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A trial looking at surgery for people with kidney cancer that has spread (SURTIME) (EORTC 30073)

This trial is looking at the best time to have surgery for people with kidney cancer that has spread to other parts of the body. It is for a type of kidney cancer called clear cell kidney cancer. This trial is supported by Cancer Research UK.

Doctors usually treat clear cell kidney cancer that has spread with surgery to remove the kidney (nephrectomy). You then have a drug called sunitinib to treat the cancer that has spread elsewhere in the body.

Sunitinib is a type of biological therapy called a tyrosine kinase inhibitor (TKI for short). TKIs block tyrosine kinase, which is a chemical messenger that sends messages telling cells to divide and grow. Blocking tyrosine kinase may stop cancer cells growing.

Doctors cannot agree on the best time to have surgery to remove the kidney.

The aim of this trial is to find out if it is best to have your kidney removed before starting sunitinib or after you have taken it for a while.

Recruitment

Start 28/04/2010
End 31/12/2014

Phase

Phase 3

Who can enter

You may be able to enter this trial if you

  • Have a type of kidney cancer called clear cell kidney cancer that has spread to other parts of your body
  • Can have surgery to remove the kidney that has the cancer
  • Have satisfactory blood test results
  • Have cancer spread that can be measured on CT scan or MRI scan
  • Are well enough to carry out all your normal activities, apart from heavy physical work (performance status 0 or 1)
  • Are willing to use reliable contraception 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 already had part of your kidney removed due to cancer
  • Have had treatment for your kidney cancer before apart from radiotherapy for bone metastases
  • Are taking steroids – your doctor will discuss this with you
  • Have heart problems that are a cause for concern
  • Have raised blood pressure that cannot be controlled with tablets
  • Have had any other cancer, apart from carcinoma in situ of the cervix, non melanoma skin cancer or prostate cancer in situ that was successfully treated at least 5 years ago
  • Have cancer in your central nervous system (CNS)
  • Have any other medical problem that is a cause for concern
  • Are pregnant or breast feeding

Trial design

This 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.

Both groups take sunitinib as a tablet. You take it every day for 4 weeks then have 2 weeks off. Each 6 week period is called a cycle of treatment.

  • Group 1 have surgery to remove the kidney followed by sunitinib
  • Group 2 have 3 cycles of sunitinib, then surgery, then more sunitinib   

You continue taking sunitinib for as long as it is helping you.

If you agree to take part in this study, the researchers will ask for a sample of tissue taken when you had your kidney biopsy. They will also ask for an extra blood sample for research. If you do not want to give tissue and extra blood samples for this study, you don’t have to. You can still take part in the trial.

Hospital visits

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

• Blood tests
• Physical examination
• Heart trace (ECG)
CT scan or MRI scan
• Heart ultrasound (echocardiogram) or MUGA scan

You see the doctors and have blood tests frequently while you are having treatment. Everyone has a CT or MRI scan before surgery, 4 weeks after surgery and then every 12 weeks.

After you finish treatment, the doctors will contact you every 12 weeks to see how you are.

Side effects

There can be possible problems after any surgery, including pain, infection, bleeding, blood clots (DVT) and slow wound healing. We have more information about surgery for kidney cancer in our surgery for kidney cancer section.

Common side effects of sunitinib include

We have more information about the side effects of sunitinib in our cancer drugs section.

Location of trial

  • Basildon
  • Bath
  • Bournemouth
  • Bristol
  • Cardiff
  • Leeds
  • London
  • Manchester
  • Swansea

For more information

Please note: we cannot help you to join a specific trial. Unless we state otherwise in this trial summary, you need to print this page and take it to your own doctor to discuss.

Find out how to join a trial or contact our cancer information nurses for other questions about cancer by phone (0808 800 4040), by email, or at

The Information Nurses
Cancer Research UK
Angel Building
407 St John Street
London
EC1V 4AD

Chief Investigator

Dr Axel Bex
John Haanen

This is Cancer Research UK trial number CRUK/10/050.

Supported by

Cancer Research UK
European Organisation for Research and Treatment of Cancer (EORTC)
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
Pfizer
Wales Cancer Trials Unit
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Updated: 28 May 2014