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

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01344304 on ClinicalTrials.gov