UMIN-CTR Clinical Trial

Basic information
Public title	Randomized Controlled Trial to Evaluate Laparoscopic versus Open Surgery for Advanced Gastric Cancer (JLSSG0901: Adv.GC-LAP/OPEN, PII/III)
Acronym	Randomized Controlled Trial to Evaluate Laparoscopic versus Open Surgery for Advanced Gastric Cancer (JLSSG0901: Adv.GC-LAP/OPEN, PII/III)
Scientific Title	Randomized Controlled Trial to Evaluate Laparoscopic versus Open Surgery for Advanced Gastric Cancer (JLSSG0901: Adv.GC-LAP/OPEN, PII/III)
Scientific Title:Acronym	Randomized Controlled Trial to Evaluate Laparoscopic versus Open Surgery for Advanced Gastric Cancer (JLSSG0901: Adv.GC-LAP/OPEN, PII/III)
Region	Japan

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

Objectives
Narrative objectives1	To evaluate oncological outcome of patients for advanced gastric cancer undergoing laparoscopic versus open surgery
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase II,III

Assessment
Primary outcomes	phaseII: Incidence of anastomotic leakage or pancreatic fistula phaseIII:relapse-free survival
Key secondary outcomes	overall survival, proportion of LADG completion, proportion of conversion to open surgery, adverse events, short-term clinical outcomes, number of retrieved lymph node, recurrent sites

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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 D2 lymph node dissection
Interventions/Control_2	B: Laparoscopy assisted distal gastrectomy with D2 lymph node 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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	For inclusion in the study, patients must fulfill the following requirements preoperatively: 1) histologically proven gastric carcinoma 2) MP,SS or deeper lesion without involvement of other organs, N0-2 excluding bulky N2 and M0 according to the Japanese classification system 3) tumor located in the body and antrum of the stomach and indication for distal gastrectomy 4)No invasion to duodenum 5) Aged 20 to 80 year 6) PS (ECOG)0 or 1 7) Body mass index < 30 8) no history of gastrointestinal surgery 9) no history of chemotherapy or radiotherapy 10) Sufficient organ functions 11) provided written informed consent
Key exclusion criteria	1) Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ. 2) Women during pregnancy or breast-feeding. 3) Severe mental disease. 4) Continuous systemic steroid therapy. 5) History of myocardial infarction or unstable angina pectoris within six months. 6) Uncontrollable hypertension. 7) Uncontrollable diabetes millutus or administration of insulin. 8) Severe respiratory disease requiring continuous oxygen therapy.
Target sample size	500

Research contact person
Name of lead principal investigator	1st name Middle name Last name Seigo Kitano
Organization	Japanese Laparoscopic Surgery Study Group (JLSSG)
Division name	Oita University
Zip code
Address	1-1 Hasama-machi, Yufu city, Oita, 879-5593, Japan
TEL	097-586-5843
Email	geka1@oita-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Tsuyoshi Etoh
Organization	Japanese Laparoscopic Surgery Study Group (JLSSG) Coordinating Office
Division name	Department of Gastroenterological and Pediatric Surgery, Oita University Faculty of Medicine
Zip code
Address	1-1 Hasama-machi, Yufu city, Oita, 879-5593, Japan
TEL	097-586-5843
Homepage URL
Email	geka1@oita-u.ac.jp

Sponsor
Institute	Japanese Laparoscopic Surgery Study Group (JLSSG)
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Japanese Laparoscopic Surgery Study Group (JLSSG)
Organization
Division
Category of Funding Organization	Other
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

大分大学医学部消化器・小児外科（大分県） 佐賀大学医学部附属病院一般・消化器外科（佐賀県） 福岡大学病院消化器外科（福岡県） 兵庫県立がんセンター消化器外科（兵庫県） 岩手医科大学外科（岩手県） 大阪医科大学一般・消化器外科（大阪府） 大阪大学医学部附属病院消化器外科（大阪府） 泉大津市立病院外科・内視鏡外科（大阪府） 名古屋大学医学部附属病院消化器外科（愛知県） 岐阜大学腫瘍外科（岐阜県） 長野市民病院外科（長野県） 慶應義塾大学病院外科（東京都） 東京医科歯科大学大学院腫瘍外科（東京都） 駿河台日本大学病院外科（東京都） 北里大学東病院外科（神奈川県） 石川県立中央病院消化器外科（石川県） 富山県済生会高岡病院外科（富山県） 函館五稜郭病院外科（北海道） 聖マリアンナ医科大学(東京都） 大阪市立総合医療センター消化器外科（大阪府） 福井県済生会病院外科（福井県） 九州大学臨床・腫瘍外科（福岡県） 愛媛大学消化管・腫瘍外科(愛媛県） 横浜市立大学附属市民総合医療センター消化器病センター（神奈川県） 岡山大学消化管外科（岡山県） 埼玉医科大学国際医療センター上部消化管外科（埼玉県） 静岡県立静岡がんセンター胃外科（静岡県） 愛知県がんセンター消化器外科（愛知県） 神戸大学食道・胃腸外科（兵庫県） 新潟市民病院消化器外科（新潟県） がん・感染症センター都立駒込病院外科（東京都） 近畿大学外科学内視鏡外科部門（大阪府） 大阪市立大学腫瘍外科（大阪府） 国立がん研究センター東病院胃外科（千葉県） 佐賀県医療センター好生館消化器外科（佐賀県）

Other administrative information
Date of disclosure of the study information	2010 Year 03 Month 31 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	No longer recruiting
Date of protocol fixation	2009 Year 09 Month 15 Day
Date of IRB
Anticipated trial start date	2009 Year 11 Month 01 Day
Last follow-up date	2021 Year 08 Month 01 Day
Date of closure to data entry	2021 Year 08 Month 31 Day
Date trial data considered complete	2021 Year 09 Month 30 Day
Date analysis concluded	2021 Year 11 Month 16 Day

Other
Other related information

Management information
Registered date	2010 Year 03 Month 31 Day
Last modified on	2022 Year 04 Month 10 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004144

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