Abstract Body

Radiotherapy plays an essential role in the treatment of more than half of all cancer patients. FLASH radiotherapy (FLASH-RT) delivers radiation treatment at ultra-high dose rates that are several orders of magnitude higher than current clinical practice. In multiple pre-clinical studies in different model systems, FLASH-RT has demonstrated consistent normal tissue sparing effects while preserving equivalent anti-tumor activity in comparison to conventional dose rate radiation treatment. In this talk, I will outline how such normal tissue sparing could address important clinical needs and I will describe Varian’s approach to addressing these clinical questions in a rational sequence of clinical trials. Varian’s FAST-01 was the first clinical trial to study proton FLASH in patients with cancer. Following demonstration of feasibility and safety in the FAST-01 and FAST-02 clinical trials of palliative FLASH-RT for bone metastases, clinical trials of definitive dose RT will be required to establish the future clinical role of FLASH-RT. In this talk, I will discuss regulatory and clinical aspects of these future trials.