UMIN-CTR Clinical Trial

Basic information
Public title	Nonrandomized confirmatory study of laparoscopy assisted total gastrectomy and proximal gastrectomy with nodal dissection for clinical stage I gastric cancer (JCOG1401, cSt-I GC LATG PG sP3)
Acronym	Nonrandomized confirmatory study of laparoscopy assisted total gastrectomy and proximal gastrectomy with nodal dissection for clinical stage I gastric cancer (JCOG1401, cSt-I GC LATG PG sP3)
Scientific Title	Nonrandomized confirmatory study of laparoscopy assisted total gastrectomy and proximal gastrectomy with nodal dissection for clinical stage I gastric cancer (JCOG1401, cSt-I GC LATG PG sP3)
Scientific Title:Acronym	Nonrandomized confirmatory study of laparoscopy assisted total gastrectomy and proximal gastrectomy with nodal dissection for clinical stage I gastric cancer (JCOG1401, cSt-I GC LATG PG sP3)
Region	Japan

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

Objectives
Narrative objectives1	To demonstrate the safety of laparoscopy assisted total gastrectomy (LATG) or laparoscopy assisted proximal gastrectomy (LAPG) with nodal dissection for clinical T1N0, T1N+ or T2N0 gastric cancer which is not indicated for EMR/ESD.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase III

Assessment
Primary outcomes	Proportion of anastomotic leak
Key secondary outcomes	Overall survival, relapse-free survival, proportion of LATG or LAPG completion, proportion of conversion to open surgery, adverse events, and short-term clinical 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	LATG or LAPG with nodal dissection with D1, D1+ or D2 lymph node dissection
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Histologically proven gastric adenocarcinoma. 2) Clinical stage T1N0, T1N(+)*, or T2N0 according to the 14th edition of Japanese Classification of Gastric Carcinoma (3rd English edition). *T1N(+) corresponds to T1N1 according to the 13th edition of Japanese Classification of Gastric Carcinoma (2nd English edition). 3) In case of T2N0, tumor does not involve greater curvature 4) In case without preceding endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD), either 'cN(+)' or 'cN0 and no indication of EMR or ESD' is eligible. 5) In case with preceding EMR or ESD, the following conditions are all fulfilled: i) pathological findings require additional gastrectomy ii) within 91 days from EMR or ESD iii) no perforation by EMR or ESD 6) R0 resection is expected by total gastrectomy or proximal gastrectomy. 7) No invasion to duodenum or esophagus. 8) Aged 20 to 80 years. 9) PS (ECOG) of 0 or 1. 10) Body mass index less than 30. 11) No history of upper abdominal surgery and no history of intestinal resection except for appendectomy. 12) No prior treatment of chemotherapy or radiation therapy against any other malignancies. History of hormone therapy after more than 1 year from the last administration is eligible. 13) Sufficient organ functions. i. WBC >= 3,000/mm3 ii. Platelet >= 100,000/mm3 iii. T.Bil =< 2.0 mg/dL iv. AST =< 100 IU/L v. ALT =< 100 IU/L vi. Creatinine =< 1.5 mg/dL 14) Written informed consent.
Key exclusion criteria	1) Synchronous or metachronous (within 5 years) malignancies except for carcinoma in situ or mucosal tumors curatively treated with local therapy. 2) Infectious disease with systemic therapy indicated. 3) Body temperature of 38 or more degrees Celsius. 4) Pregnancy, possible pregnancy, within 28 days after delivery or breast-feeding. 5) Severe psychiatric disease. 6) Continuous systemic steroid or immune-suppressive drug therapy. 7) Unstable angina pectoris, or history of myocardial infarction within six months. 8) Poorly controlled hypertension. 9) Poorly controlled diabetes mellitus in spite of continuous use of insulin. 10) Severe respiratory disease requiring continuous oxygen therapy.
Target sample size	245

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hitoshi Katai
Organization	National Cancer Center Hospital
Division name	Gastric Surgery Division
Zip code
Address	5-1-1, Tsukiji, Chuo-ku, Tokyo 104-0045, JAPAN
TEL	03-3542-2511
Email	hkatai@ncc.go.jp

Public contact
Name of contact person	1st name Middle name Last name Hitoshi Katai
Organization	JCOG1401 Coordinating Office
Division name	Gastric Surgery Division, National Cancer Center Hospital
Zip code
Address	5-1-1, Tsukiji, Chuo-ku, Tokyo 104-0045, JAPAN
TEL	03-3542-2511
Homepage URL	http://www.jcog.jp/
Email	JCOG_sir@ml.jcog.jp

Sponsor
Institute	Japan Clinical Oncology Group (JCOG)
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization
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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

函館厚生院函館五稜郭病院（北海道） 恵佑会札幌病院（北海道） 岩手医科大学（岩手県） 山形県立中央病院（山形県） 栃木県立がんセンター（栃木県） 埼玉県立がんセンター（埼玉県） 埼玉医科大学国際医療センター（埼玉県） 国立がん研究センター東病院（千葉県） 千葉県がんセンター（千葉県） 国立がん研究センター中央病院（東京都） がん・感染症センター都立駒込病院（東京都） 東京医科歯科大学（東京都） がん研究会有明病院（東京都） 虎の門病院（東京都） 神奈川県立病院機構神奈川県立がんセンター（神奈川県） 横浜市立大学附属市民総合医療センター（神奈川県） 新潟県厚生連長岡中央綜合病院（新潟県） 富山県立中央病院（富山県） 石川県立中央病院（石川県） 岐阜大学医学部（岐阜県） 静岡県立総合病院（静岡県） 静岡県立静岡がんセンター（静岡県） 愛知県がんセンター中央病院（愛知県） 国立病院機構京都医療センター（京都府） 大阪大学医学部（大阪府） 近畿大学医学部（大阪府） 大阪府立病院機構大阪府立成人病センター（大阪府） 国立病院機構大阪医療センター（大阪府） 大阪府立病院機構大阪府立急性期・総合医療センター（大阪府） 市立堺病院（大阪府） 関西医科大学附属枚方病院（大阪府） 大阪労災病院（大阪府） 神戸大学医学部（兵庫県） 関西労災病院（兵庫県） 市立伊丹病院（兵庫県） 天理よろづ相談所病院（奈良県） 和歌山県立医科大学（和歌山県） 岡山大学病院（岡山県） 広島大学病院（広島県） 福山市民病院（広島県） 徳島赤十字病院（徳島県） 大分大学医学部附属病院（大分県）

Other administrative information
Date of disclosure of the study information	2015 Year 04 Month 17 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
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Results Delayed
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Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
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Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2015 Year 02 Month 23 Day
Date of IRB	2015 Year 04 Month 06 Day
Anticipated trial start date	2015 Year 04 Month 17 Day
Last follow-up date	2023 Year 04 Month 17 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 04 Month 17 Day
Last modified on	2021 Year 01 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019757