UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase II study of trastuzumab added to docetaxel and S-1 for human epidermal growth factor receptor 2 (HER2)-positive advanced gastric cancer.
Title of the study (Brief title)	A phase II study of trastuzumab added to docetaxel and S-1 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 the efficacy and tolerability of trasuzumab added to S-1+docetaxel in HER2-positive advanced gastric cancer patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	progression free survival
Key secondary outcomes	safety, objective response rate, 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	Intravenous infusion of trastuzumab (loading dose 8 mg/kg, 6 mg/kg) on day1, Intravenous administration of 40 mg/m2 docetaxel on Day 1, and oral administration of 80 mg/m2/day S-1 on Days 1 to 14 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	80 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 20-79 years 4) Measurable disease or non-measurable but assessable disease 5) No prior chemotherapy except for adjuvant chemotherapy with S-1 6) Adequate organ function 7) ECOG performance status<=2 8) Ejection fraction more than 50% by ultrasound or MUGA 9) Expected more than 3 months survival 10) Sufficient oral intake 11) With written informed consent
Key exclusion criteria	1) with severe allergy to Trastuzumab, S-1 and docetaxel 2) Active infection or other inflammatory disease 3) synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ 4) Other severe complications such as paralytic ileus, intestinal pneumonitis, pulmonary fibrosis, uncontrollable diabetes millutus, hypertension, and respiratory insufficiency. 5) History of cardiac disease 6) Dyspnea at rest, due to complications of advanced malignancy or other cardiovascular disease 7) Metastasis to CNS 8) Grade 3-4 peripheral sensory neuropathy 9) pregnant or nursing patient or with intent to bear baby 10) Inappropriate for the trial at the physician's assessment
Target sample size	40

Research contact person
Name of lead principal investigator	Toshiyoshi Fujiwara
Organization	Okayama University Graduate school of Medicine, Dentistry, and Pharmaceutical Sciences
Division name	Department of Gastroenterological Surgery
Address	2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan
TEL	+81-86-235-7257
Email	toshi_f@md.okayama-u.ac.jp

Public contact
Name of contact person	Shunsuke Kagawa
Organization	Okayama University Hospital
Division name	Department of Gastroenterological Surgery
Address	2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan
TEL	+81-86-235-7257
Homepage URL
Email	skagawa@md.okayama-u.ac.jp

Sponsor
Institute	Okayama University
Institute
Department

Funding Source
Organization	Okayama University
Organization
Division
Category of Funding Organization	Other
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 04 Month 26 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 03 Month 25 Day
Anticipated trial start date	2011 Year 04 Month 01 Day
Last follow-up date	2017 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2017 Year 12 Month 26 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://link.springer.com/article/10.1007/s00280-017-3505-4?wt_mc=Internal.Event.1.SEM.ArticleAuthor
Results
Other related information

Management information
Registered date	2011 Year 04 Month 01 Day
Last modified on	2018 Year 01 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006291