UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase ll study of TS-1+L-OHP(SOX) therapy for Her2-negative advanced/metastatic gastric cancer with measurable lesions (OGSG1405)
Title of the study (Brief title)	SOX therapy for Her2-negative gastric cancer (OGSG1405)
Region	Japan

Condition
Condition	Gastric carcinoma
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To confirm the efficacy and safety of TS-1+L-OHP (SOX) therapy for Her2-negative advanced/matastatic gastric cancer with measurable lesions.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Response rate (RR)
Key secondary outcomes	Overall survival (OS) Progression free survival (PFS) Time to Treatment Failure (TTF) Incidence of adverse events

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	S-1: 80mg/m2 twice a day oral intake on days 1-14 followed by 7 days rest. L-OHP: 130mg/m2 div. on day 1.
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 proven advanced/recurrent gastric adenocarcinoma with Her2-nagative or unknown 2) with measurable lesions by RECIST version 1.1 3) 20 years of age and older 4) Performance Status by Eastern Cooperative Oncology Group of 0 or 1 5) without any history of chemotherapy or radiation therapy and for recurrent cases, with longer than 6 months rest of adjuvant chemotherapy 6) with good functions of important organs by a data taken within 2 weeks at registration 1. Neutrophil: =>1,500/mm3 2.Platelet: =>100,000/mm3 3. Hemoglobin: =>8.0 g/dL 4. T.bil.: =<2.0 mg/dL 5. AST(GOT): =< 100 IU/L (=<200 IU/L in patients with liver metastasis) 6. ALT(GPT): =< 100 IU/L (=<200 IU/L in patients with liver metastasis) 7.SCr: =<1.5mg/dL 8. cleatinine clearance : =>50mL/min * CC by Cockcroft-Gault method is available 7) with an expected survival longer than 3 months 8) Patients able to take orally 9) with written Informed Consent
Key exclusion criteria	1) With history of chemotherapy and/or radiation therapy 2) with active double cancers excluding carcinoma in situ and/or prior cancer cured with longer than 5 year interval 3) with symptoms due to metastasis in the central nerve 4) have a history of severe drug hypersensitivity 5) with below comorbidity; 1. uncontrolled DM 2. uncontrolled hypertension 3. liver cirrhosis, hepatic failure 4. renal failure 5. interstitial pneumonia, pulmonary fibrosis, severe pulmonary emphysema 6. with active infectious diseases 7. with a history of heart failure, cardiac infarction, angina pectoris and/or abnormal electrocardiogram within 6 months 6) HBs antigen positive 7) with active bleeding 8) with sensory neuropathy 9) with severe diarrhea (over 4 times a day or watery diarrhea ) 10) under medication of flucytosine phenytoin or warfarin 11) under continuous steroids medication 12) women pregnant and/or nursing or men who like to have children in future 13) patients with a psychological disease or symptoms whom physician in charge judges to be unable to participate 14) Any patients judged by the physician in charge to be unfit to participate in the study
Target sample size	55

Research contact person
Name of lead principal investigator	Masahiro Goto
Organization	Osaka Medical College
Division name	Chemotherapy Center
Address	2-7 Daigaku-cho, Takatsuki, Osaka, 569-8181
TEL	072-683-1221
Email	in2030@poh.osaka-med.ac.jp

Public contact
Name of contact person	Kazumasa Fujitani
Organization	Osala General Medical Center
Division name	Department of surgery
Address	3-1-56, Bandaihigashi, Sumiyoshi-ku, Osaka-City
TEL	06-6692-1201
Homepage URL
Email	fujitani@gh.opho.jp

Sponsor
Institute	Osaka Gastrointestinal Cancer Chemotherapy Study Group
Institute
Department

Funding Source
Organization	Osaka Clinical Study Supporting Organization
Organization
Division
Category of Funding Organization	Self funding
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	Terminated
Date of protocol fixation	2015 Year 02 Month 07 Day
Anticipated trial start date	2015 Year 04 Month 01 Day
Last follow-up date	2019 Year 02 Month 28 Day
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	2018 Year 05 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019699