ACTRN12608000588392已完成3 期
A Phase III, randomised trial of adding nitroglycerin to first line chemotherapy to improve progression free survival in advanced non-small cell lung cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 372
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Confirmed diagnosis of stage III or IV non-small cell lung cancer
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
- •Adequate bone marrow, kidney and liver function
- •Radiotherapy completed at least 1 week before randomisation
- •Patient is willing and able to comply with protocol requirements
- •Patient has completed quality of life questionnaires or is unable to complete due to illiteracy, language or limited vision
- •Female patients of childbearing potential must be willing to use adequate contraception
- •Plan to start chemotherapy within 8 days of randomisation
排除标准
- •Untreated brain or meningeal metastases
- •Life expectancy less than 3 months
- •Any prior systemic therapy for advanced non-small cell lung cancer
- •History of previous or concomitant malignancies at other sites within the last 5 years
- •On nitrates, dihydroergotamine or phosphodiesterase inhibitors
- •History of allergic disease or reactions likely to be exacerbated by nitroglycerin
- •Uncontrolled cardiovascular disease
- •Other concomitant medical problems which would limit compliance with the study procedures or expose the patient to unacceptable risk
- •Active and uncontrolled infections
研究者
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