November 2, 2021 —Varian, a Siemens Healthineers company, and theCincinnati Children's/UC Health Proton Therapy Centerannounced the completion of enrollment in FAST-01 (FeAsibility Study of FLASH Radiotherapy for the Treatment of Symptomatic Bone Metastases), the first human clinical trial of FLASH therapy.
The FAST-01 trial, which is evaluating clinical workflow feasibility of the FLASH therapy and treatment-related side effects, met its enrollment target of 10 participants with bone metastases in the extremities. The clinical trial, informed by years of preclinical work, was designed by experts at Varian and multiple centers in the FlashForward Consortium, including Cincinnati's Children's/UC Health Proton Therapy Center and the New York Proton Center.
The FAST-01 trial is being led byJohn C. Breneman, M.D., principal investigator, and Medical Director of the Cincinnati Children's/UC Health Proton Therapy Center, UC Health radiation oncologist, and professor emeritus at the University of Cincinnati College of Medicine. "The completion of enrollment brings the clinical community one step closer to making an informed evaluation of FLASH therapy," said Breneman. "The team is looking forward to reviewing and sharing the findings, while also looking ahead toward the next clinical phase of research," he added.
The trial is supported byEmily Daugherty, M.D., assistant professor of radiation oncology at UC and a UC Health radiation oncologist, andAnthony Mascia, PhD, DABR, adjunct assistant professor of radiation oncology at UC and Director of Medical Physics at the Cincinnati Children's/UC Health Proton Therapy Center.
“过去一年，临床试验研究人员努力工作，完成了FAST-01的注册。瓦里安FLASH解决方案副总裁Agam Sharda说:“实现这一重要的里程碑是向前迈出的重要一步，以证明在临床环境中使用FLASH治疗的可行性，而不仅仅是在实验室。”“我们感谢这些试验对象，他们凭借自己的参与，为FLASH技术的进步做出了贡献，为将来可能需要接受癌症治疗的其他人带来潜在的好处。”
"Initial findings indicate that the Varian ProBeam system, modified to deliver FLASH therapy, is performing as planned during the study. To date, none of the trial participants have suffered any serious adverse events related to FLASH," said Ricky Sharma, M.D. Ph.D., Vice President of Clinical Affairs at Varian. "There is still much work and research to be done, and we are eager to explore all the clinical trial data."
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For more information:www.varian.com
August 10, 2022
