BRAVO Feasibility Study
Research type
Research Study
Full title
BRAVO: High risk Bladder cancer: A randomised controlled feasibility study of Radical Cystectomy against intra-vesical immunotherapy
IRAS ID
167968
Contact name
James Catto
Contact email
Sponsor organisation
Sheffield Teaching Hospitals NHS Foundation Trust
Duration of Study in the UK
1 years, 8 months, 30 days
Research summary
Bladder cancer is a common disease with worse outcomes in Yorkshire than the rest of the UK. We eventually want to conduct a randomised trial to evaluate the best treatment for aggressive bladder cancer when found at an early stage. This could be complete bladder removal (radical cystectomy(RC)) or instillation of BCG into the bladder. This study will look at whether it is feasible to carry out a future definitive phase III trial. This feasibility study will not directly compare BCG with RC but will show if it is possible to randomise patients for a future study. In this feasibility study patients with high risk non-muscle invasive bladder cancer will be randomised to receive either BCG or RC. Both BCG and RC are standard therapies for this patient group and both have a well established safety and efficacy profile.
REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
16/YH/0268
Date of REC Opinion
12 Aug 2016
REC opinion
Further Information Favourable Opinion