UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021330
Receipt number R000024596
Scientific Title The efficiency of Ramucirumab therapy for advanced gastric cancer after chemotherapy
Date of disclosure of the study information 2016/06/01
Last modified on 2016/03/04 09:25:50

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Basic information

Public title

The efficiency of Ramucirumab therapy for advanced gastric cancer after chemotherapy

Acronym

Ramuciru-AC

Scientific Title

The efficiency of Ramucirumab therapy for advanced gastric cancer after chemotherapy

Scientific Title:Acronym

Ramuciru-AC

Region

Japan


Condition

Condition

gastric cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

Objective is to examine the efficiency for the treatment of gastric cancer.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase IV


Assessment

Primary outcomes

PSF,RR,OS

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

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine Device,equipment

Interventions/Control_1

Try Ramucirumab monotherapy for gastric cancer.
Over a period of 60 minutes once Ramucirumab 8mg / kg for intravenous infusion every two weeks.
Administration of Ramucirumab will continue until worsen of disease.

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

95 years-old >

Gender

Female

Key inclusion criteria

Patients who were received all kind of chemotherapy as much as possible

Key exclusion criteria

serious underlying disease

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tomoyuki Shibata

Organization

Fujita Health University

Division name

Gastroenterology

Zip code


Address

1-98 Denagakugakubo, Kutsukake-cho, Toyoake 470-1192, Japan

TEL

+81-562-93-9240

Email

tshibata-04@umin.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tomoyuki Shibata

Organization

Fujita Health University

Division name

Gastroenterology

Zip code


Address

1-98 Denagakugakubo, Kutsukake-cho, Toyoake 470-1192, Japan

TEL

+81-562-93-9240

Homepage URL


Email

tshibata-04@umin.ac.jp


Sponsor or person

Institute

Fujita Health University Hospital

Institute

Department

Personal name



Funding Source

Organization

Fujita Health University Hospital

Organization

Division

Category of Funding Organization

Other

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

2016 Year 06 Month 01 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

Preinitiation

Date of protocol fixation

2015 Year 10 Month 31 Day

Date of IRB


Anticipated trial start date

2016 Year 06 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

2016 Year 03 Month 04 Day

Last modified on

2016 Year 03 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024596


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name