Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
A trial looking at chemotherapy after surgery for transitional cell cancer of the urinary system (POUT)
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
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 (
- 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 situof the prostate or breast, or bladder cancer that had not spread into the muscle
- You are pregnant or breastfeeding
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.
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.
The most common side effects of cisplatin and gemcitabine are
- Feeling or being sick
- Ringing in your ears (tinnitus)
- Flu like symptoms
- Tiredness (fatigue)
- A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
- Sore mouth
- A rash
- Hair loss
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.
Dr Alison Birtle
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
Institute of Cancer Research (ICR)
NIHR Clinical Research Network: Cancer
This is Cancer Research UK trial number CRUK/11/027.