Stereotactic Radiosurgery in Treating Patients With Spinal Metastases
RATIONALE: Stereotactic radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue. It may also help patients with spinal metastases live more comfortably.
PURPOSE: This phase I trial is studying the side effects and best dose of stereotactic radiosurgery in treating patients with spinal metastases.
Other: questionnaire administration
Procedure: diffusion tensor imaging
Procedure: functional magnetic resonance imaging
Radiation: hypofractionated radiation therapy
Radiation: stereotactic radiosurgery
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Cyberknife Radiosurgery for Improving Palliation of Metastatic Tumors of the Spine|
- Maximum tolerated dose of CyberKnife® hypofractionated stereotactic radiosurgery [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
- Pain as measured by the Brief Pain Inventory and Roland scale [ Time Frame: baseline and then at 3, 6, 9, 12, 18, and 24 months after completion of treatment ] [ Designated as safety issue: No ]
- Spinal cord response as measured by functional MRI [ Time Frame: baseline and then at 6 weeks and 6 months after completion of treatment ] [ Designated as safety issue: No ]
|Study Start Date:||January 2009|
|Estimated Study Completion Date:||June 2016|
|Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Experimental: Stereotactic radiosurgery
Radiation: stereotactic radiotherapy Questionnaire administration diffusion tensor imaging functional magnetic resonance imaging hypofractionated radiation therapy
Other: questionnaire administration
prior to radiosurgery, at radiosurgery completion, and then at subsequent follow-ups (3, 6, 9, 12, 18, and 24 months after treatmentProcedure: diffusion tensor imaging
prior to initiating CyberKnife radiosurgery, at 6 weeks after CyberKnife therapy, and at 6 months after CyberKnife therapyProcedure: functional magnetic resonance imaging
prior to CyberKnife, at 6 weeks, and 3 months after CyberKnife?, every 3 months for the first year, and every 6 months thereafterRadiation: hypofractionated radiation therapy
two to three consecutive daily sessions within one weekRadiation: stereotactic radiosurgery
two to three consecutive daily sessions within one week
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00853528
|United States, Massachusetts|
|Boston University Cancer Research Center|
|Boston, Massachusetts, United States, 02118|
|Principal Investigator:||Lawrence S. Chin, MD||Boston Medical Center|