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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000005421
Receipt No. R000006431
Scientific Title Randomized phase II study of omentum-preserving gastrectomy for advanced gastric cancer
Date of disclosure of the study information 2011/04/11
Last modified on 2019/10/17

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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
Middle name
Last name Yuji Yamamoto
Organization Fujisawa Shounandai Hospital
Division name surgery
Zip code
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
Middle name
Last name Takanobu Yamada
Organization Yokohama City University Hospital
Division name General surgery
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama City, 236-0004, Japan
TEL 045-787-2800
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
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 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
2019 Year 10 Month 17 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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