Thoracic Radiotherapy Combined With EGFR-TKI for Wild-type Non-small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Response rate
研究概览
简要总结
Concurrent chemoradiotheray is the standard care for patients with locally advanced non-small cell lung cancer (NSCLC), but often accompanying with high toxicity and poor tolerability. Radiosensitization of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKI) has been proved in preclinical studies, and the safety of TKI combined with thoracic radiotherapy has also been evaluated in several phase II trials. The aim of study is to investigate the efficacy and safety of thoracic radiotherapy combined with TKI in wild-type EGFR patients who refused or unsuitable for concurrent chemoradiotherapy.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •NSCLC confirmed by histopathology or cytology;
- •Stage IIA - IV NSCLC ,unresectable and could not tolerate chemoradiotherapy;
- •Has measurable lesion [according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, must have at least one evaluable lesion with the longest dimension >= 10mm; if the evaluable lesion is lymph node, the shortest dimension should be measured and >=15mm];
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1;
- •Expectancy life >= 3 months;
排除标准
- •Had systemic anit-NSCLC treatments;
- •Had be treated by HER-targeting agents;
- •Had local radiotherapy for NSCLC;
- •Has upper gastrointestinal physiological disorders, or malabsorption syndrome, or intolerance of oral medication, or active peptic ulcer;
- •Diagnosed other malignant tumor besides NSCLC within 5 years prior the study treatment (except having simple surgical resection with 5-year disease free survival, cured in situ of cervical carcinoma, cured basal cell carcinoma and bladder epithelial tumor);
- •Any evidence to indicate moderate or severe chronic obstructive pulmonary disease (COPD);
- •Known hypersensitivity to EGFR-TKI agents or relevant components in the formulation;
- •Uncontrolled eye inflammation or infection, or any potential circumstances lead to eye inflammation or infection;
- •Pregnancy or breast-feeding women;
- •Ingredients mixed with small cell lung cancer patients;
- •Evidence of any other disease, neurological or metabolic dysfunction, physical examination or laboratory finding giving reasonable suspicion of a disease or condition that contraindicated the use of an investigational drug or puts the subject at high risk for treatment-related complications.
研究组 & 干预措施
Bioradiotherapy
Erlotinib (trade name: Tarceva®) (150mg oral daily) or Icotinib (trade name: Conmana®) (125mg oral three times a day) with concurrent radiotherapy to a total radiation dose of 60-66 Gray (Gy).
干预措施: Radiotherapy (Radiation)
结局指标
主要结局
Response rate
时间窗: week 3-4
次要结局
- Progression-free survival(year 0- year 2)
- Overall survival(year 0- year 2)
- Number of participants with treatment-related adverse events as assessed by CTCAE v3.0.(year 0- year 2)
研究者
Zhishuang Zhen
MD
Hangzhou Cancer Hospital