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RecruitingInterventionalPhase 2

A Phase II Study Evaluating Definitive Radiosurgical Decompression in Patients With High-Risk Spinal Metastases

NCT ID: NCT06165419Sponsor: Stony Brook UniversityLast updated: 2025-05-14

Summary

This study is looking at whether patients with cancer that has aggressively spread to the spine can be treated with stereotactic body radiation therapy only and avoid a large spine surgery

Arms & interventions

  • RadiationSBRT to the spine

    Stereotactic body radiation therapy (SBRT) administered to spine metastases

Outcome measures

Primary

  • Cumulative incidence of spinal surgery/stabilization within 6 months following SBRT

    Assess the efficacy of spine SBRT alone in controlling spine metastases

    Time frame: 6 months

Secondary

  • Reduction in epidural tumor volume

    Time frame: 3 months

  • Changes on Neck Disability index

    Time frame: 1 months, 3 months, 6 months

  • Changes on Oswestry Low Back Disability Questionnaire

    Time frame: 1 months, 3 months, 6 months

  • Changes on EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) questionnaire

    Time frame: 1 months, 3 months, 6 months

  • Progression-free survival

    Time frame: 6 months

  • Overall survival

    Time frame: 6 months

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
Eligible patients must have: * Any pathologically proven solid tumor diagnosis not of central nervous system origin with radiographic or pathologic evidence of metastatic disease * Metastatic spine involvement documented by imaging * Involvement of maximum 3 contiguous vertebral bodies at the index site * Intact neurologic function, or only minor neurologic deficits with muscle strength greater or equal to 4 out of 5 with or without steroids * An evaluation by an radiation oncology and orthopedic spine/neurosurgery attending * ECOG Performance Status of 0-3 Patients are ineligible if they have: * An unstable spine defined as a Spinal Instability Neoplastic Score (SINS) greater than 12 * Had previous surgery or radiation to address the target spinal metastases * Radiosensitive tumors (e.g. small cell lung cancer, lymphoma, multiple myeloma, and germ-cell tumors)

Study locations (1)

Stony Brook University Hospital

Stony Brook, New York, 11794

Recruiting