Dose-Escalated Spine SbRT for Localized Metastasis to the Spinal Column
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBaptist Health South Florida
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Spine stereotactic body radiotherapy
Treatment groups
60 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov