Phase II Study That Evaluates Concurrent Chemotherapy and Radiotherapy With Nitroglycerin in Patients With Locally Advanced Non-Small Cell Lung Cancer
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
- Time to progression, over-all survival
研究概览
简要总结
Nitroglycerin will increase the effectiveness of treatment with induction chemotherapy and concurrent chemo-radiotherapy by reducing chemo-radio resistance through an increased oxygen pressure in tumoral tissue. The combination treatment of nitroglycerin and chemotherapy will result in longer disease-free and over-all survival in patients with locally advanced NSCLC
详细描述
Nitroglycerin decreases hypoxia-induced resistance to antitumor drugs due to inhibition of Hypoxia Inducible Factor alfa (HIF-1α), it increases oxygen pressure in tumoral tissue by augmenting tumor blood flow, increases apoptosis, activation of p53, and induces cellular growth inhibition. Randomized studies showed that the addition of transdermal nitroglycerin to non small cell lung cancer (NSCLC) patients with metastasis treated with vinorelbine and cisplatin achieved a significantly better global response to treatment than conventional treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- 否
入选标准
- •Histopathologic diagnosis of non small-cell lung cancer
- •Clinical stage IIIA and/or IIIB without pleural effusion
- •ECOG functional status 0 or 1
- •No renal function alteration (GFR >50%)
- •No hepatic function alteration (ALT and AST less than 2 times its normal value)
- •Leucocytes more than 2,000/mcl
- •Hemoglobin more than 10mg/dL
- •Platelets more than 100,000/mcl
排除标准
- •Ischemic heart disease
- •Abnormal electrocardiogram
研究组 & 干预措施
Nytroglicerin
干预措施: Transdermal nitroglycerin (Drug)
结局指标
主要结局
Time to progression, over-all survival
时间窗: 5 years
次要结局
- Levels of oxidative stress through lipid peroxidation and quantification of VEGF Toxicity from treatment with chemotherapy and concurrent chemo-radiotherapy combined with transdermal nitroglycerin(5 years)