Stereotactic Radiosurgery (SRS) for One or Two Localized Spine Metastases
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Musculoskeletal Function as Measured by the Oswestry Disability Index
研究概览
简要总结
This study will evaluate the most effective radiation dose. Patients will be randomized (like flipping a coin) to receive either low dose stereotactic radiotherapy (defined as "14 Gy") or high dose stereotactic radiotherapy (defined as 18 Gy).
详细描述
This study will evaluate the pain control and the quality of life of patients with spinal metastases using stereotactic radiotherapy. Stereotactic radiotherapy is referred to as "targeted therapy". It uses special equipment to position the patient and guide the focused beams of radiation toward the cancer and away from normal surrounding tissue. This higher dose technique may work better to kill cancer cells with fewer side effects than standard radiation therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent.
- •Age greater than or equal to 18 years old.
- •Prior histologically-proven, non-hematogenous malignancy (Specific exclusions are multiple myeloma and lymphoma).
- •Radiographic evidence of one or two non-contiguous spinal metastases amenable to SRS.
- •Metastatic disease must be symptomatic (causing either pain or neurologic symptoms).
- •Maximum tumor size less than or equal to 5 cm.
- •Zubrod performance status of less than or equal to
- •Life expectancy of greater than or equal to 3 months.
- •Women/Men of childbearing potential must use effective contraception.
排除标准
- •No prior radiation delivered to the involved area
- •No evidence of spinal instability requiring urgent surgical intervention.
- •No evidence of spinal cord compression requiring emergent surgical or radiotherapeutic intervention.
- •No plans for concomitant antineoplastic therapy (including standard fractionated RT, chemotherapy, biologic, vaccine therapy, or surgery) while on this protocol except at disease progression.Concomitant is defined as within 3 days before or after radiosurgery.
- •No pregnant or lactating women.
- •No active systemic infection.
- •No evidence of myelopathy or cauda equina syndrome on clinical evaluation
结局指标
主要结局
Musculoskeletal Function as Measured by the Oswestry Disability Index
时间窗: 6 months after completion of treatment
The Oswestry Disability Index (ODI) has 10 sections (pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling), each of which contains 6 questions detailing the effect of pain on the ability of the patient to perform activities related to the topic of each section.
Quality of Life as Measured by the FACT-CNS Questionnaire
时间窗: 6 months after completion of treatment
The Functional Assessment of Cancer Therapy - Central Nervous System (FACT-CNS). The FACT-CNS consists of Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, Functional Well-Being, and Additional Concerns. Participants can choose 0 (Not At All) up to 4 (Very Much) for each question.
Pain Control Rate as Measured by the The Brief Pain Inventory
时间窗: 6 months after completion of treatment
The Brief Pain Inventory (BPI) is a 17 item patient self-rating scale assessing demographic data, use of medications, as well as sensory, and reactive components of pain.
次要结局
- Local Control Rate(6 months after end of treatment)