Phase IV Trial Evaluating the Use of Stereotactic Body Radiotherapy for the Treatment of Spine Metastases and Primary Spine Tumors
This study is a single site, non-randomized, prospective, phase IV trial. Patients are
composed of 2 groups:Spine Metastases OR Benign Spine Tumors. Data collected will include
patient demographics, pathology data, tumor stage, SBRT dose fractionation scheme, dose
received by adjacent critical normal tissues, tumor recurrence data, and acute and late
toxicities.
Follow up data will be collected during the patient's standard office visits. The
anticipated duration of this study is 5 years
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
symptom control
Evaluation of pain relief will be assessed using a 10-point visual analog scale. Analgesic use will be documented to ensure that pain improvement is not due to an increase in the amount of analgesic usage. Evaluation of neurologic improvement will be assessed by physical exam using the ASIA Impairment Scale.
6 weeks post RT
No
United States: Institutional Review Board
08-044
NCT01347307
September 2008
September 2015
Name | Location |
---|---|
St. John's Mercy Medical Center | Saint Louis, Missouri 63141 |