Status:
COMPLETED
Stereotactic Radiosurgery in Treating Patients With Spinal Metastases
Lead Sponsor:
Boston Medical Center
Collaborating Sponsors:
United States Department of Defense
Conditions:
Metastatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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: Thi...
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 r...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2017
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00853528
Start Date
January 1 2009
End Date
June 1 2017
Last Update
July 19 2017
Active Locations (1)
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1
Boston University Cancer Research Center
Boston, Massachusetts, United States, 02118