Study Comparing Radiofrequency Ablation and Bone Augmentation Plus Radiotherapy Versus Radiotherapy Alone for Spine Metastases Treatment

What this Trial Is About

Researchers are evaluating a treatment for patients with metastatic disease affecting the spine from T5 to L5. The study compares a combination of radiofrequency ablation and bone augmentation RFABA plus radiotherapy RT against radiotherapy alone. The goal is to assess how these treatments impact skeletal-related events SREs, which include fractures, nerve compression, pain, instability, or the need for additional interventions. This pilot study is randomized and controlled, with patients assigned in a 21 ratio to each treatment group. Participants in one group receive radiofrequency-generated heat to destroy cancer cells followed by a bone-stabilizing agent for reinforcement, together with radiotherapy that targets cancer cells with high-energy radiation to provide pain relief and possibly reduce tumor size. The other group receives only radiotherapy. Treatment is given once, and patients are monitored over multiple time points for up to 24 months. Throughout the study, participants will be followed at 1, 3, 6, 12, and 24 months to check for skeletal-related events through clinical and radiologic assessments. Researchers will evaluate the occurrence of fractures, nerve compression, pain, and treatment needs during these visits. Safety and treatment effects will be monitored, with the total duration of participation lasting two years after treatment.

Radiofrequency Ablation/Bone Augmentation + Radiotherapy vs Radiotherapy Alone