UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015181 |
|---|---|
| Receipt number | 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 10:41:56 |
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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
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
takeh1977@gmail.com
Sponsor or person
Institute
Kobe City Medical Center General Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017650
