A trial looking at different types of surgery for bladder cancer (BOLERO)

This study is being done to see if it will be possible to recruit enough people to a larger trial comparing open surgery with keyhole surgery for bladder cancer.

If you have bladder cancer that has grown beyond the innermost lining of the bladder, your doctors may suggest you have an operation to remove the bladder. This is called an open radical cystectomy and is a standard treatment. But it is a complicated operation and people have to stay in hospital for about 3 weeks. And there are possible complications, such as wound infection.

Surgeons at many UK hospitals can now remove the bladder in a different way using a type of keyhole surgery called laparoscopic or robotic cystectomy. But we don’t yet know which type of surgery is best for people with bladder cancer

This is a feasibility study to find out if people would be willing to take part in a trial comparing the 2 types of surgery.

The aims of the feasibility study are to

See if patients are willing to take part in a trial comparing open cystectomy with keyhole surgery for bladder cancer
Understand more about what might stop people agreeing to take part
Learn more about which type of surgery is safest, works best and has fewer complications
Find out how each type of surgery affects quality of life

Recruitment

Start 17/01/2011

End 30/06/2013

Phase

Phase 2

Who can enter

You can enter this trial if you

Have been diagnosed with bladder cancer that is stage T1, T2 or T3
Are well enough to have a general anaesthetic
Are at least 18 years old

If you have chemotherapy before surgery, you must have finished this treatment at least 3 weeks ago, but no more than 10 weeks ago.

You cannot enter this trial if you

Have any enlarged lymph nodes or a scan shows that the cancer has spread somewhere else
Have cancer affecting the upper part of your urinary tract
Have a severe infection of the urinary tract that has spread to your bloodstream (urosepsis)
Have any other medical condition that could affect you taking part in this study
Are pregnant or breastfeeding

Trial design

This is called a feasibility study. It aims to recruit about 72 people from up to 20 hospitals in the UK. If this study shows that people are willing to take part in a trial comparing the 2 types of surgery, the researchers will carry out a larger phase 3 trial to learn more.

The study is randomised so 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.

People in group A have an open radical cystectomy
People in group B have keyhole surgery

Everybody taking part will also be asked to fill out 2 questionnaires when they join the trial, and then after 4 weeks, 6 weeks, 8 weeks, 3 months and 6 months. The questionnaires will ask about any side effects you have had and about how you have been feeling. This is called a quality of life study.

The trial team will also ask your permission to take some samples of cancer tissue removed when you have surgery. And they will ask for extra blood and urine samples. The researchers will study these samples to learn more about bladder cancer. If you don’t want to give these samples for research you don’t have to. You can still take part in the trial.

If you decide that you don’t want to take part in the main trial, the trial team may ask if you would be willing to take part in a sub study. This aims to get a better understanding of the reasons why people decide not to take part in a trial. You don’t have to take part in this sub study if you don’t want to.

If you do agree to take part, you will have a short interview with a researcher at a time that is convenient for you. This may be at the hospital or in your home. The interview will last between 30 minutes and an hour and the researcher will make an audio recording of it. All the information collected is confidential and it will not be possible to identify you in any results.

Hospital visits

You will see the doctors and have some tests before you start treatment. The tests include

Physical examination
Blood and urine tests
CT scan

The length of time you stay in hospital will vary depending on how quickly you recover after surgery. But you are likely to be in hospital for at least a week.

The trial team will look at your medical notes from your time in hospital to see

What painkillers you needed
How quickly after your operation you started eating and drinking
How long it was before you were up and about
When you went home
If you had complications such as problems with your wound or if you needed to have any blood transfusions

You will go back to hospital to see the trial team about 6 weeks after surgery, and then 3 months and 6 months later.

Side effects

Your surgeon will discuss the operation with you in detail and explain exactly what the surgery will involve and what to expect afterwards. There is more information about surgery for invasive bladder cancer on CancerHelp UK.