跳至主要内容
临床试验/NCT01130779
NCT01130779Unknown2 期

The Continuation of Erlotinib Treatment in Non-small Cell Lung Cancer Patients Whose Brain Lesion is the Only Site of Progression : Pilot Study

Samsung Medical Center1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2009年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
入组人数
23
试验地点
1
主要终点
progression free survival

研究概览

简要总结

Newly developed or progressive brain metastasis during erlotinib treatment is considered progressive disease requiring change of treatment regimens despite no progression in extracranial lesions. Given that there is a dissociation in terms of response to erlotinib between brain and extracranial sites, we intend to conduct this pilot study to determine whether the continuation of erlotinib treatment can prolong the progression free interval of extracranial lesions as long as cranial lesion is controlled separately by conventional treatment modalities such as surgical resection, stereotactic radiosurgery, and whole brain radiotherapy.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

入选标准

  • Histologically or cytologically proven non small cell lung cancer
  • New developed or progression of brain lesions among patients with good control of extracranial lesions to erlotinib
  • patients who are receiving erlotinib as salvage therapy
  • At least one unidimensionally measurable lesion with a diameter > 10mm using brain MRI
  • at least on unidimensionally measurable or evaluable lesion
  • male or female patients aged >18 years
  • ECOG performance status 0-2
  • Adequate hematologic function
  • adequate renal function
  • adequate hepatic function
  • Exclusion criteria
  • leptomeningeal metastases
  • acute severe infection requiring antibiotic therapy
  • significant cardiovascular disease
  • uncontrolled DM
  • severe ophthalmologic disease

排除标准

  • 未提供

研究组 & 干预措施

tarceva

Experimental

continuation of tarceva

干预措施: Erlotinib (TARCEVA®) (Drug)

结局指标

主要结局

progression free survival

时间窗: 6 months

次要结局

  • overall survival(6 months)
  • response rate(6 months)
  • time to treatment failure(6 months)
  • toxicity profiles(6 months)

研究者

申办方类型
Other

研究点 (1)

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