Study of Aprepitant / Fosaprepitant for the Prevention of Chemotherapy-induced Nausea and Vomiting (CINV) in Colorectal Cancer Patients - SENRI Trial

February 25, 2021 updated by: Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group

Multicenter Randomized Controlled Trial of Combination Antiemetic Therapy With Aprepitant / Fosaprepitant in Patients With Colorectal Cancer Receiving Oxaliplatin-based Chemotherapy

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
413

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Osaka, Japan, 5300001
        • Kenporen Osaka Central Hospital
      • Osaka, Japan, 5330022
        • Iseikai Hospital
      • Osaka, Japan, 5378511
        • Osaka Medical Center for Cancer and Cardiovascular Diseases
      • Osaka, Japan, 5400006
        • National Hospital Organization Osaka National Hospital
      • Osaka, Japan, 5430042
        • NTT WEST Osaka Hospital
      • Osaka, Japan, 5500012
        • Nissay Hospital
      • Osaka, Japan, 5500024
        • Tane General Hospital
      • Osaka, Japan, 5520021
        • Osaka Seninhoken Hospital
      • Osaka, Japan, 5530003
        • Osaka Koseinenkin Hospital
      • Osaka, Japan, 5588558
        • Osaka General Medical Center
    • Hyogo
      • Amagasaki, Hyogo, Japan, 6600064
        • Kansai Rosai Hospital
      • Itami, Hyogo, Japan, 6640872
        • Kinki Central Hospital
      • Kobe, Hyogo, Japan, 6520042
        • Kawasaki Hospital
    • Nara
      • Ikoma, Nara, Japan, 6300293
        • Nara Hospital Kinki University Faculty of Medicine
    • Osaka
      • Higashi-Osaka, Osaka, Japan, 5788588
        • Higashiosaka City General Hospital
      • Ibaraki, Osaka, Japan, 5670085
        • Saito Yukoukai Hospital
      • Izumisano, Osaka, Japan, 5988577
        • Rinku General Medical Center
      • Kaizuka, Osaka, Japan, 5970015
        • Kaizuka City Hospital
      • Matsubara, Osaka, Japan, 5800023
        • Hannan Chuo Hospital
      • Minoo, Osaka, Japan, 5620014
        • Minoh City Hospital
      • Sakai, Osaka, Japan, 5900064
        • Sakai City Hospital
      • Sakai, Osaka, Japan, 5918025
        • Osaka Rosai Hospital
      • Suita, Osaka, Japan, 5640082
        • Suita Municipal Hospital
      • Suita, Osaka, Japan, 5650862
        • Saiseikai Senri Hospital
      • Suita, Osaka, Japan
        • Graduate School of Medicine / Faculty of Medicine, Osaka University
      • Toyonaka, Osaka, Japan, 5608565
        • Toyonaka Municipal Hospital
      • Yao, Osaka, Japan, 5810069
        • Yao Municipal Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Standard therapy
The patients are treated with 5HT3-receptor antagonist + dexamethasone during the first course, then treated with aprepitant / fosaprepitant + 5HT3-receptor antagonist + dexamethasone
Experimental: Aprepitant / Fosaprepitant therapy
The patients are treated with aprepitant / fosaprepitant + 5HT3-receptor antagonist + dexamethasone during first and second courses.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Patient diary recording nausea, emesis, food ingestion, and rescue therapy
Time Frame: From initiating administration of anticancer agents to day 6 (120 hours)
From initiating administration of anticancer agents to day 6 (120 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 27, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 29, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 26, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SENRI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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