Dose-Escalated Spine SbRT for Localized Metastasis to the Spinal Column
NCT ID: NCT04802603
Last Updated: 2025-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2021-03-14
2029-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Radiotherapy
Cohort 1 (De novo) No Prior radiotherapy Cohort 2 (Prior radiotherapy) Prior radiotherapy
Spine stereotactic body radiotherapy
Cohort 1 - De novo: Spine stereotactic body radiotherapy to a dose of 40 Gy in 5 fractions.
Cohort 2 - Prior radiotherapy: Risk-adapted spinal cord tolerance based on prior spine stereotactic body radiotherapy to a dose of 40 Gy in 5 fractions.
Interventions
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Spine stereotactic body radiotherapy
Cohort 1 - De novo: Spine stereotactic body radiotherapy to a dose of 40 Gy in 5 fractions.
Cohort 2 - Prior radiotherapy: Risk-adapted spinal cord tolerance based on prior spine stereotactic body radiotherapy to a dose of 40 Gy in 5 fractions.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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Baptist Health South Florida
OTHER
Responsible Party
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Principal Investigators
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Rupesh Kotecha, MD
Role: PRINCIPAL_INVESTIGATOR
Miami Cancer Institute (MCI) at Baptist Health, Inc.
Locations
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Miami Cancer Institute at Baptist Health, Inc
Miami, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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Rupesh Kotecha, MD
Role: primary
Related Links
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MCI - Website
Other Identifiers
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2020-KOT-003
Identifier Type: -
Identifier Source: org_study_id