Phase II Study of Combining Vertebroplasty and Radiotherapy for Painful Spinal Metastases to Improve Quality of Life

What this Trial Is About

Researchers are studying patients with painful spinal metastases to evaluate whether combining vertebroplasty with radiotherapy can provide better pain relief, spine stabilization, and tumor control compared to radiotherapy alone. This phase II randomized trial aims to determine if this combined approach can reduce the need for opioids and prevent vertebral compression fractures, potentially improving quality of life for patients with spinal metastases. Participants are randomly assigned to one of two treatment groups radiotherapy alone or vertebroplasty followed by radiotherapy within 2 to 3 weeks. Radiotherapy doses are either 20 Gy given in 5 fractions over 1 week or a single 8 Gy fraction, decided by the radiation oncologist. Vertebroplasty is a procedure where bone cement is injected into fractured vertebrae to stabilize the spine. During the study, participants will be monitored at 1, 3, 6, and 12 months after treatment to assess pain levels using the Visual Analog Scale and Brief Pain Inventory. Researchers will also evaluate back-specific physical function and the occurrence of vertebral compression fractures. The study includes follow-up imaging at baseline, 6 months, and 12 months. Participants are expected to comply with scheduled visits, treatments, and assessments throughout the study period.

Trial of Combined Radiotherapy and Vertebroplasty for Patients With Painful Metastatic Spinal Lesions