UMIN-CTR Clinical Trial

Basic information
Public title	Single-arm feasibility study of laparoscopic gastrectomy for upper-third gastric cancer and esophago-gastric junction cancer
Acronym	Single-arm feasibility study of laparoscopic gastrectomy for upper-third gastric cancer and esophago-gastric junction cancer
Scientific Title	Single-arm feasibility study of laparoscopic gastrectomy for upper-third gastric cancer and esophago-gastric junction cancer
Scientific Title:Acronym	Single-arm feasibility study of laparoscopic gastrectomy for upper-third gastric cancer and esophago-gastric junction cancer
Region	Japan

Condition
Condition	Upper-third gastric cancer and esophago-gastric junction cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to validate non-inferiority in safety of laparoscopic gastrectomy compared to open gastrectomy for cT1N2-3, cT2N0-3, cT3N0 and cT4aN0 upper-third gastric cancer or esophago-gastric junction cancer.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Incidence of anastomotic leakage
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	Maneuver
Interventions/Control_1	Laparoscopic proximal gastrectomy or laparoscopic total gastrectomy
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) Pathologically diagnosed as gastric or esophago-gastric adenocarcinoma. 2) Curatively resectable cT1N2-3M0, cT2N0-3M0, cT3N0M0 and cT4N0M0 (excluding bulky N2) cancer by proximal or total gastrectomy without splenectomy. 3) Older than 20 y.o. 4) PS 0~2 5) No previous treatment for gastric cancer. 6) BMI<35 7) Consented to be enrolled to the trial from participant him/herself.
Key exclusion criteria	1) Double cancer 2) cT4b 3) P1, Cy1 or cM1 4) Cases of received neoadjuvant treatment. 5) Pregnant or breast feeding. 6) Mental disorder 7) Continuous systemic administration of steroid. 8) Infectious disease with systemic treatment. 9) Uncontrollable diabetes mellitus. 10) Unstable coronary angina or history of MI within 6 months. 11) Respiratory disease with continuous administration of oxygen.
Target sample size	200

Research contact person
Last name of lead principal investigator	1st name Soya Middle name Last name Nunobe
Organization	Cancer Institute Hospital of JFCR
Division name	Gastroenterology Center
Zip code	1358550
Address	3-8-31, Ariake, Koto-ku, Tokyo, Japan
TEL	+81-3-3520-0111
Email	souya.nunobe@jfcr.or.jp

Public contact
1st name of contact person	1st name En Middle name Last name Amada
Organization	Cancer Institute Hospital of JFCR
Division name	Gastroenterology Center
Zip code	1358550
Address	3-8-31, Ariake, Koto-ku, Tokyo, Japan
TEL	+81-3-3520-0111
Homepage URL
Email	en.amada@jfcr.or.jp

Sponsor
Institute	JFCR
Institute
Department

Funding Source
Organization	JFCR
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Cancer Institute Hospital of JFCR
Address	3-8-31, Ariake, Koto-ku, Tokyo, Japan
Tel	+81-3-3520-0111
Email	en.amada@jfcr.or.jp

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	2019 Year 10 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	2019 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date	2019 Year 10 Month 01 Day
Last follow-up date	2032 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 04 Month 28 Day
Last modified on	2019 Year 04 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041721