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

NCT04802603 | Recruiting DMC FDA Device

• 1 other identifier: 2020-KOT-003
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

Localized Metastasis; Spinal Column

Outcome Measures

Primary Outcomes (3)

• Change in response to spine Stereotactic Body Radiotherapy (SBRT) for Brief Pain Inventory (BPI)

  Assess the change in the feasibility and tolerability response of dose-escalated spine SBRT in patients with de novo or recurrent spine metastases with the Brief Pain Inventory questionnaire. The scale is from 0-10.

  within 5 days of treatment completion

• Change in response to spine Stereotactic Body Radiotherapy (SBRT) for FACT-G

  4 scales: physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items) and functional well-being (7 items). The FACT-G, developed by Cella, et al.20 is a five point patient self-rating scale (from "not at all" to "very much").

  within 5 days of treatment completion

• Change in response to spine Stereotactic Body Radiotherapy (SBRT) for EQ-5D-5L

  Consists of 5 items covering 5 dimensions including: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension can be graded on 3 levels including: 1=no problems; 2= moderate problems; and 3=extreme problems

  within 5 days of treatment completion

Secondary Outcomes (8)

• Pain relief

  3 months

• Pain response

  12 months

• Duration of pain response

  12 months

• Number of safety events

  12 months

• Change in response over time for the FACT-G

  baseline, 12 months

Study Arms (1)

Radiotherapy

OTHER

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

Radiation: Spine stereotactic body radiotherapy

Interventions

Spine stereotactic body radiotherapy RADIATION

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.

Radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Baptist Health South Florida: lead

Study Sites (1)

Miami Cancer Institute at Baptist Health, Inc

Miami, Florida, 33176, United States

RECRUITING

Related Links

• MCI - Website

Study Officials

• Rupesh Kotecha, MD

  Miami Cancer Institute (MCI) at Baptist Health, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rupesh Kotecha, MD

CONTACT

786-596-2000; RupeshK@baptisthealth.net

Antoinette Pimentel

CONTACT

17865962000; antoinette.pimentel@baptisthealth.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cohort 1 (De novo) Cohort 2 (Prior radiotherapy)

Study Record Dates

• First Submitted: March 15, 2021
• First Posted: March 17, 2021
• Study Start: March 14, 2021
• Primary Completion (Estimated): September 28, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: November 14, 2025

Record last verified: 2025-11

Locations

US (1)