A Phase II Study Evaluating Definitive Radiosurgical Decompression in Patients With High-Risk Spinal Metastases
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
Study locations (1)
Stony Brook University Hospital
Stony Brook, New York, 11794