Dose-Escalated Spine SbRT for Localized Metastasis to the Spinal Column

Description

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

Spine Metastases, Metastasis Spine

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Study Overview

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Study Details

Study overview

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.

Dose-Escalated Spine SbRT (DESSRT) for Localized Metastasis to the Spinal Column

Dose-Escalated Spine SbRT for Localized Metastasis to the Spinal Column

Condition
Spine Metastases
Intervention / Treatment

-

Contacts and Locations

Miami

Miami Cancer Institute at Baptist Health, Inc, Miami, Florida, United States, 33176

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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)
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Baptist Health South Florida,

Rupesh Kotecha, MD, PRINCIPAL_INVESTIGATOR, Miami Cancer Institute (MCI) at Baptist Health, Inc.

Study Record Dates

2026-12-31