Background:
Quality assurance (QA) practices improve radiotherapy trials by ensuring protocol compliance and thus lead to valid and reproducible results. They have also been associated with better oncological outcomes. However, external QA for some studies requires significant resource allocation for cost, time and administrative burden, especially when performed real time.
A phase 2, single arm prospective study assessing moderately hypofractionated chemoradiation in the definitive treatment of unresectable stage 3 Non-Small Cell Lung Cancer elected to avoid external QA of radiotherapy. Instead, the study protocol stipulated internal QA practices of the participating academic centres, accredited by TROG trials group for undertaking technologically advanced trials.
Aims:
The aim of this audit is to assess the compliance of the participating institutions to the MODERN-LUNG study protocol guidelines in the absence of real-time external QA.
Methods:
A retrospective audit was performed on the first 36 participants on the MODERN-lung study, who were treated at four institutions. Thirty QA items pertaining to the radiotherapy component of their treatment were measured, including imaging, motion management, peer reviewed contouring, dosimetry, organ-at-risk parameters and delivery times. All deviations from protocol were recorded and reviewed by two Radiation Oncologists who subspecialise in lung cancer and categorised as acceptable, acceptable variation or unacceptable variation.
Results:
Compliance to radiotherapy protocol was high and most deviations were minor or considered acceptable as they were considered unlikely to either be clinically meaningful or alterable by any real time formal QA process.
Conclusions:
This audit supports the hypothesis that well established QA processes within research-focused institutions is a viable alternative to resource intensive external QA. Such a strategy provides a possible option in selected circumstances to reduce costs of conducting research in radiotherapy.