A trial looking at using a combination of imaging methods to improve radiotherapy treatment for bladder cancer (IDEAL Trial)

This trial is looking at combining 3 different ways to plan radiotherapy treatment for bladder cancer. This is so the doctors can target the cancer more accurately and give a higher dose of radiotherapy than they are normally able to.

Before starting treatment the doctors will carefully plan your radiotherapy treatment, so they know how much to give and where to give it. This is to make sure that they give the highest dose of radiation to your cancer and as little as possible to the surrounding healthy tissue. As a part of the planning they will do a ‘planning CT scan’.

But the bladder is a stretchy bag of muscle that can change size, shape and position. In this study the researchers will make a set of treatment plans so that they are able to treat the different sizes of the bladder.

They will also use a combination of 3 different ways to plan the radiotherapy treatment of your bladder tumour, to make sure that they are giving the highest dose of radiation to the tumour and as little as possible to the surrounding healthy tissue.

The 3 ways are

Gold seeds
MRI scan
Cone beam CT scan

Gold seeds are small bits of gold placed around the tumour in your bladder. By placing the gold seeds around your tumour the doctors are better able to see where it is on a scan.

The cone beam CT scan is a new type of CT scan. When you are in the treatment room and ready to have your radiotherapy, the researchers will take a picture using the cone beam CT scan before your treatment. They will use the pictures from the scan to see where your tumour is and so choose the best treatment plan for you on that day.

The MRI scan is a new type, taken in a way that the researchers think will be able to give them more information about where the tumour is and if the treatment has worked.

The aims of this trial are to find out

What is the highest dose of radiotherapy that can safely be given
What are the side effects of the radiotherapy
What is the effect on people’s quality of life

Recruitment

Start 01/01/2009

End 30/06/2013

Phase

Phase 1

Who can enter

You can enter this trial if you

Have bladder cancer that has grown into the muscle layer of the bladder (invasive bladder cancer) but has not gone beyond the surrounding tissue of the bladder (stage T2a – T4)
Have had a procedure called trans urethral resection of bladder tumour (TURBT) to remove as much of your tumour as possible
Are due to have radiotherapy to try and cure your cancer
Are fully active and able to carry out your normal daily activities apart from heavy physical work (performance status 0, 1)
Have satisfactory blood test results

You cannot enter this trial if you

Have bladder cancer that has spread to the lymph nodes or another part of the body (stage T4a and T4b)
Have had any other cancer in the last 2 years (if you have had basal cell skin cancer or carcinoma in situ of the cervix that was successfully treated or superficial transitional cell carcinoma of the bladder you can still enter this trial)
Have had radiotherapy to the area between your hips (your pelvis) before
Have a serious bowel disease, such as inflammatory bowel disease
Have had both your hips replaced
Are pregnant

Trial design

This is a phase 1 trial. It will recruit between 30 to 60 people from The Royal Marsden Hospital NHS Foundation Trust.

The first 10 to 20 people taking part in the trial will have radiotherapy at the lowest dose. If they don’t have any serious side effects, the next 10 to 20 people taking part will have radiotherapy at a higher dose. And so on, until they find the best dose of radiotherapy to give. This is called a ‘dose escalation’ study.

Everyone will have daily radiotherapy 5 times a week (Monday to Friday) for 7 to 7 ½ weeks.

Before planning radiotherapy your doctor will assess you to see if you are suitable to have gold seeds placed around your tumour. If you are, you will have a cystoscopy under a general anaesthetic to put the gold seeds in place.

When the doctors are planning your radiotherapy, they will take CT scans of the area between your hips (your pelvis). Each scan takes a few minutes. For the first scan you will empty your bladder. You then drink about 2 to 3 cups of water. You will have 2 more scans taken as your bladder fills, about 30 and 60 minutes after the first scan.

In the first week and the last 4 weeks of radiotherapy, you will empty your bladder before treatment. When you are in the treatment room and ready to have treatment, the researchers will take a picture of the area between your hips with the cone beam CT scan. They will use this to find out the size, shape and position of your bladder on each day and choose the best treatment plan for that day.

In the 2nd and 3rd weeks of radiotherapy, the researchers will tell you how much water to drink before your treatment. Then they will use the cone beam CT scan as before to choose your daily treatment plan.

You will be asked to fill in a questionnaire before you start treatment and then after treatment at 1, 3 and 6 months, then at 1, 2, 3, 4 and 5 years.

The questionnaire will ask you about how you are feeling and any side effects you have. This is called a quality of life study.

Hospital visits

You will see the doctor and have some tests before you start treatment. These test include

Physical examination
Blood tests
Chest X-ray
MRI scan
Cystoscopy

During treatment you see the doctor every week and have blood tests.

After your radiotherapy you see the doctor

Monthly for 3 months
At 6 months
Every 6 months to 3 years
Every year to 5 years

Side effects

You will have an extra amount of radiation from the extra CT scans and cone beam CT scans. But it is a small amount compared with the overall dose from your radiotherapy.

You can find out about the side effects of radiotherapy to the bladder on CancerHelp UK.

You have the gold seeds put in place while you are asleep, during an internal examination of your bladder (a cystoscopy under a general anaesthetic).