A Prospective Randomized Controlled Study for Prophylactic Cranial Irradiation After Chemotherapy and Thoracic Radiation Therapy in Patients With Extensive-stage Small Cell Lung Cancer
试验速览
- 阶段
- 3 期
- 入组人数
- 414
- 试验地点
- 1
- 主要终点
- overall survival
研究概览
简要总结
prophylactic cranial irradiation （PCI）was verified to decrease the brain metastases rates and improve the overall survival（OS）for patients with limited stage small cell lung cancer.We hypothesis that patients with extensive-stage small cell lung cancer after chemotherapy and thoracic radiation can also benefit from PCI.
详细描述
Patients with extensive-stage small cell lung cancer achieving CR or PR after chemotherapy and thoracic radiation therapy were randomly divided into observation group and prophylactic cranial irradiation (PCI) group to evaluate the effect of PCI on survival after radiation therapy for thoracic lesions. To preliminarily analyze the clinical characteristics of patients who would benefit from thoracic radiation therapy plus PCI. To explore the optimal treatment modality after chemotherapy + thoracic radiation therapy in patients with extensive-stage SCLC.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-65 years old,KPS≥70
- •Pathological or cytological diagnosis of stage IV small cell lung cancer (by using AJCC 7th edition staging criteria);
- •1-3 extra-cranial metastatic organs before chemotherapy; 4-6 cycles of CE or EP ；
- •CR or PR after chemotherapy；
- •no grade ≥II side effects;
- •the estimated overall survival time ≥ 3 months;
- •no serious medical disease or major organ dysfunction.
排除标准
- •Patients with brain or nervous system metastases;
- •Presence of high grade radiation comorbidities;
- •Patients who are pregnant or lactating
结局指标
主要结局
overall survival
时间窗: 2 year
rate of patients survival in 2 years
次要结局
- side effect(2 year)
- progression-free survival(2 year)
- brain metastases rates(2 year)
研究者
Zongmei Zhou
clinical professor
Chinese Academy of Medical Sciences