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 was 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 was designed to discover whether taking a drug called sorafenib after the operation can reduce the risk of kidney cancer returning. We hoped that if sorafenib reduced the risk of kidney cancer returning, that it would also help patients live longer.
What difference did this study make?
The SORCE trial found no benefit for treatment with sorafenib, whether it was given for three years or one year. The results have been presented at an international medical conference and will be published in the Journal of Clinical Oncology, a peer-reviewed medical journal.
Please see the attached patient summary of our results.
See this related news article on the results of the trial.
Type of study
Who funded the study?
The trial was funded by the charity Cancer Research UK, the Medical Research Council and University College London. The pharmaceutical company Bayer provided the drug sorafenib and matching placebo free of charge and an educational grant to help conduct the trial.
When did it take place?
Patients were randomised to the trial between July 2007 and April 2013. Trial treatment with sorafenib or placebo continued until April 2016. Patients were then followed up until the trial data was analysed in the Summer of 2019.
Where did it take place?
SORCE was active at 82 UK hospitals, and 48 hospitals internationally in Australia, Denmark, France, Belgium, The Netherlands and Spain.
Who was included?
1711 patients were randomised into the SORCE trial. Main eligibility criteria include:
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.
Please see the SORCE protocol for the full list of inclusion criteria.
SORCE trial update
27 Jun 2014