Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.
A trial looking at sorafenib after surgery for kidney cancer that has not spread (SORCE)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is comparing a drug called sorafenib with a dummy tablet (
Surgery is the main treatment for kidney cancer that has not spread. This often works very well, but there is a risk that the cancer may come back or spread to another part of the body.
This trial is for people who have kidney cancer that has not spread. The aims of the trial are to
- Find out if sorafenib after surgery can help to stop or delay kidney cancer coming back
- Learn more about the side effects
- Find out if sorafenib helps, whether it is best to have it for 1 year or 3 years
Who can enter
You can enter this trial if
- You have had surgery to remove renal cell cancer in the last 3 months
- Your doctors were able to remove all of the cancer (you will have a CT scan to check there are no signs of any cancer remaining)
- Your doctors think there is a medium or high risk of your cancer coming back
- You had your surgery at least 4 weeks ago
- You have satisfactory blood test results
- You are well enough to take part in the trial (performance status 0 or 1)
- You are willing to use reliable contraception during this trial if there is any chance you or your partner could become pregnant
- You are at least 18 years old
You cannot enter this trial if you
- Have had any other treatment for renal cell cancer (apart from surgery)
- Have had any other cancer, apart from carcinoma in situ of the cervix or basal cell skin cancer that have been treated successfully
- Have a serious heart condition
- Have high blood pressure that cannot be controlled with medicine
- Have had a heart attack in the last 6 months
- Have an infection
- Are known to be HIV, hepatitis B or hepatitis C positive
- Take any other medicine that may interact with sorafenib (the trial doctor will advise you on this)
- Have had an experimental treatment as part of another clinical trial in the last 30 days
- Are pregnant or breastfeeding
This is an international study. It will recruit 1,656 people. As 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. And neither you nor your doctor will know which group you are in, as everybody will have treatment that looks the same. This is called a ‘double blind’ trial. There are 3 treatment groups
- People having the dummy tablet (placebo) for 3 years
- People having sorafenib for 1 year, followed by placebo for 2 years
- People having sorafenib for 3 years
Everybody taking part in the trial will take tablets for 3 years. For the first 3 weeks of treatment, you take 2 tablets once a day. If you don't have any bad side effects, you then start taking 2 tablets twice a day for the rest of the trial. If you do have some side effects, the trial doctors may wait for another 3 weeks before increasing your dose.
You swallow the tablets whole with a glass of water. You take them morning and evening at least one hour before, or 2 hours after, eating.
Your doctors will ask you to fill in questionnaires before you start treatment, after 3 weeks, after 6 weeks, and then every 3 months for 3 years. The questionnaires will ask you about any side effects you have had and about how you have been feeling. This is called a quality of life study.
Your doctors may ask if they can take an extra blood sample and get a sample of tissue taken when you had surgery to remove your cancer. This will help the researchers to learn more about what may cause kidney cancer or affect the way it responds to treatment. If you don’t want to give these samples for research, you don’t have to. You can still take part in the trial.
You will go to the hospital to see the doctors and have some tests before you take part in the trial. These include
- Physical examination
- CT scan
- Blood tests
You will see your doctor and have blood tests
- In the 3rd week of treatment
- In the 6th week of treatment
- After 3 months of treatment (at this visit you will also have a chest X-ray)
Then you will see the doctors and have blood tests every 3 months for the next 3 years. You will have a CT scan and a chest X-ray every 6 months.
After you finish the tablets, you will see the doctors every 6 months for 2 years and once a year after that. You will have a chest X-ray at each visit and a blood test once a year.
As sorafenib is a new drug, there may be some side effects doctors don’t know about yet. In trials so far, the most common side effects were
- Tiredness (fatigue)
- Redness and peeling of the hands and feet
- Hair loss
- A drop in the number of white blood cells, causing an increased risk of infection
- Feeling sick
- Loss of appetite
- Weight loss
- Low levels of phosphate in your blood
- Increased blood levels of enzymes from your pancreas
- Bleeding, including nose bleeds
- Back pain, tummy (abdominal pain), and painful joints and muscles
How to join a clinical trial
Professor Tim Eisen
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
Medical Research Council (MRC)
NIHR Clinical Research Network: Cancer
This is Cancer Research UK trial number CRUK/06/004.