Intrapleural Hypertonic Cisplatin Treatment for Malignant Pleural Effusion in Patients With Non-small-cell Lung Cancer.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- overall response rate
研究概览
简要总结
To assess the effect and toxicity of intrapleural administration of hypertonic cisplatin for malignant pleural effusion in patients with non-small-cell lung cancer.
详细描述
The lung was fully expanded by a thoracostomy using a chest tube with a double lumen, and then the patients were enrolled into the trial.First, premedication including antiemetics and hydration were performed. Thereafter, 75 mg of body surface area of cisplatin in 50 ml of distilled water was injected through a chest tube.The patients were asked to change position (supine and bilateral decubital) from time to time for 30 minutes. The chest tube was clamped for 48 h and then the tube was declamped and allowed to drain. When the drainage effusion was less than 100 ml a day, the chest tube was removed. Any patient whose drainage effusion continued for over 2 weeks was withdrawn from the trial and was also judged to be a nonresponder.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cytologically proven and previously untreated malignant pleural effusion of Non-small-cell Lung Cancer;
- •An Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1;
- •A leucocyte count of≥4000µl;
- •A platelet count of≥100000µl;
- •A normal creatinine level;
- •Serum glutamic oxaloacetic transaminase/glutamic pyruvic transaminase levels of no more than twice the upper limit of normal;
- •Survival time ≥12 weeks.
排除标准
- •Previously treated malignant pleural effusion;
- •Pericardial effusion；
- •Pregnant；
- •Uncontrolled hypertension or diabetes；
- •Liver cihrosis.
研究组 & 干预措施
Cisplatin
75 mg of body surface area of ciplatin in distilled water is injected in to the chest through a chesttube.
干预措施: cisplatin (Drug)
结局指标
主要结局
overall response rate
时间窗: one month
次要结局
未报告次要终点
研究者
Hongbiao Wang
Associate chief physician
Shantou University Medical College