A Phase II Study of Spinal Radiosurgery
NCT00573872 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 43
Last updated 2017-12-05
Summary
Phase I of the study (motion and quality assurance \[QA\] study) is being used to determine intrafraction target motion and define quality assurance procedures for single fraction spinal radiosurgery. The Phase II portion of the study is being used to estimate the palliative response (pain or relief of neurologic symptoms) and local control for single fraction radiosurgery delivered with TomoTherapy and to assess the acute and late toxicity of spinal radiosurgery.
Conditions
- Neoplasm
- Arteriovenous Malformations
Interventions
- RADIATION
-
Radiosurgery
Phase I: 20-25 Gy in 5 fractions Phase II: 9-24 GY in 1 fraction
Sponsors & Collaborators
-
Health Services Foundation
collaborator UNKNOWN -
The Kirklin Clinic at Acton Road
collaborator UNKNOWN -
University of Alabama at Birmingham
lead OTHER
Principal Investigators
-
John B. Fiveash, M.D. · University of Alabama at Birmingham
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 19 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-04-30
- Primary Completion
- 2016-09-30
- Completion
- 2016-09-30
Countries
- United States
Study Locations
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