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FLASH Radiotherapy for the Treatment of Symptomatic Bone Metastases (FAST-01): Protocol for the First Prospective
Emily C Daugherty1, Anthony Mascia1,2, Yong Zhang1,2
1Department of Radiation Oncology, University of Cincinnati, Cincinnati, OH, United States.
JMIR Research Protocols
|October 7, 2022
Summary
This study investigates proton FLASH therapy, an ultrahigh dose rate radiation, for painful bone metastases. Early findings will guide future FLASH treatment optimization and understanding of its effects.
Area of Science:
- Oncology
- Radiation Oncology
- Medical Physics
Background:
- Preclinical studies show ultrahigh dose rate radiation (FLASH therapy, ≥40 Gy/s) causes less normal tissue injury than conventional radiotherapy.
- This paper details the protocol for the first human clinical trial of proton FLASH therapy.
Purpose of the Study:
- FAST-01 trial assesses workflow feasibility, toxicity, and efficacy of proton FLASH therapy for painful bone metastases.
- The study aims to evaluate patient-reported pain scores and adverse effects.
Main Methods:
- 10 adult subjects with painful bone metastases in extremities enrolled in a prospective, single-center trial.
- Treatment involves 8 Gy single fraction proton FLASH therapy (≥40 Gy/s) using a Varian ProBeam unit.
- Primary endpoints: workflow feasibility and toxicity; Secondary endpoint: pain response compared to historical conventional dose rate data.
Main Results:
- FAST-01 trial opened November 3, 2020.
- Initial results are anticipated in 2022.
Conclusions:
- Results will refine FLASH-enabled ProBeam proton therapy workflow and system optimization.
- Data on pain response and toxicity will enhance understanding of FLASH treatment effects on tumors and normal tissues, informing future trial designs.
