A trial comparing BEP and Taxol-BEP chemotherapy for male germ cell tumours (MRC TE21, EORTC 30983)
Cancer type:
Status:
Phase:
This trial looked at BEP chemotherapy with or without paclitaxel (Taxol) for male germ cell tumours.
Germ cells are cells that produce eggs in females and sperm in males. Male germ cell cancers usually develop in the testicles, but can be found in other parts of the body.
Doctors often treat germ cell cancers with surgery if it is in the testicle or chemotherapy if it is somewhere else in the body. They usually give a combination of chemotherapy called BEP. This is bleomycin, etoposide and cisplatin.
BEP often works very well. But doctors are always keen to improve treatments. They thought that adding a drug called paclitaxel (Taxol) may have been better for germ cell tumours classed as ‘intermediate prognosis’. There are 2 main types of germ cell tumour. Intermediate prognosis for seminoma germ cell tumour means that the tumour has spread beyond the lung and lymph nodes. Intermediate prognosis for non seminoma germ cell tumours means that the tumour started in your testicle or abdomen. It may have spread to the lungs or lymph nodes, but no further. Paclitaxel is a drug that doctors sometimes use after other treatments such as BEP, or for more advanced germ cell tumours. They do not currently use it at the same time as BEP, or for this group of patients.
The aim of this trial was to compare BEP with Taxol-BEP (T-BEP) to see which was better for intermediate prognosis germ cell tumours and to find out more about the side effects of this combination of treatment.
Summary of results
The trial team found that Taxol-BEP (T-BEP) seemed to be safe and may help to stop intermediate prognosis germ cell tumours coming back.
This was a randomised trial. The people taking part were put into 1 of 2 treatment groups. Neither they nor their doctor could choose which group they were in.
People in the first group had BEP. People in the second group had T-BEP.
The trial team intended to recruit 498 people. Unfortunately the trial didn’t recruit as well as they thought it would. They recruited a total of 337 people. Of these
- 169 had BEP
- 168 had T-BEP
After an average follow up of just over 5 years the trial team looked at the number of people whose germ cell tumour had not come back. This was the case in
- Just under 80 out of every 100 people (80%) who had T-BEP
- Just over 71 out of every 100 people (71%) who had BEP
Included in these 337 people were 26 people whose germ cell tumour was not intermediate prognosis. The research team took these 26 people out and looked again at the number of people whose germ cell tumour had not come back. This was the case in
- Just under 83 out of every 100 people (83%) who had T-BEP
- Just over 70 out of every 100 people (70%) who had BEP
The trial team stated that these figures showed T-BEP was better and that they were unlikely to have happened by chance (they were
The trial team found no difference between the groups when they looked at the overall number of people who were alive after an average follow up of 5 years.
There were very few severe side effects in either group. The most common side effects reported by both groups were
The team accepted that the trial didn’t recruit as well as they hoped and so the results were not as conclusive as they had hoped. It also included some people whose tumour wasn’t of intermediate prognosis. But they concluded that T-BEP seemed to be safe and may have helped to treat intermediate prognosis germ cell tumour.
We have based this summary on information from the team who ran the trial. The information they sent us has been reviewed by independent specialists (
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.
Chief Investigator
Dr R de Wit
Supported by
European Organisation for Research and Treatment of Cancer (EORTC)
Experimental Cancer Medicine Centre (ECMC)
Medical Research Council (MRC)
National Institute for Health Research Cancer Research Network (NCRN)
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040