NCT01344304已完成不适用
Multicenter Randomized Controlled Trial of Combination Antiemetic Therapy With Aprepitant / Fosaprepitant in Patients With Colorectal Cancer Receiving Oxaliplatin-based Chemotherapy
Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group27 个研究点 分布在 1 个国家目标入组 413 人开始时间: 2011年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 413
- 试验地点
- 27
- 主要终点
- Patient diary recording nausea, emesis, food ingestion, and rescue therapy
研究概览
简要总结
The object of this study is to evaluate the superiority of aprepitant therapy with a 5HT3-receptor antagonist, dexamethasone and aprepitant compared to standard therapy with a 5HT3-receptor antagonist and dexamethasone for prevention of nausea and vomiting in first course chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: ≥20 years old
- •Sex: Not specified
- •Patients with colon/rectal cancer who first underwent FOLFOX, XELOX or SOX regimen including oxaliplatin at ≥85 mg/m2 (naive patient), or those who had already started chemotherapy and had nausea of Grade 2 or higher in the last course or an earlier course (non-naive patient).
- •Stage: not specified (neoadjuvant/adjuvant chemotherapy, advanced or recurrent type are allowed)
- •Combination of molecular targeted therapy: allowable
- •Written informed consent for participation in the study.
排除标准
- •Severe liver or kidney disease
- •Nausea/vomiting within 24 hr prior to chemotherapy.
- •Treatment with antiemetics within 24 hr prior to chemotherapy.
- •Presence of factors causing nausea/vomiting other than chemotherapy (e.g. brain tumor, gastrointestinal obstruction, active peptic ulcer disease, brain metastasis)
- •Presence of a disease precluding 3-day administration of dexamethasone (e.g. uncontrollable diabetes)
- •Pregnant or lactating women, women who plan to become pregnant.
- •Current treatment with pimozide.
- •Any patient judged to be inappropriate for the study by the investigator.
研究组 & 干预措施
Aprepitant / Fosaprepitant therapy
Experimental
The patients are treated with aprepitant / fosaprepitant + 5HT3-receptor antagonist + dexamethasone during first and second courses.
干预措施: Aprepitant / Fosaprepitant (Drug)
结局指标
主要结局
Patient diary recording nausea, emesis, food ingestion, and rescue therapy
时间窗: From initiating administration of anticancer agents to day 6 (120 hours)
次要结局
未报告次要终点
研究者
研究点 (27)
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