BACKGROUND AND PURPOSE: Review of plans early in treatment offers the potential to reduce the chance of sub-optimal treatment delivery. We compare the use of real time reviews (RTR) either before randomization (pre-rand 3D RTR) or following randomization (post-rand 2D RTR). MATERIALS AND METHODS: PROFIT is an international randomised trial for men with prostate cancer which had credentialing via multiple dummy runs. In Australia, but not Canada, all plans were submitted for pre-rand 3D RTR using 3D software, and resubmission was requested if significant protocol deviations (PD) were seen. All plans from Canada and Australia then underwent post-rand 2D RTR using a 2D assessment. RESULTS: For 147 Australian patients, pre-rand 3D RTR was fast (median 1 day, 95% range 0-4 days). 51 minor and 5 major PD were observed and 15 of the 147 cases (10%) required resubmission. Of the 5 major PD, 4 were remedied on resubmission and 1 was withdrawn from study. For the post-rand 2D RTR, reports from 147 Australian cases and 193 Canadian cases were reviewed. No major PD were reported from Australian cases, but 3 were seen in Canadian cases (0% versus 1.5%; p=0.26). There was also no difference in the rate of minor PD (14.3% versus 15.3%; p=NS). CONCLUSIONS: In a study using relatively simple treatment volumes after comprehensive credentialing, pre-rand 3D RTR offers only modest benefits compared with post-rand 2D RTR. In the future the intensity of RTR may need to vary according to protocol and site specific factors.
RCT Entities:
BACKGROUND AND PURPOSE: Review of plans early in treatment offers the potential to reduce the chance of sub-optimal treatment delivery. We compare the use of real time reviews (RTR) either before randomization (pre-rand 3D RTR) or following randomization (post-rand 2D RTR). MATERIALS AND METHODS: PROFIT is an international randomised trial for men with prostate cancer which had credentialing via multiple dummy runs. In Australia, but not Canada, all plans were submitted for pre-rand 3D RTR using 3D software, and resubmission was requested if significant protocol deviations (PD) were seen. All plans from Canada and Australia then underwent post-rand 2D RTR using a 2D assessment. RESULTS: For 147 Australian patients, pre-rand 3D RTR was fast (median 1 day, 95% range 0-4 days). 51 minor and 5 major PD were observed and 15 of the 147 cases (10%) required resubmission. Of the 5 major PD, 4 were remedied on resubmission and 1 was withdrawn from study. For the post-rand 2D RTR, reports from 147 Australian cases and 193 Canadian cases were reviewed. No major PD were reported from Australian cases, but 3 were seen in Canadian cases (0% versus 1.5%; p=0.26). There was also no difference in the rate of minor PD (14.3% versus 15.3%; p=NS). CONCLUSIONS: In a study using relatively simple treatment volumes after comprehensive credentialing, pre-rand 3D RTR offers only modest benefits compared with post-rand 2D RTR. In the future the intensity of RTR may need to vary according to protocol and site specific factors.
Authors: Christos Melidis; Walter R Bosch; Joanna Izewska; Elena Fidarova; Eduardo Zubizarreta; Satoshi Ishikura; David Followill; James Galvin; Ying Xiao; Martin A Ebert; Tomas Kron; Catharine H Clark; Elizabeth A Miles; Edwin G A Aird; Damien C Weber; Kenneth Ulin; Dirk Verellen; Coen W Hurkmans Journal: Radiother Oncol Date: 2014-05-08 Impact factor: 6.280
Authors: Tomas Skripcak; Claus Belka; Walter Bosch; Carsten Brink; Thomas Brunner; Volker Budach; Daniel Büttner; Jürgen Debus; Andre Dekker; Cai Grau; Sarah Gulliford; Coen Hurkmans; Uwe Just; Mechthild Krause; Philippe Lambin; Johannes A Langendijk; Rolf Lewensohn; Armin Lühr; Philippe Maingon; Michele Masucci; Maximilian Niyazi; Philip Poortmans; Monique Simon; Heinz Schmidberger; Emiliano Spezi; Martin Stuschke; Vincenzo Valentini; Marcel Verheij; Gillian Whitfield; Björn Zackrisson; Daniel Zips; Michael Baumann Journal: Radiother Oncol Date: 2014-10-28 Impact factor: 6.280
Authors: Jarad Martin; Paul Keall; Shankar Siva; Peter Greer; David Christie; Kevin Moore; Jason Dowling; David Pryor; Peter Chong; Nicholas McLeod; Avi Raman; James Lynam; Joanne Smart; Christopher Oldmeadow; Colin I Tang; Declan G Murphy; Jeremy Millar; Keen Hun Tai; Lois Holloway; Penny Reeves; Amy Hayden; Tee Lim; Tanya Holt; Mark Sidhom Journal: BMJ Open Date: 2019-08-20 Impact factor: 2.692