On May 12, 2023 IntraOp Medical Corporation announced the world’s first Phase II Electron FLASH Trial. It marks the first time a randomized trial will compare FLASH radiotherapy* to conventional radiotherapy in treating nonmelanoma skin cancer (NMSC) (Press release, IntraOp Medical, MAY 12, 2023, View Source [SID1234631614]). It is the second clinical human trial to use the IntraOp Mobetron electron-based linear accelerator (LINAC).
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Conducted by leading FLASH researchers from the University Hospital of Lausanne (CHUV) in Switzerland, the study will focus on the safety and efficacy of local tumor control rates in patients with localized cutaneous squamous cell or basal cell carcinomas. Investigators will compare the toxicity and efficacy of Ultra-High Dose Rate (UHDR) radiotherapy (FLASH therapy) to standard of care (SOC) conventional radiotherapy in two different irradiation schemes: 22Gy single dose radiotherapy as well as 5 x 6Gy fractionated dose administered in less than two weeks. Patient enrollment is ongoing.
"This feels like a breakthrough moment in our collective study of the role and effectiveness of FLASH radiotherapy as compared to standard of care radiotherapy. This trial is another important step in the feasibility of FLASH for clinical treatment," said Prof J Bourhis, head of CHUV Radiation Oncology Department.
FLASH is a pre-clinical treatment modality that delivers radiation therapy at ultra-high dose rates within microseconds. Prior studies indicate lower toxicity, the sparing of healthy tissue delivered in less time than traditional radiotherapy, and fewer required fractionations. Pre-clinical testing has demonstrated that FLASH radiotherapy may provide biological benefits and improve the therapeutic index by producing a protective effect for normal tissue.
"Our partners at CHUV are once again boldly leading the charge toward FLASH, and we couldn’t be more excited that Mobetron will continue to play a critical role," said Sanjay Arora, CEO at IntraOp. "This study represents a milestone in patient treatment using radiotherapy with electrons and reveals the future of patient care."
CHUV leads innovation by offering international and in-house clinical trials dedicated to treating patients with the latest advancements in medicine. The main investigators for the study include O. Gaide, R. Kinj, W. Jeanneret, F. Duclos, R. Moeckli, P. Jorge, and J. Bourhis. Together, they represent CHUV as a multidisciplinary team from its Department of Radiation Oncology, Radiation Oncology Laboratory, Institute of Radiation Physics, and Department of Dermatology within Lausanne University Hospital and University of Lausanne, Switzerland.
*Ultra-High Dose Rate (UHDR) functionality for FLASH Radiotherapy is for investigational use only and is not cleared for sale by the US FDA.