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临床试验/NCT00864266
NCT00864266已完成不适用

Biological Factors Predicting Response to Chemotherapy in Advanced Non Small Cell Lung Cancer : a Prospective Study

European Lung Cancer Working Party6 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2009年3月最近更新:
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

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

申办方类型
Other
责任方
Sponsor

研究点 (6)

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