EUCTR2008-002197-35-DE进行中（未招募）不适用
Multizentrische randomisierte Phase II Studie zur Therapie des lokal fortgeschrittenen oder metastasierten NSCLC (Stadium IIIB/IV) mit Cisplatin/Docetaxel oder Oxaliplatin/DocetaxelA multicenter randomized phase II trial for the therapy of locally advanced or metastatic NSCLC (stage IIIB/IV) with cisplatin/docetaxel or oxaliplatin/docetaxel
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 88
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
- •histologically or cytologically confirmed NSCLC, stadium IIIB (curative treatment impossible) or IV.
- •no prior cytostatic chemotherapy in metastatic state
- •female and male patients aged >18 years
- •Leukozytes > 3.000/µl
- •Thrombozytes > 100.000/µl
- •creatinine serum level = 1.25x ULN or Creatinine-Clearance > 45 ml/min
- •parallel radiotherapy possible if target lesion not in radiation field
- •written informed consent
- •life expectancy > 3 months
- •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
- •Hypersensitivity for Cisplatin, Oxaliplatin or Docetaxel
- •Neoadjuvant or adjuvant chemotherapy in the last 6 months
- •radiotherapy in the last 28 days
- •relevant systemic concomitant diseases
- •Cardiomyopathy or heart insufficiency stadium II-IV according to NYHA
- •second malignancy < 5 years ago
- •brain metastases
- •severe internal dysfunction or acute infection
- •peripheral polyneuropathy > NCI grade II
- •severe impairment of liver function (AST/ALT>3,5xULN, AP>6xULN, Bilirubin>1,5xULN)participation in another clinical trial
- •pregnancy or lactation
研究者
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