JPRN-jRCTs041180080已完成2 期
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
Murakami Haruyasu0 个研究点目标入组 28 人开始时间: 2019年3月11日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
研究概览
简要总结
Among unresectable locally-advanced NSCLC patients with EGFR mutation, gefitinib with concurrent thoracic radiotherapy showed manageable safety profiles, but did not improve PFS rate at 2 years.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 < 75age old（—）
- 性别
- All
入选标准
- •1) Pathologically confirmed NSCLC
- •2) Treatment naive unresectable stage III disease
- •3) Harboring EGFR mutation
- •4) Age of 20 to 75 years
- •5) ECOG PS of 0 or 1
- •6) Evaluable target lesions as per RECIST ver. 1.1
- •7) Adequate organ function
- •8) Confirmed as eligible for the protocol defined radiotherapy by radiologists
- •9) Written informed consent
排除标准
- •1) Harboring exon 20 T790M mutation.
- •2) Incapable of oral intake
- •3) With intestinal paralysis, or ileus
- •4) Chronic diarrhea
- •5)Exhibiting significant interstitial pneumonitis, or pulmonary fibrosis in the chest CT
- •6) Active infection
- •7) Positive for HBs antigen
- •8) Uncontrolled diabetes mellitus
- •9) Severe heart disease
- •10) Systemic treatment with steroids
- •11) Concomitant cancers within 5 years
- •12) Prior history of thoracic radiotherapy
- •13) History of sereous drug allegies
- •14) Pregnancy, breast feeding, or hesitation in contraception
- •15) Other conditions not suitable for this study
研究者
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