UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Neoadjuvant chemotherapy of S-1/OXaliplatin for locally advanced Gastric cancer PI
Title of the study (Brief title)	Neo G-SOX PI study
Region	Japan

Condition
Condition	gastric cancer
Classification by specialty	Medicine in general Gastroenterology Hematology and clinical oncology Surgery in general Gastrointestinal surgery Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Determining the maximum tolerable dose(MTD) and recomended dose(RD)
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase I

Assessment
Primary outcomes	Safety
Key secondary 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	Medicine
Interventions/Control_1	2course of S-1/oxaliplatin
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)histlogically proven gastric adenocarcinoma 2)Clinical T4, or T3 disease in cases of tumors invading the esophagus or of the schirrhous type including giant type 3 with a maximal diameter of more than 8 cm, bulky N2 confirmed by abdominal CT and laparoscopy. The T and N stages are determined according to the method proposed by Haberrmann. 3)Curative resection possible by total body computed tomography (CT) scan 4)Performance status must be Eastern Cooperative Oncology Group (ECOG) 0, or 1 5)Age >= 20 years 6)Patients who can take medication orally 7)Adequate bone marrow, hepatic, renal, cardiac and respiratory functions 8)Written informed consent
Key exclusion criteria	1) active synchronous or metachronous malignancy other than carcinoma in situ 2) pregnant or nursing 3) severe mental disorders 4) systemic steroid user 5) diabetes mellitus, uncontrolled or controlled with insulin 6) history of myocardial infarction, unstable angina within 3 months prior to the registration 7) serious coexisting illness 8) active infection 9) peripheral neuropathy greater than Grade 2 10) ileus 11) massive pleural effusion or ascites
Target sample size	9

Research contact person
Name of lead principal investigator	Akihito Tsuji
Organization	Kobe City Medical Center General Hospital
Division name	Division of Oncology
Address	2-1-1, Minatojima minamimachi,chuo-ku,Kobe city,Hyogo
TEL	81-078-302-4321
Email	hsatake@kcho.jp

Public contact
Name of contact person	Hironaga Satake
Organization	Kobe City Medical Center General Hospital
Division name	Division of Oncology / Gastroenterology,
Address	2-1-1, Minatojima minamimachi,chuo-ku,Kobe city,Hyogo
TEL	81-078-302-4321
Homepage URL
Email	takeh1977@gmail.com

Sponsor
Institute	Kobe City Medical Center General Hospital
Institute
Department

Funding Source
Organization	Kobe City Medical Center General Hospital
Organization
Division
Category of Funding Organization	Local Government
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	2014 Year 09 Month 16 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 08 Month 25 Day
Anticipated trial start date	2014 Year 09 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 09 Month 16 Day
Last modified on	2017 Year 06 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017650