A Prospective, Multi-center Trial of NovoTTF-100A Together With Temozolomide Compared to Temozolomide Alone in Patients With Newly Diagnosed GBM.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 700
- 试验地点
- 89
- 主要终点
- Progression Free Survival (PFS) time
研究概览
简要总结
The study is a prospective, randomly controlled pivotal trial, designed to test the efficacy and safety of a medical device, the NovoTTF-100A, as an adjuvant to the best standard of care in the treatment of newly diagnosed GBM patients. The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.
详细描述
PAST CLINICAL EXPERIENCE:
The effect of the electric fields generated by the NovoTTF-100A device (TTFields, TTF) has been tested in a large prospective, randomized trial, in recurrent GBM. The outcome of subjects treated with the NovoTTF-100A device was compared to those treated with an effective best standard of care chemotherapy (including bevacizumab). NovoTTF-100A subjects had comparable overall survival to subjects receiving the best available chemotherapy in the US today. Similar results showing comparability of NovoTTF-100A to BSC chemotherapy were seen in all secondary endpoints.
Recurrent GBM patients treated with the NovoTTF-100A device in this trial experienced fewer side effects in general, significantly fewer treatment related side effects, and significantly lower gastrointestinal, hematological and infectious adverse events compared to controls. The only device-related adverse events seen were a mild to moderate skin irritation beneath the device electrodes. Finally, quality of life measures were better in NovoTTF-100A subjects as a group when compared to subjects receiving effective best standard of care chemotherapy.
In a small scale pilot trial in newly diagnosed GBM patients, the treatment was well tolerated and suggested that NovoTTF-100A may improve time to disease progression and overall survival of newly diagnosed GBM patients. Although the number of patients in the pilot trial was small, The FDA has determined that the data gathered so far warrant testing of NovoTTF-100A treatment as a possible therapy for patients with newly diagnosed GBM.
DESCRIPTION OF THE TRIAL:
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.
- •Received maximal debulking surgery and radiotherapy concomitant with Temozolomide (45-70Gy):
- •Patients may enroll in the study if received Gliadel wafers before entering the trial
- •Any additional treatments received prior to enrollment will be considered an exclusion.
- •Minimal dose for concomitant radiotherapy is 45 Gy
- •Karnofsky scale ≥ 70
- •Life expectancy at least 3 months
- •Participants of childbearing age must use effective contraception.
- •All patients must sign written informed consent.
- •Treatment start date at least 4 weeks out from surgery.
- •Treatment start date at least 4 weeks out but not more than 7 weeks from the later of last dose of concomitant Temozolomide or radiotherapy.
排除标准
- •Progressive disease (according to MacDonald Criteria). If pseudoprogression is suspected, additional imaging studies must be performed to rule out true progression.
- •Actively participating in another clinical treatment trial
- •Significant co-morbidities at baseline which would prevent maintenance Temozolomide treatment:
- •Thrombocytopenia (platelet count < 100 x 103/μL)
- •Neutropenia (absolute neutrophil count < 1.5 x 103/μL)
- •CTC grade 4 non-hematological Toxicity (except for alopecia, nausea, vomiting)
- •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)
- •Implanted pacemaker, programmable shunts, defibrillator, deep brain stimulator, other implanted electronic devices in the brain, 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)
- •History of hypersensitivity reaction to Temozolomide or a history of hypersensitivity to DTIC.
研究组 & 干预措施
NovoTTF-100A device in combination with Temozolomide
patients will be treated continuously with the NovoTTF-100A device, in addition to Temozolomide. NovoTTF-100A treatment will consist of wearing four electrically insulated electrode arrays on the head. The treatment enables the patient to maintain regular daily routine.
干预措施: NovoTTF-100A device (Device)
Temozolomide alone, as the best known standard of care
Patients will be treated with Temozolomide, as the best known standard of care for Glioblastoma Multiforme patients.
干预措施: Temozolomide (Drug)
结局指标
主要结局
Progression Free Survival (PFS) time
时间窗: 5 years
次要结局
- Overall survival (OS)(5 years)