Stereotactic Body Radiotherapy for Spine Tumors

Mercy Research

Status

Completed

Conditions

Benign Spinal Tumors

Neurofibroma

Arteriovenous Malformations

Meningioma

Vertebral Metastases

Spinal Metastases

Chordoma

Schwannoma

Paragangliomas

Treatments

Radiation: SBRT for Vertebral/Paraspinal Metastases

Radiation: SBRT for Benign Extradural Spine Tumors

Study type

Interventional

Funder types

Other

Identifiers

NCT01347307

08-044

Details and patient eligibility

About

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.

Full description

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

Enrollment

38 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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