UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008430 |
|---|---|
| Receipt number | R000009918 |
| Scientific Title | CINV by MEC in clinical practice and rescue of it by NK1RA |
| Date of disclosure of the study information | 2012/07/14 |
| Last modified on | 2019/05/31 10:28:45 |
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Basic information
Public title
CINV by MEC in clinical practice and rescue of it by NK1RA
Acronym
CINV by MEC and NK1RA
Scientific Title
CINV by MEC in clinical practice and rescue of it by NK1RA
Scientific Title:Acronym
CINV by MEC and NK1RA
Region
| Japan |
Condition
Condition
Lung cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Frequency of CINV by MEC
Basic objectives2
Others
Basic objectives -Others
Efficacy and toxicity of rescue of CINV by aprepitant
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Frequency of CINV
Key secondary outcomes
Toxicity and efficacy
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Oral aprepitant
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
MEC regimen for 1st cycle of line chomotherapy for lung cancer
Key exclusion criteria
Unable to intake aprepitant orally
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Fumio |
| Middle name | |
| Last name | Imamura |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Dept of Thoracic Oncology
Zip code
5418567
Address
1-3-3 Nakamichi Hagashinari-ku, Osaka 537-8511
TEL
6-6972-1181
imamura-fu@mc.pref.osaka.jp
Public contact
Name of contact person
| 1st name | Fumio |
| Middle name | |
| Last name | Imamura |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Dept of Thoracic Oncology
Zip code
5418567
Address
1-3-3 Nakamichi Hagashinari-ku, Osaka 537-8511
TEL
6-6972-1181
Homepage URL
imamura-fu@mc.pref.osaka.jp
Sponsor or person
Institute
Osaka Medical Center for Cancer and Cardiovascular Diseases
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Address
1-3-3 Nakamichi Hagashinari-ku, Osaka 537-8511
Tel
0669721181
imamura-fu@mc.pref.osaka.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
大阪府立成人病センター
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 07 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 07 | Month | 13 | Day |
Date of IRB
| 2012 | Year | 07 | Month | 15 | Day |
Anticipated trial start date
| 2012 | Year | 07 | Month | 17 | Day |
Last follow-up date
| 2013 | Year | 08 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 07 | Month | 13 | Day |
Last modified on
| 2019 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009918
| Research Plan | |
|---|---|
| Registered date | File name |
| 2018/01/16 | イメンドrescue-ver2.doc |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2018/01/16 | 試験内容サマリ.docx |
| Research case data | |
|---|---|
| Registered date | File name |
