Expert consensus on clinical trial design guidelines for FLASH radiotherapy.

Abstract

In recent years, ultra-high dose-rate FLASH radiotherapy (FLASH-RT) has emerged as a prominent research focus in radiation oncology. A series of preclinical data indicate that FLASH-RT can achieve tumor-killing efficacy that is not inferior to that of conventional radiotherapy (CONV-RT) while significantly reducing radiation damage to normal tissues. This distinctive tissue-sparing effect is known as the "FLASH effect." Rapid progress has been made in the clinical translation and application of FLASH-RT. Against this backdrop, the China Anti-Cancer Association Radiation Oncology Committee and the Chinese Medical Doctor Association Radiation Oncology Physician Committee gathered a group of experts and compiled the "Expert Consensus on Clinical Trial Design Guidelines for FLASH Radiotherapy" based on the latest domestic and international research advancements. This document summarizes the latest advances in FLASH-RT and offers practical guidance for its design and translational application in future clinical trials.