UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005975 |
|---|---|
| Receipt number | 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 18:20:39 |
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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
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
tshimura@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007066
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
