Status:
RECRUITING
Dose-Escalated Spine SbRT for Localized Metastasis to the Spinal Column
Lead Sponsor:
Baptist Health South Florida
Conditions:
Spine Metastases
Metastasis Spine
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
Detailed Description
Given the limitations with conventional external-beam radiotherapy, spine stereotactic radiosurgery was developed as an alternative treatment for localized spine metastasis. Stereotactic radiosurgery ...
Eligibility Criteria
Inclusion
- Zubrod Performance Status 0-2
- Localized spine metastasis from a solid tumor from the C1 to L5 levels (a solitary spine metastasis, two separate spine levels, or up to 3 separate sites; each of the separate sites may have a maximal involvement of 2 contiguous vertebral bodies)
- Patients with epidural extension are eligible as long as there is a ≥ 2 mm gap between the spinal cord and the edge of the epidural lesion
- Paraspinal disease extension is allowed as long as it measures ≤ 5 cm in the greatest dimension and that it is contiguous with the spine metastasis
- For patients enrolled in cohort 2, the minimum time to re-irradiation should be 6 months
- Numerical Rating Pain Scale (NRPS) score of ≥ 5 at the index site(s) (as rated when the patient is not taking pain medication)
Exclusion
- Radiosensitive histologies (myeloma, lymphoma, germ cell tumors, small cell lung cancer)
- Non-ambulatory patients
- \>50% loss of vertebral body height or spinal instability to due pathologic compression fracture
- Frank spinal cord compression, spinal cord displacement, or epidural extension within 2 mm of the spinal cord
- Rapid neurologic decline
- Patients for whom an MRI of the spine is medically contraindicated
- Pregnant women
Key Trial Info
Start Date :
March 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2029
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04802603
Start Date
March 14 2021
End Date
December 31 2029
Last Update
November 14 2025
Active Locations (1)
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1
Miami Cancer Institute at Baptist Health, Inc
Miami, Florida, United States, 33176