NCT00888511已完成2 期
Concomitant Tarceva® and Irradiation in Patients in Local-regionally Advanced Non-small Cell Lung Cancer. A Phase II Study
Olfred Hansen7 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2009年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 7
- 主要终点
- Progression Free Survival
研究概览
简要总结
The trial is a phase II study of daily Tarceva combined with definitive radiotherapy in inoperable locally advanced non small cell lung cancer (stage IIB-IIIB). The objective of the phase II trial is to examine Tarceva concomitant with curatively intended irradiation 66 Gy (2 Gy x 33 F, 5 F per week).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
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
研究组 & 干预措施
1
Experimental
干预措施: Tarceva (Drug)
1
Experimental
干预措施: Radiotherapy (Radiation)
结局指标
主要结局
Progression Free Survival
时间窗: 3 years
Progression free survival from registration according to RECIST 1.1
次要结局
- Overall Response Rate (CR + PR)(May 2012)
- Disease Free Survival(May 2012)
- Local Tumor Control by CT-scan(May 2012)
- Toxicity(3 years)
- Local Tumor Control at 9 Months Evaluated by PET-CT(May 2012)
- Overall Survival(May 2012)
- Late Toxicity(May 2012)
研究者
Olfred Hansen
MD
Odense University Hospital
研究点 (7)
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