SORCE is 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.
1656 patients will be randomised over the next 5 years at hospitals both in the UK and internationally. Patients will be randomly assigned in a 2:3:3 ratio to one of the following:
- Control arm: 3 years of placebo (400mg po bd)
- Experimental arm 1: 1 year sorafenib & 2 years placebo (both 400mg po bd)
- Experimental arm 2: 3 years sorafenib (400 mg po bd)
Patients receive treatment for 3 years or until progressive disease or unacceptable toxicity is encountered.
Main eligibility criteria:
- No evidence of residual disease after resection of RCC with Leibovich score 3-11
- No prior anti-cancer treatment other than nephrectomy
- At least 4 weeks and no more than 3 months since surgery
The first UK patient was entered into SORCE on 26th July 2007. There are now 16 centres in the UK open to recruitment with another 41 undergoing the accreditation process. International centres such as Belgium, The Netherlands and Italy, via the EORTC, along with sites in Denmark, France and Australia have been approved to join the trial. We hope that other international centres will also come on board in 2008.
TRANSORCE is a translational sub-study to investigate the mode of action of sorafenib in RCC and to aid selection of patients most likely to benefit from sorafenib. Participation in is optional. Patients are asked to give consent for the collection of blood and/or tissue specimens for translational research. Patients may be enrolled into TRANSORCE (a) prior to planned surgery for suspected RCC, (b) post-nephrectomy if they have low risk disease or (c) at the same time as they are randomised into SORCE.
If you would like more information on any aspect of the SORCE trial or the TRANSORCE study please contact the SORCE Trial Team at the MRC Clinical Trials Unit.