by Lisa Chamoff
, Contributing Reporter | October 12, 2020
Radiotherapy technology company Varian Medical Systems announced today that it has received investigational device exemption (IDE) from the FDA for the first-ever clinical trial of FLASH therapy.
This is considered a milestone in the development of the treatment, which delivers an ultra-high, cancer-killing radiation dose in less than a second, leading to fewer side effects.
The study, named FeAsibility Study of FLASH Radiotherapy for the Treatment of Symptomatic Bone Metastases, or FAST-01, will use Varian’s ProBeam proton particle accelerator modified with a specialized module with FLASH capabilities. The trial will enroll 10 patients with bone metastases, which are typically deep-seated tumors.
The technology may be over 100 times faster compared to conventional radiation therapy, according to the company, and preclinical trials have found that the treatment causes less damage to the surrounding, healthy tissue.
The company had previously partnered with the University of Maryland School of Medicine’s Department of Radiation-Oncology on a preclinical trial that found 25 to 30 percent less damage to lung tissue and an average 35 percent decrease in skin dermatitis in mice receiving FLASH therapy.
The company has also supported the FLASHForward Consortium, a 20-member group of institutions from around the world, which includes experts in radiation oncology, translational sciences and medical physics.
“This milestone would not be possible without the significant collaboration we've had from the FLASHForward Consortium,” Kolleen Kennedy, chief growth officer and president of Proton Therapy Solutions at Varian, told HCB News. “We will continue to collaborate as we develop and invest in a comprehensive clinical program for FLASH therapy.”
Kennedy said in a statement that FLASH therapy “could be one of the most significant advancements in cancer treatment in decades.”
Varian anticipates enrollment of the first patient in the FAST-01 Feasibility Study by the end of 2020. The study will evaluate clinical workflow feasibility, treatment-related side effects and efficacy of treatment as assessed by measuring trial participants’ pain relief.
“The study is an important proof of concept, especially in deep-seated and not just superficial tumors, that adds to a growing body of data necessary to advance our understanding of how FLASH therapy works,” said Dr. Deepak Khuntia, senior vice president and chief medical officer of Varian, in a statement announcing the news of the trial.
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