A Phase II Study on the Safety and Efficacy of Radiation Therapy and Concurrent Erlotinib in Locally Advanced Non-small-cell Lung Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Evidence of clinically definite disease progression
研究概览
简要总结
The purpose of this study is to determine the safety and efficacy of the concurrent use of erlotinib and radiation therapy in the treatment of locally advanced non-small lung cancer.
详细描述
Non-small cell lung cancer (NSCLC) is still the leading cause of cancer death world-wide. Radiation therapy (RT) is one of the most important treatment choices in locally advanced NSCLC. Combination of RT and chemotherapy could improve treatment outcomes. However, the combined modality could not be used in many patients due to severe toxicities. EGFR-TKI shows great efficacy in the treatment of NSCLC, and many phase I/II studies established its safety in combination with RT. This phase II study is to further evaluate the efficacy and safety of the combination of RT and erlotinib in the treatment of locally advanced NSCLC. Eligible patients include patients with stage IIIA/IIIB NSCLC, who are not suitable for or refused to receive concurrent chemoradiotherapy. Eligible patients will receive oral erlotinib (150mg qd)throughout the course of thoracic RT (60-70 Gy). The primary endpoint is progression free survival and the second endpoints are overall survival and any grade III and above toxicities. We are going to recruit 50 patients for this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-70 years，
- •Patients with stage IIIA-IIIB NSCLC
- •adequate hematologic (WBC and platelet counts within normal limits), hepatic (total bilirubin level <= two times the upper limit of normal), and renal (creatinine clearance >= 50mL/min) functions
- •No history of chemotherapy or less than 4 cycles neoadjuvant chemotherapy
- •Can not tolerate or refuse concurrent chemoradiotherapy
- •No history of thoracic RT
- •Written informed consent obtained
排除标准
- •With other malignancy
- •With severe cardiopulmonary disease
- •Compromised liver or renal function that could not tolerate the combined therapy
- •Received thoracic RT before
- •Pregnant or breast-feeding women
- •Present with active infection
- •Uncontrolled diabetes
- •Concurrent use of other anti-cancer agents
结局指标
主要结局
Evidence of clinically definite disease progression
时间窗: 3 year
次要结局
- All cause mortality and any grade III and above toxicities(3 years)