Spine Stereotactic Body Radiation Therapy for Metastatic Epidural Spinal Cord: Prospective Phase II Study
The definition of metastatic epidural spinal cord compression (MESCC)
- MESCC is defined as both an evidence of cord compression by radiologic evaluation and a
manifestation of clinical feature at the level of cord compression.
- A cord compression by radiologic evaluation is defined as < 3mm gap between epidural
mass and true spinal cord or indentation of thecal sac at the level of clinical feature
- Clinical features include any or all of the followings: pain (local or radicular) or
motor weakness or sensory change or incontinence.
Simulation -A Computed tomography (CT) scan will be acquired with the use of intravenous
contrast and planning MRI will be also performed on the same day of simulation.
- One to four sessions of SBRT will be performed.
- Patients need to be assessed at 1 week, 1 month and 3 months after the completion of
SBRT and will be followed up at 3 month intervals thereafter.
- Pain score, neurologic examination, adverse events and simple X-ray of involved spine
should be evaluated at every follow-up visit.
- MRI of involved spine will be performed at 3 months after the completion of SBRT.
Up to 43 patients will be enrolled in this study in Samsung Medical Center
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Neurologic response is defined as maintaining grade 4 or more motor power after completing SBRT or as an increase of motor power by at least 1 grade from the baseline motor power. There should no decrease of motor power after completing SBRT. The motor weakness is graded from 0 to 5 by Medical Research Council (MRC) scale.
South Korea: Institutional Review Board