NCT01130766Unknown3 期
Randomized Phase III Trial of Stereotactic Radiosurgery (SRS) Versus Observation for Patients With Asymptomatic Cerebral Oligo-metastases in Non-small Cell Lung Cancer (NSCLC)
适应症
试验速览
- 阶段
- 3 期
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
The prognosis of NSCLC patients with asymptomatic brain metastasis, who are not treated with SRS or WBRT has not been fully investigated yet. This randomized phase III trial is conducted to determine the exact role of SRS in NSCLC patients with asymptomatic oligo brain metastases whether early treatment with SRS would improve survival even in patients with asymptomatic brain metastasis.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed non-small cell lung cancer with synchronous brain metastases (diagnosis of brain lesion before or within 2 months from diagnosis of the primary site tumor)
- •One to 4 intraparenchymal brain metastases by contrast-enhanced MRI, meeting the following criteria:
- •Well circumscribed tumor(s) with brain edema Grade 0-1
- •Maximum diameter ≤ 3.0 cm
- •No prior complete resection of all known brain metastases or RT ④ No leptomeningeal metastases by MRI or cerebrospinal fluid evaluation
- •Patients without any symptoms or signs from brain metastases (RTOG neurologic functions status of 0) ⑥ Age, 18 and over ⑦ ECOG performance status 0-1 ⑧ Written informed consent
排除标准
- •severe co-morbid illness and/or active infections ② pregnant or lactating women
- •RTOG neurologic function status of 1~4 ④ Uncontrollable extracranial metastases
结局指标
主要结局
Overall survival
时间窗: 36 months
次要结局
- time to CNS progression(36 months)
- time to symptomatic brain metastasis(36 months)
- quality of life(36 months)
- cause of death (neurologic vs. others)(36 months)
- neurocognitive function(36 months)
研究者
研究点 (1)
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