UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Optimal treatment strategy for esophago-gastric junctional cancer
Title of the study (Brief title)	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	Hiroaki Ito, MD, PhD
Organization	Showa University Nothern Yokohama Hospital
Division name	Digestive Disease Center
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	Hiroaki Ito, MD, PhD
Organization	Showa University Nothern Yokohama Hospital
Division name	Digestive Disease Center
Address	Chigasaki-chuo 35-1 Tsuzuki-ku, Yokohama 224-503, Japan.
TEL	0459497000
Homepage URL
Email	h.ito@med.showa-u.ac.jp

Sponsor
Institute	Digestive Disease Center, Showa University Nothern Yokohama Hospital
Institute
Department

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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2012 Year 08 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010099