IntraOp Medical Corporation announced the Phase II Electron FLASH Trial, reportedly the first time a randomized trial will compare FLASH radiotherapy, an investigational technology, to conventional radiotherapy in treating nonmelanoma skin cancer (NMSC). It is the second clinical human trial to use the IntraOp Mobetron electron-based linear accelerator (LINAC).
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.”
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Phase II Electron FLASH Trial for Nonmelanoma Skin Cancer to Commence. Appl Rad Oncol.