Actively Recruiting
Standard Dose Versus High Dose Stereotactic Spine Radiosurgery for Metastatic Spinal Neoplasms
Led by National Taiwan University Hospital · Updated on 2025-06-26
196
Participants Needed
2
Research Sites
521 weeks
Total Duration
On this page
Sponsors
N
National Taiwan University Hospital
Lead Sponsor
N
National Taiwan University Hospital Hsin-Chu Branch
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Standard Dose Versus High Dose Stereotactic Spine Radiosurgery for Metastatic Spinal Neoplasms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with a confirmed diagnosis of non-hematopoietic cancer
- Evidence of localized spinal metastases without spread to spinal fluid or inside the spinal cord
- Up to four separate spinal tumor sites involving no more than two continuous vertebral levels
- No prior radiation treatment to the target spine areas
- Age 18 years or older
- Karnofsky performance status of 60% or higher
- Life expectancy of at least 12 months
- Women of childbearing potential and male participants must use effective contraception
- Ability to follow study procedures and provide informed consent
You will not qualify if you...
- Previous radiation therapy or radiosurgery to the target spine areas
- Serum creatinine level greater than 2.0 mg/dL within 90 days before enrollment
- Unable to have MRI due to metal implants or severe claustrophobia
- Epidural spinal cord compression grade 2 or higher requiring immediate surgery
- Unable to tolerate the radiation treatment procedure
- Severe active health conditions such as uncontrolled infection, recent heart attack or unstable heart conditions, serious cardiac arrhythmias, liver failure with jaundice or bleeding problems, severe lung disease requiring hospitalization, or uncontrolled psychiatric disorders
- Receiving other investigational treatments or chemotherapy during study
- Women who are pregnant or breastfeeding
- Women of childbearing potential and male participants unwilling or unable to use medically acceptable contraception
AI-Screening
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Trial Site Locations
Total: 2 locations
1
National Taiwan University Hospital
Taipei, Taiwan, 100
Actively Recruiting
2
National Taiwan University Cancer Center
Taipei, Taiwan, 106
Actively Recruiting
Research Team
F
Feng-Ming Hsu, M.D., Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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