TY - JOUR
T1 - Framework for Quality Assurance of Ultrahigh Dose Rate Clinical Trials Investigating FLASH Effects and Current Technology Gaps
AU - Zou, Wei
AU - Zhang, Rongxiao
AU - Schüler, Emil
AU - Taylor, Paige A.
AU - Mascia, Anthony E.
AU - Diffenderfer, Eric S.
AU - Zhao, Tianyu
AU - Ayan, Ahmet S.
AU - Sharma, Manju
AU - Yu, Shu Jung
AU - Lu, Weiguo
AU - Bosch, Walter R.
AU - Tsien, Christina
AU - Surucu, Murat
AU - Pollard-Larkin, Julianne M.
AU - Schuemann, Jan
AU - Moros, Eduardo G.
AU - Bazalova-Carter, Magdalena
AU - Gladstone, David J.
AU - Li, Heng
AU - Simone, Charles B.
AU - Petersson, Kristoffer
AU - Kry, Stephen F.
AU - Maity, Amit
AU - Loo, Billy W.
AU - Dong, Lei
AU - Maxim, Peter G.
AU - Xiao, Ying
AU - Buchsbaum, Jeffrey C.
N1 - Publisher Copyright:
© 2023 The Authors
PY - 2023/8/1
Y1 - 2023/8/1
N2 - FLASH radiation therapy (FLASH-RT), delivered with ultrahigh dose rate (UHDR), may allow patients to be treated with less normal tissue toxicity for a given tumor dose compared with currently used conventional dose rate. Clinical trials are being carried out and are needed to test whether this improved therapeutic ratio can be achieved clinically. During the clinical trials, quality assurance and credentialing of equipment and participating sites, particularly pertaining to UHDR-specific aspects, will be crucial for the validity of the outcomes of such trials. This report represents an initial framework proposed by the NRG Oncology Center for Innovation in Radiation Oncology FLASH working group on quality assurance of potential UHDR clinical trials and reviews current technology gaps to overcome. An important but separate consideration is the appropriate design of trials to most effectively answer clinical and scientific questions about FLASH. This paper begins with an overview of UHDR RT delivery methods. UHDR beam delivery parameters are then covered, with a focus on electron and proton modalities. The definition and control of safe UHDR beam delivery and current and needed dosimetry technologies are reviewed and discussed. System and site credentialing for large, multi-institution trials are reviewed. Quality assurance is then discussed, and new requirements are presented for treatment system standard analysis, patient positioning, and treatment planning. The tables and figures in this paper are meant to serve as reference points as we move toward FLASH-RT clinical trial performance. Some major questions regarding FLASH-RT are discussed, and next steps in this field are proposed. FLASH-RT has potential but is associated with significant risks and complexities. We need to redefine optimization to focus not only on the dose but also on the dose rate in a manner that is robust and understandable and that can be prescribed, validated, and confirmed in real time. Robust patient safety systems and access to treatment data will be critical as FLASH-RT moves into the clinical trials.
AB - FLASH radiation therapy (FLASH-RT), delivered with ultrahigh dose rate (UHDR), may allow patients to be treated with less normal tissue toxicity for a given tumor dose compared with currently used conventional dose rate. Clinical trials are being carried out and are needed to test whether this improved therapeutic ratio can be achieved clinically. During the clinical trials, quality assurance and credentialing of equipment and participating sites, particularly pertaining to UHDR-specific aspects, will be crucial for the validity of the outcomes of such trials. This report represents an initial framework proposed by the NRG Oncology Center for Innovation in Radiation Oncology FLASH working group on quality assurance of potential UHDR clinical trials and reviews current technology gaps to overcome. An important but separate consideration is the appropriate design of trials to most effectively answer clinical and scientific questions about FLASH. This paper begins with an overview of UHDR RT delivery methods. UHDR beam delivery parameters are then covered, with a focus on electron and proton modalities. The definition and control of safe UHDR beam delivery and current and needed dosimetry technologies are reviewed and discussed. System and site credentialing for large, multi-institution trials are reviewed. Quality assurance is then discussed, and new requirements are presented for treatment system standard analysis, patient positioning, and treatment planning. The tables and figures in this paper are meant to serve as reference points as we move toward FLASH-RT clinical trial performance. Some major questions regarding FLASH-RT are discussed, and next steps in this field are proposed. FLASH-RT has potential but is associated with significant risks and complexities. We need to redefine optimization to focus not only on the dose but also on the dose rate in a manner that is robust and understandable and that can be prescribed, validated, and confirmed in real time. Robust patient safety systems and access to treatment data will be critical as FLASH-RT moves into the clinical trials.
UR - http://www.scopus.com/inward/record.url?scp=85164239228&partnerID=8YFLogxK
U2 - 10.1016/j.ijrobp.2023.04.018
DO - 10.1016/j.ijrobp.2023.04.018
M3 - Review article
C2 - 37121362
AN - SCOPUS:85164239228
SN - 0360-3016
VL - 116
SP - 1202
EP - 1217
JO - International Journal of Radiation Oncology Biology Physics
JF - International Journal of Radiation Oncology Biology Physics
IS - 5
ER -