A trial looking at chemotherapy after surgery for transitional cell cancer of the urinary system (POUT)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Kidney cancer
Transitional cell cancer

Status:

Closed

Phase:

Phase 3

This trial is looking at the best time to have chemotherapy after surgery for transitional cell cancer of the kidney and ureter (transitional cell cancer of the urinary system). This trial is supported by Cancer Research UK.

The ureter is the tube that takes urine from the kidney to the bladder. Cancer of the ureter can spread up into the kidney. If this happens, doctors usually remove the kidney and ureter.

After surgery, people don’t usually start chemotherapy unless the cancer starts to grow again. But in some similar types of cancer, having chemotherapy after surgery can stop the cancer from coming back. This is called adjuvant chemotherapy Open a glossary item.

In this trial doctors want to find out if adjuvant chemotherapy can stop transitional cell cancer of the urinary system coming back after surgery.

The aims of the trial are to

  • Find out if chemotherapy after surgery can stop cancer coming back
  • Learn about the side effects
  • See how the treatment affects your quality of life

Who can enter

You may be able to enter this trial if you

  • Have transitional cell cancer of the kidney and ureter and have had surgery to remove it
  • Are well enough to carry out all your normal activities, apart from heavy physical work (performance status 0 or 1)
  • Have satisfactory blood test results
  • Are willing to use reliable contraception during treatment if there is any chance that you or your partner could become pregnant
  • Are at least 18 years old

You cannot enter this trial if

  • You have cancer that has spread to other parts of your body (metastases Open a glossary item)
  • You’ve had surgery and not all the cancer could be removed
  • Your other kidney is not working properly
  • You have any other illness that is a cause for concern
  • You’ve had any other cancer, apart from carcinoma in situ of the cervix, non melanoma skin cancer, carcinoma in situ Open a glossary item of the prostate or breast, or bladder cancer that had not spread into the muscle
  • You are pregnant or breastfeeding

Trial design

This trial will recruit 345 people from around the world. Everyone taking part will have had surgery to remove their kidney and ureter.

It is a randomised trial. 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 1 see the doctor for regular checkups after surgery. If their cancer comes back, their doctor will discuss treatment options with them. They may have chemotherapy at this time.

People in group 2 have chemotherapy after surgery. They have chemotherapy in 3 week cycles of treatment. On the first day of each cycle, they have gemcitabine and either cisplatin or carboplatin through a drip into a vein. On the 8th day of each cycle they have gemcitabine alone. They have up to 4 cycles of treatment.

The trial team will ask you to fill out a questionnaire before entering the trial, twice during the next 3 months and then 6 months, 1 year and 2 years later. The questionnaire will ask about side effects and how you have been feeling. This is called a quality of life study.

Hospital visits

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

Everyone taking part will see the doctor and have frequent blood tests for the first 13 weeks of the trial.

Everyone taking part will have a CT scan, cystoscopy and see the trial team every 6 months for 2 years, then once a year for the next 3 years.

Side effects

The most common side effects of cisplatin and gemcitabine are

There is more information about cisplatin and gemcitabine in our Cancer drugs section.

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

Dr Alison Birtle

Supported by

Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
Institute of Cancer Research (ICR)
NIHR Clinical Research Network: Cancer

Other information

This is Cancer Research UK trial number CRUK/11/027.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

8274

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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