UMIN-CTR Clinical Trial

Basic information
Public title	A phase II study of Trastuzumab with S-1 plus Oxaliplatin for HER2 positive advanced gastric cancer
Acronym	HIGHSOX study
Scientific Title	A phase II study of Trastuzumab with S-1 plus Oxaliplatin for HER2 positive advanced gastric cancer
Scientific Title:Acronym	HIGHSOX study
Region	Japan

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

Objectives
Narrative objectives1	To evaluate safety and efficacy of S-1 plus Oxaliplatin with Trastuzumab for advanced gastric cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Response Rate
Key secondary outcomes	Progression free survival,Overall survival, Safety

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 on days1-14 in 3 weeks Trastuzumab:8mg/kg(1st cycle)/6mg/kg(2nd cycle-) div. on day1 Oxaliplatin: 130mg/m2 div. 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)histrologically proven advanced/recurrence adenocarcinoma 2)no prior therapy for gastric cancer except for adjuvant chemotherapy of S-1 which was finished more than 6 months ago 3)with measurable lesions by RECIST version 1.1 4)HER2 positve(IHC 3+ or IHC2+ and ISH+) 5)Age 20-75 6)ECOG PS 0 or 1 7)no symptomatic cerebral lesions 8)adequate organ functions(according to the labo-data which was taken within 2weeks before registration) 1. WBC =>3,000/mm3 2.neutrophil=>1,500/mm3 3.platelet=>100,000/mm3 4.AST=<100 IU/l 5.ALT=<100 IU/l 6.Total bililubin =<1.5 mg/dl 7. Creatinine=<1.2mg/dl 8. Creatinine clearance=>60ml/min 9) LVEF(Left Ventricular Ejection Fraction) >50% within 4weeks before registration 10) no abnormal findings in ECG within 4weeks before registration 11) possible for oral intake 12) with an expected survival longer than 3 months 13) with written Informed Consent
Key exclusion criteria	1) could not administrate S-1,Oxaliplatin,and Trastuzumab 2)pregnant and/or nursing women or men who wish to have children in future 3)with actuve infectious disease 4)HBs antigen positive 5)with a histroy or current symptoms of heart failure, uncontrollable arrhythmia,angina pectoris,valvular disease,and uncontrollable hypertension 6)with interstitial pneumonia, pulmonary fibrosis, heart hailure, renal failure, hepatic failure, uncontrollable diabetes mellitus 7)with dyspnea at rest 8)with active bleeding from gastric cancer/ulcer 9)with severe diarrhea(over 4 times a day or watery diarrhea) 10)with severe sensory neuropathy 11)with active double cancers excluding carcinoma in situ and/or prior curative cancer with relapse free for more than 5 years 12)under meditation of flucytosine, phenytoin,or warfarin 13) under continuous meditation of steroids 14)judged to be unfit to participate in this study by investigater
Target sample size	75

Research contact person
Last name of lead principal investigator	1st name Daisuke Middle name Last name Takahari
Organization	Cancer Institute Hospital Japanese Foundation For Cancer Research
Division name	gastroenterology
Zip code	135-8550
Address	3-8-31 Ariake, Koto-ku, Tokyo 135-8550, JAPAN
TEL	03-3520-0111
Email	daisuke.takahari@jfcr.or.jp

Public contact
1st name of contact person	1st name Dasiuke Middle name Last name Takahari
Organization	Cancer Institute Hospital
Division name	gastroenterology
Zip code	135-8550
Address	3-8-31 Ariake, Koto-ku, Tokyo 135-8550, JAPAN
TEL	03-3520-0111
Homepage URL
Email	daisuke.takahari@jfcr.or.jp

Sponsor
Institute	Cancer Institute Hospital Japanese Foundation For Cancer Research
Institute
Department

Funding Source
Organization	Cancer Institute Hospital Japanese Foundation For Cancer Research
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)	Japanese Foundation for Multidisciplinary Treatment of Cancer

IRB Contact (For public release)
Organization	Cancer Institute Hospital Japanese Foundation For Cancer Research
Address	3-8-31 Ariake, Koto-ku, Tokyo 135-8550, JAPAN
Tel	03-3520-0111
Email	med.shinsa@jfcr.or.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	大阪医科大学(大阪府）、千葉県がんセンター（千葉県）、愛知県がんセンター中央病院（愛知県）、四国がんセンター（愛媛県）国立がん研究センター中央病院（東京都）、静岡県立静岡がんセンター（静岡県）静岡県立総合病院（静岡県）、聖マリアンナ医科大学（神奈川県),茨城県立中央病院（茨城県）

Other administrative information
Date of disclosure of the study information	2015 Year 05 Month 18 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	http://link.springer.com/article/10.1007/s10120-019-00973-5
Number of participants that the trial has enrolled	75
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2019 Year 05 Month 17 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2015 Year 04 Month 29 Day
Date of IRB	2015 Year 05 Month 15 Day
Anticipated trial start date	2015 Year 06 Month 24 Day
Last follow-up date	2019 Year 05 Month 31 Day
Date of closure to data entry	2020 Year 06 Month 23 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 05 Month 18 Day
Last modified on	2019 Year 05 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019954