SBRT Versus Conventional Fractionated Radiotherapy for Vertebral Metastases From Non-small Cell Lung Cancer, an Open, Randomized Phase II Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Complete pain relief rate
研究概览
简要总结
Vertebral metastases are events that affect the quality of life of tumor patients, and are often accompanied by severe pain at the site of metastasis and even by the risk of compression fracture. For vertebral metastases who are not yet at risk of vertebral instability fracture, a moderate dose (30Gy/10F) external radiation therapy is the most widely used treatment technique. Previous studies have shown that 60-80% of patients could achieve pain relief with moderate doses of radiation therapy, with median pain control duration of approximately 4 months. Stereotactic Radiation Therapy (SBRT) is currently the most advanced radiation therapy technique. This project proposes to treat vertebral metastases from non-small cell lung cancer using SBRT technology on the True Beam radiotherapy system to compare its efficacy with conventional external irradiation technology in terms of pain relief as well as local control.
详细描述
Vertebral metastases are events that affect the quality of life of tumor patients, and are often accompanied by severe pain at the site of metastasis and even by the risk of compression fracture. For vertebral metastases who are not yet at risk of vertebral instability fracture, a moderate dose (30Gy/10F) external radiation therapy is the most widely used treatment technique. Previous studies have shown that 60-80% of patients could achieve pain relief with moderate doses of radiation therapy, with median pain control duration of approximately 4 months.
Stereotactic Radiation Therapy (SBRT) is currently the most advanced radiation therapy technique. It enables focused radiation therapy with small fields through stereotactic techniques. In June 2021, Zhongnan Hospital of Wuhan University introduced the True Beam radiotherapy system, which has a higher treatment rate compared to conventional radiotherapy equipment, while It is the most reliable vehicle to achieve SBRT.
Therefore, this project proposes to treat vertebral metastases from non-small cell lung cancer using SBRT technology on the True Beam radiotherapy system to compare its efficacy with conventional external irradiation technology in terms of pain relief as well as local control.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed stage IV non-small cell lung cancer.
- •General condition score ≤
- •With vertebral metastases combined with painful symptoms.
- •Absence of neurological symptoms due to vertebral metastases, such as dyskinesia, defecation or urination abnormalities.
- •No previous radiation treatment of any kind to the vertebral body.
- •The metastatic vertebra has not been treated surgically
- •Vertebral stability score (SINS) ≤ 12
- •Patient life expectancy of more than 6 months.
排除标准
- •Small cell cell lung cancer or large cell carcinoma
- •General condition score >2, intolerant of radiotherapy.
- •Comorbid neurological symptoms such as dyskinesia, abnormal bowel movements or urination
- •Metastatic vertebrae that have received radiotherapy or surgical intervention
- •Vertebral stability score (SINS) >12
- •Patient life expectancy of less than 6 months
结局指标
主要结局
Complete pain relief rate
时间窗: 3 months
Complete pain relief rate after completion of radiotherapy
次要结局
- Quality of life scores(3 months and 6 months)
研究者
Conghua Xie,MD,PhD
Professor
Wuhan University