RecruitingPhase 2NCT07039968

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

Standard Dose Versus High Dose Stereotactic Spine Radiosurgery for Metastatic Spinal Neoplasms - SHINE: A Prospective Randomized Trial


Sponsor

National Taiwan University Hospital

Enrollment

196 participants

Start Date

Jun 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Spine Stereotactic Radiosurgery (SSRS) for people with spinal neoplasms. The study is currently recruiting participants at 2 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONSpine Stereotactic Radiosurgery (SSRS)

A non-invasive procedure that uses highly focused, high-energy radiation beams to precisely target metastatic tumors in the spine. The procedure is delivered using advanced techniques like Intensity Modulated Radiotherapy (IMRT) or Volumetric Modulated Arc Therapy (VMAT/RapidArc), which allow the radiation dose to conform tightly to the shape of the tumor. This approach maximizes the dose to the cancer while carefully sparing surrounding healthy tissues, especially the critical spinal cord. The entire course of treatment is delivered in a single session, guided by on-board imaging to ensure sub-millimeter accuracy.


Locations(2)

National Taiwan University Hospital

Taipei, Taiwan

National Taiwan University Cancer Center

Taipei, Taiwan

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NCT07039968


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