The Impact of Clinical Trial Quality Assurance on Outcome in Head and Neck Radiotherapy Treatment

Purpose: To investigate the impact of radiation treatment quality assurance (RTQA) on treatment outcomes in a phase Ill trial for advanced head and neck cancer.

Materials and Methods: A total of 767 patients from NRG/RTOG 0522 were included in this study. The contours of target volume (TV) and organ at risk (OAR), and dose-volume coverage of targets were reviewed and scored (per-protocol, variation-acceptable and deviation-unacceptable) according to the protocol. We performed log-rank tests for RTQA scores with patients' outcomes, including local control (LC), distant control (DC) and overall survival (OS). Cox models with and without RTQA score data were established. To obtain a more reasonable model, per-protocol and variation acceptable were combined into a single acceptable score.

Results: The log-rank test showed that all RTQA scores correlated with LC, which was significantly different between the per-protocol and variation-acceptable patients in target and OAR contouring (p-value = 0.004 and 0.043). For dose-volume score, the per-protocol and variation-acceptable patients were significantly different from unacceptable patients in the LC, with a p-value = 0.020 and 0.006, respectively. The DC of patients with variation-acceptable was significantly different than that of the unacceptable patients (p-value = 0.043). There were no correlations between RTQA scores with other outcomes. By incorporating RTQA scores into outcome modeling, the performance of LC model can be improved from 0.62 to 0.63 (c-index). The RTQA scores had no impact on DC and OS.

Conclusion: RTQA scores are related to patients' local control rates in head and neck cancer radiotherapy.