Status:
RECRUITING
Definitive Radiation for High-Risk Spine Metastases
Lead Sponsor:
Stony Brook University
Collaborating Sponsors:
The University of Texas Health Science Center at San Antonio
Conditions:
Metastatic Cancer
Metastatic Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
December 14 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2026
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT06165419
Start Date
December 14 2023
End Date
May 31 2026
Last Update
May 14 2025
Active Locations (1)
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1
Stony Brook University Hospital
Stony Brook, New York, United States, 11794