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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000018661
Receipt No. R000021603
Scientific Title Neoadjuvant chemotherapy of S-1/OXaliplatin for locally advanced Gastric cancer PII
Date of disclosure of the study information 2015/08/14
Last modified on 2021/08/17

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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/ctr_e/ctr_view.cgi?recptno=R000021603

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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