The Efficacy and Toxicity of Aggressive Thoracic Radiotherapy for Stage Ⅳ Non-Small Cell Lung Cancer Patients With Controlled Extrathoracic Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- OS
研究概览
简要总结
This phase II trial studies the safety and efficacy of aggressive thoracic radiotherapy in treating patients with non-small cell lung cancer that has not progressed after the first line systemic therapy. In this trial, patients with stage Ⅳ non small cell lung cancer who did not progress after first line systemic therapy will receive the aggressive thoracic radiotherapy, and the safety and efficacy of aggressive thoracic radiotherapy will be evaluated. The primary end points of the study are overall survival (OS), the secondary end points are local control rate, local progression free survival(LPFS), PFS, and toxicity and quality of life(QOL).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •histologically or cytologically confirmed NSCLC
- •stage IV disease
- •no progression after first line systemic therapy
- •18 to 80 years of age
- •Karnofsky performance status(KPS) score ≥70%
- •no contraindications to radiation therapy
- •presumed ability to tolerate thoracic radiation therapy to a BED≥53Gy
排除标准
- •a history of thoracic surgery, radiation therapy, or more than first line chemotherapy
- •pregnancy or lactation at the time of enrollment
- •previous malignancy or other concomitant malignant disease
研究组 & 干预措施
Arm-R
patients in this arm will receive aggressive thoracic radiotherapy.
干预措施: Aggressive Thoracic Radiotherapy (Radiation)
结局指标
主要结局
OS
时间窗: two years after the beginning of first line systemic therapy
overall survival
次要结局
- LPFS(1 year after the beginning of first line systemic therapy)
- PFS(1 year after the beginning of first line systemic therapy)
- toxicity related to the radiotherapy(from the beginning of radiotherapy to the 3 month after the completion of radiotherapy)
研究者
yu gengsheng
Vice director of Oncology department
Jiangmen Central Hospital