UMIN-CTR Clinical Trial

Basic information
Public title	A phase III study of laparoscopy assisted versus open distal gastrectomy with nodal dissection for clinical stage I gastric cancer (JCOG0912, cSt-I GC LADG P3)
Acronym	A phase III study of laparoscopy assisted versus open distal gastrectomy with nodal dissection for clinical stage I gastric cancer (JCOG0912, cSt-I GC LADG P3)
Scientific Title	A phase III study of laparoscopy assisted versus open distal gastrectomy with nodal dissection for clinical stage I gastric cancer (JCOG0912, cSt-I GC LADG P3)
Scientific Title:Acronym	A phase III study of laparoscopy assisted versus open distal gastrectomy with nodal dissection for clinical stage I gastric cancer (JCOG0912, cSt-I GC LADG P3)
Region	Japan

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

Objectives
Narrative objectives1	To demonstrate the non-inferiority of relapse-free survival of laparoscopy assisted distal gastrectomy (LADG) with nodal dissection compared with open gastrectomy for clinical T1N0, T1N1 or T2(MP)N0 gastric cancer.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase III

Assessment
Primary outcomes	Relapse-free survival
Key secondary outcomes	Overall survival , proportion of LADG completion, proportion of conversion to open surgery, adverse events, short-term clinical outcomes, postoperative QOL

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
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	A: Open distal gastrectomy with nodal dissection
Interventions/Control_2	B: Laparoscopy assisted distal gastrectomy (LADG) with nodal dissection
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) cStage IA(T1N0) or IB(T1N1, T2[MP]N0). 3) In case without preceding endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD), either 'cN1' or 'cN0 and no indication of EMR' is eligible. 4) In case with preceding EMR or ESD, the following conditions are fulfilled: i) pathological findings require additional gastrectomy, ii) within 56 days from EMR, iii) no perforation by EMR, iv) resection margin of EMR did not reach to the upper third of the stomach. 5) Tumor located in the middle or lower third of the stomach, and curative resection is expected to be achivable by distal gastrectomy. 6) No invasion to duodenum. 7) Aged 20 to 80 years. 8) PS (ECOG) of 0 or 1. 9) Body mass index less than 30. 10) No history of upper abdominal surgery and no history of intestinal resection. 11) No prior treatment of chemotherapy or radiation therapy against any other malignancies. 12) Sufficient organ functions. 13) Written informed consent.
Key exclusion criteria	1) Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ. 2) Infectious disease with systemic therapy indicated. 3) Body temperature of 38 or more degrees Celsius. 4) Women during pregnancy or breast-feeding. 5) Severe mental disease. 6) Continuous systemic steroid therapy. 7) Unstable angina pectoris, or history of myocardial infarction within six months. 8) Uncontrollable hypertension. 9) Uncontrollable diabetes millutus or administration of insulin. 10) Severe respiratory disease requiring continuous oxygen therapy.
Target sample size	920

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	JCOG_sir@ml.jcog.jp

Public contact
Name of contact person	1st name Middle name Last name Hitoshi KATAI
Organization	JCOG0912 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
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

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） 国立病院機構仙台医療センター（宮城県） 山形県立中央病院（山形県） 栃木県立がんセンター（栃木県） 国立がん研究センター東病院（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） 北里大学医学部（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） 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） 名古屋大学医学部（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） 大阪医科大学（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） 兵庫医科大学（兵庫県） 兵庫県立がんセンター（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） 島根大学医学部（島根県） 岡山大学病院（岡山県） 広島市立広島市民病院（広島県） 福山市民病院（広島県） 国立病院機構四国がんセンター（愛媛県） 大分大学医学部附属病院（大分県）

Other administrative information
Date of disclosure of the study information	2010 Year 03 Month 12 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	Completed
Date of protocol fixation	2010 Year 02 Month 04 Day
Date of IRB	2010 Year 03 Month 04 Day
Anticipated trial start date	2010 Year 03 Month 12 Day
Last follow-up date	2020 Year 03 Month 12 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2010 Year 03 Month 12 Day
Last modified on	2022 Year 08 Month 30 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003941