JPRN-UMIN000013249已完成3 期
A randomized phase III trial of palonosetron versus palonosetron plus dexamethasone (day1) for the prevention of nausea and vomiting induced by moderately emetogenic chemotherapy (HOPE-02) - A randomized phase III trial of PALO versus PALO plus DEX for the prevention of nausea and vomiting induced by MEC (HOPE-02)
HOPE group(Hokkaido Supportive Care Oncology Project - an Expert Group Initiative)0 个研究点目标入组 320 人开始时间: 2014年2月25日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 320
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 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1)Serious or uncontrolled complication 2)Symptomatic or clinically suspected brain metastasis 3)Convulsive disorder requiring anti-convulsant 4)Ascites fluid or pleural effusion requiring paracentesis 5)Gastrointestinal obstruction 6)Vomiting and/or grade 1 or more nausea at baseline 7)Patients with planned radiotherapy 8)History of hypersensitivity to 5-HT3 receptor antagonist 9)History of hypersensitivity to dexamethasone 10) Continuous administration of steroids 11) Poorly controlled nausea by opioids 12)Pregnancy, lactation or who does not wish to contraception 13)History of palonosetorn administration 14)Without capability or intention of cooperating with study procedure 15)Participant in other anti-emetic trial 16)Undesirable for the patient to enter the trial
研究者
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