UMIN-CTR Clinical Trial

Basic information
Public title	Randomized phase II study of omentum-preserving gastrectomy for advanced gastric cancer
Acronym	omentum-preserving gastrectomy for advanced gastric cancer
Scientific Title	Randomized phase II study of omentum-preserving gastrectomy for advanced gastric cancer
Scientific Title:Acronym	omentum-preserving gastrectomy for advanced gastric cancer
Region	Japan

Condition
Condition	gastric cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the results of omentum-preserving gastrectomy for advanced gastric cancer
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	3-year relapse-free survival rate
Key secondary outcomes	five year survival rate loss of blood volume operative duration operative morbidity rate

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Complete resection of the omentum
Interventions/Control_2	Preservation of the omentum except for the site along the gastroepiploic artery
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	first registration 1) Histologically proven gastric cancer 2) Diagnosed in preoperative study for cT2(MP)-, cN0-2, cM0 3) Expected to achieve the R0 resection by total/distal gastrectomy 4) Non-Type4 5) No history of receiving the transabdominal surgery, except for the surgery for appendicitis and the laparoscopic chelecystectomy 6) Not received neoadjuvant chemotherapy 7) No history of receiving gastrectomy 8) An age of 20 years or more 9) ECOG-PS 0-2 10) An adequate organ function 11) Written informed consent second registration 1) MP-SE, N0-2, H0, P0, M0 in surgical findings 2) Expected to achieve the R0 or R1(CY1) resection by total/distal gastrectomy 3) Expected to achieve the resection of the omentum 4) Not required the transthoracic surgery
Key exclusion criteria	1) The history of unstable angina, or myocardial infarction occurred in 6 months 2) Diabetes Mellitus with poor control 3) Required the oxygen administration due to severe respiratory disease 4) The history of severe drug allergic reaction 5) Acute inflammatory disease 6) Pregnant female 7) Another malignant disease 8) The history of mental disease 9) Not appropriate for the trial by other reasons
Target sample size	250

Research contact person
Name of lead principal investigator	1st name Yuji Middle name Last name Yamamoto
Organization	Fujisawa Shounandai Hospital
Division name	surgery
Zip code	252-0802
Address	2345 Takakura Fujisawa-city, Kanagawa Prefecture, 252-0802, Japan
TEL	0466-44-1451
Email	y_yamamoto@fj-shounandai.or.jp

Public contact
Name of contact person	1st name Takanobu Middle name Last name Yamada
Organization	Kanagawa Cancer Center
Division name	Gastrointestinal Surgery
Zip code	241-8515
Address	2-3-2 Nakao, Asahi-ku, Yokohama City, 241-8515, Japan
TEL	045-520-2222
Homepage URL
Email	takay0218@yahoo.co.jp

Sponsor
Institute	Fujisawa Shounandai 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)

IRB Contact (For public release)
Organization	Kanagawa Cancer Center Ethics Committee
Address	2-3-2 Nakao, Asahi-ku, Yokohama City, 241-8515, Japan
Tel	045-520-2222
Email	u_syomu@yokohama-cu.ac.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	神奈川県立足柄上病院（神奈川県） 恵生会　上白根病院（神奈川県） 国際医療福祉大学　熱海病院（静岡県） 国家公務員共済組合連合会　平塚共済病院（神奈川県） 国家公務員共済組合連合会　横浜南共済病院（神奈川県） 総合病院　秦野赤十字病院（神奈川県） 同友会　藤沢湘南台病院（神奈川県） 三浦市立病院（神奈川県） 横浜市立大学附属病院（神奈川県） 済生会横浜市南部病院（神奈川県） 神奈川県立がんセンター（神奈川県）

Other administrative information
Date of disclosure of the study information	2011 Year 04 Month 11 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	251
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	No longer recruiting
Date of protocol fixation	2010 Year 12 Month 15 Day
Date of IRB	2011 Year 03 Month 24 Day
Anticipated trial start date	2011 Year 05 Month 01 Day
Last follow-up date	2023 Year 12 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	2011 Year 04 Month 11 Day
Last modified on	2022 Year 03 Month 16 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006431