UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Phase II study of laparoscopic gastrectomy for clinical stage II or higher gastric cancer
Title of the study (Brief title)	A Phase II study of laparoscopic gastrectomy for stage II or higher gastric cancer (KUGC04)
Region	Japan

Condition
Condition	Stage II or higher gastric cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate safety and efficacy of laparoscopic gastrectomy for stage II or higher gastric cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	incidence of intra- and post-operative complications, postoperative mortality
Key secondary outcomes	overall survival, relapse-free survival,three-year overall survival rate, three-year relapse free survival rate

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 surgery
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Pathologically confirmed gastric cancer 2)Amenable to potentially curative resection 3)Either of below as evaluated by endoscopy and CT scans a)T2 or higher and lymph node metastasis b)Tumor larger than 5cm c)T3 of higher by laparoscopy 4)Age 20 years old or above 5)Informed concent 6)Amenable to general anesthesia
Key exclusion criteria	1)Patient with severe phyciatric disease 2)Patient who is judged to be inappropriate as subject to this study by the principal investigator or the doctors in charge
Target sample size	73

Research contact person
Name of lead principal investigator	Yoshiharu SAKAI
Organization	Graduate School of Medicine, Kyoto University
Division name	Department of Surgery
Address	54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, JAPAN
TEL
Email

Public contact
Name of contact person
Organization	Graduate School of Medicine, Kyoto University
Division name	Department of Surgery
Address
TEL	075-751-3227
Homepage URL
Email	hokabe@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Department of Surgery Graduate School of Medicine, Kyoto University
Institute
Department

Funding Source
Organization	Department of Surgery Graduate School of Medicine, Kyoto University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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

Other administrative information
Date of disclosure of the study information	2009 Year 06 Month 22 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2009 Year 04 Month 08 Day
Anticipated trial start date	2009 Year 07 Month 01 Day
Last follow-up date	2017 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2009 Year 06 Month 17 Day
Last modified on	2016 Year 12 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002249