A trial comparing surgery with treatment that may help people to keep their bladder after invasive bladder cancer (SPARE)

Please note this trial is no longer recruiting patients.

This trial is comparing surgery to remove the bladder (radical cystectomy) with radiotherapy after chemotherapy to shrink the cancer. The trial aims to find out which is the best treatment for bladder cancer in the long term.

Bladder cancer that has grown into the muscle layer of the bladder wall is called invasive bladder cancer. Doctors usually treat invasive bladder cancer with surgery to remove the bladder. But some doctors use radiotherapy. And they sometimes use chemotherapy as well.

One main difference between these treatments is that radiotherapy allows you to keep your bladder. But it has side effects and if the cancer comes back, you may still have to have surgery to remove your bladder.

Doctors think that having chemotherapy first may help these treatments to work better. Everyone in this trial will first have had chemotherapy to try and shrink their cancer. You then go into 1 of 2 groups. Group 1 will have surgery to remove the bladder. If you are in group 2 and the chemotherapy has shrunk your bladder cancer enough, you have radiotherapy. If the chemotherapy has not shrunk the bladder cancer enough, you have the same surgery as group 1. This is called selective bladder preservation.

This is a pilot study, which means it is a small scale version of a larger trial. If the pilot trial goes well, the researchers will recruit more people into a large phase 3 trial. The aim of this trial is to

Find out if selective bladder preservation works as well as surgery after chemotherapy for bladder cancer
Compare quality of life after the two treatments

Recruitment

Start 01/07/2007

End 16/02/2010

Phase

Pilot

Who can enter

You can enter this trial if you

Have transitional cell carcinoma (TCC) of the bladder
Have stage T2 or T3 bladder cancer, which has not spread to the lymph nodes (N0) or anywhere else in your body (M0)
Are well enough to have surgery to remove your bladder (a radical cystectomy)
Are well enough to have radiotherapy
Are having 3 cycles of neoadjuvant chemotherapy, and you are willing and well enough to have a 4th cycle of chemotherapy
Have satisfactory blood results
Are well enough to take part (performance status 0 or 1)
Are at least 18 years old

You cannot enter this trial if you

Have a type of bladder cancer other than transitional cell carcinoma (TCC), (you may still be able to take part if you have a mixed TCC and squamous cell bladder cancer)
Have a large area of carcinoma in situ of the bladder (CIS) (if you have a small area of CIS you may still be able to take part)
Have an area of CIS in your bladder away from the muscle invasive cancer
Have had any other invasive cancer in the last 5 years (if you have had superficial TCC or CIS you can still take part)
Have had radiotherapy to your pelvis in the past
Have any other medical conditions that mean you cannot have radiotherapy to your pelvis (for example inflammatory bowel disease or severe diverticular disease)
Have swollen kidneys (hydronephrosis) and cannot have chemotherapy (if you have had treatment for your hydronephrosis, you may be able to take part. Your doctor can tell you more about this)
Have had both hips replaced (this makes planning radiotherapy more difficult)
Have any other medical conditions that the doctors think this will affect the treatment
Are pregnant

Trial design

This is a pilot study and will recruit 110 people. If it goes well, the researchers will go on to do a larger trial.

This is a randomised trial. The people taking part are put into one of two treatment groups by computer. Neither you, nor your doctor, will be able to decide which group you are in.

Everyone taking part will have had 3 cycles of chemotherapy before any other treatment. This is called neoadjuvant chemotherapy. Both groups will then have a test to examine the inside of your bladder (cystoscopy) and see how well the chemotherapy has worked.

If you are in group 1, if your cystoscopy shows your cancer has shrunk with the chemotherapy, you will have another cycle of chemotherapy before having surgery to remove your bladder. If the cystoscopy shows your cancer has stayed the same size, or has grown bigger, then you have surgery without any more chemotherapy.

If you are in group 2, you will have selective bladder preservation. If the cystoscopy shows your cancer has shrunk with chemotherapy, you will have one more cycle of chemotherapy. Then you will have radiotherapy. If the cystoscopy shows your cancer has stayed the same size or has grown larger, you will have surgery without radiotherapy or any more chemotherapy. The surgery will be to remove your bladder and will be the same operation as for group 1.

If you are having surgery, it will be between 1 and 2 months after your chemotherapy. The operation is called a radical cystectomy. If you are a man, the surgeon will remove your bladder, prostate and lymph nodes. If you are a woman, the surgeon will remove your bladder, womb, vagina and lymph nodes. This is a large operation and you will be in hospital for 1 or 2 weeks. After surgery, most people will need to have a bag to collect their urine (urostomy). Some people may have more complex surgery to make a new bladder (bladder reconstruction).

Both groups will be asked to fill in questionnaires as part of this trial. These are called quality of life questionnaires. They will ask how you have been feeling generally and about your symptoms after treatment. You will fill in the questionnaires

Before you start treatment
6 weeks after treatment
9 and 12 months after treatment
Yearly, until 5 years after treatment

Hospital visits

You will need to have some tests before you can take part in this trial. These include

A cystoscopy under general anaesthetic to remove some of the cancer (transurethral resection)
Physical examination
Chest X-ray
Blood tests
MRI scan or CT scan

You will come to the hospital for a cystoscopy after your 3rd cycle of chemotherapy. You may have to stay in hospital overnight when you have this test.

If you are in group 1 (or in group 2 and your cancer has not responded to chemotherapy) you will come into hospital for the radical cystectomy. You may stay in hospital for up to 2 weeks. You can read more about having a radical cystectomy on CancerHelp UK.

If you are in group 2 and have responded to chemotherapy, you will go to the hospital daily to have radiotherapy for either 4 or 6 1/2 weeks depending on the normal practice at your hospital. You will have the radiotherapy once a day from Monday to Friday, with a rest over the weekend. You will see the doctors and have a blood test at least every 2 weeks. You can read more about having radiotherapy for bladder cancer on CancerHelp UK.

Everyone taking part will see the doctor about 4 to 6 weeks after finishing treatment and then again about 2 or 3 months later, depending on what treatment you have had. You will then see the doctors

Every 3 months for rest of the first year
Every 6 months for the second and third year
Yearly for the fourth and fifth year

You will have a yearly CT scan in the first 2 years after the trial treatment. If you had radiotherapy, you will have a cystoscopy about 3 months after the end of the radiotherapy course, then every 3 months for the first year, six monthly in the second year and then yearly until 5 years after treatment.

Side effects

Radiotherapy to the pelvic area can have side effects. You may only have one or two side effects. Or you may have more. Side effects of radiotherapy to the pelvic area may include