HYBRID
Research type
Research Study
Full title
A multicentre randomised phase II study of HYpofractionated Bladder Radiotherapy with or without Image guided aDaptive planning
IRAS ID
126350
Contact name
Robert Huddart
Contact email
Sponsor organisation
The Institute of Cancer Research
Clinicaltrials.gov Identifier
Research summary
Bladder cancer is the seventh most common cancer in the UK, with 10,324 new cases diagnosed in 2010. In a quarter of these cases the cancer has infiltrated the muscular wall of the bladder (muscle invasive) and is life threatening. This type of bladder cancer is usually treated either with surgical removal of the bladder, or daily radiotherapy treatment (high strength x-rays which kill cells), given every day for 4 or 7 weeks. Many patients diagnosed with muscle invasive bladder cancer find it difficult to attend hospital for daily radiotherapy, therefore HYBRID is investigating an alternative, using larger doses of radiotherapy given once a week for six weeks. This type of treatment is often offered to those who are unsuitable for daily radiotherapy, however it has not been formally tested within a prospective multicentre trial.
HYBRID aims to collect robust information about the side effects of weekly bladder radiotherapy, and is also investigating whether side effects can be reduced by using scans taken before each weekly treatment to tailor radiotherapy delivery (adaptive radiotherapy). Radiotherapy is normally delivered using a single plan throughout treatment. In adaptive radiotherapy the delivery plan is chosen from 3 possible plans. Participants will be randomly allocated between weekly radiotherapy and weekly adaptive radiotherapy. Both groups will receive the same radiotherapy dose.
Participants will visit the hospital 4 weeks, 3, 6, 12 and 24 months after radiotherapy to receive treatment for any symptoms and to check whether the cancer has returned.
The main aim of HYBRID is to establish whether use of adaptive radiotherapy can reduce non-bladder side effects by reducing the amount of non-bladder tissue exposed to high doses of radiotherapy. HYBRID will also combine the results of both treatment groups to investigate how well weekly radiotherapy controls bladder cancer.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
13/LO/1350
Date of REC Opinion
23 Sep 2013
REC opinion
Favourable Opinion