Actively Recruiting
Dose-Escalated Spine SbRT for Localized Metastasis to the Spinal Column
Led by Baptist Health South Florida · Updated on 2025-11-14
60
Participants Needed
1
Research Sites
459 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is being done to determine the feasibility and tolerability of a novel regimen of spine stereotactic radiosurgery (SSRS). SSRS delivers high doses of radiation to tumors of the spine using precision techniques. In standard medical care, conventional SSRS is delivered in only 1 or 2 treatments. When this treatment is delivered in only 1-2 treatments, a high dose is used which can increase the side effects of treatment. This study aims to test an alternative technique of delivering SSRS over 5 treatments. By delivering the radiation therapy over multiple treatments, the dose of radiation is less per treatment.
CONDITIONS
Official Title
Dose-Escalated Spine SbRT for Localized Metastasis to the Spinal Column
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Zubrod Performance Status of 0 to 2
- Localized spine metastasis from a solid tumor between C1 and L5 levels, including solitary metastasis, two separate spine levels, or up to 3 sites with up to 2 contiguous vertebral bodies involved
- Patients with epidural extension eligible if there is at least a 2 mm gap between spinal cord and epidural lesion edge
- Paraspinal disease extension allowed if 5 cm or less in greatest dimension and contiguous with spine metastasis
- For patients with prior radiotherapy, minimum of 6 months since last spine stereotactic body radiotherapy
- Pain score of 5 or higher at the spine site without pain medication
You will not qualify if you...
- Radiosensitive cancer types such as myeloma, lymphoma, germ cell tumors, or small cell lung cancer
- Patients unable to walk (non-ambulatory)
- More than 50% loss of vertebral body height or spinal instability due to compression fracture
- Spinal cord compression, displacement, or epidural extension within 2 mm of spinal cord
- Rapid neurological decline
- Medical contraindication for spine MRI
- Pregnant women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Miami Cancer Institute at Baptist Health, Inc
Miami, Florida, United States, 33176
Actively Recruiting
Research Team
R
Rupesh Kotecha, MD
CONTACT
A
Antoinette Pimentel
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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