首席调查员(Principal Investigator): Samuel Ryu, MD
主要目标(Primary Objective):
(第二阶段临床试验任务)Phase II Component: (确定图像引导放射外科治疗脊柱转移瘤/ SBRT的可行性)Determine the feasibility of successfully delivering image-guided radiosurgery/SBRT for spine metastases in a cooperative group setting.Completed.
(第三阶段临床试验任务)Phase III Component: (确定图像引导放疗/ SBRT(单剂量16 Gy)与常规外照射放疗(单剂量8 Gy)改善疼痛疗效对比)Determine whether image-guided radiosurgery/SBRT (single dose of 16 Gy) improves pain control (as measured by the 11 point NRPS) as compared to conventional external beam radiotherapy (single dose of 8 Gy).
(入组条件)Patient Population:
(局部从C1到L5水平脊柱转移瘤(孤立性脊柱转移瘤;2个脊柱水平;或3个脊柱水平);每个病灶必须2个相邻椎体受累)Patients with localized spine metastasis from the C1 to L5 levels (a solitary spine metastasis; 2 separate spine levels; or up to 3 separate sites); each of the separate sites must have a maximal involvement of 2 contiguous vertebral bodies.
(计划入组)Target Accrual: 395
(实际入组)Current Accrual: 346
(状态)Status: Open to Accrual
(日期)Date: 9/22/2011