CTRI/2010/091/000344Other2 期
A Randomized, Phase II, Double-Blind Study of NimotuzumabPlus Whole-Brain Radiation Therapy (WBRT) Compared withWBRT Alone in Patients with Brain Metastases from Non SmallCell Lung Cancer
Biocon India Limited on behalf of YM Biosciences Inc., Ontario, Canada.0 个研究点目标入组 10 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- Other
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Providing a written informed consent
- •2.Age >18 years
- •3.Histologic or cytologic confirmed diagnosis of NSCLC of any epithelial type (squamous, adenocarcinoma, large cell, or other)
- •4.At least one newly diagnosed measurable metastatic lesion from NSCLC in
- •the brain not suitable for surgical resection
- •5.Patient with initial diagnosis of brain metastases by image, within 8 weeks
- •of registration
- •6.KPS >70
排除标准
- •1. Previous WBRT
- •2. Brain metastases resection with no other measurable lesion remaining
- •3. Extracranial metastases in 2 organs
- •4. Known leptomeningeal or subarachnoid spread
- •5. Plan to use radiosurgery or radiation boost after completion of WBRT
- •6. Plan to use chemotherapy or any other antineoplastic modality during WBRT
- •7. Previous use of an anti-EGFR drug (e.g. Tarceva, Erbitux etc.)
- •8. Patients receiving any other investigational agents
- •9. Presence of known seropositive HIV,
- •10.Severe co morbidities or other malignant neoplasm within the past 5 years (except adequately treated basal- or squamous-cell carcinoma of skin and in situ carcinoma of the uterine cervix)
- •11. Hypersensitivity or allergy to the drugs to be administered in this study
- •12. Inability or unwillingness to complete the required assessments
研究者
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