Abstract
IntroductionQuality assurance (QA) of treatment plans in clinical trials improves protocol compliance and patient outcomes. Retrospective use of knowledge-based-planning (KBP) in clinical trials has demonstrated improved treatment plan quality and consistency. We report the results of prospective use of KBP for real-time QA of treatment plan quality in the TROG 15.03 FASTRACK II trial, which evaluates efficacy of stereotactic ablative body radiotherapy (SABR) for kidney cancer.MethodsA KBP model was generated based on single institution data. For each patient in the KBP phase (open to the last 31 patients in the trial), the treating centre submitted treatment plans 7 days prior to treatment. A treatment plan was created by using the KBP model, which was compared with the submitted plan for each organ-at-risk (OAR) dose constraint. A report comparing each plan for each OAR constraint was provided to the submitting centre within 24 h of receiving the plan. The centre could then modify the plan based on the KBP report, or continue with the existing plan.ResultsReal-time feedback using KBP was provided in 24/31 cases. Consistent plan quality was in general achieved between KBP and the submitted plan. KBP review resulted in replan and improvement of OAR dosimetry in two patients. All centres indicated that the feedback was a useful QA check of their treatment plan.ConclusionKBP for real-time treatment plan review was feasible for 24/31 cases, and demonstrated ability to improve treatment plan quality in two cases. Challenges include integration of KBP feedback into clinical timelines, interpretation of KBP results with respect to clinical trade-offs, and determination of appropriate plan quality improvement criteria.
Highlights
Quality assurance (QA) of treatment plans in clinical trials improves protocol compliance and patient outcomes
These had been treated at a single institution either as part of a prospective Phase I trial or off-trial following the FASTRACK II protocol (23 patients treated with single fraction, 30 treated with three fractions)
It was expected the majority of plans in the present trial would be treated with a Volumetric Modulated Arc Therapy (VMAT) technique, all patients in this cohort were optimised with a class solution VMAT plan created with two ipsilateral arcs spanning 210° from the posterior-anterior direction around to 30° past midline
Summary
Quality assurance (QA) of treatment plans in clinical trials improves protocol compliance and patient outcomes. Retrospective use of knowledge-based-planning (KBP) in clinical trials has demonstrated improved treatment plan quality and consistency. Real time QA in clinical trials, is resource intensive, requiring substantial effort to de-identify and submit radiation therapy treatment planning data to a central repository and significant investment of time from volunteer reviewers. This is compounded by time constraints, where plan review must be performed efficiently, often in the context of timing with delivery of systemic agents. Dose distributions are often reviewed only to ensure compliance with trial protocol, with limited scope for reviewers to provide input and feedback on whether a treatment plan is optimal for that particular patient
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