UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase II trial of tri-week cycle TS-1+L-OHP+Trastuzumab combination therapy for HER2 positive advanced or recurrent gastric cancer
Title of the study (Brief title)	A phase II trial of TS-1+L-OHP+Trastuzumab combination therapy for HER2 positive advanced gastric cancer
Region	Japan

Condition
Condition	gastric cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate safety and efficacy of TS-1+L-OHP+Trastuzumab combination therapy for advanced gastric cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	response rate
Key secondary outcomes	incidence and extent of adverse events, progression-free survival, overall survival, time to treatment failure

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 or 100mg/m2 or 120mg/m2 twice a day on days 1-14 in 3 weeks L-OHP:130mg/m2 intravenous injection on day1 Trastuzumab:8mg/kg(1st cycle) or 6mg/kg(after 2nd cycle) intravenous injection on day1
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	1)Histopathologically proven advanced / recurrence gastric adenocarcinoma 2)Have measurable lesions by RECIST version 1.1 3)Positive for HER2 (IHC 3+ or IHC2+/FISH+) 4)Age 20-75 5)ECOG PS 0 or 1 6)No previous therapy for gastric cancer except for adjuvant chemotherapy which was finished more than 6 months 7)Neither ascites nor pleural effusion 8)No symptomatic cerebral lesions 9)Adequate organ functions (according to the hematologic test which was taken within 2 weeks before registration) WBC => 3,500/mm3 and =< 12,000/mm3 Neutrophil => 2,000/mm3 Platelet => 100,000/mm3 Hemoglobin => 9.0g/dL AST and ALT =< 100 IU/L Total bilirubin =< 1.5 mg/dL Creatinine =< 1.2mg/dL Creatinine clearance => 60ml/min 10)LVEF (Left Ventricular Ejection Fraction) >50% within 3 weeks before registration 11)No abnormal findings in ECG within 3 weeks before registration 12)Possible for oral ingestion 13)With an expectation of survival more than 3 months 14)With written Informed Consent
Key exclusion criteria	1) Who cannot administrate TS-1, L-OHP and Trastuzumab 2)Pregnant and / or nursing women or men who wish to have children in future 3)With active infectious disease 4)Positive for HBs antigen 5)Have a history or current symptoms of heart failure, uncontrollable arrhythmia, angina pectoris, valvular disease and uncontrollable hypertension 6)With interstitial pneumonia, pulmonary fibrosis, heart failure, renal failure, hepatic failure and uncontrollable diabetes mellitus 7)With dyspnea at rest 8)With active bleeding from gastric cancer or ulcer 9)With severe diarrhea (over 4 times a day or watery diarrhea) 10)With active double cancers excluding carcinoma in situ and / or prior curative cancer with relapse free for more than 5 years 11)Under medication of flucytosine or phenytoin,or warfarin 13)Under continuous medication of steroids 14)Judged to be unfit for this study by investigator
Target sample size	20

Research contact person
Name of lead principal investigator	Mitsui Takashi
Organization	Dokkyo Medical University Saitama Medical Center
Division name	Department of Surgery
Address	2-1-50 Minami-Koshigaya, Koshigaya city, Saitama 343-8555, JAPAN
TEL	048-965-1111
Email	mitsuitakashi3@gmail.com

Public contact
Name of contact person	Mitsui Takashi
Organization	Dokkyo Medical University Saitama Medical Center
Division name	Department of Surgery
Address	2-1-50 Minami-Koshigaya, Koshigaya city, Saitama 343-8555, JAPAN
TEL	048-965-1111
Homepage URL
Email	mitsuitakashi3@gmail.com

Sponsor
Institute	Dokkyo Medical University Saitama Medical Center
Institute
Department

Funding Source
Organization	None
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	2016 Year 03 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 02 Month 24 Day
Anticipated trial start date	2016 Year 03 Month 01 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	2016 Year 02 Month 25 Day
Last modified on	2018 Year 02 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024455