NCT00568841Unknown2 期
A Phase-II Clinical Trial to Evaluate the Accuracy of FDG-/FLT-PET for Early Prediction of Non-progression in Patients With Advanced NSCLC Treated With Erlotinib and to Associate PET Findings With Molecular Markers
Lung Cancer Group Cologne1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2007年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To evaluate the accuracy of FDG-/FLT-PET analyses for early prediction of non-progression in patients with NSCLC treated with Erlotinib
研究概览
简要总结
This is a Phase-II Study to evaluate the accuracy of Fluorodeoxyglucose-/Fluorothymidine-Positron Emission Tomography (FDG-/FLT-PET) analyses for early prediction of non-progression in patients with non-small-cell lung cancer (NSCLC) treated with Erlotinib.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •≥ 18 years of age
- •Untreated non-small-cell lung cancer stage IIIB/IV
- •Life expectancy > 3 months
- •Performance status ECOG 0-2
排除标准
- •Concurrent systemic immune therapy, chemotherapy or therapy with any anticancer drug not indicated in the study protocol
- •Any investigational agent(s) within 4 weeks prior to study entry
- •Previous administration of any EGFR-targeted therapy (antibodies, small molecules and others)
- •Any medical, mental or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or understand the patient information
研究组 & 干预措施
1
Experimental
干预措施: erlotinib (Drug)
1
Experimental
干预措施: FDG-/FLT-PET (Procedure)
结局指标
主要结局
To evaluate the accuracy of FDG-/FLT-PET analyses for early prediction of non-progression in patients with NSCLC treated with Erlotinib
时间窗: 34 months
次要结局
- To identify PET characteristics for progression, response and stable disease; To identify EGFR and KRAS sequence characteristics for clinical response and stable disease; Safety; Response rates; One-year FFTF; One-year OS; Median overall survival time(34 months)
研究者
研究点 (1)
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