UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005020 |
|---|---|
| Receipt number | R000005957 |
| Scientific Title | A Phase II study of Aprepitant in patients receiving chemotherapy included carboplatin for gynecological canncer. |
| Date of disclosure of the study information | 2011/02/04 |
| Last modified on | 2018/08/11 06:46:07 |
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Basic information
Public title
A Phase II study of Aprepitant in patients receiving chemotherapy included carboplatin for gynecological canncer.
Acronym
A Phase II study of Aprepitant in patients receiving chemotherapy included carboplatin for gynecological canncer.
Scientific Title
A Phase II study of Aprepitant in patients receiving chemotherapy included carboplatin for gynecological canncer.
Scientific Title:Acronym
A Phase II study of Aprepitant in patients receiving chemotherapy included carboplatin for gynecological canncer.
Region
| Japan |
Condition
Condition
gynecological cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We compared efficacy and tolerability of aprepitant regimen with those of control regimen in patients receiving chemotherapy included carboplatin for gynecological canncer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
the proportion of patients with no emesis in the overall phase (120 hour after administration of carboplatin).
Key secondary outcomes
the proportion of patients with no emesis in the acute phase (24 hour after administration of carboplatin) and delay phase (120 hour)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Azasetron 10mg(d1) + dexamethasone(d1-3) + aprepitant(d1-3)
Interventions/Control_2
Azasetron 10mg(d1) + dexamethasone(d1-3)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1. Gynecological cancer
2. Received the chemotherapy including carboplatin.
Key exclusion criteria
1. Dysfunction of liver
2. Vomiting prior to chemotherapy
3. Antiemetic use prior to chemotherapy
4. Pregnant or lactating women or women of childbearing potential
5. Hypersensitivity for Aprepitant
6. Under treatment used antiallergic agents or corticosteroid
7. patients with emetic factor except for chmotherapy
8. Patients judged inappropriate for this study by physicians
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ikuo Konishi |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Gynecology and Obstetrics
Zip code
Address
54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto
TEL
0757513269
babatsu@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masafumi Koshiyama |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Gynecology and Obstetrics
Zip code
Address
54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto
TEL
0757513269
Homepage URL
babatsu@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Graduate School of Medicine, Department of Gynecology and Obstetrics
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
京都大学大学院医学研究科産科婦人科（京都府）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 02 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.medscimonit.com/download/index/idArt/899741
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
| 2011 | Year | 01 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 02 | Month | 03 | Day |
Last modified on
| 2018 | Year | 08 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005957
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
