NCT00864266已完成不适用
Biological Factors Predicting Response to Chemotherapy in Advanced Non Small Cell Lung Cancer : a Prospective Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 6
- 主要终点
- Response rate
研究概览
简要总结
The primary aim of the study is to identify a predictive molecular signature for response to chemotherapy, according to WHO criteria, in patients with non-small cell lung cancer by studying the transcriptome (miRNAs and mRNAs) and the single nucleotide polymorphism (SNPs) by using high throughput techniques.
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
- •Histological diagnosis of non-small-cell lung cancer (NSCLC)
- •Obtention of a biopsy of the tumour according to the procedure defined in the protocol
- •NSCLC of any stage to be treated by standard conventional first-line chemotherapy, as defined in the ELCWP guidelines (www.elcwp.org)
- •Presence of at least one assessable lesion
- •Availability for participating in the detailed follow-up of the protocol
- •Signed informed consent.
- •Age above 18 years
排除标准
- •Patient who was previously treated with chemotherapy for NSCLC or who has any contra-indication precluding the administration of conventional chemotherapy for NSCLC
- •NSCLC treated by exclusive surgery or radiotherapy
- •A history of prior malignant tumour, except non-melanoma skin cancer or in situ carcinoma of the cervix or of the bladder or cured malignant tumour (more than 5-year disease free interval)
研究组 & 干预措施
1
Experimental
After obtaining the biopsy, patients will be treated by standard chemotherapy (the regimen has to be in agreement with the ELCWP guidelines, available on the website www.elcwp.org)
干预措施: Chemotherapy (Drug)
结局指标
主要结局
Response rate
时间窗: response will be assessed every 3 cycles of chemotherapy according to WHO criteria
次要结局
- Progression-free survival(Period between the date of treatment and the date of first progression or death)
- Duration of response(period between the day of treatment and the date of first progression in patients with an objective response)
- Survival(Survival will be dated from the date of treatment)
研究者
研究点 (6)
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