ABC-07
Research type
Research Study
Full title
Addition of stereotactic body radiotherapy to systemic chemotherapy in locally advanced biliary tract cancers
IRAS ID
173350
Contact name
Maria Hawkins
Contact email
Sponsor organisation
University College London
Eudract number
2014-003656-31
ISRCTN Number
ISRCTN10639376
Duration of Study in the UK
8 years, 0 months, 1 days
Research summary
The purpose of the ABC-07 trial is examine whether adding radiotherapy called Stereotactic Body Radiotherapy (SBRT) to chemotherapy will improve the outcome for patients with locally advanced biliary tract cancer that are unfit for surgery. All patients will receive 6 cycles of chemotherapy and then they will receive either 5 fractions of SBRT or 2 more cycles of chemotherapy depending on which treatment they are randomised to.
Initially we plan to undertake a feasibility phase to see if it is possible to recruit patients into the trial and then we will continue with the randomised phase II study. Patients recruited during this feasibility stage will be included in the analysis of the full randomised phase II study.REC name
London - Hampstead Research Ethics Committee
REC reference
15/LO/1077
Date of REC Opinion
31 Jul 2015
REC opinion
Further Information Favourable Opinion