A Multi-Institutional Pilot Study of Prophylactic Cranial Tumor-Treating Fields for Patients With Extensive-stage Small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Percentage of Patients Continuing Therapy Until Intracranial Tumor
研究概览
简要总结
This trial studies how well tumor-treating fields therapy works in preventing brain tumors in participants with small cell lung cancer that has spread to other places in the body. Tumor-treating fields therapy involves the use of the NovoTTF-200A which delivers alternating electrical fields, or tumor treating fields, through ceramic discs placed on the head. This electric force may slow and/or reverse tumor growth by disrupting the way cancer cells grow.
详细描述
PRIMARY OBJECTIVES:
I. To measure the feasibility and compliance of NovoTTF-200A as prophylactic cranial tumor treatment fields (TTF) therapy, determined by percent (%) of patients continuing TTF therapy until intracranial tumor progression, discontinuation due to dose limiting toxicity (DLT), or 6 months.
SECONDARY OBJECTIVES:
I. To evaluate time to intracranial failure after NovoTTF-200A. II. To evaluate overall survival after NovoTTF-200A. III. To evaluate the rates of intracranial failure at 2, 4, 6, 8, 10, 12 months after NovoTTF-200A.
IV. To evaluate intracranial failure free survival after NovoTTF-200A. V. To evaluate the rate of decline in Hopkins Verbal Language Test-Revised (HVLT-R) free recall, delayed recall and delayed recognition, Controlled Oral Word Association Test (COWAT) and Trail Making Test (TMT) Parts A and B at 2, 4, 6, 8, 10, 12 months after NovoTTF-200A.
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
- •Life expectancy of > 3 months
- •Histologically proven extensive stage small cell lung carcinoma (ES-SCLC) (any T any N and any M stage) within 6 months prior to start of study treatment with the NovoTTF-200A, with a partial or complete response to at least four cycles of first-line chemotherapy
- •Karnofsky performance status (KPS) > 70
- •Neutrophil count > 1.5 x 10^9/L
- •Platelet count > 100 x 10^9/L
- •Bilirubin < 1.5 x upper limit of normal (ULN)
- •Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) < 2.5 x ULN or < 5 x ULN if patient has documented liver metastases
- •Serum creatinine < 1.5 x ULN
排除标准
- •Evidence of brain metastases on magnetic resonance imaging (MRI) of brain with and without contrast
- •History of other prior malignancy within the past 5 years except for superficial skin cancers
- •No severe comorbidities:
- •History of significant cardiovascular disease unless the disease is well controlled. Significant cardiac disease includes second/third degree heart block; significant ischemic heart disease; poorly controlled hypertension; congestive heart failure of the New York Heart Association (NYHA) Class II or worse (slight limitation of physical activity; comfortable at rest, but ordinary activity results in fatigue, palpitation or dyspnea)
- •History of arrhythmia that is symptomatic or requires treatment. Patients with atrial fibrillation or flutter controlled by medication are not excluded from participation in the trial
- •History of cerebrovascular accident (CVA) within 6 months prior to start of study treatment
- •Active infection or serious underlying medical condition that would impair the ability of the patient to receive protocol therapy
- •History of any psychiatric condition that might impair patient's ability to understand or comply with the requirements of the study or to provide consent
- •Active implantable electronic medical devices in the brain; a skull defect, a shunt, or bullet fragments
- •Known allergies to medical adhesives or hydrogel
- •Unable to operate the NovoTTF-200A device independently or with the help of a caregiver
- •If a female, currently pregnant, breastfeeding, or unwilling to avoid pregnancy while on study treatment
- •Concurrent brain directed therapy (beyond NovoTTF-200A as per protocol)
- •Prior clinical trial participation with brain directed therapy
- •Concurrent treatment clinical trials
结局指标
主要结局
Percentage of Patients Continuing Therapy Until Intracranial Tumor
时间窗: Up to 6 months
Count of patients developed intracranial tumor divided by total number of patients.
次要结局
- Incidence of Adverse Events(Up to 12 months)
- Time to Intracranial Failure(Up to 3 years)
- Overall Survival(Up to 3 years)
- Rate of Intracranial Failure(Up to 12 months)
- Rate of Decline in Cognitive Function(Up to 12 months)
- Time to Neurocognitive Failure(Up to 3 years)
- Neurocognitive Failure-free Survival(Up to 3 years)
- Evaluate Quality of Life Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30(Up to 3 years)
研究者
Wade Iams
Principal Investigator
Vanderbilt-Ingram Cancer Center