EUCTR2010-019637-96-DE进行中（未招募）不适用
A Randomized, Phase II, Double-Blind Study of Nimotuzumab Plus Whole-Brain Radiation Therapy (WBRT) Compared with WBRT Alone in Patients with Brain Metastases from Non-Small Cell Lung Cancer
YMBiosciences INC0 个研究点目标入组 88 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
- 进行中（未招募）
- 发起方
- 入组人数
- 88
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Providing written informed consent
- •Age >|18 years
- •hystologic or cytologic confirmed diagnoses of NSCLC of any epithelial type
- •At least one newly diagnosed measurable metastatic lesion from NSCLC in the brain not suitable for surgical resection
- •Patient had initial diagnosis of brain metastases by image, within 8 weeks of registration
- •Women of childbearing potential and men must agree to use adequate contraception
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Pregnancy, lactation or parturition within the previous 30 days
- •Previous WBRT
- •Brain metastases resection with no other measurable lesion remaining
- •Extracranial metastases in >| 2 organs
- •Known leptomeningeal or subarachnoid spread
- •Plan to use radiosurgery or radiation boost after completion of WBRT
- •Plan to use chemotherapy or any other antineoplastic modality during WBRT
- •Previous use of an anti-EGFR drug (e.g. Tarceva, Erbitux etc.)
- •Patients receiving any other investigational agents
研究者
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