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

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Aprepitant / Fosaprepitant
Sponsored by
Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Cancer focused on measuring aprepitant therapy, fosaprepitant therapy, 5HT3-receptor antagonist, dexamethasone, colorectal cancer, FOLFOX, XELOX, SOX

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Kansai Rosai Hospital
  • Kinki Central Hospital
  • Kawasaki Hospital
  • Nara Hospital Kinki University Faculty of Medicine
  • Higashiosaka City General Hospital
  • Saito Yukoukai Hospital
  • Rinku General Medical Center
  • Kaizuka City Hospital
  • Hannan Chuo Hospital
  • Minoh City Hospital
  • Sakai City Hospital
  • Osaka Rosai Hospital
  • Suita Municipal Hospital
  • Saiseikai Senri Hospital
  • Graduate School of Medicine / Faculty of Medicine, Osaka University
  • Toyonaka Municipal Hospital
  • Yao Municipal Hospital
  • Kenporen Osaka Central Hospital
  • Iseikai Hospital
  • Osaka Medical Center for Cancer and Cardiovascular Diseases
  • National Hospital Organization Osaka National Hospital
  • NTT West Osaka Hospital
  • Nissay Hospital
  • Tane General Hospital
  • Osaka Seninhoken Hospital
  • Osaka Koseinenkin Hospital
  • Osaka General Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard therapy

Aprepitant / Fosaprepitant therapy

Arm Description

The patients are treated with 5HT3-receptor antagonist + dexamethasone during the first course, then treated with aprepitant / fosaprepitant + 5HT3-receptor antagonist + dexamethasone

The patients are treated with aprepitant / fosaprepitant + 5HT3-receptor antagonist + dexamethasone during first and second courses.

Outcomes

Primary Outcome Measures

Patient diary recording nausea, emesis, food ingestion, and rescue therapy

Secondary Outcome Measures

Full Information

First Posted
April 27, 2011
Last Updated
February 25, 2021
Sponsor
Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
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1. Study Identification

Unique Protocol Identification Number
NCT01344304
Brief Title
Study of Aprepitant / Fosaprepitant for the Prevention of Chemotherapy-induced Nausea and Vomiting (CINV) in Colorectal Cancer Patients - SENRI Trial
Official Title
Multicenter Randomized Controlled Trial of Combination Antiemetic Therapy With Aprepitant / Fosaprepitant in Patients With Colorectal Cancer Receiving Oxaliplatin-based Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
aprepitant therapy, fosaprepitant therapy, 5HT3-receptor antagonist, dexamethasone, colorectal cancer, FOLFOX, XELOX, SOX

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
413 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard therapy
Arm Type
No Intervention
Arm Description
The patients are treated with 5HT3-receptor antagonist + dexamethasone during the first course, then treated with aprepitant / fosaprepitant + 5HT3-receptor antagonist + dexamethasone
Arm Title
Aprepitant / Fosaprepitant therapy
Arm Type
Experimental
Arm Description
The patients are treated with aprepitant / fosaprepitant + 5HT3-receptor antagonist + dexamethasone during first and second courses.
Intervention Type
Drug
Intervention Name(s)
Aprepitant / Fosaprepitant
Intervention Description
Aprepitant: 125 mg PO on day 1 80 mg PO on days 2 to 3 Fosaprepitant: 150 mg IV on day 1
Primary Outcome Measure Information:
Title
Patient diary recording nausea, emesis, food ingestion, and rescue therapy
Time Frame
From initiating administration of anticancer agents to day 6 (120 hours)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Kansai Rosai Hospital
City
Amagasaki
State/Province
Hyogo
ZIP/Postal Code
6600064
Country
Japan
Facility Name
Kinki Central Hospital
City
Itami
State/Province
Hyogo
ZIP/Postal Code
6640872
Country
Japan
Facility Name
Kawasaki Hospital
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
6520042
Country
Japan
Facility Name
Nara Hospital Kinki University Faculty of Medicine
City
Ikoma
State/Province
Nara
ZIP/Postal Code
6300293
Country
Japan
Facility Name
Higashiosaka City General Hospital
City
Higashi-Osaka
State/Province
Osaka
ZIP/Postal Code
5788588
Country
Japan
Facility Name
Saito Yukoukai Hospital
City
Ibaraki
State/Province
Osaka
ZIP/Postal Code
5670085
Country
Japan
Facility Name
Rinku General Medical Center
City
Izumisano
State/Province
Osaka
ZIP/Postal Code
5988577
Country
Japan
Facility Name
Kaizuka City Hospital
City
Kaizuka
State/Province
Osaka
ZIP/Postal Code
5970015
Country
Japan
Facility Name
Hannan Chuo Hospital
City
Matsubara
State/Province
Osaka
ZIP/Postal Code
5800023
Country
Japan
Facility Name
Minoh City Hospital
City
Minoo
State/Province
Osaka
ZIP/Postal Code
5620014
Country
Japan
Facility Name
Sakai City Hospital
City
Sakai
State/Province
Osaka
ZIP/Postal Code
5900064
Country
Japan
Facility Name
Osaka Rosai Hospital
City
Sakai
State/Province
Osaka
ZIP/Postal Code
5918025
Country
Japan
Facility Name
Suita Municipal Hospital
City
Suita
State/Province
Osaka
ZIP/Postal Code
5640082
Country
Japan
Facility Name
Saiseikai Senri Hospital
City
Suita
State/Province
Osaka
ZIP/Postal Code
5650862
Country
Japan
Facility Name
Graduate School of Medicine / Faculty of Medicine, Osaka University
City
Suita
State/Province
Osaka
Country
Japan
Facility Name
Toyonaka Municipal Hospital
City
Toyonaka
State/Province
Osaka
ZIP/Postal Code
5608565
Country
Japan
Facility Name
Yao Municipal Hospital
City
Yao
State/Province
Osaka
ZIP/Postal Code
5810069
Country
Japan
Facility Name
Kenporen Osaka Central Hospital
City
Osaka
ZIP/Postal Code
5300001
Country
Japan
Facility Name
Iseikai Hospital
City
Osaka
ZIP/Postal Code
5330022
Country
Japan
Facility Name
Osaka Medical Center for Cancer and Cardiovascular Diseases
City
Osaka
ZIP/Postal Code
5378511
Country
Japan
Facility Name
National Hospital Organization Osaka National Hospital
City
Osaka
ZIP/Postal Code
5400006
Country
Japan
Facility Name
NTT West Osaka Hospital
City
Osaka
ZIP/Postal Code
5430042
Country
Japan
Facility Name
Nissay Hospital
City
Osaka
ZIP/Postal Code
5500012
Country
Japan
Facility Name
Tane General Hospital
City
Osaka
ZIP/Postal Code
5500024
Country
Japan
Facility Name
Osaka Seninhoken Hospital
City
Osaka
ZIP/Postal Code
5520021
Country
Japan
Facility Name
Osaka Koseinenkin Hospital
City
Osaka
ZIP/Postal Code
5530003
Country
Japan
Facility Name
Osaka General Medical Center
City
Osaka
ZIP/Postal Code
5588558
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

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

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