Randomized Phase II Trial of Stereotactic Radiation Therapy (SRT) Versus SRT Plus Vertebral Augmentation Procedure (VAP) for Vertebral Metastasis
Eligible Vertebral Metastatic Lesion/s-> randomized-> SRT versus SRT+ VAP Stereotactic
Radiation Therapy(SRT): 16 Gy X 1 Evaluation: prior to treatment; 1 month, 2-4 months, 5-6
months and 1 year post-treatment
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Numerical Rating Pain Scale (NRPS) Change in Patients
To determine pain control rate (Percentage of patients in each arm that achieve pain control) at the treated site(s)at 1 month, 2-4 months and 5-6 months post-treatment and to validate of the movement-related pain score
For 6 months post treatment
No
Shiao Y Woo, MD
Principal Investigator
James Graham Brown Cancer Center
United States: Institutional Review Board
BCC-RAD-11-01
NCT01527292
February 2012
April 2014
Name | Location |
---|---|
James Graham Brown Cancer Center | Louisville, Kentucky 40202 |