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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015181
Receipt No. R000017650
Scientific Title Neoadjuvant chemotherapy of S-1/OXaliplatin for locally advanced Gastric cancer PI
Date of disclosure of the study information 2014/09/16
Last modified on 2017/06/17

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Basic information
Public title Neoadjuvant chemotherapy of S-1/OXaliplatin for locally advanced Gastric cancer PI
Acronym Neo G-SOX PI study
Scientific Title Neoadjuvant chemotherapy of S-1/OXaliplatin for locally advanced Gastric cancer PI
Scientific Title:Acronym 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
1st name
Middle name
Last name Akihito Tsuji
Organization Kobe City Medical Center General Hospital
Division name Division of Oncology
Zip code
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
1st name
Middle name
Last name Hironaga Satake
Organization Kobe City Medical Center General Hospital
Division name Division of Oncology / Gastroenterology,
Zip code
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)

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

Other administrative information
Date of disclosure of the study information
2014 Year 09 Month 16 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2014 Year 08 Month 25 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000017650

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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