jRCTs041180080已完成不适用
A phase II study of gefitinib with concurrent thoracic radiotherapy in patients with unresectable, stage III Non-Small Cell Lung Cancer harboring EGFR mutations (A phase II study of gefitinib with concurrent thoracic radiotherapy in patients with unresectable, stage III Non-Small Cell Lung Cancer harboring EGFR mutations)
未提供0 个研究点目标入组 27 人开始时间: 2013年1月24日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Prevention Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 75age old not（—）
- 性别
- All
入选标准
- •Pathologically confirmed NSCLC
- •Treatment naive unresectable stage III disease
- •Harboring EGFR mutation
- •Age of 20 to 75 years
- •ECOG PS of 0 or 1
- •Evaluable target lesions as per RECIST ver. 1.1
- •Adequate organ function
- •Confirmed as eligible for the protocol defined radiotherapy by radiologists
- •Written informed consent
排除标准
- •Harboring exon 20 T790M mutation.
- •Incapable of oral intake
- •With intestinal paralysis, or ileus
- •Chronic diarrhea
- •Exhibiting significant interstitial pneumonitis, or pulmonary fibrosis in the chest CT
- •Active infection
- •Positive for HBs antigen
- •Uncontrolled diabetes mellitus
- •Severe heart disease
- •Systemic treatment with steroids
- •Concomitant cancers within 5 years
- •Prior history of thoracic radiotherapy
- •History of sereous drug allegies
- •Pregnancy, breast feeding, or hesitation in contraception
- •Other conditions not suitable for this study
结局指标
主要结局
-
Progression free survival rate at 2 years.
次要结局
未报告次要终点
研究者
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