UMIN-CTR Clinical Trial

Basic information
Public title	Neoadjuvant chemotherapy of S-1/OXaliplatin for locally advanced Gastric cancer PII
Acronym	Neo G-SOX PII study
Scientific Title	Neoadjuvant chemotherapy of S-1/OXaliplatin for locally advanced Gastric cancer PII
Scientific Title:Acronym	Neo G-SOX PII study
Region	Japan

Condition
Condition	gastric cancer
Classification by specialty	Medicine in general Gastroenterology Surgery in general Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	to evaluate the efficacy and safety of neo G-SOX for locally advanced gastric cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	curative resection rate
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	Historical
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 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) uncontrolled diabetes mellitus 5) history of myocardial infarction, unstable angina within 3 months prior to the registration 6) serious coexisting illness 7) active infection 8) peripheral neuropathy greater than Grade 2 9) ileus 10) massive pleural effusion or ascites
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Hironaga Middle name Last name Satake
Organization	Kobe City Medical Center General Hospital
Division name	Department of Medical Oncology
Zip code	6500047
Address	2-1-1, Minatojima minamimachi,chuo-ku,Kobe city,Hyogo
TEL	078-302-4321
Email	takeh1977@gmail.com

Public contact
Name of contact person	1st name Yoshihiro Middle name Last name Okita
Organization	Kagawa University Hospital
Division name	Department of Clinical Oncology
Zip code	7610701
Address	1750-1, Ikenobe, Miki-cho, Kita-gun, Kagawa
TEL	087-898-5111
Homepage URL
Email	yokita@med.kagawa-u.ac.jp

Sponsor
Institute	Kobe City Medical Center General Hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Kobe City Medical Center General Hospital
Address	2-1-1, Minatojima minamimachi,chuo-ku,Kobe city,Hyogo
Tel	0783024321
Email	rinken@kcho.jp

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	神戸市立医療センター中央市民病院（兵庫県）、西神戸医療センター（兵庫県）、姫路赤十字病院（兵庫県）、神戸労災病院（兵庫県）、西宮中央病院（兵庫県）、香川大学（香川県）、岡山労災病院（岡山県）、慶應義塾大学（東京都）

Other administrative information
Date of disclosure of the study information	2015 Year 08 Month 14 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	2015 Year 07 Month 30 Day
Date of IRB
Anticipated trial start date	2015 Year 08 Month 14 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	2015 Year 08 Month 13 Day
Last modified on	2021 Year 08 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021603