A trial looking at chemotherapy and surgery for early bladder cancer (CALIBER)

Cancer type:

Bladder cancer
Transitional cell cancer

Status:

Open

Phase:

Phase 2

This trial is looking at different ways of treating early stage bladder cancer that has come back after treatment. It is comparing surgery with a type of chemotherapy called mitomycin C. It is for people with the most common type of bladder cancer called transitional cell cancer.

More about this trial

Doctors usually treat bladder cancer that hasn’t grown into the muscle wall (early bladder cancer) with surgery. This may be followed by a type of chemotherapy called mitomycin C. You have a single treatment of chemotherapy into the bladder. This is called intravesical treatment. But sometimes bladder cancer can come back and you may need to have more surgery.

Researchers think that mitomycin C could be a useful treatment for low risk bladder tumours that have come back, without the need for surgery. But they aren’t sure yet how well it will work. So in this trial, they are comparing mitomycin C with surgery as treatment for bladder cancer that has come back.

The aims of this trial are to find out

  • If mitomycin C alone is a useful treatment to control cancer growth
  • More about the side effects and how  treatment affects quality of life

Who can enter

You may be able to join this trial if all of the following apply. You

  • Were diagnosed with low risk transitional cell cancer of the bladder that hadn’t grown into the muscle wall in the past that has now come back
  • Have satisfactory blood test results
  • Are at least 16 years old
  • Are willing to use reliable contraception during the trial and for up to 1 month afterwards if there is any chance you or your partner could become pregnant

You cannot join this trial if any of these apply.

  • Your bladder cancer has grown into the muscle wall
  • You have a medium to high risk of your cancer coming back (your doctor can advise you about this)
  • You have more than 7 areas of cancer in your bladder
  • Your cancer has come back more than once in a year
  • You have a type of early stage bladder cancer called carcinoma in situ of the bladder
  • You have had mitomycin C in the past (unless it was a single treatment after your surgery for bladder cancer)
  • You are known to be allergic to mitomycin C
  • Your cancer is also in your prostate gland, or in either kidney, or the tubes that drain urine from your kidneys to your bladder (ureters)
  • Your bladder can only hold a limited volume (your doctor can advise you about this)
  • You have a urine infection that is difficult to control with medication
  • You can’t have a tube (a catheter) put into your bladder for any reason. For example you have a narrowing of the tube carrying urine from the bladder out of the body (a urethral stricture)
  • You have significant problems with urine leakage (urinary incontinence)
  • You have a weak bladder that has bulging pouches in the muscle wall (your doctor can tell you more about this)
  • You have a significant bleeding problem
  • You have any other condition that could affect you taking part in this trial
  • You are pregnant or breastfeeding

Trial design

This is a phase 2 trial. The researchers need 174 people to join. It is a randomised trial. You are put into 1 of 2 groups by a computer. Neither you nor your doctor can decide which group you are in.

  • People in one group have mitomycin C into the bladder
  • People in the other group have a surgery as usual

 

For every 3 people joining the trial, 2 will have mitomycin C and 1 will have surgery.

If you are in the chemotherapy group, you have mitomycin C into the bladder  once a week for 4 weeks. You have it through a thin tube (a catheter) put into your bladder through your urethra Open a glossary item. You will be asked not to pass urine for an hour. For 6 hours after each treatment you need to be careful when you pass urine as it will contain chemicals from the chemotherapy. For example, men should sit down to pass urine to reduce the chance of splashing.

If you are in the surgery group, you have surgery as usual. You may have a single treatment with mitomycin C into your bladder after surgery. Your doctor can tell you more about this.

If you agree to take part in this trial, the researchers may ask for extra urine samples and samples of your cancer (biopsies Open a glossary item). These samples will be stored safely and used only for research. They may help researchers to learn more about bladder cancer and how to treat it. If you don’t wish to give these extra samples for research, you don’t have to. You can still take part in the trial.

The trial team may ask you to fill out a questionnaire at set times during the trial. The questionnaires will ask about side effects and how you’ve been feeling. This is called a quality of life study. If you don’t wish to fill out these research questionnaires, you don’t have to. You can still take part in the trial.

Hospital visits

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

  • A physical examination
  • Blood tests

If you have mitomycin C, you go to the hospital once a week to have your chemotherapy.

If you have surgery, you go to hospital just once, but you may stay in overnight. You will have a catheter in place for a few hours after surgery to help you pass urine. You can go home when the catheter has been removed and you can pass urine normally.

Everyone will have a test to look inside the bladder (a cystoscopy), to see if the cancer has gone, 3 months after treatment has finished. If it appears the cancer has gone, the doctor will take a biopsy Open a glossary item of the previous tumour area to check there is no cancer in your bladder.

If the cystoscopy shows there is still cancer in your bladder you will have surgery to remove it. Should this happen, you then have a further cystoscopy 3 months after that to check there is no cancer in your bladder.

Everyone will have a final cystoscopy a year after treatment finished. The trial team will check how you are getting on every year at your routine hospital visits.

Side effects

The most common side effects of mitomycin C are

  • Bladder irritation and pain when you pass urine
  • Needing to pass urine more often

The most common side effects of surgery are

  • Discomfort passing urine after the catheter is removed
  • A bladder infection

You may see a small amount of blood in your urine for up to 2 weeks after surgery. You should avoid any heavy lifting, sports, sexual activity or driving a car during this time.

Location

Basingstoke
Bournemouth
Bury
Carlisle
Chelmsford
Cheltenham
Chichester
Coventry
Croydon
Dartford
Derby
Dorset
Exeter
Gillingham
Gloucester
Guildford
Harrow
Hereford
Ipswich
Leeds
Leicester
London
Macclesfield
Manchester
Middlesbrough
Newcastle upon Tyne
Oldham
Plymouth
Preston
Rochdale
Sheffield
Southampton
Stockport
Wakefield
Whitehaven
Wolverhampton
Worcestershire
Worcestershire
Worthing
York

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

Mr Hugh Mostafid

Supported by

Experimental Cancer Medicine Centre (ECMC)
The Institute of Cancer Research
NIHR Clinical Research Network: Cancer
NIHR Research for Patient Benefit (RfPB) Programme

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

12770

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

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

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