UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004135
Receipt number 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 09:22:13

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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 or person

Institute

Kochi Health Sciences Center

Institute

Department

Personal name



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

Value
https://center6.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