Prostate radiotherapy clinical trial quality assurance: how real should real time review be? (A TROG-OCOG Intergroup...

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).

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.

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 Of the 5 major PD, 4 were remedied on resubmission and 1 was withdrawn from study.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).

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.