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

VIFOR FRANCE0 个研究点目标入组 426 人开始时间: 2018年6月13日最近更新: 2020年9月7日

适应症

试验速览

暂无简介。

•Informed consent of the patient
•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
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 426
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Pregnancy;
•Hypersensitivity to active substances, excipients or other ingredients of Akynzeo® or Emend®;

发起方