NCT00054795已完成3 期
Randomized Phase III Trial of Xcytrin® (Motexafin Gadolinium) Injection for the Treatment of Brain Metastases in Patients With Non-Small Cell Lung Cancer Undergoing Whole Brain Radiation Therapy
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 550
- 试验地点
- 92
研究概览
简要总结
The primary purpose of the study is to determine if patients with brain metastases from non-small cell lung cancer treated with Motexafin Gadolinium and whole brain radiation therapy retain their neurologic function and ability to think for a longer time compared to patients treated with whole brain radiation therapy alone.
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
- •Adults (≥18 years old) with radiologically proven parenchymal brain metastases from histologically confirmed non-small cell lung cancer;
- •KPS score of ≥70;
- •Each patient must sign a study-specific Informed Consent form
排除标准
- •Liver metastases;
- •Extracranial metastases in two or more organs;
- •Known leptomeningeal metastases or subarachnoid spread of tumor;
- •Prior whole brain radiation;
- •Plan to use radiosurgery or radiation boost after completion of WBRT;
- •Planned chemotherapy during study treatment (prior and subsequent chemotherapy is allowed);
- •Prior total resection of a single brain metastasis;
- •Laboratory values as follows:
- •LDH > 1.3 x upper limit of normal (ULN); ANC < 1500 /mm³; Platelets < 50,000 /mm³; Creatinine > 2.0 mg/dL; AST or ALT > 2 x ULN; Total bilirubin > 2 x ULN;
- •Women who are pregnant or lactating
研究者
研究点 (92)
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