Stereotactic Body Radiotherapy for Spine Tumors

Phase IV Trial Evaluating the Use of Stereotactic Body Radiotherapy for the Treatment of Spine Metastases and Primary Spine Tumors

This study will evaluate the local control rate as well as acute and late toxicity rates of stereotactic body radiotherapy (SBRT) for the treatment of spine metastases and benign spine tumors.

This study is a single site, non-randomized, prospective, phase IV trial. Patients are composed of 2 groups:Spine Metastases OR Benign Spine Tumors. Data collected will include patient demographics, pathology data, tumor stage, SBRT dose fractionation scheme, dose received by adjacent critical normal tissues, tumor recurrence data, and acute and late toxicities.

Follow up data will be collected during the patient's standard office visits. The anticipated duration of this study is 5 years

Eligibility Criteria:

• Patient age >= 18 years
• 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 segment
• 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