UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005215 |
|---|---|
| Receipt number | 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 10:50:46 |
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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
| Obstetrics 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
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
Sponsor or person
Institute
Kyushu University
Obstetrics gynecology
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006165
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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