IntraOp Medical Corporation is set to begin a Phase II trial comparing its FLASH radiotherapy to conventional radiotherapy in nonmelanoma skin cancer (NMSC) treatment, the California, US-based company announced.

The randomised Phase II Electron FLASH trial will be carried out at the University Hospital of Lausanne in Switzerland, and compare toxicity and efficacy of Ultra-High Dose Rate (UHDR) radiotherapy (FLASH therapy) to standard of care (SOC) conventional radiotherapy in patients with localised cutaneous squamous cell or basal cell carcinomas.

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According to the company, it marks the first time a randomised trial will compare FLASH radiotherapy to conventional radiotherapy in treating NMSC.

The trial will use the IntrOp Mobetron – an electron therapy linear accelerator system. FLASH is a radiation therapy technique involving the delivery of ultra-high dose rates within microseconds.

Two irradiation schemes will be used by investigators: a 22Gy single dose radiotherapy and 5 x 6Gy fractionated dose. FLASH radiotherapy is not yet cleared for sale by the U.S. Food and Drug Administration (FDA). However, investigational use of the therapy for cancer treatment is showing promise. It is known to reduce radiation-induced toxicity in tissues without weakening the effects of anti-cancer treatment. Some scientists predict it may become one of the main radiotherapy technologies in the future. 

“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 Professor Jean Bourhis, head of the radiation oncology department at University Hospital of Lausanne.

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In January 2023, the company announced that a patient with pancreatic cancer was treated using IntraOp Mobetron Intra-Operative Radiation Therapy.