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

NCT07039968 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2025-06-26

No results posted yet for this study

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.

Conditions

  • Spinal Neoplasms

Interventions

RADIATION

Spine 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.

Sponsors & Collaborators

  • National Taiwan University Hospital Hsin-Chu Branch

    collaborator OTHER

  • National Taiwan University Hospital, Yun-Lin Branch

    collaborator OTHER

  • National Taiwan University

    collaborator OTHER

  • National Taiwan University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-30
Primary Completion
2035-06-30
Completion
2035-06-30

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07039968 on ClinicalTrials.gov