NCT07699276招募中2 期
Steroid-sparing Regimen With Olanzapine and Ondansetron to Prevent Emesis Caused by High Dose Cisplatin in Solid Cancer Patient : A Single Arm Phase II Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- complete response rate
研究概览
简要总结
A phase II study evaluating dexamethasone sparing regimen with olanzapine and palonosetron for patients receiving high dose cisplatin to prevent chemotherapy induced nausea and vomiting
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •histologically confirmed solid malignancy
- •scheduled for first cycle of cisplatin at dosage of at least 50 mg/m2
排除标准
- •pregnancy
- •pelvic or abdominal radiation within 4 weeks
- •uncontrolled brain metastasis
- •other moderate or high emetic risk chemotherapy on day 2-5
- •untreated gut obstruction
- •known allergy or severe adverse effect from palonosetron or olanzapine
- •AST/ ALT > 2.5x or serum creatinine clearance less than 50 ml/min
研究组 & 干预措施
study arm
Experimental
olanzapine palonosetron with dexamethasone on day 1 only
干预措施: dexamethasone sparing (Drug)
结局指标
主要结局
complete response rate
时间窗: 5 days after receiving chemotherapy
no vomiting and no rescue therapy
次要结局
- no -nausea rate(5 days after receiving chemotherapy)
- degree of nausea vomiting(5 days after receiving chemotherapy)
- adverse effects(5 days after receiving chemotherapy)
- rescue therapy(5 days after chemotherapy)
研究者
研究点 (1)
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