跳至主要内容
临床试验/NCT04832672
NCT04832672已完成不适用

The Optimal Sequence of Intracranial Radiotherapy Compared to Systematic Tyrosine Kinase Inhibitors for Gene-driven Brain Metastases in Targeted Treatment Era

Chinese Academy of Medical Sciences1 个研究点 分布在 1 个国家目标入组 570 人开始时间: 2010年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
570
试验地点
1
主要终点
Intracranial progression-free survival

研究概览

简要总结

The investigators conducted a single institutional, retrospective cohort study to demonstrate the appropriate treatment strategy of upfront intracranial radiotherapy or upfront targeted therapy in patients with brain metastases, including an assessment of its feasibility and toxicity.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Had histologically proven primary cancer.
  • Had newly diagnosed brain metastases in contrast-enhanced MRI.
  • Brain metastases focus should be measurable.
  • All the patients should safely receive radiotherapy and/or systematic tyrosine kinase inhibitors.
  • Karnofsky performance score (KPS) ≥60 or KPS ≥40, but only caused by brain metastases.

排除标准

  • Patients with prior intracranial local treatments, such as surgery and radiotherapy without dose prescription in detail
  • Patients with leptomeningeal metastases at first diagnosis.
  • Had synchronous or metachronous malignancies that might affect survival.
  • Had severe systemic diseases, abnormal conditions that might lead to incoordinate behavior during the implementation of clinical measures.
  • Had incomplete sociodemographic and/or clinicopathologic baseline data

结局指标

主要结局

Intracranial progression-free survival

时间窗: The interval from the start of initial intracranial treatment to first documented intracranial progression, or date of death from any cause, whichever came first, assessed up to 3 to 5 years

The survival time of patients before any intracranial progression

次要结局

  • Brain metastasis-specific survival(The interval from the start of initial intracranial treatment to death from brain metastases or censored on the last follow-up, whichever came first, assessed up to 3 to 5 years)
  • Overall survival(The time from the date of initial intracranial treatment until death from any cause or censored on the last follow-up, whichever came first, assessed up to 3 to 5 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jianping Xiao

Professor

Chinese Academy of Medical Sciences

研究点 (1)

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