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
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new approach to spine stereotactic radiosurgery (SSRS) for patients with localized spine metastasis from solid tumors. SSRS delivers high doses of radiation precisely to spine tumors and has shown benefits in pain control and neurological function improvement. This study aims to test a novel regimen delivering radiation over five treatments instead of the standard one or two, potentially reducing side effects by lowering the dose per session. Participants receive spine stereotactic body radiotherapy (SbRT) to a total dose of 40 Gy divided into five fractions. The study includes two groups: patients without prior radiotherapy and those with prior radiotherapy, where treatment is adjusted for spinal cord tolerance. The radiation targets spinal metastases from C1 to L5 vertebrae, including some epidural and paraspinal disease under specific conditions. Throughout the study, participants will be assessed for changes in pain and quality of life using tools like the Brief Pain Inventory, FACT-G, and EQ-5D-5L within five days after treatment and up to 24 months afterward. Safety events and pain relief outcomes will also be monitored. Total participation may vary, with follow-up visits and evaluations occurring up to two years after treatment completion.
CONDITIONS
Brief 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 0-2
- Localized spine metastasis from a solid tumor between C1 and L5 vertebrae, including up to 3 separate sites with limited vertebral involvement
- Epidural extension allowed if there is at least a 2 mm gap between spinal cord and lesion edge
- Paraspinal disease extension allowed if 5 cm or less and contiguous with spine metastasis
- For prior radiotherapy patients, at least 6 months since last spine radiotherapy
- Numerical Rating Pain Scale score of 5 or greater at the affected site when not taking pain medication
You will not qualify if you...
- Radiosensitive tumor types such as myeloma, lymphoma, germ cell tumors, or small cell lung cancer
- Patients who cannot walk (non-ambulatory)
- More than 50% loss of vertebral body height or spinal instability due to compression fracture
- Severe spinal cord compression, displacement, or epidural extension within 2 mm of spinal cord
- Rapid worsening of neurological condition
- Medical contraindication for spine MRI
- Pregnant women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 1 to 2 weeks
Participants receive spine stereotactic body radiotherapy to treat localized spine metastasis. This involves a dose of 40 Gy delivered in 5 fractions, with dosing adjusted for those with prior spine radiotherapy.
5 treatment visits (in-person)
Duration - Up to 24 months
Participants are monitored for pain relief, safety, and quality of life over 12 to 24 months following treatment.
Visits at baseline, within 5 days of treatment completion, and at 3, 12, and 24 months post-treatment
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
A
Antoinette Pimentel
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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