title: Introduction of online adaptive radiotherapy for bladder cancer through a multicentre clinical trial (Trans-Tasman Radiation Oncology Group 10.01): Lessons learned.
abstract: Online adaptive radiotherapy for bladder cancer is a novel radiotherapy technique that was found feasible in a pilot study at a single academic institution. In September 2010 this technique was opened as a multicenter study through the Trans-Tasman Radiation Oncology Group (TROG 10.01 bladder online adaptive radiotherapy treatment). Twelve centers across Australia and New-Zealand registered interest into the trial. A multidisciplinary team of radiation oncologists, radiation therapists and medical physicists represented the trial credentialing and technical support team. To provide timely activation and proper implementation of the adaptive technique the following key areas were addressed at each site: Staff education/training; Practical image guided radiotherapy assessment; provision of help desk and feedback. The trial credentialing process involved face-to-face training and technical problem solving via full day site visits. A dedicated "help-desk" team was developed to provide support for the clinical trial. 26% of the workload occurred at the credentialing period while the remaining 74% came post-center activation. The workload was made up of the following key areas; protocol clarification (36%), technical problems (46%) while staff training was less than 10%. Clinical trial credentialing is important to minimizing trial deviations. It should not only focus on site activation quality assurance but also provide ongoing education and technical support.
authors.affiliation: Department of Radiation Therapy Services, Peter MacCallum Cancer Centre, Melbourne, Australia.
authors.forename: Daniel
authors.initials: D
authors.lastname: Pham
authors.forename: Paul
authors.initials: P
authors.lastname: Roxby
authors.forename: Tomas
authors.initials: T
authors.lastname: Kron
authors.forename: Aldo
authors.initials: A
authors.lastname: Rolfo
authors.forename: Farshad
authors.initials: F
authors.lastname: Foroudi
keywords: Adaptive radiotherapy; clinical trial; credentialing; image-guided radiotherapy