EUCTR2006-002708-33-IT进行中（未招募）不适用
RANDOMIZED PHASE III TRIAL OF PREOPERATIVE VERSUS POSTOPERATIVE CHEMOTHERAPY WITH CISPLATIN AND GEMCITABINE IN STAGE IB-IIIA NON-SMALL CELL LUNG CANCER NSCLC - POP 01
ISTITUTI FISIOTERAPICI OSPITALIERI0 个研究点开始时间: 2007年7月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •All patients must have pathologic documentation either histologic or cytologic of non-small cell lung cancer. 5.2 All patients must have a. Clinical Stage IB T2N0 negative mediastinoscopy or no enlarged 1 cm mediastinal lymph nodes on CT scan, no evidence of N1 disease on imaging studies OR b. Clinical Stage II T1 - 2N1 negative mediastinoscopy or no enlarged 1 cm mediastinal or hilar only level 10 lymph nodes on CT scan , T3N0 negative mediastinoscopy or no enlarged 1 cm mediastinal lymph nodes on CT scan c. Pathological Stage IIIA T1-3 pN2 confirmed by FNAB/mediastinoscopy/mediastinotomy and suitable for radical surgery
- •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
- •Uncontrolled diabetes mellitus. Patients must not have psychological, familial, sociological or geographical conditions that do not permit weekly medical follow-up and compliance with the study protocol. Patients must not have Grade 1 neuropathy - motor/sensory as judged by the investigator. Patients must not have dementia or significantly altered mental status that would prohibit the understanding and giving of informed consent. Patient must not have significant history of cardiac disease, i.e., uncontrolled high blood pressure, unstable angina, congestive heart failure, myocardial infarction within the past year, or cardiac ventricular arrhythmias requiring medication. Patients must not have any immediate life-threatening complications of their malignancies. Patients must not have pleural effusion and/or N3 disease. Patients should not receive any other investigational drugs post-surgery
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