UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase 2 study of S-1, docetaxel, cisplatin and trastuzumab combination chemotherapy (DCS-T) in patients with HER2-positive unresectable metastatic gastric cancer
Title of the study (Brief title)	Phase 2 study of DCS-T for HER2-positive unresectable metastatic gastric cancer
Region	Japan

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

Objectives
Narrative objectives1	To investigate efficacy and safety of DCS-T (docetaxel 50mg/m2, CDDP 60mg/m2, S-1 80mg/m2, trastuzumab 6mg/kg) for HER2 positive unresectable metastatic 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

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	Treatment with docetaxel (50mg/m2), CDDP (60mg/m2), S-1 (80mg/m2) and trastuzumab (6mg/kg) combination chemotherapy
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)Written informed consent. 2)Histologicaly (cytologically) proven gastric cancer. 3)HER2 positive by IHC or FISH method 4)Unresectable gastric cancer. 5)To have measurable lesions. 6)No prior chemotherapy or no influence of prior therapy. 7)Tolerable function of bone marrow, liver and kidney. 8)LVEF more than 50% 9)PS 0 - 1. 10)Expected survival for 3 months. 11)Possible oral intake.
Key exclusion criteria	1)History of hypersensitivity to DCS. 2)Contraindication to TXT, CDDP, S-1, G-CSF. 3)Infectious disease. 4)Severe compliaction. 5)Neuropathy greater than grade 2. 6)Brain metastasis with clinical symptoms. 7)Watery diarea. 8)Active double cancer. 9)Persons to be pregnant or to make pregnant.
Target sample size	30

Research contact person
Name of lead principal investigator	Yasushi Sato
Organization	Tokushima University Graduate School of Biomedical Sciences
Division name	Department of Community Medicine for Gastroenterology and Oncology
Address	3-18-15, Kuramoto-cho, Tokushima city, 770-8503
TEL	088-633-7124
Email	sato.yasushi@tokushima-u.ac.jp

Public contact
Name of contact person	Yasushi Sato
Organization	Tokushima University Graduate School of Biomedical Sciences
Division name	Department of Community Medicine for Gastroenterology and Oncology
Address	3-18-15, Kuramoto-cho, Tokushima city, 770-8503
TEL	011-611-2111
Homepage URL
Email	sato.yasushi@tokushima-u.ac.jp

Sponsor
Institute	Tokushima-Hokkaido cancer therapy clinical trial group
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	2013 Year 10 Month 16 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2013 Year 08 Month 19 Day
Anticipated trial start date	2013 Year 10 Month 16 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	2013 Year 10 Month 15 Day
Last modified on	2017 Year 04 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014065