Stereotactic Body Radiotherapy for Spine Tumors

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2017-09-30

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Spinal Metastases Vertebral Metastases Benign Spinal Tumors Chordoma Meningioma Schwannoma Neurofibroma Paragangliomas Arteriovenous Malformations

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SBRT for Benign Extradural Spine Tumors

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

Group Type OTHER

SBRT for Benign Extradural Spine Tumors

Intervention Type RADIATION

14-25 Gy / 1 fraction OR 21-27 Gy / 3 fractions (7-9 Gy per fraction) OR 25-30 Gy / 5 fractions (5-6 Gy per fraction)

SBRT for Vertebral/Paraspinal Metastases

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

Group Type OTHER

SBRT for Vertebral/Paraspinal Metastases

Intervention Type RADIATION

12-16 Gy / 1 fraction OR 21-27 Gy / 3 fractions (7-9 Gy per fraction) OR 25-30 Gy / 5 fractions (5-6 Gy per fraction)

Interventions

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SBRT for Benign Extradural Spine Tumors

14-25 Gy / 1 fraction OR 21-27 Gy / 3 fractions (7-9 Gy per fraction) OR 25-30 Gy / 5 fractions (5-6 Gy per fraction)

Intervention Type RADIATION

SBRT for Vertebral/Paraspinal Metastases

12-16 Gy / 1 fraction OR 21-27 Gy / 3 fractions (7-9 Gy per fraction) OR 25-30 Gy / 5 fractions (5-6 Gy per fraction)

Intervention Type RADIATION

Other Intervention Names

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Stereotactic Body Radiotherapy (SBRT) Stereotactic Body Radiotherapy (SBRT)

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No