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

Haoyu Zhong, Kuo Men*, Jiazhou Wang, Johan van Soest, David Rosenthal, Andre Dekker, Zhen Zhang, Ying Xiao

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

10 Citations (Web of Science)

Abstract

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.

Original languageEnglish
Article number792
Number of pages7
JournalFrontiers in Oncology
Volume9
DOIs
Publication statusPublished - 21 Aug 2019
Event59th Annual Scientific Meeting of the American Society fo Radiation Oncology - San Diego Convention Center, San Diego, United States
Duration: 24 Sep 201727 Sep 2017
Conference number: 59

Keywords

  • radiotherapy
  • quality assurance
  • treatment outcomes
  • clinical trial
  • contour
  • dose
  • RADIATION-THERAPY
  • RANDOMIZED-TRIAL
  • QA

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