The Clinical Effect and Safety of Radiotherapy Concurrent of TTFields in the Treatment of Post-operation Patients With Glioblastoma.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Disease-free survival
研究概览
简要总结
TTFields has been approved by the FDA for the treatment of patients with glioblastoma multiforme. However, the clinical effect and safety of radiotherapy concurrent of TTFields is not definite. In this study, the investigators conduct a phase II clinical trial to evaluate the efficacy and safety of this strategy.
详细描述
the investigators plan to recruit 30 patients to evaluate the efficacy and safety of this strategy.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •performance status of 0-1 (Eastern Cooperative Oncology Group performance status)
- •histologically confirmed glioblastoma
- •no cerebrospinal fluid and distant metastatic disease.
排除标准
- •with a history of brain radiotherapy
- •severe hepatic and renal dysfunction
研究组 & 干预措施
E group
All patients received chemoradiotherapy (CRT) ( PTV-GTV: 60Gy at 2.0Gy per fraction, 5 fractions per week for 6 weeks; PTV-CTV: 54Gy at 1.8Gy per fraction, 5 fractions per week for 6 weeks) with a Temozolomide (TMZ) regimen（75mg/m2 per day during RT）and TTFields therapy during RT. The TTFields therapy started on the day the radiotherapy started.
干预措施: TTFields (Device)
C group
All patients received chemoradiotherapy (CRT) ( PTV-GTV: 60Gy at 2.0Gy per fraction, 5 fractions per week for 6 weeks; PTV-CTV: 54Gy at 1.8Gy per fraction, 5 fractions per week for 6 weeks) with a Temozolomide (TMZ) regimen（75mg/m2 per day during RT）
结局指标
主要结局
Disease-free survival
时间窗: 1 year
the length of time after primary treatment for glioblastoma ends that the patient survives without any signs or symptoms of glioblastoma.
次要结局
- Overall survival(2 years)