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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000005984
Receipt No. R000007079
Scientific Title Feasibility study of combination Docetaxel, Cisplatin, and S-1 as neoadjuvant chemotherapy for advanced gastric cancer.
Date of disclosure of the study information 2011/07/15
Last modified on 2016/07/15

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Basic information
Public title Feasibility study of combination Docetaxel, Cisplatin, and S-1 as neoadjuvant chemotherapy for advanced gastric cancer.
Acronym Feasibility study of combination Docetaxel, Cisplatin, and S-1 as neoadjuvant chemotherapy for advanced gastric cancer.
Scientific Title Feasibility study of combination Docetaxel, Cisplatin, and S-1 as neoadjuvant chemotherapy for advanced gastric cancer.
Scientific Title:Acronym 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

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

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
1st name
Middle name
Last name Yasushi Sato
Organization Sapporo Medical University
School of Medicine
Division name Dept. of Internal Medicine(4)
Zip code
Address S1W17, Chuo-ku, Sapporo, 060-8556, Japan
TEL 011-611-2111
Email yasushis@sapmed.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasushi Sato
Organization Sapporo Medical University School of Medicine
Division name Dept. of Internal Medicine(4)
Zip code
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

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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2011 Year 05 Month 12 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000007079

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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