A study looking at improving radiotherapy for bladder cancer (APPLY)

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Cancer type:

Bladder cancer

Status:

Results

Phase:

Phase 2
This study looked at using a type of CT scan to improve radiotherapy planning for people with invasive bladder cancer. The type of CT scan they looked at is called a cone beam CT scan. 
 
The study was for people who weren’t well enough to have:
  • surgery to remove the bladder
  • radiotherapy everyday

More about this trial

Radiotherapy is one of the possible treatments for bladder cancer that has grown into the muscle layer of the bladder. This is called invasive bladder cancer.  Everyone has CT scans to help doctors plan where to aim the radiotherapy beam. These are called planning scans. This is to make sure that they give the highest dose of radiation to the cancer and as little as possible to the surrounding healthy tissue. 

Before the planning CT scan and treatment, you empty your bladder. This is to make sure that the bladder is in the same position when they plan treatment and when you have treatment. But the bladder can move slightly in the body. Earlier research showed that having an empty bladder doesn’t mean that it will be the same size, shape or in the same position for treatment as it was for the planning CT scan.

This study was for people who couldn’t have the normal radiotherapy which is used with the aim to cure (radical radiotherapy). This was because they weren’t well enough or they had other health problems.

The researchers used the cone beam CT scan to plan radiotherapy on each day of treatment. This scan takes pictures in 3D before treatment. Based on the pictures, doctors could then choose the best treatment plan for that day. 

Researchers hoped this would mean the radiotherapy could target the cancer more accurately. And would result in fewer side effects.

Summary of results

The study team found it was possible to use cone beam CT scans to design an ‘on the day’ treatment plan for people with invasive bladder cancer. They say this improved radiotherapy for this group of people. It made it more accurate and the side effects were well tolerated. 
 
This was a phase 2 study. The researchers published results in 2013 and 2017.
 
Treatment
55 people took part in the study. The average age was 86. 
 
Everyone had radiotherapy, once a week, for 4 to 6 weeks. Most completed their treatment. 
 
Everyone had the cone beam CT scans before and after each radiotherapy treatment.
 
Results 
3 months after radiotherapy, the study team looked at how well radiotherapy worked. To do this, they examined the inside of the bladder. This examination is called a cystoscopy Open a glossary item.
 
Of the 55 who took part:
  • 36 had a cystoscopy
  • 19 didn’t have a cystoscopy
The study team had the cystoscopy results for 30 out of 36 people. In this group, they found that in just over 9 out of 10 people, the bladder cancer was under control. This meant it had either gone away, got a bit better or was stable. 
 
They also looked at the number of people living after treatment. At 1 year, this was just over 6 out of 10 people (63%).
 
Side effects
The researchers looked at the short term side effects of radiotherapy:
  • during treatment
  • at 6 weeks
  • at 12 weeks
The study team found that the most common side effects included:
  • problems passing urine such as pain or passing it more often
  • diarrhoea
  • tiredness (fatigue)
Short term side effects 
The researchers looked at the number of people who had moderate to severe problems with their bladder or passing urine. During treatment this included:
  • 22 people who had a moderate problem
  • 10 people who had a more serious problem 
12 weeks after radiotherapy:
  • 6 people had a moderate problem 
  • 1 person had a more serious problem
At some point within 12 weeks of radiotherapy, 21 had a moderate problem and 2 had a severe problem with their digestive system Open a glossary item such as diarrhoea. Though after 12 weeks only 1 person had a moderate problem.
 
Long term side effects
The study team also looked at the long term side effects of treatment at 6 months and 1 year. They had the information for 31 people at 6 months and 23 people at 1 year. 
 
At 6 months:
  • 6 people had a moderate side effect
  • 2 people had a severe side effect
At 12 months:
  • 3 people had a moderate side effect
  • 1 person had a severe side effect
The most common side effects at both timepoints were:
  • problems passing urine or pain passing urine
  • diarrhoea 
So overall, they found the severe side effects had improved over time and were mild, moderate or had got better.   
 
Conclusion 
The study team concluded that it was possible to give radiotherapy using the ‘on the day’ CT scans to plan treatment. Radiotherapy worked to control the cancer in most patients and the side effects weren’t too bad. 
 
The study team recommend this as a possible way to control bladder cancer in people have other health conditions and can’t have radical radiotherapy. 
 
We have based this summary on information from the research team. 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 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.

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

Chief Investigator

Professor Robert Huddart

Supported by

Institute of Cancer Research (ICR)

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Freephone 0808 800 4040

Last review date

CRUK internal database number:

4574

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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