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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004135
Receipt No. R000004966
Scientific Title A Clinical study to which Anti-emetic effect of 5-HT3RA is evaluated by using MAT in HEC for gastric cancer.
Date of disclosure of the study information 2010/09/02
Last modified on 2013/10/04

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Basic information
Public title A Clinical study to which Anti-emetic effect of 5-HT3RA is evaluated by using MAT in HEC for gastric cancer.
Acronym A Clinical study to which Anti-emetic effect of 5-HT3RA is evaluated by using MAT in HEC for gastric cancer.
Scientific Title A Clinical study to which Anti-emetic effect of 5-HT3RA is evaluated by using MAT in HEC for gastric cancer.
Scientific Title:Acronym A Clinical study to which Anti-emetic effect of 5-HT3RA is evaluated by using MAT in HEC for gastric cancer.
Region
Japan

Condition
Condition Gastric Cancer
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Collection of information concerning of effectiveness of aloxi
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The level of each observation point of the nausea and vomiting before and after 5- HT3RA change is evaluated by MAT.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 The aloxi 0.75mg is administered before the anti-cancer drug of day1 is administered.
Interventions/Control_2
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 Male and Female
Key inclusion criteria 1) Gastric Cancer
2) Patient of administering schedule when 5- HT3RA is being administered for HEC.
3) 20 years old or more
4) Performance Status(ECOG scale): 0-2
5) Adequate organ function for enrollment.
6) Necessary data can be accumulated.
7) Written informed consent.
Key exclusion criteria 1) Hypersensitivity or severe drug allergy for Aloxi or other 5-HT3RA.
2) Hypersensitivity or severe drug allergy for dexamethasone.
3) Any other patient whom the physician in charge of the study judges to be not eligible
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akihito Tsuji
Organization Kochi Health Sciences Center
Division name Medical Oncology
Zip code
Address Ike 2125-1, Kochi city, Kochi prefecture, 781-8555, JAPAN
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kochi Health Sciences Center
Division name Medical Oncology
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Kochi Health Sciences Center
Institute
Department

Funding Source
Organization Nome
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

Other administrative information
Date of disclosure of the study information
2010 Year 09 Month 02 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
2010 Year 08 Month 19 Day
Date of IRB
Anticipated trial start date
2010 Year 11 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
2010 Year 08 Month 31 Day
Last modified on
2013 Year 10 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004966

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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