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Sponsors and Collaborators: |
University of Alabama at Birmingham Health Services Foundation The Kirklin Clinic at Acton Road |
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Information provided by: | University of Alabama at Birmingham |
ClinicalTrials.gov Identifier: | NCT00573872 |
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.
Condition | Intervention | Phase |
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Neoplasm Arteriovenous Malformations |
Radiation: Radiosurgery |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Active Control, Single Group Assignment |
Official Title: | A Phase II Study of Spinal Radiosurgery |
Estimated Enrollment: | 36 |
Study Start Date: | April 2005 |
Estimated Study Completion Date: | December 2011 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Optimal radiation plan is generated that treats the tumor (CTV) and spares normal tissue, especially the spinal cord. Motion and QA study will determine intrafraction motion for phase II portion of the study. Dose prescription to tumor is based upon maximal dose received by 0.5 cc of spinal cord and whether patient has had prior radiation therapy to that area:
Phase I - Motion and QA Study: 20-25 Gy in 5 fractions/10-20 patients/previous RT = <50% CTV dose/No previous RT = <80% CTV dose.
Phase II - 9-24 Gy in 1 fraction/30 total in order to have 20 evaluable patients (15 patients with prior RT and 15 without prior RT/previous RT = 8 Gy/No previous RT = 10 Gy.
Motion and QA study will treat CTV to 20-25 Gy in 5 fractions to study intrafraction motion for QA of single fraction administration. This will define treatment margins for single fraction radiosurgery.
Previous RT:
Ages Eligible for Study: | 19 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Latania Oldham, RN, BSN, OCN | 205-975-2880 | loldham@uabmc.edu |
Contact: Teresa Ross, RN | 205-978-0250 | tross@uabmc.edu |
United States, Alabama | |
University of Alabama at Birmingham/The Kirklin Clinic at Acton Road | Recruiting |
Birmingham, Alabama, United States, 35233 | |
Contact: Teresa Ross, RN 205-978-0250 tross@uabmc.edu | |
Contact: Latania Oldham, RN, BSN, OCN 205-975-2880 loldham@uabmc.edu | |
Principal Investigator: John Fiveash, M.D. | |
Sub-Investigator: James A. Bonner, M.D. | |
Sub-Investigator: Sharon Spencer, M.D. | |
Sub-Investigator: Jennifer De Los Santos, M.D. | |
Sub-Investigator: Robert Nordal, M.D. | |
Sub-Investigator: Barton Guthrie, M.D. | |
Sub-Investigator: James Market, M.D. | |
Sub-Investigator: Richard Morawetz, M.D. | |
Sub-Investigator: Paul Matz, M.D. |
Principal Investigator: | John B. Fiveash, M.D. | University of Alabama at Birmingham |
Responsible Party: | University of Alabama at Birmingham ( John Fiveash, M.D. / Assistant Professor of Medicine ) |
Study ID Numbers: | F050103003, T0408240012 |
Study First Received: | December 12, 2007 |
Last Updated: | February 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00573872 History of Changes |
Health Authority: | United States: Institutional Review Board |
Radiosurgery Phase II Cancer Spinal AVM |
Cardiovascular Abnormalities Aneurysm Vascular Malformations Vascular Diseases |
Hemangioma Arteriovenous Malformations Congenital Abnormalities |
Neoplasms Neoplasms by Histologic Type Cardiovascular Abnormalities Aneurysm Vascular Malformations Neoplasms, Vascular Tissue |
Vascular Diseases Hemangioma Cardiovascular Diseases Arteriovenous Malformations Congenital Abnormalities |