UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase II study of S-1/Cisplatin/Trastuzumab for human epidermal growth factor receptor 2 (HER2)-positive advanced and/or recurrent gastric cancer
Title of the study (Brief title)	HOG-GC 01
Region	Japan

Condition
Condition	advanced and/or recurrent gastric cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and tolerability of trasuzumab added to S-1+cisplatin in HER2-positive advanced and/or recurrent gastric cancer patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
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 is orally administered for 3 weeks followed by 2 weeks rest according to body surface area (80mg/m2/day). CDDP is administered intravenously in each dosage of level(60mg/m2/day) at day 8. Trastuzumab is administered intravenously 6mg/kg at day 8 and 4mg/kg at day 21.
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) Pathological proven adenocarcinoma of inoperable locally advanced, recurrent, and/or metastatic cancer of the stomach 2) HER2-positive tumors 3) Age 20-75 years 4) ECOG performance status<=2 5) Measurable disease or non-measurable but assessable disease 6)No prior chemotherapy except for adjuvant chemotherapy with S-1 7)Sufficient oral intake 8)Adequate organ function 9) Ejection fraction more than 50% by ultrasound or MUGA 10) Expected more than 3 months survival 11) With written informed consent
Key exclusion criteria	1) history of a previous drug allergy 2) pregnant or nursing patient or with intent to bear baby 3)R1 gastrectomy 4)need continuing use of flucytosine, phenytoin, warfarin potassium 5)Active infection or other inflammatory disease 6)with severe allergy to Trastuzumab, S-1 and cisplatin 7)History of cardiac disease 8)patients with serious concomitant diseas 9)with diarrhea 10)with ascites or pleural effusion 11)with multiple bone metastasis 12)peripheral sensory neuropathy 13)with brain metastasis 14)received operation within 28 days 15)simultaneous or metachronous double cancers 16)with clinically important mental disorder need to treat 17)cannot stopped steroids or immunosuppressing drug 18)Infection with hepatitis B 19)Inappropriate for the trial at the physician's assessment
Target sample size	25

Research contact person
Name of lead principal investigator	Ninomiya Motoki
Organization	Hiroshima City Hospital
Division name	Surgery
Address	7-33 Motomachi, Naka-ku, Hiroshima-shi, Hiroshima-ken
TEL	082-221-2291
Email	motoki-n@city-hosp.naka.hiroshima.jp

Public contact
Name of contact person	Tanabe Kazuaki
Organization	Hiroshima University
Division name	Gastroenterological Surgery
Address	1-2-3, Kasumi, MInami-ku
TEL	082-257-5555
Homepage URL
Email	ktanabe2@hiroshima-u.ac.jp

Sponsor
Institute	HOG-GC (Hiroshima oncology group of gastric cancer)
Institute
Department

Funding Source
Organization	HOG-GC (Hiroshima oncology group of gastric cancer)
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	2011 Year 10 Month 24 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 05 Month 30 Day
Anticipated trial start date	2011 Year 08 Month 01 Day
Last follow-up date	2015 Year 02 Month 01 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	2011 Year 10 Month 24 Day
Last modified on	2018 Year 09 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006729