Study of Aprepitant / Fosaprepitant for the Prevention of Chemotherapy-induced Nausea and Vomiting (CINV) in Colorectal Cancer Patients - SENRI Trial
Multicenter Randomized Controlled Trial of Combination Antiemetic Therapy With Aprepitant / Fosaprepitant in Patients With Colorectal Cancer Receiving Oxaliplatin-based Chemotherapy
1 other identifier
interventional
413
1 country
27
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable colorectal-cancer
Started Apr 2011
Typical duration for not_applicable colorectal-cancer
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 27, 2011
CompletedFirst Posted
Study publicly available on registry
April 29, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedFebruary 26, 2021
February 1, 2021
2.6 years
April 27, 2011
February 25, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patient diary recording nausea, emesis, food ingestion, and rescue therapy
From initiating administration of anticancer agents to day 6 (120 hours)
Study Arms (2)
Standard therapy
NO INTERVENTIONThe patients are treated with 5HT3-receptor antagonist + dexamethasone during the first course, then treated with aprepitant / fosaprepitant + 5HT3-receptor antagonist + dexamethasone
Aprepitant / Fosaprepitant therapy
EXPERIMENTALThe patients are treated with aprepitant / fosaprepitant + 5HT3-receptor antagonist + dexamethasone during first and second courses.
Interventions
Aprepitant: 125 mg PO on day 1 80 mg PO on days 2 to 3 Fosaprepitant: 150 mg IV on day 1
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
Kansai Rosai Hospital
Amagasaki, Hyōgo, 6600064, Japan
Kinki Central Hospital
Itami, Hyōgo, 6640872, Japan
Kawasaki Hospital
Kobe, Hyōgo, 6520042, Japan
Nara Hospital Kinki University Faculty of Medicine
Ikoma, Nara, 6300293, Japan
Higashiosaka City General Hospital
Higashiosaka, Osaka, 5788588, Japan
Saito Yukoukai Hospital
Ibaraki, Osaka, 5670085, Japan
Rinku General Medical Center
Izumisano, Osaka, 5988577, Japan
Kaizuka City Hospital
Kaizuka, Osaka, 5970015, Japan
Hannan Chuo Hospital
Matsubara, Osaka, 5800023, Japan
Minoh City Hospital
Minoo, Osaka, 5620014, Japan
Sakai City Hospital
Sakai, Osaka, 5900064, Japan
Osaka Rosai Hospital
Sakai, Osaka, 5918025, Japan
Suita Municipal Hospital
Suita, Osaka, 5640082, Japan
Saiseikai Senri Hospital
Suita, Osaka, 5650862, Japan
Graduate School of Medicine / Faculty of Medicine, Osaka University
Suita, Osaka, Japan
Toyonaka Municipal Hospital
Toyonaka, Osaka, 5608565, Japan
Yao Municipal Hospital
Yao, Osaka, 5810069, Japan
Kenporen Osaka Central Hospital
Osaka, 5300001, Japan
Iseikai Hospital
Osaka, 5330022, Japan
Osaka Medical Center for Cancer and Cardiovascular Diseases
Osaka, 5378511, Japan
National Hospital Organization Osaka National Hospital
Osaka, 5400006, Japan
NTT West Osaka Hospital
Osaka, 5430042, Japan
Nissay Hospital
Osaka, 5500012, Japan
Tane General Hospital
Osaka, 5500024, Japan
Osaka Seninhoken Hospital
Osaka, 5520021, Japan
Osaka Koseinenkin Hospital
Osaka, 5530003, Japan
Osaka General Medical Center
Osaka, 5588558, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2011
First Posted
April 29, 2011
Study Start
April 1, 2011
Primary Completion
November 1, 2013
Study Completion
April 1, 2015
Last Updated
February 26, 2021
Record last verified: 2021-02