“I think it’s really important that people keep signing up to these type of trials to push research forward.”
A trial looking at different ways of giving radiotherapy for bladder cancer (RAIDER)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at new techniques to try to improve radiotherapy treatment for bladder cancer. It is for people whose bladder cancer has grown into the wall of the bladder (invasive bladder cancer). This trial is supported by Cancer Research UK.
More about this trial
Doctors can use radiotherapy to treat invasive bladder cancer. They carefully plan the treatment to make sure that only the highest dose is given to the cancer and as little as possible is directed at the surrounding healthy tissue. Radiotherapy damages healthy tissue. So if more of it is included, there is a greater chance of side effects. For example, urinary and bowel problems.
You usually have a CT scan to help plan your treatment and give your doctor a good idea of the position and shape of your bladder. The bladder moves around the body depending on how full it is. So doctors usually include a border of tissue around the cancer to make sure that none of it is missed. At the moment people usually have 1 scan and 1 treatment plan.
This trial is looking at adaptive radiotherapy. This means that the doctor designs different treatment plans and then chooses the one that best fits your bladder on the day of treatment. This technique may mean that less healthy tissue is involved in the treatment area and you may have fewer side effects.
The trial team are also looking to see whether it is possible to give different doses to the treatment area.
Some people in this trial will have radiotherapy using these new techniques. Other people will have standard radiotherapy using 1 scan and 1 treatment plan.
The aims of this trial are
- To find out if adaptive radiotherapy can be carried out in the same way by different radiotherapy departments
- To see if patients are willing to take part
- To learn more about the side effects of the different radiotherapy techniques
If this trial is successful, researchers hope to carry out a larger trial to find out if these new radiotherapy techniques are better at treating bladder cancer than standard treatment.
Who can enter
The following bullet points list the entry conditions for this trial. If you are unsure about any of these speak with your doctor or the trial team. They will be able to advise you.
You may be able to join this trial if all of the following apply. You
- Have transitional cell bladder cancer that has spread to the muscle layer of your bladder (invasive bladder cancer) and is tumour stage T2 to T4a
- Are well enough to have radiotherapy and you are up and about for at least half the day (performance status 0, 1 or 2)
- Are willing to use reliable contraception during the trial and for 12 months afterwards if there is any chance that you or your partner could become pregnant
- Are at least 16 years old
You cannot join this trial if any of these apply. You
- Have cancer that has spread into your lymph nodes or to another part of the body
- Have more than one area of invasive bladder cancer (called multifocal disease)
- Have also been diagnosed with bladder cancer staged as carcinoma in situ in a separate area to your invasive bladder cancer
- Have also been diagnosed with transitional cell cancer of the upper urinary tract (the ureters or kidneys) or urethra (the tube that passes urine from the bladder to the outside of the body)
- Have had any other cancer in the last 2 years, unless it was a very early stage and has been successfully treated
- Have any other medical condition that the trial team think could affect you taking part
- Are pregnant
This is an international phase 2 trial. The researchers need at least 180 people to join in the UK.
It is a randomised trial. The people taking part are put into 1 of 3 treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. The different treatment groups are
- Adaptive tumour focused radiotherapy
- Adaptive tumour boost radiotherapy
- Standard radiotherapy (this is the control group)
Twice as many people will be in the group having adaptive tumour boost radiotherapy.
Adaptive tumour focused radiotherapy
First of all, you have radiotherapy planning. You have 2 scans and the doctor uses these to design 3 treatment plans (small, medium or large). This takes about 70 minutes.
You then have a scan before each treatment to find out which one suits the size of your bladder on that day. For each treatment you have a standard dose of radiotherapy to the cancer and a lower dose than normal to the rest of the bladder. This is called adaptive tumour focused radiotherapy
Adaptive tumour boost radiotherapy
Your radiotherapy planning involves 2 scans. The doctor uses these to design 3 treatment plans (small, medium or large). This takes about 70 minutes.
You then have a scan before each treatment to find out which one suits the size of your bladder on that day. For each treatment, you have a higher than normal dose of radiotherapy to the cancer and a lower than dose than normal to the rest of the bladder. This is called adaptive tumour boost radiotherapy.
Your radiotherapy planning involves 1 scan and the session takes about 30 minutes. You then have a CT scan as part of your treatment to help the radiographer make sure that the bladder is in the area which will receive the highest dose of radiotherapy. Each treatment will take about 20 minutes.
Everyone has radiotherapy every day from Monday to Friday, for a total of 4 or 7 weeks. The length of treatment depends on the policy of your hospital. Each treatment will take about 20 to 30 minutes.
You may also have chemotherapy on some of the days that you have radiotherapy. If your doctor recommends that you have chemotherapy you can still take part in this trial.
The trial team will ask you to fill out a questionnaire
- Before you start treatment
- At the end of treatment
- Every 3 months for 2 years.
The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study. Each questionnaire takes about 20 minutes to complete.
The researchers will also ask your permission to look at a sample of your cancer removed when you had surgery or a biopsy. They will look at the genetic information in your cells and compare these to the samples of other people taking part. This may help doctors to understand why people develop bladder cancer and why treatment works in some people and not in others.
The quality of life questionnaires and the cancer sample are optional. You don’t have to agree to do these if you don’t want to. You can still take part in the main trial.
You will see the doctors and have some tests before you start treatment. The tests include
- Blood tests
- Physical examination
- CT scan of your chest and tummy (abdomen)
- CT or MRI scan of the area between your hipbones (pelvis)
During treatment you see a doctor, nurse or radiographer every week. They will ask how you are and if you are having any side effects. You also have a blood test. You have a similar appointment (without the blood test) 4 weeks after you finish treatment.
You have a cystoscopy (examination of your bladder)
- Every 3 months in the first year
- Every 6 months in the 2nd year
- Then every year for the next 3 years
You have your first cystoscopy after treatment under general anaesthetic and the rest of the cystoscopies under a local anaesthetic.
After treatment, you have scans every 6 months in the first 2 years. And then a chest X-ray after 3, 4 and 5 years. You would have these tests anyway as part of your routine care. You do not have an extra visits or tests as a result of taking part in this trial.
With your permission, the trial team will continue to collect basic information about your health at your routine follow up appointments and via your medical records.
The most common side effects during and just after radiotherapy include
- Needing to pass urine more often
- Passing blood in urine
- Discomfort or pain when passing urine
Most people gradually recover after treatment and return to normal. Some people may have long term side effects, these include
- Needing to pass urine more often
- Women can have vaginal dryness and shortening of the vagina making intercourse difficult
- Men can have problems getting and maintaining an erection
If you have adaptive tumour boost radiotherapy, you have a higher total dose of radiotherapy compared to the other 2 treatment groups. There is a risk that your side effects may be increased, but doctors think that this won’t happen because of the new techniques used.
The trial team will keep a close eye on your side effects. If they find that side effects are higher than expected, this treatment group will stop recruiting and patients will be changed to standard radiotherapy.
We have information about the side effects of radiotherapy to the bladder
How to join a clinical trial
Professor Robert Huddart
Cancer Research UK
Clinical Trials and Statistics Unit at the Institute of Cancer Research (ICR-CTSU)
Experimental Cancer Medicine Centre (ECMC)
Institute of Cancer Research (ICR)
NIHR Clinical Research Network: Cancer
This is Cancer Research UK trial number CRUK/14/016.