NCT02815410Unknown2 期
The Prospective Trial for Validation of the Role of Levetiracetam as a Sensitizer of Temozolomide in the Treatment of Newly Diagnosed Glioblastoma Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 73
- 主要终点
- 6 months Progression free survival
研究概览
简要总结
Prospective, open-labeled, multicenter cohort trial for validation of the role of levetiracetam as a sensitizer of temozolomide in the treatment of newly diagnosed glioblastoma patients.
详细描述
I. Objectives
<Primary Endpoint>
6 months progression-free survival (6m-PFS)
<Secondary Endpoint>
- Overall survival
- Safety (adverse events)
- Quality of life using EORTC module,
- Cognitive function using NOPT module of our institution
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
- 20 Years 至 76 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed histologically proven supratentorial glioblastoma (World Health Organization [WHO] Grade IV). The histological diagnosis must be obtained from a neurosurgical resection or biopsy of a tumor including an open biopsy or stereotactic biopsy.
- •Age 20 -76 years
- •Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-2
- •Meets 1 of the following RPA classifications:
- •Class III (Age <50 years and ECOG PS 0) 4-
- •Class IV (meeting one of the following criteria: a) Age <50 years and ECOG PS 1 or b) Age ≥50 years, underwent prior partial or total tumor resection, MMSE ≥27) 4-
- •Class V (meeting one of the following criteria: a) Age ≥50 years and underwent prior partial or total tumor resection, MMSE <27 or b) Age ≥50 years and underwent prior tumor biopsy only)
- •Adequate hematologic, renal, and hepatic function:
- •ANC > 1,500/uL Platelet > 100,000/uL Serum creatinine <1.7mg/dL Bilirubin level < 2.0 mg/dL AST/ALT < 2.5 x upper limit of normal range of each institution
- •Written informed consent
排除标准
- •Prior chemotherapy within last 5 years
- •Prior radiotherapy of the head and neck area
- •Receiving concurrent investigational agents or has received an investigational agent within 30 days prior to randomization
- •Planned surgery for other diseases (e.g. dental extraction)
- •History of malignancy. Subjects with curatively treated cervical carcinoma in situ or basal cell carcinoma of the skin, or subjects who have been free of other malignancies for 5 years are eligible for this study
- •Pregnant or lactating women
- •Subject who disagree to follow acceptable methods of contraception
- •Concurrent illness including unstable heart disease despite appropriate treatment, history of myocardial infarction within 6 months, serious neurological or psychological disease, and uncontrolled infection
研究组 & 干预措施
Levetiracetam
Other
Newly diagnosed histologically proven supratentorial glioblastoma patients received levetiracetam during and after their CCRT
干预措施: levetiracetam (Drug)
结局指标
主要结局
6 months Progression free survival
时间窗: from the first operation to following 6 months
次要结局
- Overall survival(from the first operation to following 36 months)
研究者
Chae-Yong Kim
Professor
Seoul National University Hospital
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