UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005494 |
|---|---|
| Receipt number | R000006477 |
| Scientific Title | Aprepitant for nausea, vomiting with the TC therapy of the gynecology cancer patient or the DC therapy, fosaprepitant, granisetron, protective efficacy of the dexamethasone combination therapy. |
| Date of disclosure of the study information | 2011/04/25 |
| Last modified on | 2012/10/23 13:05:27 |
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Basic information
Public title
Aprepitant for nausea, vomiting with the TC therapy of the gynecology cancer patient or the DC therapy, fosaprepitant, granisetron, protective efficacy of the dexamethasone combination therapy.
Acronym
TC, aprepitant for nausea, vomiting with the DC therapy, protective efficacy of fosaprepitant.
Scientific Title
Aprepitant for nausea, vomiting with the TC therapy of the gynecology cancer patient or the DC therapy, fosaprepitant, granisetron, protective efficacy of the dexamethasone combination therapy.
Scientific Title:Acronym
TC, aprepitant for nausea, vomiting with the DC therapy, protective efficacy of fosaprepitant.
Region
| Japan |
Condition
Condition
uterine cancer, ovarian cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy and safety of aprepitant(fosaprepitant) combined with granisetron and dexamethasone for the prevention of nausea and vomiting in patients with gynecologic cancer receiving paclitaxel/carboplatin or docetaxel/carboplatin.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The proportion of patients with No Emesis in overall phase (0-120 hours after administration of carboplatin on day 1)
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 on days 1 to 3
(or fosapreitant on day1)
Granisetron on day 1
Dexamethasone on days 1 to 4
Interventions/Control_2
Granisetron on day 1
Dexamethasone on days 1 to 4
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
| 70 | years-old | > |
Gender
Female
Key inclusion criteria
1) Patient is scheduled to receive her first course of paclitaxel/carboplatin or docetaxel/carboplatin for gynecological cancer
2) Patient has not received highly or moderately emetogenic chemotherapy
3) Patient is able to sign to an approved informed consent
4) Patient is able to mention a diary
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 scheduled to receive radiation therapy to the abdomen
6) Patient has the collateral symptom that the dosage of the dexamethasone is impossible for four days
7) Patient has received Pimozide
8) Patient is judged inappropriate by the investigator as subject for this study
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideaki Masuzaki |
Organization
Nagasaki University (graduate school)
Division name
Department of Obstetrics and Gynecology
Zip code
Address
1-7-1 sakamoto, Nagasaki, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shuhei Abe |
Organization
Nagasaki University (graduate school)
Division name
Department of Obstetrics and Gynecology
Zip code
Address
1-7-1 sakamoto, Nagasaki, Japan
TEL
095-819-7363
Homepage URL
koutabe@yahoo.co.jp
Sponsor or person
Institute
Nagasaki University (graduate school) department of Obstetrics and Gynecology
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University (graduate school) department of Obstetrics and Gynecology
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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 | 04 | Month | 25 | 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
| 2011 | Year | 02 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 05 | 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 | 04 | Month | 23 | Day |
Last modified on
| 2012 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006477
