A Prospective Registry of Patients Undergoing Surgical Decompression Followed by Radiation Therapy for Spine Tumors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,000
- 试验地点
- 8
- 主要终点
- Overall survival
研究概览
简要总结
This is an observational study to evaluate hardware related and oncologic outcomes in adult patients with primary and metastatic spine disease undergoing separation surgery followed by radiation treatment.
详细描述
This study is being done to collect information about patients undergoing separation surgery followed by radiation for the treatment of primary and metastatic spine disease. Participants will be asked to complete some patient reported outcome questionnaires and researchers will collect information from medical records to evaluate oncologic and hardware related outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Diagnosis of primary or metastatic disease to the spine who undergo surgical decompression and stabilization followed by radiation therapy
排除标准
- •Inability to obtain a standard MRI or CT / CT myelogram for radiation treatment planning and dosimetry
- •Inability to receive radiation treatment.
- •Patients under 18 years of age
结局指标
主要结局
Overall survival
时间窗: 12, 18, 24 months
Local control of treated lesion based on radiographic review
时间窗: 3, 6, 9, 12, 15, 16, 21, 24 months
Patients will be classified as achieving local control if demonstrating response of treated spine lesion after treatment. Local control will be assessed by comparing the radiographic images after treatment and prospectively every 3 months for up to 24 months
Progression free survival
时间窗: 3, 6, 9, 12, 15, 16, 21, 24 months
次要结局
未报告次要终点
研究者
James Elder
Principal Investigator
Ohio State University Comprehensive Cancer Center