UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005431 |
|---|---|
| Receipt number | 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 16:11:40 |
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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
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
jnishimura@gesurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006444
