Spinal Cord Compression Clinical Trial
Official title:
Spine Stereotactic Body Radiation Therapy for Metastatic Epidural Spinal Cord: Prospective Phase II Study
Metastatic epidural spinal cord compression (MESCC) is a frequent oncologic emergency that
requires to be treated promptly. Although direct decompressive surgery is the most effective
treatment, surgery is only used in selected patients because most patients have a poor
overall condition and short life expectancy. Radiation therapy (RT), therefore, is the most
commonly used for patients with MESCC, but conventional RT alone can achieve modest
neurologic outcomes.
The hypothesis to use stereotactic body radiation therapy (SBRT) for MESCC is that the rapid
decompression of epidural mass, durable local control and subsequently improved neurologic
outcomes compared to conventional RT are expected when MESCC is treated with SBRT.
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
by MRI.
- 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.
Spine SBRT
- One to four sessions of SBRT will be performed.
Follow-up
- 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, Seoul National
University Hospital, and Gachon University Gil Medical Center.
;
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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