NCT06716775尚未招募不适用
Tumor Treating Fields (TTF) in Combination with Stereotactic Radiosurgery(SRS) for Brain Metastases from Non-small Cell Lung Cancer: a Randomized, Controlled, Open-label Study.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 主要终点
- Intracranial tumor progression-free survival (iPFS)
研究概览
简要总结
This is a randomized, controlled, open-label, phase III trials. The main purpose of this study is to evaluate the effectiveness and safety of tumor treating felds (TTF) combined with stereotactic radiosurgery (SRS) in the treatment of brain metastases from non-small cell lung cancer (NSCLC) .
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The age of the subject was between 18 and 75 years old (inclusive), regardless of gender;
- •The predicted survival time was ≥3 months;
- •Newly diagnosed with NSCLC brain metastasis;
- •MRI imaging showed 1-10 unresectable brain metastases;
- •Karnofsky performance status (KPS) score ≥70;
- •Able to operate the TTF independently or with the help of a caregiver;
- •Subjects of childbearing potential had to agree to use effective contraception for the duration of the trial;
- •Voluntarily signed the informed consent form.
排除标准
- •Positive driver genes;
- •Recurrent brain metastasis of NSCLC;
- •Suffering from severe cerebral edema;
- •Leptomeningeal metastases;
- •Participants had to meet certain criteria for bone marrow, liver and kidney function before enrollment, and were not eligible if they had any of the following:
- •platelet count < 100×103/μL;
- •absolute neutrophil count < 1.5×103/μL;
- •d. AST or ALT exceeding 2.5 times the upper limit of normal; c.Total bilirubin more than 1.5 times the upper limit of the normal range; d.Severe renal impairment (serum creatinine >1.7 mg/dL, or >150 μmol/L);
- •There were infection, ulcer and unhealed wound in the skin where the electrode was applied；
- •Patients allergic to conductive hydrogels or medical adhesives;
- •Those who are pregnant or preparing to become pregnant or who are breastfeeding;
- •Patients with poor compliance, as judged by the investigator, or other factors considered by the investigator to be not suitable for the study.
研究组 & 干预措施
TTF+Best Standard of Care
Experimental
干预措施: Best Standard of Care (Other)
TTF+Best Standard of Care
Experimental
干预措施: Tumor treating felds (TTF) (Device)
Best Standard of Care
Active Comparator
干预措施: Best Standard of Care (Other)
结局指标
主要结局
Intracranial tumor progression-free survival (iPFS)
时间窗: 3 years
Defined as the time from randomization to the first occurrence of intracranial progression (according to RANO-BM criteria) or neurologic death, whichever occurred first.
次要结局
- Objective response rate (ORR)(3 years)
- Time to neurocognitive failure(3 years)
- Rate of intracranial progression at 2, 4, 6, 8, 10, 12 months(3 years)
- Neurocognitive failure-free survival(3 years)
- Rate of decline in cognitive function(3 years)
- Overall Survival (OS)(3 years)
- Number of participants with adverse events (AEs)(3 years)
研究者
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