This trial is active, not recruiting.

Condition metastatic cancer
Treatments questionnaire administration, diffusion tensor imaging, functional magnetic resonance imaging, hypofractionated radiation therapy, stereotactic radiosurgery
Phase phase 1
Sponsor Boston Medical Center
Collaborator United States Department of Defense
Start date January 2009
End date June 2013
Trial size 36 participants
Trial identifier NCT00853528, BUMC-H-26577, CDR0000635267


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Radiation: stereotactic radiotherapy Questionnaire administration diffusion tensor imaging functional magnetic resonance imaging hypofractionated radiation therapy
questionnaire administration
prior to radiosurgery, at radiosurgery completion, and then at subsequent follow-ups (3, 6, 9, 12, 18, and 24 months after treatment
diffusion tensor imaging
prior to initiating CyberKnife radiosurgery, at 6 weeks after CyberKnife therapy, and at 6 months after CyberKnife therapy
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
hypofractionated radiation therapy
two to three consecutive daily sessions within one week
stereotactic radiosurgery
two to three consecutive daily sessions within one week

Primary Outcomes

Maximum tolerated dose of CyberKnife® hypofractionated stereotactic radiosurgery
time frame: 6 weeks

Secondary Outcomes

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
Spinal cord response as measured by functional MRI
time frame: baseline and then at 6 weeks and 6 months after completion of treatment

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed metastatic spinal tumor - Localized spinal metastasis, defined as one of the following: - Solitary spinal metastasis - Two contiguous spinal levels - No more than 2 adjacent spinal levels involved by a single tumor - Involvement of ≤ 3 separate sites (e.g., C5, T5, and T12) - Tumor size ≤ 5 cm PATIENT CHARACTERISTICS: - Karnofsky performance status 60-100% - Life expectancy ≥ 6 months - Negative pregnancy test - Fertile patients must use effective contraception - Must be ambulatory Exclusion Criteria: - Not pregnant or nursing - No spinal instability - No rapid neurological decline - No bony retropulsions causing neurological abnormalities - No total paraplegia for > 48 hours - No psychological issues that would preclude completion of study treatment PRIOR CONCURRENT THERAPY: - See Disease Characteristics - No prior treatment for spinal tumor that would result in potential overlap of radiotherapy fields - No treatment that is expected to exceed spinal cord tolerance or other regional normal tissue tolerance - No tumors that are exquisitely radiosensitive and controlled with conventional radiotherapy (e.g., lymphoma, leukemia, multiple myeloma, or germ cell tumors)

Additional Information

Official title Cyberknife Radiosurgery for Improving Palliation of Metastatic Tumors of the Spine
Principal investigator Lawrence S. Chin, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Boston Medical Center.