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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01344304
Recruitment Status : Unknown
Verified October 2012 by Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group.
Recruitment status was:  Recruiting
First Posted : April 29, 2011
Last Update Posted : October 24, 2012
Information provided by (Responsible Party):
Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: Aprepitant / Fosaprepitant Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : April 2011
Estimated Primary Completion Date : March 2014
Estimated Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

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

Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01344304

Contact: Junichi Nishimura

Kansai Rosai Hospital Recruiting
Amagasaki, Hyogo, Japan, 6600064
Contact: Rei Suzuki         
Kinki Central Hospital Recruiting
Itami, Hyogo, Japan, 6640872
Contact: Takamichi Komori         
Kawasaki Hospital Recruiting
Kobe, Hyogo, Japan, 6520042
Contact: Toshihiro Kimura         
Nara Hospital Kinki University Faculty of Medicine Recruiting
Ikoma, Nara, Japan, 6300293
Contact: Kotaro Kitani         
Higashiosaka City General Hospital Recruiting
Higashi-Osaka, Osaka, Japan, 5788588
Contact: Masaki Okuyama         
Saito Yukoukai Hospital Recruiting
Ibaraki, Osaka, Japan, 5670085
Contact: Taro Hayashi    0726416898      
Rinku General Medical Center Recruiting
Izumisano, Osaka, Japan, 5988577
Contact: Hitoshi Mizuno         
Kaizuka City Hospital Recruiting
Kaizuka, Osaka, Japan, 5970015
Contact: Hiroshi Nakano         
Hannan Chuo Hospital Recruiting
Matsubara, Osaka, Japan, 5800023
Contact: Isao Arai         
Minoh City Hospital Recruiting
Minoo, Osaka, Japan, 5620014
Contact: Yasuhiro Miyake         
Sakai City Hospital Recruiting
Sakai, Osaka, Japan, 5900064
Contact: Hiroyoshi Takemoto         
Osaka Rosai Hospital Recruiting
Sakai, Osaka, Japan, 5918025
Contact: Hajime Hirose         
Suita Municipal Hospital Recruiting
Suita, Osaka, Japan, 5640082
Contact: Takashi Yoshino         
Saiseikai Senri Hospital Recruiting
Suita, Osaka, Japan, 5650862
Contact: Hirofumi Ota         
Graduate School of Medicine / Faculty of Medicine, Osaka University Recruiting
Suita, Osaka, Japan
Contact: Junichi Nishimura   
Toyonaka Municipal Hospital Recruiting
Toyonaka, Osaka, Japan, 5608565
Contact: Taishi Hata         
Yao Municipal Hospital Recruiting
Yao, Osaka, Japan, 5810069
Contact: Yoshihito Ide         
Kenporen Osaka Central Hospital Recruiting
Osaka, Japan, 5300001
Contact: Masato Yoshikawa    0647955505      
Iseikai Hospital Recruiting
Osaka, Japan, 5330022
Contact: Takahiko Tanigawa         
Osaka Medical Center for Cancer and Cardiovascular Diseases Recruiting
Osaka, Japan, 5378511
Contact: Tatsushi Shingai         
National Hospital Organization Osaka National Hospital Recruiting
Osaka, Japan, 5400006
Contact: Masayoshi Yasui         
NTT West Osaka Hospital Recruiting
Osaka, Japan, 5430042
Contact: Katsuki Danno         
Nissay Hospital Recruiting
Osaka, Japan, 5500012
Contact: Shohei Maeda         
Tane General Hospital Recruiting
Osaka, Japan, 5500024
Contact: Atsuhiro Ogawa         
Osaka Seninhoken Hospital Recruiting
Osaka, Japan, 5520021
Contact: Yasunori Watanabe         
Osaka Koseinenkin Hospital Recruiting
Osaka, Japan, 5530003
Contact: Makoto Fujii    06-6441-5451      
Osaka General Medical Center Recruiting
Osaka, Japan, 5588558
Contact: Hiroshi Tamagawa         
Sponsors and Collaborators
Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group

Responsible Party: Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group Identifier: NCT01344304     History of Changes
Other Study ID Numbers: SENRI
First Posted: April 29, 2011    Key Record Dates
Last Update Posted: October 24, 2012
Last Verified: October 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
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
Molecular Mechanisms of Pharmacological Action