The radiotherapy quality assurance gap among phase III cancer clinical trials. (January 2022)

• Record Type: Journal Article
• Authors: Corrigan, Kelsey L.; Kry, Stephen; Howell, Rebecca M.; Kouzy, Ramez; Jaoude, Joseph Abi; Patel, Roshal R.; Jhingran, Anuja; Taniguchi, Cullen; Koong, Albert C.; McAleer, Mary Fran; Nitsch, Paige; Rödel, Claus; Fokas, Emmanouil; Minsky, Bruce D.; Das, Prajnan; Fuller, C. David; Ludmir, Ethan B.
• Is Part Of: Radiotherapy and oncology. Volume 166(2022)
• Page Start: 51
• Page End: 57
• Publication Date: 2022-01
• Subjects: QA Quality assurance -- RT Radiotherapy -- RTQA Radiotherapy quality assurance -- RCT Randomized controlled trial; Radiotherapy -- Quality assurance -- Randomized controlled trials; Oncology -- Periodicals; Radiotherapy -- Periodicals; Tumors -- Periodicals; Medical Oncology -- Periodicals; Neoplasms -- radiotherapy -- Periodicals; Radiotherapy -- Periodicals; Radiothérapie -- Périodiques; Cancérologie -- Périodiques; Tumeurs -- Périodiques; Electronic journals; 616.9940642
• DOI: 10.1016/j.radonc.2021.11.018
• Languages: English
• ISSNs: 0167-8140

Abstract

Highlights: Two-thirds of all radiotherapy (RT) randomized controlled trials (RCTs) mandated RT quality assurance (RTQA). Less than half of trials required institutional credentialing. Clinical trials involving advanced radiation techniques were not associated with utilization of RTQA. Half of radiotherapy RCTs published protocol deviation outcomes. There is a need for greater use of RTQA in RCTs to ensure protocol-specified RT is being delivered safely. 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.