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

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ClinicalTrials.gov 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
Sponsor:
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

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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


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

Aprepitant:

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

Fosaprepitant:

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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 ClinicalTrials.gov identifier (NCT number): NCT01344304


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

Locations
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Sponsors and Collaborators
Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
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Responsible Party: Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
ClinicalTrials.gov Identifier: NCT01344304    
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
dexamethasone
colorectal cancer
FOLFOX
XELOX
SOX
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Aprepitant
Fosaprepitant
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Neurokinin-1 Receptor Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action