UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Feasibility study of combination Docetaxel, Cisplatin, and S-1 as neoadjuvant chemotherapy for advanced gastric cancer.
Title of the study (Brief title)	Feasibility study of combination Docetaxel, Cisplatin, and S-1 as neoadjuvant chemotherapy for 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 examine the safety and efficacy of NAC combined with docetaxel, cisplatin, TS-1 and trastuzumab in resectable advanced gastric cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	feasibility
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Written informed consent. 2) Histologically (cytologically) proven gastric cancer. 3) HER2 positive by IHC or FISH method 4) Curative resection possible (cStage IIIA~IIIC ). 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 is 50 % and over. 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 Docetaxel, CDDP, S-1, G-CSF. 3) Infectious disease. 4) Severe complication. 5) Neuropathy greater than grade 2. 6) Watery diarrhea. 7) Active double cancer. 8) Persons to be pregnant or to make pregnant.
Target sample size	20

Research contact person
Name of lead principal investigator	Yasushi Sato
Organization	Sapporo Medical University School of Medicine
Division name	Dept. of Internal Medicine(4)
Address	S1W17, Chuo-ku, Sapporo, 060-8556, Japan
TEL	011-611-2111
Email	yasushis@sapmed.ac.jp

Public contact
Name of contact person	Yasushi Sato
Organization	Sapporo Medical University School of Medicine
Division name	Dept. of Internal Medicine(4)
Address	S1W17, Chuo-ku, Sapporo, 060-8556, Japan
TEL	011-611-2111
Homepage URL
Email	yasushis@sapmed.ac.jp

Sponsor
Institute	Sapporo Medical University School of Medicine Dept. of Internal Medicine(4)
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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	2011 Year 07 Month 15 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2011 Year 05 Month 12 Day
Anticipated trial start date	2011 Year 06 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	2011 Year 07 Month 15 Day
Last modified on	2016 Year 07 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000007079