A Multicentre Phase III Randomized Double Blind Placebo Controlled Trial of Pravastatin Added to First-Line Standard Chemotherapy in Patients With Small Lung Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 846
- 试验地点
- 86
- 主要终点
- Survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as etoposide, cisplatin, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Pravastatin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by making tumor cells more sensitive to chemotherapy. It is not yet known whether etoposide and cisplatin or carboplatin are more effective with or without pravastatin in treating small cell lung cancer.
PURPOSE: This randomized phase III trial is studying etoposide and cisplatin or carboplatin to see how well they work when given as first-line chemotherapy together with pravastatin compared with first-line chemotherapy and a placebo in treating patients with small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- Compare the survival of patients with small cell lung cancer treated with etoposide phosphate in combination with cisplatin or carboplatin as first-line chemotherapy with vs without pravastatin.
Secondary
- Compare the progression-free survival of patients treated with these regimens.
- Compare the local progression-free survival (local control) of these patients.
- Compare the response rate in these patients.
- Compare the toxicity of these regimens in these patients.
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
- Triple (Participant, Care Provider, Investigator)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Carboplatin/cisplatin and Etoposide with Pravastatin
干预措施: carboplatin (Drug)
Carboplatin/cisplatin and Etoposide with Pravastatin
干预措施: cisplatin (Drug)
Carboplatin/cisplatin and Etoposide with Pravastatin
干预措施: etoposide phosphate (Drug)
Carboplatin/cisplatin and Etoposide with Pravastatin
干预措施: pravastatin sodium (Drug)
Carboplatin/cisplatin and Etoposide with Placebo
干预措施: carboplatin (Drug)
Carboplatin/cisplatin and Etoposide with Placebo
干预措施: cisplatin (Drug)
Carboplatin/cisplatin and Etoposide with Placebo
干预措施: etoposide phosphate (Drug)
结局指标
主要结局
Survival
时间窗: Reported at death.
次要结局
- Response rate as measured by RECIST criteria after course 3(Post chemo cycle 3)
- Local progression-free survival (local control)(Time until the date of disease progression)
- Progression-free survival(Time until the date of disease progression)
- Toxicity as measured by CTCAE version 3.0(At every clinic visit or if serious, an SAE form shoudl be submitted)