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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00853528
Study type Interventional
Source Boston Medical Center
Contact
Status Completed
Phase Phase 1
Start date January 2009
Completion date June 2017

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