Clinical Trial Details
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NCT01347307 : Stereotactic Body Radiotherapy for Spine Tumors
PhasePhase 4
AgesMin: 18 Years Max: N/A
Eligibility Criteria:

- Patient age >= 18 years

- Zubrod performance status of 0-3

- Vertebral and/or paraspinal metastases, with or without prior surgery and/or
fractionated radiotherapy

- Benign extradural spine tumors such as chordomas, meningiomas, schwannomas,
neurofibromas, paragangliomas, and arteriovenous malformations (AVMs).

- Established histologic diagnosis of a benign or malignant tumor of the spine.

- Arteriovenous malformation of the spine identified radiographically (no biopsy)

- Well-defined lesion involving no more than 2 adjacent vertebral levels or spinal

- Minimal spinal canal compromise that is not rapidly progressive. Ideally, the tumor
should not be within 5 mm of the spinal cord.

- If chemotherapy is planned, ideally it should not have been given within 30 days of
starting radiation and should not resume until at least 2 weeks after completing
radiation. In addition, it is not recommended to perform SBRT when targeted
anti-angiogenesis therapy is planned within 2 months of the procedure.

- Signed study-specific consent form

Exclusion Criteria:

- Lesion involving > 3 adjacent vertebral levels

- Overt spinal instability

- Neurologic deficit due to bony fragments/bony compression of neural structures

- Prior radiotherapy at the involved level(s) within 3 months of radiosurgery, more
than one prior course of radiotherapy at the involved level(s), or more than 45 Gy
previous radiation exposure at the involved level(s)

- Rapidly progressive spinal cord compromise or neurological deficit

- Paralysis, or otherwise compromised motor function due to radiographically confirmed
cord compression

- Patient unable to undergo an MRI

- Pregnant or lactating women, due to potential exposure of the fetus to RT and unknown
effects of RT on lactating females

- Patients with psychiatric or addictive disorder that would preclude obtaining
informed consent
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