Randomized Study Comparing Same-Day Stereotactic Body Radiotherapy and Surgical Stabilization Versus Standard Surgery and Radiotherapy for Painful Unstable Spinal Metastases

What this Trial Is About

Researchers are evaluating the cost-effectiveness of delivering same-day stereotactic body radiotherapy SBRT combined with surgical stabilization, with or without decompression, for patients who have symptomatic, unstable spinal metastases. The goal is to improve physical functioning four weeks after starting treatment compared to the current standard approach, which involves surgery followed by radiotherapy after sufficient wound healing. This randomized controlled trial is conducted within a cohort of patients with bone metastases and focuses on those with cervical, thoracic, or lumbar spinal metastases requiring intervention. The trial compares two groups one receiving high-dose single-fraction SBRT targeted to the metastasis followed by surgical stabilization within 24 hours, and the other receiving standard care where surgical stabilization is followed by conventional radiotherapy or SBRT after the wound has healed adequately. Both groups may have decompression during surgery if needed. The study uses advanced radiotherapy techniques to protect soft tissues and aims to shorten the time between surgery and radiotherapy, potentially reducing hospital visits and allowing quicker pain relief and return to systemic treatment. Participants will be closely monitored through assessments of physical functioning at four weeks, pain response and duration, hospital stay length, neurological status, quality of life, adverse events, and survival outcomes up to 12 months. The study also evaluates cost-effectiveness. Researchers collect data at multiple timepoints including 2, 4, 6, and 8 weeks, as well as 3, 6, and 12 months after treatment starts. Participants are followed comprehensively to gather information on recovery, treatment side effects, and overall health impact.

Randomized Trial on Same-day SBRT and Surgical Stabilization for Symptomatic Spinal Metastases