The Australasian Gastro-Intestinal Trials Group (AGITG) SPAR trial is a randomised, placebo‐controlled phase II trial of Simvastatin in addition to standard chemotherapy and radiation in PreoperAtive treatment for Rectal cancer. In retrospective studies statin use improved overall survival, pathological response to preoperative chemoradiotherapy, and reduced acute and late toxicities from pelvic radiation[1-3]. The primary endpoint of the SPAR trial is the proportion of patients with favourable MRI-based tumour regression grading (mrTRG) by central review in simvastatin and placebo groups. mrTRG is an imaging score used...

21 radiologists from 14 sites attended a 1 day workshop on MRI reporting and mrTRG grading presented by the central radiologist, prior to patient recruitment. There was a delay of 0 to 14 months between the workshop and starting recruitment, but training materials remained available. The site MRI report with mrTRG score was collected and entered into the trial database. Original scans were imported and reviewed blind by two central radiologists. Any discrepancy between central radiologists was resolved by consensus. The weighted kappa statistic was...

The first 35 patients had post-treatment scans between 26 July 2018 and 27 July 2020 across 10 sites (each recruiting between 1-12 patients during that period). In four cases a site mrTRG score or images were unavailable, leaving 31 patients for analysis. The site and central mrTRG scores are given in Fig 2. [Fig 2] 15 patients had a disagreement of mrTRG score, with 6 deemed clinically significant (19%). The majority of disagreements were between mrTRG 3 and 4 [Fig 3]. [Fig 3] In one...

Interim analysis of mrTRG scores between site and central review showed fair and moderate inter-observer agreement in 3 and 2 category assessments, with 19% of disagreements deemed clinically significant. The rates of disagreement were likely impacted by significant delays between training and reporting, and the relative infrequency of radiologists reporting mrTRG scores at that time. Due to the results for the interim analysis, a refresher course was run for trial radiologists in July 2022.

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