A Phase III randomised double-blind study comparing Sorafenib with placebo in patients with resected primary renal cell carcinoma at high or intermediate risk of relapse.
TRANSORCE is a study to collect blood and/or tissue samples from consenting patients who have been diagnosed with renal cell cancer. Patients can join prior to surgery or post surgery. Blood samples will be tested to find out if they contain any genetic or other abnormalities that may cause kidney cancer or affect the way the cancer responds to treatment.
TRANSORCE is a sub-study of the SORCE trial, to investigate the mode of action of Sorafenib in renal cell cancer, and to aid selection of patients likely to benefit from Sorafenib.
Mutations in the Von Hippel Lindau (VHL) gene are present in approximately 70% of renal cell cancers. Mutations lead to inactivation of the VHL gene which results in up regulation of growth factors which stimulates the formation and stabilisation of new blood vessels, which are required for tumour growth.
Who’s Eligible?
Anyone who has been diagnosed with renal cell cancer is eligible and may join:
Prior to Surgery
Post Surgery - providing post-surgery Leibovich score is of 0-2 inclusive; i.e-have a low risk of relapse
Post Surgery - with Leibovich score 3-11 (May enter, but must be randomised at the same time as they are randomised for Sorce).
We currently have 50 centres in the UK recruiting for us and international centres in the process of being set up. To date we have 200 patients enrolled. If you are a site interested in taking part in this study, please email Anna Griffiths at the MRC.
Closure Date: 31/07/2012
Sample Size: 1650
Study Requirements
We ask for two 9ml blood samples and/or tissue specimens from study participants.
Funders:
Clinical Trials Advisory and Awards Committee – CTAAC
Cancer Research UK
Bayer AG
Medical Research Council
Sponsor:
Professor Richard Houlston
Study Documents