A Study of Spinal Radiosurgery (RAD0408)
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Spinal Radiosurgery|
- To determine intrafraction target motion and define quality assurance procedures for single fraction spinal radiosurgery [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- To estimate the palliative response (pain or relief of neurologic symptoms) and local control for single fraction radiosurgery delivered with Tomotherapy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- To assess the acute and late toxicity of spinal radiosurgery [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||April 2005|
|Estimated Study Completion Date:||September 2016|
|Estimated Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
Phase I: 20-25 Gy in 5 fractions
Phase II: 9-24 GY in 1 fraction
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.
- greater than six months since completion of RT
- at least 20 Gy, but no more than 50 Gy
Please refer to this study by its ClinicalTrials.gov identifier: NCT00573872
|United States, Alabama|
|University of Alabama at Birmingham/The Kirklin Clinic at Acton Road|
|Birmingham, Alabama, United States, 35233|
|Principal Investigator:||John B. Fiveash, M.D.||University of Alabama at Birmingham|