RADIO-STAR Trial

Uses

Dosage & preparation

Evidence quality

Highlighted claims

• RADIO-STAR is a first-in-human phase 1 clinical trial evaluating safety, feasibility, and dose selection for image-guided radiotherapy to the stellate ganglia in patients with recurrent ventricular arrhythmias. — Protocol of the RADIO-STAR trial: a phase 1 safety and dose finding study of hypofractionated radiotherapy to the stellate ganglia for the treatment of ventricular arrhythmia
• The primary objective is to determine whether image-guided stellate ganglion radiotherapy is feasible and safe. — Protocol of the RADIO-STAR trial: a phase 1 safety and dose finding study of hypofractionated radiotherapy to the stellate ganglia for the treatment of ventricular arrhythmia
• The trial is not powered to assess clinical efficacy; effects on arrhythmia burden are outside its main scope. — Protocol of the RADIO-STAR trial: a phase 1 safety and dose finding study of hypofractionated radiotherapy to the stellate ganglia for the treatment of ventricular arrhythmia
• The absence of a control group means observed changes in ICD therapy burden may be confounded by concurrent care. — Protocol of the RADIO-STAR trial: a phase 1 safety and dose finding study of hypofractionated radiotherapy to the stellate ganglia for the treatment of ventricular arrhythmia
• The study is designed so the serious adverse event rate does not exceed 34%, based on complication rates from surgical cardiac sympathetic denervation; 13 participants are required. — Protocol of the RADIO-STAR trial: a phase 1 safety and dose finding study of hypofractionated radiotherapy to the stellate ganglia for the treatment of ventricular arrhythmia