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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2012 by Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group Identifier:
First received: April 27, 2011
Last updated: October 22, 2012
Last verified: October 2012
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.

Condition Intervention
Colorectal Cancer
Drug: Aprepitant / Fosaprepitant

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Multicenter Randomized Controlled Trial of Combination Antiemetic Therapy With Aprepitant / Fosaprepitant in Patients With Colorectal Cancer Receiving Oxaliplatin-based Chemotherapy

Resource links provided by NLM:

Further study details as provided by Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group:

Primary Outcome Measures:
  • Patient diary recording nausea, emesis, food ingestion, and rescue therapy [ Time Frame: From initiating administration of anticancer agents to day 6 (120 hours) ]

Estimated Enrollment: 400
Study Start Date: April 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


125 mg PO on day 1 80 mg PO on days 2 to 3


150 mg IV on day 1


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01344304

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

Responsible Party: Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group Identifier: NCT01344304     History of Changes
Other Study ID Numbers: SENRI 
Study First Received: April 27, 2011
Last Updated: October 22, 2012

Keywords provided by Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group:
aprepitant therapy
fosaprepitant therapy
5HT3-receptor antagonist
colorectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors processed this record on February 20, 2017