Study of Aprepitant / Fosaprepitant for the Prevention of Chemotherapy-induced Nausea and Vomiting (CINV) in Colorectal Cancer Patients - SENRI Trial
NCT01344304 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 413
Last updated 2021-02-26
Summary
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.
Conditions
Interventions
- DRUG
-
Aprepitant / Fosaprepitant
Aprepitant: 125 mg PO on day 1 80 mg PO on days 2 to 3 Fosaprepitant: 150 mg IV on day 1
Sponsors & Collaborators
-
Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-04-30
- Primary Completion
- 2013-11-30
- Completion
- 2015-04-30
Countries
- Japan
Study Locations
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