用于治疗有症状骨转移的FLASH放疗（FAST-01）：首个前瞻性可行性研究方案
FLASH Radiotherapy for the Treatment of Symptomatic Bone Metastases (FAST-01): Protocol for the First Prospective Feasibility Study.
作者信息
Daugherty Emily C, Mascia Anthony, Zhang Yong, Lee Eunsin, Xiao Zhiyan, Sertorio Mathieu, Woo Jennifer, McCann Claire, Russell Kenneth, Levine Lisa, Sharma Ricky, Khuntia Deepak, Bradley Jeffrey, Simone Charles B, Perentesis John, Breneman John
机构信息
Department of Radiation Oncology, University of Cincinnati, Cincinnati, OH, United States.
Cancer and Blood Disease Institute, Cincinnati Children's Hospital, Cincinnati, OH, United States.
出版信息
JMIR Res Protoc. 2023 Jan 5;12:e41812. doi: 10.2196/41812.
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.
背景
在临床前研究中，FLASH疗法（即以每秒≥40 Gy的超高剂量率进行放疗）已被证明与传统剂量率放疗相比，对正常组织造成的损伤更小。本文介绍了质子FLASH疗法首次人体临床研究的方案。
目的
FAST-01是一项前瞻性单中心试验，旨在评估FLASH疗法治疗四肢疼痛性骨转移瘤的工作流程可行性、毒性和疗效。
方法
在获得知情同意后，将招募10名年龄≥18岁、四肢（不包括足部、手部和腕部）有多达3处疼痛性骨转移瘤的受试者。将从预定义的固定野大小（从7.5 cm×7.5 cm到7.5 cm×20 cm）计划库中选择一个治疗野用于治疗。受试者将单次接受8 Gy的放疗——这是一种在先前使用传统剂量率光子放疗的研究中评估过的成熟姑息治疗方案。将使用一台支持FLASH的Varian ProBeam质子治疗装置，利用质子束的坪区（透射）部分，以每秒≥40 Gy的剂量率向靶区进行治疗。治疗后，将评估受试者的疼痛反应以及FLASH放疗的任何不良反应。主要终点包括评估FLASH治疗的工作流程可行性和毒性。次要终点是通过患者报告的疼痛评分、止痛药物使用情况以及治疗后骨痛的任何加剧情况来衡量治疗部位的疼痛反应。将把结果与历史上使用相同放射剂量和分割方式的传统剂量率光子放疗报告的结果进行比较。
结果
FAST-01于2020年11月3日开始招募受试者。初步结果预计于2022年发表。
结论
这项研究的结果将有助于进一步开发和优化支持FLASH的ProBeam质子治疗系统工作流程。我们研究中获得的疼痛反应和毒性数据将使人们对FLASH治疗对肿瘤反应和正常组织毒性的影响有更深入的了解，并为未来的FLASH试验设计提供参考。
试验注册
ClinicalTrials.gov NCT04592887；http://clinicaltrials.gov/ct2/show/NCT04592887。
国际注册报告识别码（IRRID）：DERR1-10.2196/41812。
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