NCT03831633Unknown4 期
A Pragmatic Randomized Study to Evaluate the Comparative Effectiveness of AKYNZEO® and Standard of Care (Including EMEND®) for the Prevention of Nausea and Vomiting (CINV) in Cancer Patients Receiving Moderately Emetogenic Chemotherapy in France.
VIFORFRANCE1 个研究点 分布在 1 个国家目标入组 426 人开始时间: 2018年9月19日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 426
- 试验地点
- 1
- 主要终点
- Anti-emetic response
研究概览
简要总结
This pragmatic trial addresses the clinical gap through the generation of evidence on the comparative effectiveness between AKYNZEO® and Standard of Care (SoC, including EMEND®) in the real-life setting
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Male or female, Age ≥ 18 years
- •Have a histological or cytological confirmed solid tumor malignancy
- •Patient scheduled to receive their first course of anthracycline cyclophosphamide (AC) based chemotherapy regimen or Moderately Emetogenic Chemotherapy for the treatment of solid malignant tumor
- •Patient scheduled to receive CINV prevention with AKYNZEO® or Standard of Care according to the summary of product characteristics based on the judgement of their investigator's
- •Naïve of CT
- •ECOG performance up to 2
- •Able to read, understand and follow the study procedures
- •Patient with Health insurance
排除标准
- •Pregnancy and breastfeeding women;
- •Hypersensitivity to active substances, excipients or other ingredients of Akynzeo® or Emend®;
- •Protected patients: majors under guardianship, tutorship or other legal protection, deprived of liberty by judicial or administrative decision
研究组 & 干预措施
AKYNZEO
Experimental
干预措施: Akynzeo (Drug)
Standard of Care
Active Comparator
干预措施: Standard of Care (Drug)
结局指标
主要结局
Anti-emetic response
时间窗: 1 cycle (cycle length is 28 days). Primary outcome will be assessed at the end of the chemotherapy cycle.
Complete Response (no emetic episodes and no rescue medication) during overall phase for 1st cycle among patients with MEC non AC or AC chemotherapy regimen
次要结局
未报告次要终点
研究者
研究点 (1)
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