UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018661 |
|---|---|
| Receipt number | 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 11:24:29 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
yokita@med.kagawa-u.ac.jp
Sponsor or person
Institute
Kobe City Medical Center General Hospital
Institute
Department
Personal name
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
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
Value
https://center6.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 |
