NCT00853528

Stereotactic Radiosurgery in Treating Patients With Spinal Metastases

Cyberknife Radiosurgery for Improving Palliation of Metastatic Tumors of the Spine

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Boston Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Metastatic Cancer

Interventions

Type	Name	Description
OTHER	questionnaire administration	prior to radiosurgery, at radiosurgery completion, and then at subsequent follow-ups (3, 6, 9, 12, 18, and 24 months after treatment
PROCEDURE	diffusion tensor imaging	prior to initiating CyberKnife radiosurgery, at 6 weeks after CyberKnife therapy, and at 6 months after CyberKnife therapy
PROCEDURE	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 thereafter
RADIATION	hypo-fractionated SRS	two to three consecutive daily sessions within one week for 3 cohorts- Cohort 1 = 21 Gy; Cohort 2 = 24 Gy; Cohort 3 = 27 Gy
RADIATION	single-fraction SRS	two to three consecutive daily sessions within one week for 3 cohorts- for 3 cohorts- Cohort 1 = 16 Gy; Cohort 2 = 18 Gy; Cohort 3 = 20 Gy

Timeline

• Start date: 2009-01-01
• Primary completion: 2013-06-01
• Completion: 2017-06-01
• First posted: 2009-03-02
• Last updated: 2017-07-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study