before each cycle of chemotherapy. You have a CT scan and lung function tests after the first cycle.

After you finish treatment you have a CT scan, blood tests, lung function tests, a physical examination and possibly a chest X-ray.

After you finish treatment you will see the doctors once a month for 3 months, then every 2 months for 6 months, and then every 3 months for another year.

Side effects

The most common side effects of BEP chemotherapy include

There is more information about the side effects of bleomycin, etoposide and cisplatin on CancerHelp UK.

Location of trial

CLOSED

For more information

The Information Nurses
Cancer Research UK
Angel Building
407 St John Street
London
EC1V 4AD

Tel: 0808 800 4040
Email: cancer.info@cancer.org.uk

Please note: we cannot help you to join a specific trial. Unless we state otherwise in this trial summary, you must go through your own doctor.

Chief Investigator

Dr Jonathan Shamash

Supported by

Barts Health NHS Trust
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
National Cancer Research Network (NCRN)
The Orchid Cancer Appeal