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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005975
Receipt No. R000007066
Scientific Title Feasibility study of S-1/Docetaxel plus trastuzumab in fluoropirimidine and platinum agents- refractory HER-2 positive advanced gastric cancer
Date of disclosure of the study information 2011/07/20
Last modified on 2015/08/25

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Basic information
Public title Feasibility study of S-1/Docetaxel plus trastuzumab in fluoropirimidine and platinum agents- refractory HER-2 positive advanced gastric cancer
Acronym S-1/Docetaxel plus trastuzumab for HER-2 positive gastric cancer in more than second-line chemotherapy
Scientific Title Feasibility study of S-1/Docetaxel plus trastuzumab in fluoropirimidine and platinum agents- refractory HER-2 positive advanced gastric cancer
Scientific Title:Acronym S-1/Docetaxel plus trastuzumab for HER-2 positive gastric cancer in more than second-line chemotherapy
Region
Japan

Condition
Condition HER2-positive gastric cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 safety
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Frequency of adverse events
Key secondary outcomes Response rate
Progression free survival
Overall survival
Analysis of molecular marker expression

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/Docetaxel+Trastuzumab
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.Histopathological diagnosis as gastric adenocarcinoma
2.Unresectable and metastatic gastric cancer
3.HER-2 positive gastric cencer (IHC3+ or IHC2+ and FISH+)
4.Refractory gastric cancer to fluoropirimidine and plutinum agents
5.Age 20-80 years
6.ECOG PS:0-2
7.Case with target lesion or non-target
lesion
8.Patient who is possible of ingestion
9.Patient who is expected to be sorvival more than 2 months
10.LVEF>50% by UCG
11.
3000=<WBC=<12000
Neu=>1,500/mm3
Plt=>100,000/mm3
Hb=>8.0 g/dl
AST(GOT),ALT(GPT)=>100 IU / l
T-Bil=>1.5mg/dl
CCr=>50ml/min
12. Informed consent is done by document
Key exclusion criteria 1.Patient with history of chemotherapy by some taxane
2.Patient with history of severe hypersensitivity for some drugs
3.Patient with contraindication of using drugs
4.Patient who needs flucytosine, phenytoin and warfarin
5.Patiet who has active infection with fever over 38 degree
6.Case with active gastrointestinal bleeding
7.Patient with severe concomitant disease
8.Patient with previous or present heart disease
9.Patient with brain metastasis
10.Case with severe pleural effusion or ascites
11.Double cancer
12.Patient with B or C type hepatitis virus
13.Woman with plegnancy or lactation, or woman who will want to be pregnant
14.Man who will want to have a child
15.Investigator's decision as inappropriateness
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiromi Kataoka
Organization Nagoya City University Hospital
Division name Department of Gastroenterology
Zip code
Address 1 Kawasumu, Mizuho-cho, Mizuho-ku, Nagoya
TEL 052-853-8211
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takaya Shimura
Organization Nagoya City University Hospital
Division name Department of Gastroenterology
Zip code
Address 1 Kawasumu, Mizuho-cho, Mizuho-ku, Nagoya
TEL 052-853-8211
Homepage URL
Email tshimura@med.nagoya-cu.ac.jp

Sponsor
Institute Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences
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 名古屋市立大学病院(愛知県)、NTT西日本東海病院(愛知県)、名古屋市立東部医療センター(愛知県)、名古屋市立西部医療センター(愛知県)、知多厚生病院(愛知県)、岐阜県立多治見病院(岐阜県)

Other administrative information
Date of disclosure of the study information
2011 Year 07 Month 20 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 Completed
Date of protocol fixation
2011 Year 07 Month 11 Day
Date of IRB
Anticipated trial start date
2011 Year 07 Month 01 Day
Last follow-up date
2015 Year 03 Month 01 Day
Date of closure to data entry
2015 Year 03 Month 01 Day
Date trial data considered complete
2015 Year 03 Month 31 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 07 Month 14 Day
Last modified on
2015 Year 08 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007066

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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