A trial looking at radiotherapy and a new treatment for bladder cancer (Bladder Arcon - BCON)

Cancer type:

Bladder cancer
Transitional cell cancer

Status:

Results

Phase:

Phase 3

This trial looked at radiotherapy with or without carbogen and nicotinamide tablets for bladder cancer that had spread into the muscle (locally advanced). It was supported by Cancer Research UK.

The trial was open for people to join between 2000 and 2006, and the team first published results in 2010. They published further results in 2021.

More about this trial

Doctors can use both surgery and radiotherapy to treat locally advanced bladder cancer. Having radiotherapy means that people don’t have their bladder removed. But the cancer can sometimes come back and they may need more treatment.

Radiotherapy is more likely to kill cancer cells if the cells have plenty of oxygen. The aim of the treatment in this trial was to increase the amount of oxygen available to cancer cells. The researchers hoped that this would help to stop the cancer from coming back.

People in this trial took nicotinamide tablets and used a breathing apparatus called the carbogen breathing system, for a few minutes before and during each radiotherapy treatment.

The main aims of this trial were to find out:

  • how well having carbogen and nicotinamide with radiotherapy worked
  • more about the side effects

Summary of results

The trial team found that there was a significant benefit in adding carbogen and nicotinamide to radiotherapy treatment for people with locally advanced bladder cancer.

Trial design
A total of 333 people joined this trial, and 327 went on to have treatment:

  • 163 had radiotherapy only
  • 164 had radiotherapy with carbogen and nicotinamide

Results
When the researchers compared the average time people lived, they found it was:

  • about 2.5 years (30 months) for those who had radiotherapy only
  • about 4.5 years (54 months) for those who had radiotherapy with carbogen and nicotinamide

Side effects
The most common side effects of radiotherapy with carbogen and nicotinamide were:

  • feeling or being sick
  • feeling that you need to pass urine more often than normal

When the researchers compared the long term side effects of both treatments they found they were about the same.

Conclusion
The research team concluded that adding carbogen and nicotinamide to radiotherapy did help people with locally advanced bladder cancer. And the side effects were similar to having just radiotherapy.

Different doses of radiotherapy
In 2020 researchers combined the results for people who took part in two trials – this trial (BCON) and another trial for bladder cancer called BC2001. They published these results in 2021.

Radiotherapy is measured in Gray (Gy). You often have several doses called fractions. Open a glossary item Some people in each of these trials had 64Gy in 32 fractions. And others had 55Gy in 20 fractions. These were both common treatments for bladder cancer when the trials were done.

The research team combined the results from the 2 trials, to see how well people did.

They looked at the results for 326 people who took part in BCON, and 456 people who took part in BC2001. So a total of 782 people:

  • 376 who had 64Gy in 32 fractions
  • 406 who had 55Gy in 20 fractions

The results showed that, 5 years after treatment, the cancer had come back in fewer people who had 55Gy in 20 fractions. How long people lived for and the side effects they had were very similar in the two groups. 

Conclusion 
The research team concluded that 55Gy in 20 fractions is as good as 64Gy in 32 fractions, for bladder cancer that has grown into the bladder muscle wall. They suggest that 55Gy in 20 fractions should be the standard treatment for this group of patients.

Where this information came from
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 (peer reviewed) Open a glossary item and published in a medical journal. The figures we quote above were provided by the trial team. 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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Peter Hoskin

Supported by

Cancer Research UK
NIHR Clinical Research Network: Cancer

Other information

This is Cancer Research UK trial number CRUK/01/003. 

Freephone 0808 800 4040

Last review date

CRUK internal database number:

19

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Around 1 in 5 people take part in clinical trials

3 phases of trials

Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.

Last reviewed:

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