EUCTR2008-008921-30-DK进行中(未招募)1 期
Concomitant Tarceva® and irradiation in patients in local-regionally advanced non-small cell lung cancer. A phase II study
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 入组人数
- 57
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •The study population is patients with NSCLC stage IIB - IIIB without pleural effusion suitable for curatively intended irradiation and concomitant Tarceva.
- •- Age =18 years
- •- Patients with histologically or cytologically documented diagnosis locally advanced NSCLC stage IIB to IIIB without pleural effusion
- •- Performance status =2 on the ECOG scale
- •- Serum bilirubin must be =1.5 upper limit of normal (ULN)
- •- ALAT =2 x ULN
- •- Able to comply with study and follow-up procedures
- •- Patients with reproductive potential must use effective contraception
- •- Written (signed) informed consent to participate in the study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Any unstable systemic disease (including active infection, unstable angina, congestive heart failure, severe hepatic, renal, or metabolic disease)
- •- Any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer)
- •- Inability to take oral medication, or requirement of intravenous alimentation
- •- Nursing mothers
研究者
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