A study looking at giving biological therapy before surgery for advanced kidney cancer (SuMR)

Please note this trial is no longer recruiting patients.

This study is looking to see if starting sunitinib before surgery for advanced kidney cancer improves treatment outcome.

Doctors usually treat kidney cancer that has spread with a biological therapy. You may also have surgery before this. So, if you are going to have surgery, you would not start biological therapy straight away. In other cancers, having treatment that reaches your whole body (systemic treatment) before surgery can improve the outcome. So researchers want to find out if the same is true for advanced kidney cancer.

This study is looking at the timing of giving the biological therapy sunitinib. Sunitinib stops a chemical messenger, or ‘enzyme’ called tyrosine kinase telling cancer cells to grow (a ‘tyrosine kinase inhibitor’). It also stops a blood supply developing which would feed the cancer (an angiogenesis inhibitor) and help it spread around the body. We know from research that sunitinib can stop or slow the growth of advanced kidney cancer.

The aim of this study is to see if having sunitinib before surgery, as well as after, improves the outcome for people with advanced kidney cancer.

Recruitment

Start 08/01/2008

End 31/03/2010

Phase

Phase 2

Who can enter

You can enter this study if

You have a type of kidney cancer called renal cell carcinoma that has spread to other parts of the body (metastasised), and these areas of spread can be measured on a CT scan or MRI scan
Your doctor thinks that taking sunitinib may help treat your cancer
You are well enough to take part (performance status 0, 1 or 2)
You have satisfactory blood tests
You are willing to use reliable contraception during the study and for 28 days after this if there is any chance that you or your partner could become pregnant
You are willing to make all the hospital visits needed to take part in the study
You are at least 18 years old

You cannot enter this study if you

Have had a heart attack, heart bypass or a condition where your heart cannot pump blood quickly enough (congestive heart failure) in the last 6 months
Have problems with your heart rhythms
Have already had treatment for kidney cancer
Are pregnant or breastfeeding
Have any other condition that would make you unwell if you took part, or affect the results of the study – you can check this with your doctor

Trial design

This phase 2 will recruit 43 people.

Everyone will take sunitinib tablets. You take one tablet at the same time each day for 4 weeks. You then have a break for 2 weeks. This is called a 6 week cycle of treatment.

You have a PET-CT scan to see how well the treatment is working during your first treatment cycle, and again after 3 cycles. Your doctor will then discuss whether surgery is suitable for you.

If you cannot have surgery, the study team may ask if you would be willing to have another biopsy.

If you have surgery, you stop taking sunitinib 2 weeks before your operation and start taking it again 2 weeks afterwards.

Whether you have surgery or not, you can continue sunitinib for as long as your doctor feels it is treating your cancer.

The study team will also look at blood samples, and tissue taken from any biopsies and surgery you have. These may help them understand more about different people’s responses to treatment.

Hospital visits

Before you start the study, you will see the doctor and have some tests. These tests include

Blood tests
Heart trace (ECG)
PET-CT scan
Pregnancy test (if appropriate)
Taking a sample of your kidney cancer (a biopsy)

You will see the doctor twice during each 6 week cycle of treatment, before you start and when you finish sunitinib each time. At these visits you will have some blood tests and heart trace (ECG).

You may have an MRI scan before your surgery or biopsy. This is to help the study team learn more about the blood supply to the cancer.

You will have a PET-CT scan

During your first cycle of treatment
After your third cycle of treatment
After surgery, if you have it

You will also have a CT scan (without a PET scan) every 3 months after this for as long as you are in the study.

Where possible your study team will arrange these scans for when you come to see the study doctor.

If your hospital does not have a PET scanner, you will need to travel to a hospital that does. The study team will tell you which hospital to go to for this.

After you stop taking sunitinib, you continue seeing your regular specialist doctor as you did before the study. You will be in touch with the study team every 2 months, either by phone or hospital visit, so they can check how you are getting on.