A Prospective, Multi-center Trial of NovoTTF-100A Compared to Best Standard of Care in Patients With Progressive or Recurrent GBM
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 236
- 试验地点
- 39
- 主要终点
- Overall Survival
研究概览
简要总结
The study is a randomized, controlled trial, designed to test the efficacy and safety of a new medical device, the NovoTTF-100A. The device is an experimental, portable, battery operated device for chronic treatment of patients with recurrent or progressive glioblastoma multiforme (GBM) using alternating electric fields (termed TTFields).
详细描述
PAST CLINICAL EXPERIENCE:
The effect of the electric fields generated by the NovoTTF-100A device (TTFields) has been tested in two pilot trials in humans. The data from these trials suggest NovoTTF-100A may improve time to disease progression and overall survival of recurrent GBM patients. Although the number of patients in the pilot trials is small, The FDA has determined that the data gathered so far warrant testing of NovoTTF-100A treatment as a possible therapy for patients with recurrent GBM.
DESCRIPTION OF THE TRIAL:
Patients with GBM whose disease has recurred or progressed despite standard treatment (Surgery, radiation therapy, Temozolomide treatment) and meet all of the requirements for participation in the study will be randomly assigned to one of two groups:
- Treatment with the NovoTTF-100A device, or
- Treatment with the best standard of care practiced at each of the participating centers.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathological evidence of GBM using WHO classification criteria.
- •> 18 years of age.
- •Not a candidate for further radiotherapy or additional resection of residual tumor.
- •Patients with disease progression (by Macdonald criteria i.e., > 25% or new lesion) documented by CT or MRI within 4 weeks prior to enrollment
- •Karnofsky scale ≥ 70
- •Life expectancy at least 3 months
- •Participants of childbearing age must use effective contraception.
- •All patients must sign written informed consent.
排除标准
- •Actively participating in another clinical treatment trial
- •Within 4 weeks from surgery for recurrence
- •Within 4 weeks from any prior chemotherapy.
- •Within 4 weeks from radiation therapy
- •Significant co-morbidities (within 4 weeks prior to enrollment):
- •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 control in 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
- •Implanted pacemaker, defibrillator or deep brain stimulator, or documented clinically significant arrhythmias.
- •Infra-tentorial tumor
- •Evidence of increased intracranial pressure (midline shift > 5mm, clinically significant papilledema, vomiting and nausea or reduced level of consciousness)
研究组 & 干预措施
NovoTTF-100A
干预措施: NovoTTF-100A (Device)
Best Standard of Care
Patients randomized to the BSC group will be treated with one chemotherapy according to the BSC practiced at each center.
干预措施: NovoTTF-100A (Device)
结局指标
主要结局
Overall Survival
时间窗: 2 years from initiation of accrual
次要结局
- Median Time to Disease Progression (TTP)(2 years from initiation of accrual)
- Progression free survival at 6 months (PFS6)(2 years from initiation of accrual)
- Radiological response (Macdonald criteria)(2 years from initiation of accrual)
- Adverse events severity and frequency(2 years from initiation of accrual)
- Quality of life assessment (EORTC QLQ-C30)(2 years from initiation of accrual)
- % 1-year survival(2 years from initiation of accrual)