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

    j.catto@sheffield.ac.uk; ctru-bravo@leeds.ac.uk

  • 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