title: Prostate radiotherapy clinical trial quality assurance: how real should real time review be? (A TROG-OCOG Intergroup Project).
abstract: OBJECTIVE
  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).
  
  
  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 Of the 5 major PD, 4 were remedied on resubmission and 1 was withdrawn from study.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.affiliation: Department of Radiation Oncology, Calvary Mater Hospital, Newcastle, Australia. Jarad.martin@calvarymater.org.au
authors.forename: Jarad
authors.initials: J
authors.lastname: Martin
authors.forename: Jim
authors.initials: J
authors.lastname: Frantzis
authors.forename: Peter
authors.initials: P
authors.lastname: Chung
authors.forename: Ijaz
authors.initials: I
authors.lastname: Langah
authors.forename: Melissa
authors.initials: M
authors.lastname: Crain
authors.forename: Deidre
authors.initials: D
authors.lastname: Cornes
authors.forename: Ash
authors.initials: A
authors.lastname: Plank
authors.forename: Terri
authors.initials: T
authors.lastname: Finch
authors.forename: Mark
authors.initials: M
authors.lastname: Jones
authors.forename: Eric
authors.initials: E
authors.lastname: Khoo
authors.forename: Charles
authors.initials: C
authors.lastname: Catton
mesh_terms: D006801:Humans; D008297:Male; D011471:Prostatic Neoplasms / Q000473:pathology / Q000532:radiotherapy*; D011785:Quality Assurance, Health Care; D011880:Radiotherapy Planning, Computer-Assisted; D047368:Tumor Burden
keywords: Clinical trial; Prostate neoplasm; Quality assurance; Radiotherapy