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Corrigan KL, Kry S, Howell RM, et al. The radiotherapy quality assurance gap among phase III cancer clinical trials. Radiother Oncol. 2021;166:51-57doi: 10.1016/j.radonc.2021.11.018.
Corrigan, K. L., Kry, S., Howell, R. M., Kouzy, R., Jaoude, J. A., Patel, R. R., Jhingran, A., Taniguchi, C., Koong, A. C., McAleer, M. F., Nitsch, P., Rödel, C., Fokas, E., Minsky, B. D., Das, P., Fuller, C. D., & Ludmir, E. B. (2021). The radiotherapy quality assurance gap among phase III cancer clinical trials. Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology, 16651-57. https://doi.org/10.1016/j.radonc.2021.11.018
Corrigan, Kelsey L, et al. "The radiotherapy quality assurance gap among phase III cancer clinical trials." Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology vol. 166 (2021): 51-57. doi: https://doi.org/10.1016/j.radonc.2021.11.018
Corrigan KL, Kry S, Howell RM, Kouzy R, Jaoude JA, Patel RR, Jhingran A, Taniguchi C, Koong AC, McAleer MF, Nitsch P, Rödel C, Fokas E, Minsky BD, Das P, Fuller CD, Ludmir EB. The radiotherapy quality assurance gap among phase III cancer clinical trials. Radiother Oncol. 2021 Nov 25;166:51-57. doi: 10.1016/j.radonc.2021.11.018. Epub 2021 Nov 25. PMID: 34838891.
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Radiother Oncol. 2021 Nov 25;166:51-57. doi: 10.1016/j.radonc.2021.11.018. Epub 2021 Nov 25.

The radiotherapy quality assurance gap among phase III cancer clinical trials.

Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology

Kelsey L Corrigan, Stephen Kry, Rebecca M Howell, Ramez Kouzy, Joseph Abi Jaoude, Roshal R Patel, Anuja Jhingran, Cullen Taniguchi, Albert C Koong, Mary Fran McAleer, Paige Nitsch, Claus Rödel, Emmanouil Fokas, Bruce D Minsky, Prajnan Das, C David Fuller, Ethan B Ludmir

Affiliations

  1. The University of Texas MD Anderson Cancer Center, Houston, USA. Electronic address: [email protected].
  2. The University of Texas MD Anderson Cancer Center, Houston, USA. Electronic address: [email protected].
  3. The University of Texas MD Anderson Cancer Center, Houston, USA. Electronic address: [email protected].
  4. The University of Texas MD Anderson Cancer Center, Houston, USA. Electronic address: [email protected].
  5. The University of Texas MD Anderson Cancer Center, Houston, USA. Electronic address: [email protected].
  6. The University of Texas MD Anderson Cancer Center, Houston, USA. Electronic address: [email protected].
  7. The University of Texas MD Anderson Cancer Center, Houston, USA. Electronic address: [email protected].
  8. The University of Texas MD Anderson Cancer Center, Houston, USA. Electronic address: [email protected].
  9. The University of Texas MD Anderson Cancer Center, Houston, USA. Electronic address: [email protected].
  10. The University of Texas MD Anderson Cancer Center, Houston, USA. Electronic address: [email protected].
  11. The University of Texas MD Anderson Cancer Center, Houston, USA. Electronic address: [email protected].
  12. University of Frankfurt, Frankfurt, Germany; German Cancer Research Center, Heidelberg, Germany; German Cancer Consortium, Frankfurt, Germany; Frankfurt Cancer Institute, Frankfurt, Germany. Electronic address: [email protected].
  13. University of Frankfurt, Frankfurt, Germany; German Cancer Research Center, Heidelberg, Germany; German Cancer Consortium, Frankfurt, Germany; Frankfurt Cancer Institute, Frankfurt, Germany. Electronic address: [email protected].
  14. The University of Texas MD Anderson Cancer Center, Houston, USA. Electronic address: [email protected].
  15. The University of Texas MD Anderson Cancer Center, Houston, USA. Electronic address: [email protected].
  16. The University of Texas MD Anderson Cancer Center, Houston, USA. Electronic address: [email protected].
  17. The University of Texas MD Anderson Cancer Center, Houston, USA. Electronic address: [email protected].

PMID: 34838891 DOI: 10.1016/j.radonc.2021.11.018

Abstract

PURPOSE: Quality assurance (QA) practices improve the quality level of oncology trials by ensuring that the protocol is followed and the results are valid and reproducible. This study investigated the utilization of QA among randomized controlled trials that involve radiotherapy (RT).

METHODS AND MATERIALS: We searched ClinicalTrials.gov in February 2020 for all phase III oncology randomized clinical trials (RCTs). These trials were screened for RT-specific RCTs that had published primary trial results. Information regarding QA in each trial was collected from the study publications and trial protocol if available. Two individuals independently performed trial screening and data collection. Pearson's Chi-square tests analyses were used to assess factors that were associated with QA inclusion in RT trials.

RESULTS: Forty-two RCTs with RT as the primary intervention or as a mandatory component of the protocol were analyzed; the earliest was started in 1994 and one trial was still active though not recruiting. Twenty-nine (69%) trials mandated RT quality assurance (RTQA) practices as part of the trial protocol, with 19 (45%) trials requiring institutional credentialing. Twenty-one (50%) trials published protocol deviation outcomes. Clinical trials involving advanced radiation techniques (IMRT, VMAT, SRS, SBRT) did not include more RTQA than trials without these advanced techniques (73% vs. 65%, p = 0.55). Trials that reported protocol deviation outcomes were associated with mandating RTQA in their protocols as compared to trials that did not report these outcomes (100% vs. 38%, p < 0.001).

CONCLUSIONS: There is a lack of RTQA utilization and transparency in RT clinical trials. It is imperative for RT trials to include increased QA for safe, consistent, and high-quality RT planning and delivery.

Copyright © 2021 Elsevier B.V. All rights reserved.

Keywords: Quality assurance; Radiotherapy; Randomized controlled trials

Conflict of interest statement

Conflict of Interest Dr. Prajnan Das: Honorarium: ASCO, ASTRO, NCI/Leidos, Physicians Education Resource, Conveners (all unrelated to this manuscript’s content). No other authors report any conflicts

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