Recruiting

Spine SbRT

Sponsor:

Baptist Health South Florida

Code:

NCT04802603

Conditions

Spine Metastases

Metastasis Spine

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Spine stereotactic body radiotherapy

Study Details

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 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

Study ID

NCT04802603

Start date

Mar 14, 2021

Status verified date

Nov, 2025

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Sep 28, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion 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)

Exclusion Criteria:

  • 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

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Radiotherapy

Cohort 1 (De novo) No Prior radiotherapy Cohort 2 (Prior radiotherapy) Prior radiotherapy

Interventions

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.

Primary outcome measure

  • Change in response to spine Stereotactic Body Radiotherapy (SBRT) for Brief Pain Inventory (BPI) [ Time Frame: within 5 days of treatment completion ]
  • Change in response to spine Stereotactic Body Radiotherapy (SBRT) for FACT-G [ Time Frame: within 5 days of treatment completion ]
  • Change in response to spine Stereotactic Body Radiotherapy (SBRT) for EQ-5D-5L [ Time Frame: within 5 days of treatment completion ]

Central Contacts and Locations

Central contacts

Rupesh Kotecha, MD

786-596-2000RupeshK@baptisthealth.net

Antoinette Pimentel

17865962000antoinette.pimentel@baptisthealth.net

Locations

Miami Cancer Institute at Baptist Health, Inc

Recruiting

Miami, Florida, United States, 33176

Contacts

Rupesh Kotecha, MD

786-596-2000RupeshK@baptisthealth.net

Principal Investigator:

Rupesh Kotecha, MD

More Information

Sponsor

Baptist Health South Florida

Last update posted

Nov 14, 2025

Last verified

Nov, 2025

Keywords

  • Localized Metastasis
  • Spinal Column

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Baptist Health South Florida on 2025-11-14.