UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005317 |
|---|---|
| Receipt number | R000006320 |
| Scientific Title | Effect of oral neurokinin-1 antagonist, aprepitant for chemotherapy-induced nausea and vomiting in patients with gynecologic cancer receiving carboplatin/paclitaxel chemotherapy. |
| Date of disclosure of the study information | 2011/03/31 |
| Last modified on | 2011/03/25 17:15:45 |
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Basic information
Public title
Effect of oral neurokinin-1 antagonist, aprepitant for chemotherapy-induced nausea and vomiting in patients with gynecologic cancer receiving carboplatin/paclitaxel chemotherapy.
Acronym
Effect of oral neurokinin-1 antagonist, aprepitant for chemotherapy-induced nausea and vomiting in patients with gynecologic cancer receiving carboplatin/paclitaxel chemotherapy.
Scientific Title
Effect of oral neurokinin-1 antagonist, aprepitant for chemotherapy-induced nausea and vomiting in patients with gynecologic cancer receiving carboplatin/paclitaxel chemotherapy.
Scientific Title:Acronym
Effect of oral neurokinin-1 antagonist, aprepitant for chemotherapy-induced nausea and vomiting in patients with gynecologic cancer receiving carboplatin/paclitaxel chemotherapy.
Region
| Japan |
Condition
Condition
gynecologic cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of aprepitant with 5-HT3 receptor antagonist and dexamethasone for chemotherapy-induced nausea and vomiting in patients with gynecologic cancer receiving their first course of carboplatin/paclitaxel chemotherapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The proportion of patients with Complete Response (no vomiting and no use of rescue therapy) during overall phase (5 days following initiation of chemotherapy) in first cycle.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Aprepitant 125mg PO on day 1
Aprepitant 80mg PO on days 2 to 3
Granisetron 3mg IV on day 1
Dexamethasone 16mg or 8mg IV on day 1
Dexamethasone 4mg PO on days 2 to 3
Interventions/Control_2
Granisetron 3mg IV on day 1
Dexamethasone 16mg or 8mg IV on day 1
Dexamethasone 8mg PO on days 2 to 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1) Patient is 20 years and over
2) Gynecologic cancer patients who are scheduled to receive their first course of TC regimen (Carboplatin/Paclitaxel) chemotherapy
Key exclusion criteria
1) Patient has a serious hepatic insufficiency or renal failure
2) Patient has nausea or vomiting within 24 hours prior to chemotherapy
3) Patient has been treated with antiemetic agents within 48 hours prior to chemotherapy
4) Patient has any illness (e.g. central nervous system tumors, gastrointestinal obstruction, active peptic ulcer, brain metastasis) caused nausea or vomiting except for chemotherapy-induced nausea and vomiting
5) Patient is unable to be administered dexamethasone for 3 days due to associated illnesses such as out-of-control diabetes mellitus
6) Patient is receiving pimozide
7) Patient is judged inappropriate by the investigator as subject for this study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Tsujioka |
Organization
Fukuoka University Hospital
Division name
Department of gynecology
Zip code
Address
7-45-1 nanakuma, jonan-ku, fukuoka, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Fukuoka University Hospital
Division name
Department of gynecology
Zip code
Address
7-45-1 nanakuma, jonan-ku, fukuoka, Japan
TEL
092-801-1011
Homepage URL
Sponsor or person
Institute
Department of gynecology, Fukuoka University Hospital
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 03 | Month | 31 | 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
Open public recruiting
Date of protocol fixation
| 2010 | Year | 11 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 01 | 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 | 03 | Month | 25 | Day |
Last modified on
| 2011 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006320
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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