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

Cancer type:

Bladder cancer

Transitional cell cancer

Status:

Results

Phase:

Pilot

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

Cancer Research UK supported this trial.

More about this trial

Invasive bladder cancer is bladder cancer that has grown into the muscle layer of the bladder wall. Surgery to remove the bladder is commonly used as the treatment for invasive bladder cancer.

As an alternative to surgery, some doctors use radiotherapy and sometimes chemotherapy as well.

Radiotherapy allows you to keep your bladder. But it has side effects and if the cancer comes back, you might still have to have surgery to remove your bladder.

Doctors know that having chemotherapy first helps these treatments work better.

In this trial the researchers looked at how well the cancer responded to chemotherapy. They thought this would help doctors select people who might also benefit from radiotherapy.

Everyone in this trial had chemotherapy first to try and shrink their cancer. They were then randomised Open a glossary item into 1 of 2 groups.

People in group 1 had surgery to remove the bladder.

The people in group 2 had radiotherapy if the chemotherapy had shrunk their bladder cancer enough. If the chemotherapy hadn’t shrunk their bladder cancer enough, they had the same surgery as group 1. This approach is called selective bladder preservation.

This was a pilot trial, it is a small scale version of a larger trial.

The aims of this trial were to see how many people would be willing to take part and if it was possible to do a phase 3 trial Open a glossary item .

Summary of results

The team found that it wasn’t possible to do a large phase 3 trial comparing surgery with selective bladder preservation.

In this pilot trial the team needed 110 people to join in a 3 year period.

165 people were asked to join the trial. Of these 120 people declined. The reasons given were:

18 people didn’t want to be randomised
5 people didn’t want chemotherapy
51 people preferred to have radiotherapy
25 people preferred to have surgery
21 people either gave another reason or their reason wasn’t known

After being open for 2 ½ years, 45 people had joined the trial.

It was a randomised trial. Everyone was put into 1 of 2 groups.

25 people were to have surgery
20 people were to have selective bladder preservation

SPARE trial diagram

Of the 25 people who were to have surgery, 6 people had radiotherapy.

Of the 20 people who were to have selective bladder preservation:

1 person whose cancer didn’t respond to chemotherapy had radiotherapy
2 people whose cancer had responded well to chemotherapy had surgery instead of radiotherapy

After an average follow up of just under 5 years the team said they weren’t able to either confirm or reject whether treatment using selective bladder preservation worked as well as surgery.

16 people who had surgery had severe side effects. The most common side effect of surgery was tiredness (fatigue).

8 people who had radiotherapy had severe side effects. The most common side effects of radiotherapy were tiredness and getting up during the night to pass urine (nocturia).

The trial team concluded that a phase 3 trial comparing surgery to selective bladder preservation wasn’t possible. When comparing the 2 treatments they couldn’t obtain any firm conclusion because of the small numbers of people who took part.

We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item ) and published in a medical journal. The figures we quote above were provided by the trial team who did the research. We have not analysed the data ourselves.