UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of S-1 plus oxaliplatin (130 mg/m2, every 3 weeks) for advanced gastric cancer
Title of the study (Brief title)	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	Nozomu Machida
Organization	Shizuoka Cancer Center
Division name	Division of Gastrointestinal Oncology
Address	1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777, Japan
TEL	055-989-5222
Email	no.machida@scchr.jp

Public contact
Name of contact person	Yosuke Kito
Organization	Shizuoka Cancer Center
Division name	Division of Gastrointestinal Oncology
Address	1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777, Japan
TEL	055-989-5222
Homepage URL
Email	y.kito@scchr.jp

Sponsor
Institute	Shizuoka Cancer Center
Institute
Department

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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2015 Year 03 Month 18 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019672