Intratumoral Cancer Chemotherapy Through a Flexible Bronchoscope as an Adjunct to Brachytherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- To affect a faster clearing of the obstruction as compared with initial evaluation, based on the percentage of lumen opened.
研究概览
简要总结
This study is being conducted in order to determine if intratumoral chemotherapy will be helpful in the palliation of endobronchial tumors when used in conjunction with endobronchial brachytherapy.
详细描述
Injections of cisplatin are given in conjunction with the brachytherapy procedure. If the direct intratumoral injections result in a decrease in the endobronchial obstructed airways and if the therapy is well tolerated, there will be immediate clinical benefit to this minimally invasive method, the most obvious being an improved quality of life. Approximately 2 mg cisplatin per cubic centimeter of tumor are injected into each tumor through a flexible bronchoscope. A total of four to six injections are administered one week apart. Response to therapy is assessed based on improvement in intraluminal obstruction by tumor, as assessed by endobronchial observation.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with inoperable lung carcinoma and/or recurrent disease.
- •Patients with symptomatic obstruction.
- •Occlusion or partial occlusion of bronchi.
- •Disease verified via bronchoscopy.
- •Patients with a least one endobronchial tumor, measuring at least 0.5 cm.
- •Patients between ages of 20 and 80 years.
- •Documented informed consent must be obtained.
排除标准
- •Patients without diagnosis confirmed by bronchoscopy.
- •Patients with endobronchial tumors measuring less than 0.5 cm.
- •Patients younger than 20 or older than 80 years.
- •Patients who do not sign informed consent form.
研究组 & 干预措施
Cisplatin
1 mg/ml at a dosage of approximately 2 mg per cubic cm of tumor. Weekly up to 6 injections.
干预措施: Cisplatin (Drug)
结局指标
主要结局
To affect a faster clearing of the obstruction as compared with initial evaluation, based on the percentage of lumen opened.
时间窗: within 4 to 6 injections
次要结局
- Respiratory symptoms due to occlusion to be assessed both before and after the procedure.(3 years)