UMIN-CTR Clinical Trial

Basic information
Public title	A Phase II study of laparoscopic gastrectomy for advanced gastric cancer
Acronym	A Phase II study of laparoscopic gastrectomy for advanced gastric cancer
Scientific Title	A Phase II study of laparoscopic gastrectomy for advanced gastric cancer
Scientific Title:Acronym	A Phase II study of laparoscopic gastrectomy for advanced gastric cancer
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the safety of laparoscopic gastrectomy for advanced gastric cancer.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Grade 3 or higher surgical complications (Clavien-Dindo Classification)
Key secondary outcomes	Proportion of conversion to open surgery, performance of surgery, number of retrieved lymph node, adverse events, short-term clinical outcomes, completion rate of adjuvant chemotherapy, CEA mRNA in the peritoneal lavage fluid, overall survival, recurrence-free survival

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Laparoscopic gastrectomy
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 carcinoma (2)cStageII or III according to the Japanese Classification of Gastric Carcinoma [The 14th Edition] (3)R0 resection or R1 resection solely by CY1 can be obtained (4)Clinical H0, P0, M0 (5)No invasion to esophagus and duodenum (6)No apparent invasion to adjacent organs (7) No prior treatment of chemotherapy for gastric cancer (8)The macroscopic tumor type is neither Borrmann type 4 (linitis plastica) nor large (8 cm or more) type 3 (9) Aged 20 to 79 years (10)Eastern Cooperative Oncology Group (ECOG) PS of 0-2 (11)Body mass index less than 30 (12)No obvious organ failures and satisfy the following laboratory data within 30 days before registration: WBC >=3,000/mm3 WBC<12,000/mm3 Platelet >= 100,000/mm3 Hb >= 8.0 g/dL AST <= local reference range 2 ALT <= local reference range 2 T.Bil <= 2.0 mg/dL Creatinin <= 1.5 mg/dL (13)No history of upper abdominal surgery and no history of intestinal resection. (14)No prior treatment of chemotherapy or radiation therapy against any other malignancies. (15)provided written informed consent
Key exclusion criteria	(1)Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ (2)Active infection disease (3)Over 38.0 degree Celsius (4)Women during pregnancy or breast-feeding. (5)Severe mental disease. (6)Continuous systemic steroid therapy. (7)History of myocardial infarction or unstable angina pectoris within six months. (8)Uncontrollable hypertension. (9)Uncontrollable diabetes millutus or administration of insulin. (10)Severe respiratory disease requiring continuous oxygen therapy. (11)Kidney failure requiring hemodialysis or peritoneal dialysis
Target sample size	100

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Yuichiro Doki
Organization	Osaka University School of Medicine
Division name	Gastroenterological Surgery
Zip code
Address	2-2 Yamadaoka Suita City Osaka
TEL	06-6879-3251
Email	ydoki@gesurg.med.osaka-u.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Atsushi Gakuhara
Organization	Osaka University School of Medicine
Division name	Gastroenterological Surgery
Zip code
Address	2-2 Yamadaoka Suita City Osaka
TEL	06-6879-3251
Homepage URL
Email	agakuhara@gesurg.med.osaka-u.ac.jp

Sponsor
Institute	Department of Gastroenterological Surgery, Osaka University School of Medicine
Institute
Department

Funding Source
Organization	Osaka University Clinical Research Group for Gastroenterological Study
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	大阪大学医学部附属病院（大阪府）、大阪府立成人病センター（大阪府）、大阪警察病院（大阪府）

Other administrative information
Date of disclosure of the study information	2017 Year 01 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	2016 Year 12 Month 13 Day
Date of IRB
Anticipated trial start date	2017 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 01 Month 18 Day
Last modified on	2019 Year 03 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029609