Phase II Study of Icotinib Combined With Whole Brain Radiotherapy in Treating Patients With Brain Metastases From Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- partial response rate of intracranial lesions
研究概览
简要总结
The aim of this study is to explore the efficacy and toxicity of icotinib combined with WBRT in treating patients with multiple brain metastases from NSCLC.
详细描述
Brain metastases occur in 25-40% of patients with non-small cell lung cancer (NSCLC). It is one of the primary reasons resulting in treatment failure and the death. Whole-brain radiation therapy (WBRT) is the standard approach to the treatment of multiple brain metastases from NSCLC. Regardless of the treatment of brain metastases by WBRT combined with systemic chemotherapy,outcomes of NSCLC with brain metastases are still very poor. Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) can pass through the blood-brain barrier and show promising antitumor activity against brain metastases from NSCLC. Icotinib shows nearly the same effect as gefitinib in advanced NSCLC patients failed with chemotherapy.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cytologic or histological diagnosis of non-small cell lung cancer
- •Patients with disease progression after systemic chemotherapy with two-drug combination regimens that includes a platinum agent or patients with EGFR mutation status who have not been treated
- •Patients are diagnosed with multiple brain metastases for the first time in 4 weeks
- •Diagnosis of brain metastases is made based on Magnetic resonance imaging (MRI).
- •Doctors consider the patient will benefit from WBRT
- •No prior brain radiotherapy
- •ECOG performance status 0-2
- •age:18-75 years
- •Neutrophil count ≥1.5×10 to the 9th power/L and platelets≥100×10 to the 9th power/L. hemoglobin ≥90 g/L
- •Hepatic: total bilirubin less than or equal to 1.5 times upper limit of normal (ULN) Alanine transaminase (ALT) and aspartate transaminase (AST) less than or equal to 2.5 times ULN (or less than or equal to 5 times ULN in case of known liver involvement)
- •Renal: Serum Creatinine less than or equal to 1.5 times upper limit of normal (ULN)
- •Patients with measurable brain metastases according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria
- •Patients must sign an informed consent indicating that they are aware of the investigational nature of the study
排除标准
- •Prior brain radiation therapy
- •Solitary brain metastasis according to Magnetic resonance imaging (MRI)
- •Mort than 3 extracranial organs have metastatic lesions
- •Prior invasive malignancy (skin basal cell cancer, carcinoma in situ of cervix are permissible).
- •pregnant or breast feeding women
研究组 & 干预措施
Icotinib plus Whole Brain Radiotherapy
Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs), such as gefitinib and erlotinib, have shown efficacy in advanced non-small cell lung cancer (NSCLC) patients with brain metastases (BM). Icotinib is a new first generation EGFR-TKI. We conducted a phase II study to evaluate the efficacy and safety of icotinib in combination with whole brain radiotherapy （WBRT） in Chinese NSCLC patients with BM and investigated the cerebrospinal fluid (CSF)/ plasma concentrations of icotinib.
干预措施: Icotinib (Drug)
结局指标
主要结局
partial response rate of intracranial lesions
时间窗: 2 years
Partial response rate of intracranial lesions will be measured.
次要结局
- overall survival(4 years)
- the relationship between Progression-Free Survival and EGFR mutation status(4 years)
- Progression-free survival(4 years)
- partial response rate of extracranial lesions(2 years)
- Health-related quality of life(2 years)
- safety and tolerability(4 year)