A trial looking at giving a single cycle of chemotherapy for testicular cancer (111 trial)
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This trial looked at giving one cycle of BEP chemotherapy instead of two, for testicular cancer. Cancer Research UK supported this trial.
It was open for people to join between 2010 and 2014, and the research team published the results in 2020.
More about this trial
Doctors usually treat testicular cancer with surgery to begin with. Men often have a scan after their operation to check for signs that the cancer has spread (secondary cancer). But sometimes secondary cancer is too small to see on a scan. If doctors think that the cancer is likely to have spread, even if they can’t see it, they may give chemotherapy after surgery.
The most common chemotherapy drugs they give are bleomycin, etoposide and cisplatin. This combination of chemotherapy is called BEP.
When this trial was done, it was common for these men to have 2 cycles of BEP. But chemotherapy has side effects which can last for many years. If people have a higher total dose of chemotherapy, they are more likely to have long term side effects.
Doctors wanted to find out if having less chemotherapy works as well. People taking part in this trial had one cycle of BEP, rather than two. They had:
- half the usual dose of bleomycin and cisplatin
- just over two thirds of the usual dose of etoposide
The main aim of this trial was to find out if one cycle of BEP chemotherapy works as well as two, for testicular cancer.
Summary of results
The trial team found that one cycle of BEP chemotherapy worked as well as two cycles.
Trial design
236 people had treatment as part of this trial. They all had either:
- a type of testicular cancer called non seminomatous germ cell tumour (NSGCT), or
- a mixture of NSGCT and another type of testicular cancer called seminoma
They all had early stage cancer and there was no sign of secondary cancer on their scans. But doctors thought there was a significant chance that they may have areas of secondary cancer that were too small to see. So they decided it was best to treat them with chemotherapy.
Of those who took part, 221 people had the full dose (cycle) of BEP chemotherapy as planned.
Results
The research team found that the cancer came back in 4 people (2%) who had one cycle of BEP.
The cancer came back within the first 2 years in 3 of these men (1.3%). So the risk of the cancer coming back 2 years after one cycle of BEP is similar to the risk for those who have two cycles.
The 4 men whose cancer came back went on to have more treatment, and 3 of them had no signs of cancer at 5 years.
Side effects
The trial team analysed the side effects in 233 of the people who took part.
Many people had one or more side effects. Most were mild or didn’t last long. But 95 people (41%) had at least one side effect that was more severe. These included a drop in white blood cells and blood clotting cells (platelets) or a high temperature which usually lasted just a few days.
Only a small number of people (less than 3%) had longer lasting side effects.
Conclusion
The trial team concluded that the results from one cycle of BEP were similar to the results expected from 2 cycles, even if the total dose of chemotherapy is lower.
They recommend that one cycle of BEP after surgery should become standard treatment for people with early stage testicular cancer and a high risk that it has spread.
Where this information comes from
We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (
) and published in a medical journal. The figures we quote above were provided by the trial team who did the research. We have not analysed the data ourselves.
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
Prof Michael Cullen
Supported by
Cancer Research UK
Institute of Cancer Research (ICR)
NIHR Clinical Research Network: Cancer
Queen Elizabeth Hospital Birmingham Charity
University Hospital Birmingham NHS Foundation Trust
Other information
This is Cancer Research UK trial number CRUK/09/011.
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
