TCTR20170612001招募中3 期
A Prospective Randomized Controlled Clinical Trial of Prophylactic Cranial Irradiation in Metastatic HER-2 positive Breast Cancer.
Ratchadapiseksompotch research fund0 个研究点目标入组 235 人开始时间: 2017年6月12日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 235
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
- 年龄范围
- 18 Years 至 0 N/A (No limit)（—）
- 性别
- All
入选标准
- •1.MetastaticHER-2 positive breast cancer patients who had HER-2 positive on immunohistochemistry or fluorescence in situ hybridization test.
- •2.No brain metastasis is noted
- •3.Eastern Cooperative Oncology Group (ECOG) performance status <=2
- •4.More than 18 years of age.
- •5.General physical conditions must be compatible with the radio-therapeutic treatment.
- •6.Patients give permissions literally in the study informed consent form prior to participation.
- •7. The blood tests have to be fulfilled of WBC >=3000, platelet >=100,000, creatinine <=1.5 mg/do, creatinine clearance >=60ml/min
排除标准
- •1. History of previous cranial radiation or neurosurgery
- •2 .History of cerebrovascular disease or neurological disorder including seizure.
- •3 .Known or suspected brain or meningeal metastasis by present of signs of raised intra-cranial pressure, seizure, focal symptom, cognitive dysfunction and proved by MRI to have brain metastases.
- •4 .Patient with CNS disease.
- •5 .Active untreated infection which increases risk of treatment complication.
- •6 .Major medical or psychiatric illnesses that would affect to the outcome, completion of therapy, the follow up and without potential in understand the side effects and risks of the therapy.
- •7 .pregnant women.
研究者
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