A Phase II Study of Spinal Radiosurgery
Completed · Not applicable
Conditions studied: Neoplasm, Arteriovenous Malformations
In brief
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.
Key facts
- Study ID
- NCT00573872
- Run by
- University of Alabama at Birmingham
- People needed
- 43
- Starts
- 2005-04-01
- Expected to finish
- 2016-09-01
- Last updated by the study team
- 2017-12-05
Who can join
Age: 19 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- All subjects must have history of histologically confirmed neoplasm or radiographically-diagnosed AVM. Patients without a prior tissue diagnosis but who have a radiographically characteristic lesion are eligible if there is consensus agreement of the diagnosis in the UAB Neuro-oncology Tumor Board.
- ECOG performance status of less than or equal to 2
- Age greater than 18
- Life expectancy greater than 12 weeks
- Subjects given written informed consent
You may not qualify if…
- Cytotoxic chemotherapy within 7 days of treatment
- Insufficient recovery from all active toxicities of prior therapies
- Epidural spinal cord compression requiring immediate neurosurgical decompression. If a patient requires immediate surgery for neurologic compromise, they may still be eligible post operatively if tumor was incompletely resected.
- Patient is non-ambulatory. Optimization of pretreatment neurologic function with steroids is allowed. Ambulation with assistance of walker or cane is allowed.
- Patient is pregnant and it is judged by the treating Radiation Oncologist that spinal radiosurgery would place the fetus in unacceptable danger.
Where it is running
- University of Alabama at Birmingham/The Kirklin Clinic at Acton Road — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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