Radiosurgery for Severe Refractory Cancer Pain: A Sham-Controlled Pilot Trial

This pilot randomized trial assessed whether a sham-controlled comparison of triple-target stereotactic radiosurgery is feasible in adults with advanced (stage IV) cancer and severe mixed pain refractory to optimized pharmacologic and specialist management. Participants were randomized 1:1 to single-session Gamma Knife radiosurgery delivered to the hypophysis and both medial thalami, or to an identical sham procedure without radiation; both arms continued standard pain care. The main comparison was the change in pain intensity on a 0-10 visual analog scale from baseline to day 15. Opioid consumption, quality of life, and safety were explored. Enrollment was stopped after 10 of a planned 20 participants following an ethical reassessment by the investigators.