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Spine Stereotactic Body Radiotherapy for Spinal Metastases

This study is testing a new way to deliver spine stereotactic body radiotherapy (SBRT) for localized tumors in the spine (spinal metastases). SBRT uses high doses of radiation to target tumors precisely. Standard SBRT is often given in 1 or 2 treatments, which can lead to more side effects. This study aims to see if giving SBRT over 5 treatments is safe and effective, as this might reduce side effects by lowering the radiation dose per treatment. The study is looking at how your pain changes and how your quality of life is affected after treatment. You may be able to join if you are 18 or older, have localized spine metastases from a solid tumor, and meet certain health criteria. The study plans to enroll 60 participants, but its current recruitment status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It is designed to test a new radiation schedule for spine SBRT in 60 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your pain and quality of life will be measured within 5 days of completing treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04802603

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

Recruiting
NAAges 18+InterventionalTreatment
Baptist Health South Florida
~60 participants
Updated 2025-11-14 on ClinicalTrials.gov
What's tested:Spine stereotactic body radiotherapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in response to spine Stereotactic Body Radiotherapy (SBRT) for Brief Pain Inventory (BPI)
Measured over within 5 days of treatment completion
+2 more outcomes measured

Conditions

Spine Metastases
Metastasis Spine

Explore related trials

Metastatic Malignant Neoplasm in the Spine

NCT04802603

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Miami Cancer Institute at Baptist Health, Inc

    Miami, Floridastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

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

Who to contact

Rupesh Kotecha, MD
[email protected]
786-596-2000
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change in response to spine Stereotactic Body Radiotherapy (SBRT) for Brief Pain Inventory (BPI)within 5 days of treatment completion

    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.

  • Change in response to spine Stereotactic Body Radiotherapy (SBRT) for FACT-Gwithin 5 days of treatment completion

    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").

  • Change in response to spine Stereotactic Body Radiotherapy (SBRT) for EQ-5D-5Lwithin 5 days of treatment completion

    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