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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005431
Receipt No. R000006444
Scientific Title Multicenter Randomized Controlled Trial of Combination Antiemetic Therapy with Aprepitant/Fosaprepitant in Patients with Colorectal Cancer Receiving Oxaliplatin-based chemotherapy
Date of disclosure of the study information 2011/04/14
Last modified on 2019/05/15

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Basic information
Public title Multicenter Randomized Controlled Trial of Combination Antiemetic Therapy with Aprepitant/Fosaprepitant in Patients with Colorectal Cancer Receiving Oxaliplatin-based chemotherapy
Acronym Study of Aprepitant/Fosaprepitant for the Prevention of Chemotherapy-induced Nausea and Vomiting in Colorectal Cancer Patients (SENRI)
Scientific Title Multicenter Randomized Controlled Trial of Combination Antiemetic Therapy with Aprepitant/Fosaprepitant in Patients with Colorectal Cancer Receiving Oxaliplatin-based chemotherapy
Scientific Title:Acronym Study of Aprepitant/Fosaprepitant for the Prevention of Chemotherapy-induced Nausea and Vomiting in Colorectal Cancer Patients (SENRI)
Region
Japan

Condition
Condition colorectal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the superiority of aprepitant/fosaprepitant therapy with a 5HT3-receptor antagonist, dexamethasone and aprepitant/fosaprepitant compared to standard therapy with a 5HT3-receptor antagonist and dexamethasone for prevention of nausea and vomiting in first course chemotherapy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Proportion of patients with "No emesis"
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 For aprepitant therapy
Aprepitant; 125 mg PO on day 1, 80 mg PO on days 2 to 3
5HT3-receptor antagonist; IV administration on day 1
Dexamethasone; 6.6 mg IV on day 1, 4 mg PO on days 2 to 3

For fosaprepitant therapy
Fosaprepitant; 150 mg IV on day 1
5HT3-receptor antagonist; IV administration on day 1
Dexamethasone; 6.6 mg IV on day 1, 4 mg PO on day 2 and 8mg PO on day 3
Interventions/Control_2 5HT3-receptor antagonist; IV administration on day 1
Dexamethasone; 9.9 mg IV on day 1, 8 mg PO on days 2 to 3
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patient is 20 years and over
2) Patients with colon/rectal cancer who first underwent FOLFOX, XELOX or SOX regimen including oxaliplatin at 85 mg/m2 or more, or those who had already started chemotherapy and had nausea of Grade 2 or higher in the last course or an earlier course
3) Stage: not specified
4) Combination of molecular targeted therapy: allowable
Key exclusion criteria 1) Patient has a serious hepatic insufficiency or renal failure
2) Patient has nausea or vomiting within 24 hours prior to chemotherapy
3) Patient has been treated with antiemetic agents within 48 hours prior to chemotherapy
4) Patient has any illness (e.g. central nervous system tumors, gastrointestinal obstruction, active peptic ulcer, brain metastasis) caused nausea or vomiting except for chemotherapy-induced nausea and vomiting
5) Patient is unable to be administered dexamethasone for 3 days due to associated illnesses such as out-of-control diabetes mellitus
6) Patient is pregnant or lactating woman, and woman who plans to become pregnant
7) Patient is receiving treatment with pimozide
8) Patient is judged inappropriate by the investigator as subject for this study
Target sample size 400

Research contact person
Name of lead principal investigator
1st name Junichi
Middle name
Last name Nishimura
Organization Osaka University (postgraduate course)
Division name Department of Gastroenterological Surgery
Zip code 565-0871
Address 2-2 Yamadaoka, Suita, Osaka
TEL 06-6879-3251
Email jnishimura@gesurg.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name Junichi
Middle name
Last name Nishimura
Organization Osaka University (postgraduate course)
Division name Department of Gastroenterological Surgery
Zip code 565-0871
Address 2-2 Yamadaoka, Suita, Osaka
TEL 06-6879-3251
Homepage URL
Email jnishimura@gesurg.med.osaka-u.ac.jp

Sponsor
Institute Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
Institute
Department

Funding Source
Organization The Supporting Center for Clinical Research and Education (SCCRE)
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Osaka University Hospital
Address 2-15 Yamadaoka Suita city Osaka
Tel 06-6879-5111
Email rinri@hp-crc.med.osaka-u.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2011 Year 04 Month 14 Day

Related information
URL releasing protocol NA
Publication of results Published

Result
URL related to results and publications https://www.sciencedirect.com/science/article/pii/S0959804915002919?via%3Dihub
Number of participants that the trial has enrolled 413
Results
Combination antiemetic therapy with aprepitant/fosaprepitant in patients with colorectal cancer receiving oxaliplatin-based chemotherapy (SENRI trial): a multicentre, randomised, controlled phase 3 trial. Eur J Cancer. 2015 Jul;51(10):1274-82.

Combination antiemetic therapy with aprepitant/fosaprepitant in patients with colorectal cancer receiving oxaliplatin-based chemotherapy in the SENRI trial: analysis of risk factors for vomiting and nausea. Int J Clin Oncol 2017;22(1):88-95.
Results date posted
2019 Year 05 Month 15 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2015 Year 04 Month 24 Day
Baseline Characteristics
 Patients were randomly allocated to either the aprepitant group or the control group. 
Participant flow
A total of 413 patients entered this clinical trial from 25 centers in Japan. 
Adverse events
Adverse events were not signficant between the groups.
Outcome measures
Significantly more patients in the aprepitant group achieved no vomiting than those in the control group (95.7 % vs. 83.6 %; P<0.0001). 
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2011 Year 03 Month 17 Day
Date of IRB
2011 Year 04 Month 14 Day
Anticipated trial start date
2011 Year 04 Month 14 Day
Last follow-up date
2013 Year 10 Month 31 Day
Date of closure to data entry
2014 Year 09 Month 01 Day
Date trial data considered complete
2014 Year 09 Month 01 Day
Date analysis concluded
2015 Year 12 Month 31 Day

Other
Other related information Takemoto H, Nishimura J, Komori T, Kim HM, Ota H, Suzuki R, et al. Combination antiemetic therapy with aprepitant/fosaprepitant in patients with colorectal cancer receiving oxaliplatin-based chemotherapy in the SENRI trial: analysis of risk factors for vomiting and nausea. Int J Clin Oncol 2017;22(1):88-95.

Management information
Registered date
2011 Year 04 Month 13 Day
Last modified on
2019 Year 05 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006444

Research Plan
Registered date File name
2014/10/21 SENRITrial SOX追加プロイメンド追加.zip

Research case data specifications
Registered date File name

Research case data
Registered date File name
2019/05/15 20140901全症例 照合済み.xlsx


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