NCT00573872

A Phase II Study of Spinal Radiosurgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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: * greater than six months since completion of RT * at least 20 Gy, but no more than 50 Gy

Conditions

• Neoplasm
• Arteriovenous Malformations

Interventions

Type	Name	Description
RADIATION	Radiosurgery	Phase I: 20-25 Gy in 5 fractions Phase II: 9-24 GY in 1 fraction

Timeline

• Start date: 2005-04-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2007-12-14
• Last updated: 2017-12-05
• Results posted: 2017-10-20

Locations

1 site across 1 country: United States