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临床试验/EUCTR2008-008921-30-DK
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

Odense University Hospital0 个研究点目标入组 57 人开始时间: 2009年1月22日最近更新:
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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Concomitant Tarceva® and irradiation in patients in... | 临床试验