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

This study is currently recruiting participants.
Verified October 2012 by Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
Sponsor:
Information provided by (Responsible Party):
Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
ClinicalTrials.gov Identifier:
NCT01344304
First received: April 27, 2011
Last updated: October 22, 2012
Last verified: October 2012
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
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:

U.S. FDA Resources

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) ] [ Designated as safety issue: Yes ]

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

Aprepitant:

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

Fosaprepitant:

150 mg IV on day 1

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01344304

Contacts
Contact: Junichi Nishimura jnishimura@gesurg.med.osaka-u.ac.jp

Locations
Japan
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            
Osaka Rosai Hospital Recruiting
Sakai, Osaka, Japan, 5918025
Contact: Hajime Hirose            
Sakai City Hospital Recruiting
Sakai, Osaka, Japan, 5900064
Contact: Hiroyoshi Takemoto            
Graduate School of Medicine / Faculty of Medicine, Osaka University Recruiting
Suita, Osaka, Japan
Contact: Junichi Nishimura         jnishimura@gesurg.med.osaka-u.ac.jp    
Suita Municipal Hospital Recruiting
Suita, Osaka, Japan, 5640082
Contact: Takashi Yoshino            
Saiseikai Senri Hospital Recruiting
Suita, Osaka, Japan, 5650862
Contact: Hirofumi Ota            
Toyonaka Municipal Hospital Recruiting
Toyonaka, Osaka, Japan, 5608565
Contact: Taishi Hata            
Yao Municipal Hospital Recruiting
Yao, Osaka, Japan, 5810069
Contact: Yoshihito Ide            
Osaka Koseinenkin Hospital Recruiting
Osaka, Japan, 5530003
Contact: Makoto Fujii     06-6441-5451        
Tane General Hospital Recruiting
Osaka, Japan, 5500024
Contact: Atsuhiro Ogawa            
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            
Osaka Seninhoken Hospital Recruiting
Osaka, Japan, 5520021
Contact: Yasunori Watanabe            
Nissay Hospital Recruiting
Osaka, Japan, 5500012
Contact: Shohei Maeda            
Osaka General Medical Center Recruiting
Osaka, Japan, 5588558
Contact: Hiroshi Tamagawa            
Kenporen Osaka Central Hospital Recruiting
Osaka, Japan, 5300001
Contact: Masato Yoshikawa     0647955505        
Iseikai Hospital Recruiting
Osaka, Japan, 5330022
Contact: Takahiko Tanigawa            
NTT West Osaka Hospital Recruiting
Osaka, Japan, 5430042
Contact: Katsuki Danno            
Sponsors and Collaborators
Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
  More Information

No publications provided

Responsible Party: Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
ClinicalTrials.gov Identifier: NCT01344304     History of Changes
Other Study ID Numbers: SENRI
Study First Received: April 27, 2011
Last Updated: October 22, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Dexamethasone
Aprepitant
Anti-Inflammatory Agents
 Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 19, 2013