Original Research ARTICLE
The impact of clinical trial quality assurance on outcome in head and neck radiotherapy treatment
- 1University of Pennsylvania, United States
- 2Cancer Hospital (CAMS), China
- 3Fudan University Shanghai Cancer Center, China
- 4Maastro Clinic, Netherlands
- 5Department of Radiation Oncology, MD Anderson Cancer Center, United States
Purpose: To investigate the impact of radiation treatment quality assurance (RTQA) on treatment outcomes in a phase III 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.
Keywords: Radiotherapy, Quality Assurance, Treatment outcomes, Clinical Trial, contour, Dose
Received: 18 Jun 2019;
Accepted: 06 Aug 2019.
Copyright: © 2019 Zhong, Men, Wang, van Soest, Rosenthal, Dekker, Zhang and Xiao. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Dr. Kuo Men, University of Pennsylvania, Philadelphia, 19104, Pennsylvania, United States, firstname.lastname@example.org