UKP3BEP: A randomised phase 3 trial of accelerated versus standard BEP chemotherapy for patients with intermediate and poor-risk metastatic germ cell tumours.
Who can take part
Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.
You may be able to take part in this clinical trial if you:
- are under the age of 45
- have a stage IV ovarian germ cell tumour
- have blood test values within a certain range
- are able to start trial treatment within 14 days of randomisation and to comply with all trial requirements
This is not an exhaustive list. If you're interested in participating in a clinical trial, you should speak to your doctor about what other criteria might apply.
About the trial
Germ cells are cells in the body that develop into sperm or eggs. Cancerous tumours can develop from these germ cells. This trial is looking at a number of different germ cell tumours, this summary, however, focuses only on ovarian germ cell tumours in adult women.
The current standard treatment for germ cell tumours is a combination of chemotherapy drugs, known as BEP. BEP consists of three chemotherapy drugs, bleomycin, etoposide and cisplatin, which are given in a set order every three weeks.
The purpose of this trial is to compare the effects of giving BEP every two weeks (called accelerated BEP) with giving BEP every three weeks (called standard BEP). The trial will be looking at:
- which schedule of BEP is most effective in treating germ cell cancers
- what side effects are reported
- the severity of the side effects on each schedule
- which schedule of treatment is preferred by patients
To be able to enter the trial you will need to have screening tests to ensure that you are eligible to take part.
If you go on to take part in this study, you'll be randomised (placed into a treatment group by a computer) into one of two treatment groups:
- Standard BEP – you'll receive treatment over a cycle lasting three weeks and will have four cycles.
- Accelerated BEP – you'll receive your treatment over a cycle lasting two weeks and will have four cycles followed by another four weeks of bleomycin-only treatment, once a week for each week. In addition to the chemotherapy drugs, you'll receive a drug called pegfilgrastim. This is used to stimulate the growth of 'healthy' white blood cells in the bone marrow, once chemotherapy is given. White blood cells help the body to fight infection.
Women in both treatment groups will have regular tests to make sure they're well enough to continue with treatment and will also be followed up at regular intervals after treatment.
