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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005215
Receipt No. R000006165
Scientific Title Randomized double blind study about the prophylatic effects of aprepitant on the HSR in the chemotherapy using TC regimen against the gynecologic cancers
Date of disclosure of the study information 2011/04/01
Last modified on 2014/09/16

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Basic information
Public title Randomized double blind study about the prophylatic effects of aprepitant on the HSR in the chemotherapy using TC regimen against the gynecologic cancers
Acronym Randomized study about the prophylatic effects of aprepitant on the HSR in the chemotherapy using TC regimen
Scientific Title Randomized double blind study about the prophylatic effects of aprepitant on the HSR in the chemotherapy using TC regimen against the gynecologic cancers
Scientific Title:Acronym Randomized study about the prophylatic effects of aprepitant on the HSR in the chemotherapy using TC regimen
Region
Japan

Condition
Condition Gynecologic cancer
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We investigate the clinical effect of aprepitant for prevention of hypersensitive reaction associated with paclitaxel in patients with gynecologic cancer who undertake paclitaxel and carboplatin combination chemotherapy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II,III

Assessment
Primary outcomes Rate of hypersensitive reaction
Key secondary outcomes Rate of the patient without vomiting
Rate of the patient without significant nausea

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Oral medication for 3 days (day 1: 125mg, day2-3 80mg)
Interventions/Control_2 Oral medication for 3 days(placebo)
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
80 years-old >=
Gender Female
Key inclusion criteria 1.Patient of gynecologic cancer who received TC regimen as first line chemotherapy
2. Age: 20-80 years old
3. PS: 0-2
4. Patients who sign informed consent
Key exclusion criteria 1.Patients with severe liver or renal dysfunction
2.Patients with nausea or vomiting before chemotherapy within 24 hours
3.Patients who received antiemetic drug before chemotherapy within 48 hours
4.Patients who continuously received anti-allergic drug or steroid
5.Patients with a current diagnosis that induced nausea or vomiting
6.Patients who received prior abdominal or pelvic radiotherapy
7.Patients with DM required continuous insulin therapy
8.Patients with pregnancy
9.Patients who judged that the doctor is inadequate
Target sample size 320

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kiyoko Kato
Organization Kyushu University
Division name Obstetrics gynecology
Zip code
Address Maidashi 3-1-1, Higashi-ku, Fukuoka, 812-8582
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hideaki Yahata
Organization Kyushu University
Division name Obstetrics gynecology
Zip code
Address Maidashi 3-1-1, Higashi-ku, Fukuoka, 812-8582
TEL 092-642-5395
Homepage URL
Email

Sponsor
Institute Kyushu University
Obstetrics gynecology
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 九州大学病院(福岡県)
国立病院機構九州がんセンター(福岡県)
福岡赤十字病院(福岡県)
国立病院機構九州医療センター(福岡県)
北九州市立医療センター(福岡県)
宮崎県立宮崎病院(宮崎県)
九州厚生年金病院(福岡県)
国家公務員共済組合連合会浜の町病院(福岡県)
福岡県済生会福岡総合病院(福岡県)

Other administrative information
Date of disclosure of the study information
2011 Year 04 Month 01 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
2011 Year 03 Month 03 Day
Date of IRB
Anticipated trial start date
2011 Year 04 Month 01 Day
Last follow-up date
2014 Year 02 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 03 Month 08 Day
Last modified on
2014 Year 09 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006165

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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