Quality improvements in radiation oncology clinical trials

• Type of Material: Article
• Authors: Koren Smith, UMass Chan Medical School; Kenneth Ulin, UMass Chan Medical School; Michael Knopp, The Ohio State University Wexner Medical Center; Stephen Kry, University of Texas Health Science Center at Houston; Ying Xiao, University of Pennsylvania; Mark Rosen, University of Pennsylvania; Jeff Michalski, Washington University in St. Louis; Matthew Iandoli, UMass Chan Medical School; Fran Laurie, UMass Chan Medical School; Jean Quigley, UMass Chan Medical School; Heather Reifler, UMass Chan Medical School; Juan Santiago, UMass Chan Medical School; Kathleen Briggs, UMass Chan Medical School; Shawn Kirby, UMass Chan Medical School; Kate Schmitter, UMass Chan Medical School; Fred Prior, University of Arkansas at Little Rock; Joel Saltz, Stony Brook University; Ashish Sharma, Emory University; Maryann Bishop-Jodoin, UMass Chan Medical School; Janaki Moni, UMass Chan Medical School; Giulia M Cicchetti, UMass Chan Medical School; Thomas J FitzGerald, UMass Chan Medical School
• Language: English
• Date: 2023-01-26
• Publisher: Emory University Libraries
• Publication Version: Final Published Version
• Copyright Statement: © 2023 Smith, Ulin, Knopp, Kry, Xiao, Rosen, Michalski, Iandoli, Laurie, Quigley, Reifler, Santiago, Briggs, Kirby, Schmitter, Prior, Saltz, Sharma, Bishop-Jodoin, Moni, Cicchetti and FitzGerald
• License: Creative Commons Attribution 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.3389/fonc.2023.1015596
• Title of Journal or Parent Work: Frontiers in Oncology
• Volume: 13
• Start Page: 1015596
• End Page: 1015596
• Grant/Funding Information: The work done at QARC and within the IROC program were supported in part by U10CA029511, U24CA180803 and U24CA215109.
• Keywords: oncology; quality; patient care; radiation therapy; clinical trials
• Research Categories: Health Sciences, Oncology; Biology, Radiation; Health Sciences, Radiology

Abstract

Clinical trials have become the primary mechanism to validate process improvements in oncology clinical practice. Over the past two decades there have been considerable process improvements in the practice of radiation oncology within the structure of a modern department using advanced technology for patient care. Treatment planning is accomplished with volume definition including fusion of multiple series of diagnostic images into volumetric planning studies to optimize the definition of tumor and define the relationship of tumor to normal tissue. Daily treatment is validated by multiple tools of image guidance. Computer planning has been optimized and supported by the increasing use of artificial intelligence in treatment planning. Informatics technology has improved, and departments have become geographically transparent integrated through informatics bridges creating an economy of scale for the planning and execution of advanced technology radiation therapy. This serves to provide consistency in department habits and improve quality of patient care. Improvements in normal tissue sparing have further improved tolerance of treatment and allowed radiation oncologists to increase both daily and total dose to target. Radiation oncologists need to define a priori dose volume constraints to normal tissue as well as define how image guidance will be applied to each radiation treatment. These process improvements have enhanced the utility of radiation therapy in patient care and have made radiation therapy an attractive option for care in multiple primary disease settings. In this chapter we review how these changes have been applied to clinical practice and incorporated into clinical trials. We will discuss how the changes in clinical practice have improved the quality of clinical trials in radiation therapy. We will also identify what gaps remain and need to be addressed to offer further improvements in radiation oncology clinical trials and patient care.