Pilot Trial of NovoTTF -200A (TTFields) in Patients With Newly Diagnosed High Risk Oligodendrogliomas
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Safety and Tolerability of the NovoTTFields treatment in patients with high risk oligodendroglioma
研究概览
简要总结
This pilot clinical trial studies the side effects of NovoTTF-200A device in treating patients with newly diagnosed high risk oligodendroglioma. NovoTTF-200A device is a portable battery operated device which produces tumor treating (TT)Fields in the body by means of surface electrodes placed on the skin. TTFields are very low intensity, intermediate frequency electric fields that may slow the growth of tumor cells in patients with high risk oligodendroglioma.
详细描述
PRIMARY OBJECTIVES:
I. To describe the safety and tolerability of the TTFields treatment in patients with newly diagnosed high risk oligodendroglioma following standard of care treatment.
SECONDARY OBJECTIVES:
I. To estimate the proportion of patients who tolerated 75% of treatment goal at months 6, 12, 24.
II. To estimate the progression free survival time. III. To assess quality of life. IV. To assess whether or not there is a correlation between genomics and the efficacy of the TTFields treatment.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed oligodendroglioma (oligo) (low grade oligo, low grade mixed oligoastrocytoma, anaplastic oligo, anaplastic mixed oligo) by histology and or molecular classification
- •Surgically sub-total or unresectable tumors, i.e. in insula, including but not limited to the insula and received standard of care (SOC) radiation
- •Historical pathological tissue evidence of high risk oligo (low grade oligo, low grade mixed oligoastrocytoma, anaplastic oligo, anaplastic mixed oligo) by histology and or molecular classification
- •1p and 19q deletion status known
- •IDH 1 & 2 mutations status known
- •MGMT status known
- •Karnofsky equal or greater than 70
- •Life expectancy at least 3 months
- •Participants of childbearing age must use effective contraception
- •A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- •Has not undergone a hysterectomy or bilateral oophorectomy; or
- •Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
- •Ability to understand and the willingness to sign a written informed consent
排除标准
- •Actively participating in another clinical treatment trial
- •Tumor progression after radiation
- •Has implanted pacemaker, programmable shunts, defibrillator, deep brain stimulator, other implanted electronic devices in the brain
- •Documented clinically significant cardiac arrhythmias
- •Infra-tentorial tumor
结局指标
主要结局
Safety and Tolerability of the NovoTTFields treatment in patients with high risk oligodendroglioma
时间窗: Up to 2 months after treatment
Number of patients with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events version 4.03
次要结局
未报告次要终点