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© 2023. This work is licensed under https://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.

Abstract

Background:In preclinical studies, FLASH therapy, in which radiation delivered at ultrahigh dose rates of ≥40 Gy per second, has been shown to cause less injury to normal tissues than radiotherapy delivered at conventional dose rates. This paper describes the protocol for the first-in-human clinical investigation of proton FLASH therapy.

Objective:FAST-01 is a prospective, single-center trial designed to assess the workflow feasibility, toxicity, and efficacy of FLASH therapy for the treatment of painful bone metastases in the extremities.

Methods:Following informed consent, 10 subjects aged ≥18 years with up to 3 painful bone metastases in the extremities (excluding the feet, hands, and wrists) will be enrolled. A treatment field selected from a predefined library of plans with fixed field sizes (from 7.5 cm × 7.5 cm up to 7.5 cm × 20 cm) will be used for treatment. Subjects will receive 8 Gy of radiation in a single fraction—a well-established palliative regimen evaluated in prior investigations using conventional dose rate photon radiotherapy. A FLASH-enabled Varian ProBeam proton therapy unit will be used to deliver treatment to the target volume at a dose rate of ≥40 Gy per second, using the plateau (transmission) portion of the proton beam. After treatment, subjects will be assessed for pain response as well as any adverse effects of FLASH radiation. The primary end points include assessing the workflow feasibility and toxicity of FLASH treatment. The secondary end point is pain response at the treated site(s), as measured by patient-reported pain scores, the use of pain medication, and any flare in bone pain after treatment. The results will be compared to those reported historically for conventional dose rate photon radiotherapy, using the same radiation dose and fractionation.

Results:FAST-01 opened to enrollment on November 3, 2020. Initial results are expected to be published in 2022.

Conclusions:The results of this investigation will contribute to further developing and optimizing the FLASH-enabled ProBeam proton therapy system workflow. The pain response and toxicity data acquired in our study will provide a greater understanding of FLASH treatment effects on tumor responses and normal tissue toxicities, and they will inform future FLASH trial designs.

Trial Registration:: ClinicalTrials.gov NCT04592887; http://clinicaltrials.gov/ct2/show/NCT04592887

International Registered Report Identifier (IRRID):DERR1-10.2196/41812

Details

Title
FLASH Radiotherapy for the Treatment of Symptomatic Bone Metastases (FAST-01): Protocol for the First Prospective Feasibility Study
Author
Daugherty, Emily C  VIAFID ORCID Logo  ; Mascia, Anthony  VIAFID ORCID Logo  ; Zhang, Yong  VIAFID ORCID Logo  ; Lee, Eunsin  VIAFID ORCID Logo  ; Xiao, Zhiyan  VIAFID ORCID Logo  ; Sertorio, Mathieu  VIAFID ORCID Logo  ; Woo, Jennifer  VIAFID ORCID Logo  ; McCann, Claire  VIAFID ORCID Logo  ; Russell, Kenneth  VIAFID ORCID Logo  ; Levine, Lisa  VIAFID ORCID Logo  ; Sharma, Ricky  VIAFID ORCID Logo  ; Khuntia, Deepak  VIAFID ORCID Logo  ; Bradley, Jeffrey  VIAFID ORCID Logo  ; Simone, Charles B, II  VIAFID ORCID Logo  ; Perentesis, John  VIAFID ORCID Logo  ; Breneman, John  VIAFID ORCID Logo 
First page
e41812
Publication year
2023
Publication date
2023
Publisher
JMIR Publications
e-ISSN
19290748
Source type
Scholarly Journal
Language of publication
English
ProQuest document ID
2918518180
Copyright
© 2023. This work is licensed under https://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.