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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005020
Receipt No. 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

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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
Obsterics 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
Email 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
Email babatsu@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University Graduate School of Medicine, Department of Gynecology and Obstetrics
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005957

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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