NCT06346821已完成不适用
Optimizing Tumor Treating Fields Intervention Timing for Newly Diagnosed Glioblastoma: Insights From Two Emulated Trials With Chinese Multi-Hospital Based Real-World Data
Sichuan University1 个研究点 分布在 1 个国家目标入组 181 人开始时间: 2022年11月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 181
- 试验地点
- 1
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
The goal of this observational study is to learn about the effectiveness of Optune® (Tumor Treating Fields) in newly diagnosed glioblastoma (GBM) in China. The main question it aims to answer are:
- The efficacy of Optune® as an concomitant/adjuvant to radiation therapy (RT) and temozolomide (TMZ) alone in the treatment of newly diagnosed GBM patients.
- The effectiveness of Optune® given concomitantly with RT and TMZ in newly diagnosed GBM patients, compared to RT and TMZ alone.
Participants will:
- Receive or not receive TTFields.
- Concomitantly or adjuvantly receive TTFields.
详细描述
The goal of this observational study is to learn about the effectiveness of Optune® (Tumor Treating Fields) in newly diagnosed glioblastoma (GBM) in China. The main question it aims to answer are:
- The efficacy of Optune® as an concomitant/adjuvant to radiation therapy (RT) and temozolomide (TMZ) alone in the treatment of newly diagnosed GBM patients.
- The effectiveness of Optune® given concomitantly with RT and TMZ in newly diagnosed GBM patients, compared to RT and TMZ alone.
Participants will:
Step 1:
- Treatment arm I: Patients receive standard RT + TMZ, followed by maintenance TMZ, with Optune® starts during peri-radiotherapy period (2 month before to 3 months after radiotherapy). The duration of TTFields lasts for at least 2 months.
- Treatment arm II: Patients receive RT and TMZ alone, followed by maintenance TMZ concomitant.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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.
- •Age ≥ 18 years.
- •Recovered from maximal debulking surgery.
- •Karnofsky performance status ≥
- •Planned treatment with RT/TMZ followed by maintenance TMZ.
排除标准
- •Progressive disease (per investigator's assessment).
- •Infratentorial or leptomeningeal disease.
- •Significant co-morbidities at baseline which would preclude maintenance RT or TMZ treatment.
- •Any serious surgical/post-operative condition that may risk the patient according to the investigator.
结局指标
主要结局
Overall Survival (OS)
时间窗: 5 years
Survival will be measured from the time of randomization until date patient is alive.
次要结局
未报告次要终点
研究者
Zhongzheng Xiang
Principal Investigator
Sichuan University
研究点 (1)
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