UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008596
Receipt number R000010099
Scientific Title Optimal treatment strategy for esophago-gastric junctional cancer
Date of disclosure of the study information 2012/08/01
Last modified on 2016/08/04 10:24:43

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Basic information

Public title

Optimal treatment strategy for esophago-gastric junctional cancer

Acronym

Optimal treatment strategy for esophago-gastric junctional cancer

Scientific Title

Optimal treatment strategy for esophago-gastric junctional cancer

Scientific Title:Acronym

Optimal treatment strategy for esophago-gastric junctional cancer

Region

Japan


Condition

Condition

Esophago-gastric junctional cancer

Classification by specialty

Gastroenterology Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to study clinicopathological characters and survival outcomes and recurrence in the patients with esophago-gastric junctional cancer, and to investigate the optimal treatment strategy for esophago-gastric junctional cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Overall survival and relapse-free survival

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Factorial

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

4

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Siewert type I tumor

Interventions/Control_2

Siewert type II tumor

Interventions/Control_3

Siewert type III tumor

Interventions/Control_4

Proximal gastric cancer

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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

(1) histologically proven esophago-gastric junctional carcinoma
(2) clinical solitary tumor
(3) age 20-80 years
(4) sufficient organ function

Key exclusion criteria

(1) synchronous or metachronous malignancy

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroaki Ito, MD, PhD

Organization

Showa University Nothern Yokohama Hospital

Division name

Digestive Disease Center

Zip code


Address

Chigasaki-chuo 35-1 Tsuzuki-ku, Yokohama 224-503, Japan.

TEL

0459497000

Email

h.ito@med.showa-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiroaki Ito, MD, PhD

Organization

Showa University Nothern Yokohama Hospital

Division name

Digestive Disease Center

Zip code


Address

Chigasaki-chuo 35-1 Tsuzuki-ku, Yokohama 224-503, Japan.

TEL

0459497000

Homepage URL


Email

h.ito@med.showa-u.ac.jp


Sponsor or person

Institute

Digestive Disease Center, Showa University Nothern Yokohama Hospital

Institute

Department

Personal name



Funding Source

Organization

None

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

2012 Year 08 Month 01 Day


Related information

URL releasing protocol


Publication of results

Published


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

Main results already published

Date of protocol fixation

2012 Year 08 Month 01 Day

Date of IRB


Anticipated trial start date

2012 Year 08 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

2012 Year 08 Month 01 Day

Last modified on

2016 Year 08 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010099


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name