Actively Recruiting
Testing a New Spine Stereotactic Radiosurgery Method for Treating Localized Spine Metastasis Using Multiple Lower-Dose Treatments
Led by Baptist Health South Florida · Updated on 2025-11-14
60
Participants Needed
1
Research Sites
13 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating a new approach to spine stereotactic radiosurgery SSRS for patients with localized spine metastasis from solid tumors. SSRS delivers high doses of radiation precisely to spine tumors and has shown benefits in pain control and neurological function improvement. This study aims to test a novel regimen delivering radiation over five treatments instead of the standard one or two, potentially reducing side effects by lowering the dose per session. Participants receive spine stereotactic body radiotherapy SbRT to a total dose of 40 Gy divided into five fractions. The study includes two groups patients without prior radiotherapy and those with prior radiotherapy, where treatment is adjusted for spinal cord tolerance. The radiation targets spinal metastases from C1 to L5 vertebrae, including some epidural and paraspinal disease under specific conditions. Throughout the study, participants will be assessed for changes in pain and quality of life using tools like the Brief Pain Inventory, FACT-G, and EQ-5D-5L within five days after treatment and up to 24 months afterward. Safety events and pain relief outcomes will also be monitored. Total participation may vary, with follow-up visits and evaluations occurring up to two years after treatment completion.
CONDITIONS
Brief Title
Dose-Escalated Spine SbRT for Localized Metastasis to the Spinal Column
Research Team
R
Rupesh Kotecha, MD
A
Antoinette Pimentel
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