UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016973 |
|---|---|
| Receipt number | R000019672 |
| Scientific Title | Phase II study of S-1 plus oxaliplatin (130 mg/m2, every 3 weeks) for advanced gastric cancer |
| Date of disclosure of the study information | 2015/03/31 |
| Last modified on | 2016/09/30 12:00:52 |
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Basic information
Public title
Phase II study of S-1 plus oxaliplatin (130 mg/m2, every 3 weeks) for advanced gastric cancer
Acronym
G-SOX(130) P-II
Scientific Title
Phase II study of S-1 plus oxaliplatin (130 mg/m2, every 3 weeks) for advanced gastric cancer
Scientific Title:Acronym
G-SOX(130) P-II
Region
| Japan |
Condition
Condition
Advanced gastric cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
| Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the feasibility, safety and efficacy of S-1 plus oxaliplatin (130 mg/m2, every 3 weeks) for advanced gastric cancer
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
The proportion of patients who recieved at least 80% of the planned dose for the first three cycles
Key secondary outcomes
Response rate, progression-free survival, overall survival, treatment discontinuation due to adverse events, and relative dose intensity
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
S-1 plus oxaliplatin (130 mg/m2, every
3 weeks)
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) Histologically confirmed gastric adenocarcinoma
2) Unresectable advanced or recurrent gastric cancer
3) Adequate oral intake
4) Measurable or non-measurable disease
5) Age >= 20 years
6) Eastern Cooperative Oncology Group Performance status 0 or 1
7) HER-2 negative, or unknown at registration
8) No prior chemotherapy, immunotherapy or radiation therapy for advanced disease
9) Adequate organ function
10) Written informed consent
Key exclusion criteria
1) Massive ascites
2) Massive pleural effusion
3) Evidence of central nervous system metastasis, or clinically suspected
4) Poorly controlled diabetes mellitus
5) Serious lung or cardiovascular disease
6) Active concomitant malignancy
7) Active infection
8) Diarrhea
9) Peripheral neuropathy
10) Blood transfusion, blood products or G-CSF within 21 days at registration
11) Pregnant, nursing or unwilling to practice contraception during the study
12) Severe mental illness
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nozomu Machida |
Organization
Shizuoka Cancer Center
Division name
Division of Gastrointestinal Oncology
Zip code
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777, Japan
TEL
055-989-5222
no.machida@scchr.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yosuke Kito |
Organization
Shizuoka Cancer Center
Division name
Division of Gastrointestinal Oncology
Zip code
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777, Japan
TEL
055-989-5222
Homepage URL
y.kito@scchr.jp
Sponsor or person
Institute
Shizuoka Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Shizuoka Cancer Center
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
| 2015 | Year | 03 | Month | 31 | 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 | 03 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | Month | 31 | 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 | 03 | Month | 30 | Day |
Last modified on
| 2016 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019672
