NCT02425072撤回2 期
NovoTTFTM-100A System Therapy for Refractory CNS Involved Small Cell Lung Cancer
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- John Villano
- 试验地点
- 2
- 主要终点
- Time to treatment failure
研究概览
简要总结
The hypothesis of this study is that the addition of NovoTTF-100A System treatment to salvage chemotherapy will significantly increase time to treatment failure in the brain of small cell lung cancer patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed small cell lung cancer histology with CNS metastases
- •Parenchymal disease, ten or less lesions, and supratentorial
- •PS 70% or greater
- •Prior CNS radiotherapy.
- •No previous or currently active second malignancy
- •Age > 22 years.
- •Life expectancy of ≥ 3 months.
排除标准
- •Significant liver function impairment - AST or ALT > 3 times the upper limit of normal; Total bilirubin > upper limit of normal.
- •Significant renal impairment (serum creatinine > 1.7 mg/dL).
- •Coagulopathy (as evidenced by PT or APTT >1.5 times in control patients not undergoing anticoagulation).Thrombocytopenia (platelet count < 100 x 103/μL).
- •Neutropenia (absolute neutrophil count < 1 x 103/μL).
- •Anemia (Hb < 10 g/L).
- •Severe acute infection. Serious non-healing wound or ulcer on scalp
- •Significant co-morbidities within 4 weeks prior to enrollment.
- •Implanted pacemaker, defibrillator or deep brain stimulator, or documented clinically significant arrhythmias.
- •Active implanted medical device (e.g. deep brain stimulators, spinal cord stimulators, vagus nerve stimulators, pacemakers, defibrillators, and programmable shunts).
- •Skull defect (e.g. missing bone with no replacement).
- •Bullet fragments
- •Evidence of increased intracranial pressure (midline shift > 5mm, clinically significant papilledema, vomiting and nausea or reduced level of consciousness).
- •Sensitivity to conductive hydrogels.
- •Pregnant or lactating women
研究组 & 干预措施
NovoTTF-100A plus chemotherapy
Experimental
NovoTTF-100A System with Physician's Choice Chemotherapy
干预措施: NovoTTF-100A plus chemotherapy (Device)
结局指标
主要结局
Time to treatment failure
时间窗: Up to 3 months
次要结局
- Progression Free Survival(Up to 6 months)
- Duration of response(Up to 2 years)
- Overall response rate(Up to 2 years)
- Safety of treatment assessed by number of participants with adverse events(Up to 2 years)
研究者
John Villano
Principal Investigator
University of Kentucky
研究点 (2)
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