RecruitingPhase 2NCT06165419

Definitive Radiation for High-Risk Spine Metastases

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


Sponsor

Stony Brook University

Enrollment

26 participants

Start Date

Dec 14, 2023

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Inclusion Criteria11

  • 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)

Interventions

RADIATIONSBRT to the spine

Stereotactic body radiation therapy (SBRT) administered to spine metastases


Locations(1)

Stony Brook University Hospital

Stony Brook, New York, United States

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NCT06165419


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