Placebo-Controlled, Double-Blinded Phase III Study Comparing Dexamethasone on Day 1 With Dexamethasone on Days 1 to 4 With Combined Neurokinin-1 Receptor Antagonist, Palonosetron and Olanzapine in High- Emetogenic Chemotherapy - SPARED trial

St.Marianna University School of Medicine Hospital0 个研究点目标入组 281 人开始时间: 2018年4月16日最近更新: 2023年10月17日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: St.Marianna University School of Medicine Hospital
入组人数: 281

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

Delayed CR rates in arm D4 and arm D1 were 79.7% and 75.0%, respectively (risk difference: -4.1%, 95% CI: -14.1% to 6.0%, P = 0.023). CR rates in arm D4 and arm D1 were 96.4% and 97.1%, (95% CI: -3.5% to 4.9%, P = 0.75) in the acute phase (0-24 h), and 79.0% and 72.8% (95% CI: -16.3% to 3.9%, P = 0.23) in the overall phase (0-120 h), respectively.

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) Patients taking systemic corticosteroid (oral and intravenous) 2) Patients taking antiemetics 3) Patients who receive moderately emetogenic chemotherapy within six days before and after cisplatin administration (Minimally to low emetogenic agents are allowed) 4) Patients who receive radiation therapy to abdomen or pelvis within six days prior to enrollment until six days after cisplatin 5) Patients with symptomatic brain metastasis 6) Patients who have diabetes mellitus with use of any antidiabetic or patients with HbA1c (NGSP) >= 6.5 7) Patients who have any convulsive disorder with medication

研究者

发起方

St.Marianna University School of Medicine Hospital

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