A multi-centre phase III double-blind placebo-controlled study designed to examine the efficacy and tolerability of sorafenib (Nexavar) in patients with resected (total or partial) primary renal cell carcinoma (RCC) at high or intermediate risk of relapse
Can a tablet called Sorafenib stop kidney cancer coming back and how long should Sorafenib be taken for?
What is this study about?
Each year there are over 200,000 cases of kidney cancer. Surgery to remove a kidney or part of a kidney is usually the best treatment for kidney cancer. Although this often works, the cancer returns in 30-50% of patients.
The SORCE study has been designed to discover whether taking a drug called sorafenib after the operation can reduce the risk of kidney cancer returning. We would also like to know how long treatment with sorafenib should continue (one year or three years). We hope that if sorafenib reduces the risk of kidney cancer returning that it will also help patients live longer. Sorafenib may prevent tumour cells from growing and spreading, for example, by preventing the development of new blood vessels.
Type of study
Who is funding the study?
The trial is being paid for by the charity Cancer Research UK and by the Medical Research Council. The pharmaceutical company Bayer is providing the drug sorafenib and matching placebo free of charge and is also providing an educational grant to help manage the trial.
When is it taking place?
The trial accrued 1711 patients between July 2007 and April 2013. Treatment with sorafenib or placebo will continue until April 2016, with trial results expected in 2017.
Where is it taking place?
SORCE accrued in 82 UK hospitals, and 48 hospitals from outside the UK in Australia, Denmark, France, Belgium, The Netherlands and Spain.
Who is included?
1711 patients have been randomised into the SORCE trial.
Main eligibility criteria include(see the table below for the full list of inclusion criteria):
1. No evidence of residual disease after resection of kidney cancer and Leibovich score 3-11
2. No prior anti-cancer treatment other than nephrectomy
3. At least 4 weeks and no more than 3 months (91 days) from surgery to planned treatment start date
4. Written informed consent.