A Prospective Trial of NovoTTF-200A Together With Temozolomide and Radiotherapy in Patients With Newly Diagnosed GBM
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Safety of concomitant Radiotherapy/Temozolomide with NovoTTF-200A: The incidence of Radiotherapy treatment delays during concomitant Radiotherapy/Temozolomide/NovoTTF-200A will be documented including severity and relationship to NovoTTF-200A.
研究概览
简要总结
The study is a prospective, single arm open label study, designed to test the to evaluate the tolerability and safety outcome of newly diagnosed GBM patients treated with NovoTTF-200A concomitant to Radiotherapy/Temozolomide followed by Temozolomide. The device is a 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:
A phase III trial of Optune® (200 kHz) as monotherapy compared to active chemotherapy in recurrent glioblastoma patients showed TTFields to be equivalent to active chemotherapy in extending survival, associated with minimal toxicity, good quality of life, and activity within the brain (14% response rate). In addition, a phase III trial of Optune® combined with maintenance temozolomide compared to maintenance temozolomide alone has shown that combined therapy led to a significant improvement in both progression free survival and overall survival in patients with newly diagnosed glioblastoma without the addition of high grade toxicity and without decline in quality of life.
DESCRIPTION OF THE TRIAL:
All patients included in this trial are newly diagnosed GBM patients who underwent a biopsy or surgery. In addition, all patients must meet all eligibility criteria.
Eligible patients will be enrolled to receive Radiotherapy(RT)/Temozolomide/NovoTTF-200A followed by maintenance TMZ and 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed diagnosis of GBM according to WHO classification criteria.
- •Supratentorial tumor location
- •Age ≥ 18 years
- •Recovered from maximal debulking surgery, if applicable (gross total resection, partial resection and biopsy-only patients are all acceptable)
- •Planned standard adjuvant chemoradiotherapy of approx. 60 Gy of Radiotherapy (RT), or biologically equivalent dose, according to local practice, and concomitant Temozolomide (TMZ) chemotherapy (75mg/m^2 daily). Any other cytotoxic or biologic anti-tumor therapy received prior to enrollment will be considered an exclusion.
- •Planned treatment with adjuvant/maintenance TMZ (150-200 mg/m^2 daily x 5 d, q28 days)
- •Karnofsky performance status ≥ 70
- •Life expectancy ≥ 3 months
- •Participants of childbearing age must use effective contraception.
- •All patients must sign written informed consent.
- •NovoTTF-200A treatment start date at least 2 weeks out from brain surgery.
- •NovoTTF-200A treatment start prior to or at the beginning of RT/TMZ
- •Stable or decreasing dose of corticosteroids for the last 7 days prior to enrollment, if applicable.
排除标准
- •Participation in another clinical treatment trial
- •Pregnancy or breast feeding
- •Significant co-morbidities at baseline which would preclude TMZ treatment
- •Implanted pacemaker, programmable shunts, defibrillator, deep brain stimulator, other implanted electronic devices in the brain, or documented clinically significant arrhythmias.
- •Infra-tentorial tumor location
- •Evidence of increased intracranial pressure (midline shift > 5mm, clinically significant papilledema, vomiting and nausea or reduced level of consciousness)
- •History of hypersensitivity reaction to TMZ or a history of hypersensitivity to DTIC.
- •Known allergies to medical adhesives or gel
研究组 & 干预措施
NovoTTF-200A/Radiotherapy/Temozolomide
Patients will receive multiple 1 month courses of continuous NovoTTF-200A treatment together with standard Radiotherapy/Temozolomide followed by maintenance Temozolomide.
干预措施: NovoTTF-200A (Device)
NovoTTF-200A/Radiotherapy/Temozolomide
Patients will receive multiple 1 month courses of continuous NovoTTF-200A treatment together with standard Radiotherapy/Temozolomide followed by maintenance Temozolomide.
干预措施: Radiotherapy (Radiation)
NovoTTF-200A/Radiotherapy/Temozolomide
Patients will receive multiple 1 month courses of continuous NovoTTF-200A treatment together with standard Radiotherapy/Temozolomide followed by maintenance Temozolomide.
干预措施: Temozolomide (Drug)
结局指标
主要结局
Safety of concomitant Radiotherapy/Temozolomide with NovoTTF-200A: The incidence of Radiotherapy treatment delays during concomitant Radiotherapy/Temozolomide/NovoTTF-200A will be documented including severity and relationship to NovoTTF-200A.
时间窗: 2 years
The incidence of Radiotherapy treatment delays during concomitant Radiotherapy/Temozolomide/NovoTTF-200A will be documented including severity and relationship to NovoTTF-200A.
次要结局
- Progression free survival(2 years)
- Overall survival(2 years)
- Adverse events, severity and frequency(2 years)