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临床试验/NCT00801736
NCT00801736终止3 期

A Multicentre, Randomised, Phase III Trial of Platinum-based Chemotherapy Versus Non-platinum Chemotherapy, After ERCC1 Stratification, in Patients With Advanced/Metastatic Non-small Cell Lung Cancer

University College, London1 个研究点 分布在 1 个国家目标入组 648 人开始时间: 2009年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
终止
入组人数
648
试验地点
1
主要终点
Overall Survival

研究概览

简要总结

Lung cancer is the leading cause of cancer death in the UK, leading to 34 000 deaths each year (22% of cancer deaths). Non-small cell lung cancer (NSCLC) is the most common histology, accounting for approximately 80% of cases and most present with advanced, stage IIIb or IV disease. The recommended treatment for advanced disease is a doublet platinum-based chemotherapy, although the survival benefits are modest. Even among those fit enough for chemotherapy, the response rate is only 20-40%, and median survival averages 9-10 months with the newer platinum-containing chemotherapy regimen (Schiller et al, 2002; Rudd et al, 2005; Lee et al, 2007). Only 11% of patients went on to survive 2 years when treated with the newer gemcitabine/carboplatin regimen established by the London Lung Cancer Group (Rudd et al, 2005; Lee et al, 2007). New strategies are needed to further improve the prognosis of this disease.

详细描述

TRIAL OBJECTIVES

Primary objective

The trial will have two main objectives:

  • To detect an improvement in survival for ERCC1+ve patients treated with a non-platinum chemotherapy compared to platinum-based treatment.
  • To establish non-inferiority or improvement in survival for ERCC1-ve patients treated with a platinum-based chemotherapy compared to non-platinum treatment.

Secondary objectives

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
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

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Platinum Arm

Experimental

Cisplatin (IMP) / Pemetrexed (IMP)

干预措施: Cisplatin, Paclitaxel (Drug)

Non Platinum Arm

Experimental

Paclitaxel (IMP) / Pemetrexed (IMP)

干预措施: Cisplatin, Paclitaxel (Drug)

结局指标

主要结局

Overall Survival

时间窗: Dec 2014

次要结局

  • Time to progression(Dec 2014)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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