"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A trial to learn more about weekly radiotherapy for invasive bladder cancer and to look at a different way of planning treatment (HYBRID)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at weekly radiotherapy for bladder cancer and at a new way of planning treatment called image guided adaptive planning. The trial is supported by Cancer Research UK.
More about this trial
If you have bladder cancer that has spread into the muscle layer of your bladder, it is called invasive bladder cancer. Doctors usually treat invasive bladder cancer with surgery to remove the bladder or radiotherapy everyday for a few weeks.
But surgery is not a suitable treatment for everybody and some people may also find daily radiotherapy too difficult to cope with. People in this situation may be offered radiotherapy once a week for 6 weeks.
In this trial, researchers want to learn more about how well this radiotherapy treatment plan works for people with invasive bladder cancer. And they are also looking at a new way of planning the radiotherapy.
Before you start radiotherapy, the doctors plan your treatment very carefully. This is to make sure that they give the highest dose of radiation to your bladder and as little as possible to the surrounding healthy tissue. As part of radiotherapy planning, you have a CT scan to show the position and shape of your bladder.
But your bladder can move within your body. In this trial, you have a scan before each radiotherapy session to show where the bladder is on that day. For some of the people taking part, the researchers will design 3 different treatment plans during the radiotherapy planning. They then choose the plan that fits best according to the scan on each treatment day. This is called adaptive radiotherapy.
The aims of the trial are to see
- If people who have adaptive radiotherapy have fewer side effects
- How well this type of weekly radiotherapy works for invasive bladder cancer
Who can enter
You may be able to join this trial if all of the following apply. You
- Have bladder cancer that has spread into the muscle layer of your bladder (invasive bladder cancer) and is tumour stage T2 to T4a (your doctor can advise you about this)
- Aren’t going to have daily radiotherapy for any reason
- Are well enough to be up and about for at least some of each day, even if you need help looking after yourself (performance status 0, 1, 2 or 3)
- Are at least 18 years old
You cannot join this trial if any of these apply. You
- Have cancer that has spread into your
lymph nodesor to another part of your body
- Have already had radiotherapy to the area between your hip bones (your
- Can’t have radiotherapy for some reason (the trial team can advise you about this)
- Have a tube in your bladder (a catheter) to drain urine away
- Have had any other cancer in the last 2 years, unless it was a very early stage and has been successfully treated (the trial team can advise you about this)
This is a phase 2 trial. The researchers need 62 people to join. It is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.
Everybody taking part has radiotherapy once a week for 6 weeks. Half the people will have radiotherapy using the same treatment plan each time. The other half will have radiotherapy using 1 of 3 different plans (adaptive radiotherapy).
Before you start radiotherapy, you have a planning session in the hospital radiotherapy department. This includes having a CT scan after you have emptied your bladder.
You then have radiotherapy once a week for 6 weeks. You will be asked to empty your bladder before each session and then have a scan to check the position of your bladder. If you are in the adaptive radiotherapy group, the trial team will use this scan to choose which treatment plan to use that day.
The trial team will monitor any side effects you have and see how well the treatment is working. They will also ask you to fill out a questionnaire before you start treatment, when you have your 6th session of radiotherapy, then 3 months and 6 months after you finish treatment. The questionnaire will ask about any side effects you have. It shouldn’t take longer than 20 minutes each time. You don’t have to complete the questionnaires if you don’t want to. You can still take part in the trial.
You see the trial team and have some tests before you start treatment. The tests include
The session to plan your radiotherapy usually takes about half an hour.
You then have radiotherapy once a week for 6 weeks. You will need to lie still for about 20 minutes each time.
After you finish treatment, you see the trial team 4 weeks later, than after 3 months, 6 months, 1 year and 2 years.
They will ask you to have a test to check the inside of your bladder (a cystoscopy) after 3 months, 6 months and 1 year. If you are unable to have any of these tests, the trial team will ask you to give a urine sample and have a CT scan.
The side effects of radiotherapy to the bladder include
- Needing to pass urine frequently
- Bleeding, pain or discomfort when you pass urine
- Opening your bowels frequently or having pain when you open your bowels
Most side effects get better when you finish radiotherapy, but a few people develop long term side effects. They are usually mild but can occasionally be serious and may need treatment. Possible long term side effects include
- A need to pass urine more often or more urgently
- Pain or bleeding when you open your bowels
Radiotherapy can cause scar tissue to form in the vagina, making the tissues less stretchy. Men may have problems with getting and keeping erections. And radiotherapy for bladder cancer can affect your ability to get pregnant or father a child.
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.
Professor Robert Huddart
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
Institute of Cancer Research (ICR)
NIHR Royal Marsden Biomedical Research Centre
NIHR Clinical Research Network: Cancer
This is Cancer Research UK trial number CRUK/12/055.