A trial looking at radiotherapy with or without chemotherapy for people with bladder cancer (BC2001)

Cancer type:

Bladder cancer
Transitional cell cancer

Status:

Results

Phase:

Phase 3

This trial compared radiotherapy and chemotherapy with radiotherapy alone for bladder cancer that had grown into the muscle layer of the bladder (invasive bladder cancer), but had not spread to other parts of the body. It also looked at different ways of giving radiotherapy. This trial was supported by Cancer Research UK.

Doctors often treat invasive bladder cancer with surgery. But people who are not well enough for, or don't want to have, an operation to remove their bladder can have radiotherapy instead. But sometimes the cancer comes back in the bladder after radiotherapy and they may need more treatment.

Doctors knew that having radiotherapy and chemotherapy at the same time helped people with some other types of cancer. So they wanted to find out if giving chemotherapy at the same time as radiotherapy would improve the treatment of bladder cancer. This is sometimes called chemoradiotherapy or chemoradiation. The chemotherapy drugs used in this study were fluorouracil (5-FU) and mitomycin C.

When doctors give radiotherapy for invasive bladder cancer, they usually use the same dose for the whole of the bladder. But this can cause side effects. So they wanted to find out if targeting the highest dose of the radiotherapy to the cancer, and reducing the dose to the rest of the bladder, could reduce the side effects. The researchers call this modified radiotherapy.

The aims of the trial were to find out

  • Which treatment was best at reducing the risk of bladder cancer coming back
  • More about the side effects
  • If modified radiotherapy would reduce side effects without increasing the risk of cancer coming back in the bladder

Summary of results

The trial team found that adding chemotherapy to radiotherapy can reduce the chance of cancer coming back in the bladder.

The trial recruited a total of 458 people who had invasive bladder cancer. The average age of everyone who took part was 73, and 4 out of 5 people taking part (81%) were men. It looked at adding chemotherapy to radiotherapy, as well as 2 different ways of giving radiotherapy. People could choose to enter 1 or both parts of the trial.

For each part of the trial, people were put into treatment groups by a computer. This is called randomisation. Neither the patient, nor their doctor could decide which treatment they had.

The part of the study that looked at chemoradiation recruited 360 people

  • 182 people had chemotherapy and radiotherapy
  • 178 people had radiotherapy alone

The trial team have now followed up the people taking part for an average of almost 6 years. They found that bladder cancer had come back in fewer people in the group who had chemoradiation than in the group who had radiotherapy alone. It had come back in the bladder in

  • Nearly 1 in 5 people (18%) who had chemoradiation
  • About 1 in 3 people (32%) who had radiotherapy alone

More people in the chemoradiation group had non serious short term side effects during treatment. But they didn't have more serious side effects and the side effects didn't last long after treatment had finished. Most people had few or no long term side from the radiotherapy. And the people who had chemotherapy as well didn't have any extra long term side effects.

The research team also looked at how many people were living 5 years after treatment. They found it was

  • Nearly half (48%) of the group who had chemoradiation
  • About a third (35%) of the group who had radiotherapy alone

These results show some benefit in having chemoradiation. But the people taking part need to be followed up for longer before we know for sure that chemoradiation helps people live longer. Also, some people can have surgery to remove the cancer that comes back (doctors sometimes call this salvage surgery), so there may not be much difference between the groups in the long term.

The part of the trial that looked at different ways of giving radiotherapy recruited 219 people

  • 108 people had standard radiotherapy
  • 111 people had modified radiotherapy

The trial team found that changing the way of giving radiotherapy did not affect the risk of the cancer coming back or the side effects.

The research team concluded that having 5FU and mitomycin C chemotherapy at the same time as radiotherapy for bladder cancer that had spread into the muscle did help to reduce the risk of the cancer coming back, without causing more long term side effects. They suggest that chemoradiation is a good alternative to surgery for invasive bladder cancer.

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

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Nick James
Professor Robert Huddart

Supported by

Birmingham University
Cancer Research UK
Institute of Cancer Research (ICR)
NIHR Clinical Research Network: Cancer

Other information

This is Cancer Research UK trial number CRUK/01/004.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 16

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Around 1 in 5 people take part in clinical trials

3 phases of trials

Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.

Last reviewed:

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