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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000005494
Receipt No. 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

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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
Obsterics 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
Email

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
Email koutabe@yahoo.co.jp

Sponsor
Institute Nagasaki University (graduate school) department of Obstetrics and Gynecology
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006477

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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