Cyberknife Radiosurgery for Improving Palliation of Metastatic Tumors of the Spine
OBJECTIVES:
- To implement CyberKnife® technology for improving palliation in patients with spinal
metastases.
- To determine the maximum tolerated dose of CyberKnife® hypofractionated stereotactic
radiosurgery in these patients.
- To evaluate functional and diffusion MRI parameters in the spinal cord and tumor after
treatment with Cyberknife® radiosurgery.
OUTLINE: Patients undergo placement of gold fiducial markers at the time of open surgical
resection or percutaneous needle biopsy. Patients then undergo CyberKnife® hypofractionated
stereotactic radiosurgery over 30-90 minutes daily for 2-3 days.
Patients undergo functional MRI and diffusion tensor imaging at baseline and then at 6 weeks
and 6 months after completion of treatment. Patients also complete a pain questionnaire at
baseline and then at 3, 6, 9, 12, 18, and 24 months after completion of treatment.
After completion of study treatment, patients are followed periodically for up to 2 years.
Interventional
Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose of CyberKnife® hypofractionated stereotactic radiosurgery
6 weeks
Yes
Lawrence S. Chin, MD
Principal Investigator
Boston Medical Center
United States: Food and Drug Administration
CDR0000635267
NCT00853528
January 2009
February 2014
Name | Location |
---|---|
Boston University Cancer Research Center | Boston, Massachusetts 02118 |