A randomised phase II trial of intensive induction chemotherapy (CBOP/B15EP) and standard BEP chemotherapy in poor prognosis male germ cell tumours
Testing a new treatment for a rarer form of testicular cancer
What is this study about?
There has been great progress in treating men with testicular cancer and when detected early, most men are now cured. However, amongst men with very advanced (poor prognosis) disease up to half may not be cured. The TE23 trial aimed to improve on this.
At the start of the trial, the standard treatment for these men was to give three chemotherapy drugs over twelve weeks. These drugs are called Bleomycin, Etoposide and Cisplatin, also known as BEP. We compared how well this worked by giving some men who took part in this trial a combination of five different chemotherapy drugs given over a fifteen week period. The new 5 drug combination contained the drugs Carboplatin, Vincristine, as well as Bleomycin, Etoposide and Cisplatin, and together this regimen is known as CBOP/B15EP. A small study in Europe using the same combination had shown promising results but had not made a direct comparison with standard treatment. We recruited 89 patients, half of whom were randomly allocated to BEP and half to CBOP/B15EP. We then assessed how patients responded to these treatments.
The main study results were published in March 2015. These reported that, for men with poor prognosis disease, CBOP/B15EP may be better than BEP at shrinking the cancer, but also that people receiving CBOP/B15EP had more side effects than those receiving BEP. A larger international trial is needed to find out how well it works to prevent cancer coming back. A more detailed summary of the trial results can be found on the Cancer Research UK website (TE23 Results summary)
Type of study
Who is funding the study?
CRUK and MRC, via the Clinical Trials Advisory and Awards Committee (CTAAC).
When is it taking place?
The trial finished recruiting patients in December 2009, and the main trial results were published in March 2015 (see below for details).
Where is it taking place?
Hospitals across the UK.
Who is included?
Patients with poor prognosis male germ cell tumours.