Clinical Trial

Standard Dose Versus High Dose Stereotactic Spine Radiosurgery for Metastatic Spinal Neoplasms

Recruiting Phase 2
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Summary
The goal of this clinical trial is to learn if a higher dose of Stereotactic Spine Radiosurgery (SSRS), an advanced radiation technique, is better for treating cancer that has spread to the spine (spinal metastases). The study will also learn about the safety of using a higher dose. The main questions it aims to answer are: Does a higher radiation dose lead to fewer treatment failures (meaning the tumor growing back or causing serious side effects) one year after treatment? What are the side effects associated with the high dose compared to the standard dose? How does each radiation dose affect a patient's pain and quality of life? Researchers will randomly assign participants (like a coin toss) to one of two groups to compare the outcomes: The Standard Dose Group: Will receive a single radiation treatment of 16 Gy. The High Dose Group: Will receive a single, more powerful radiation treatment of 20 Gy. Participants in this study will: Receive a single, one-time, highly-focused radiation treatment (SSRS) to the spinal tumor. Attend regular follow-up visits at the clinic for checkups and imaging scans (like MRI). Complete questionnaires about their pain levels and quality of life during these visits.
Trial Details
NCT Number NCT07039968
Lead Sponsor National Taiwan University Hospital
Collaborators: National Taiwan University Hospital Hsin-Chu Branch, National Taiwan University Hospital, Yun-Lin Branch, National Taiwan University
Conditions Spinal Neoplasms
Enrollment 196 participants
Start Date 2025-06
Primary Completion 2035-06 (estimated)
Study Completion 2035-06 (estimated)
Updated on ClinicalTrials.gov 2025-06-26