JPRN-UMIN000005551已完成2 期
Preventive effect of combination therapy with aprepitant, palonosetron and dexamethasone on chemotherapy-induced nausea and vomiting (CINV) in esophageal cancer patients receiving 5-FU plus cisplatin: a prospective phase II study - Preventive effect of combination therapy with aprepitant, palonosetron and dexamethasone on CINV in esophageal cancer patients receiving 5-FU plus cisplatin: a prospective phase II study
niversity of Toyama0 个研究点目标入组 40 人开始时间: 2011年6月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
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
- 20years-old 至 75years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1. Severe complications (intestinal paralysis, symptomatic cardiovascular disease, pulmonary fibrosis, uncontrollable diabetes mellitus, active peptic ulcer, psychiatric disorder, cerebrovascular disorder) 2. Brain metastasis 3. Seizure disorder needing anticonvulsants 4. Massive ascites or pleural effusion 5. Intestinal obstruction 6. Vomiting, or grade 2 or higher nausea according to CTCAE ver4.0 7. QTc>470msec (examined within 28 days before registration) 8. Hypersensitivity or severe drug allergy to aprepitant, palonosetron or other 5-HT3-receptor antagonists 9. Hypersensitivity or severe drug allergy to dexamethasone 10. Pregnant or breast-feeding woman 11. Men of wishing fertility 12. Administration of pimozide 13. Not appropriate for the study at the physician's assessment
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