UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006403 |
|---|---|
| Receipt number | R000007598 |
| Scientific Title | A phase II study of paclitaxel plus trastuzumab in patients with pretreated recurrent or metastatic gastric cancer. |
| Date of disclosure of the study information | 2011/09/24 |
| Last modified on | 2018/03/30 17:30:43 |
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Basic information
Public title
A phase II study of paclitaxel plus trastuzumab in patients with pretreated recurrent or metastatic gastric cancer.
Acronym
A phase II study of paclitaxel plus trastuzumab in patients with pretreated recurrent or metastatic gastric cancer.
Scientific Title
A phase II study of paclitaxel plus trastuzumab in patients with pretreated recurrent or metastatic gastric cancer.
Scientific Title:Acronym
A phase II study of paclitaxel plus trastuzumab in patients with pretreated recurrent or metastatic gastric cancer.
Region
| Japan |
Condition
Condition
advanced gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to evaluate the efficacy and safety of paclitaxel with trastuzumab as after first-line chemotherapy for advanced gastric cancer patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
response rate
Key secondary outcomes
Progression-free survival (PFS), Overall survival(OS), Toxicity
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
patients are recieved paclitaxel plus trastuzumab as after 1st-line 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
Histologically confirmed HER2 postive: IHC(3+) or IHC(2+) and FISH+
A history of first-line chemotherapy with resistant or recurrent disease
At least one measurable target lesion
Key exclusion criteria
central nervous system metastasis
other active double cancer
inadequately controlled diabetes, heart disease, renal disease or liver disfunction.
severe peritoneal metastasis, interstitial pneumonia or pulmonary fibrosis
previous history of angina or myocardinal infarction
severe drug hypersensitivity
bleeding tendency
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yosuke Horita |
Organization
Toyama Prefectural Central Hospital
Division name
Department of chemotherapy
Zip code
Address
Nishinagae 2-2-78, Toyama city, Toyama 930-8550, Japan
TEL
076-424-1531
york@mud.biglobe.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yosuke Horita |
Organization
Toyama Prefectural Central Hospital
Division name
Department of chemotherapy
Zip code
Address
2-2-78, Nishinagae, Toyama, Japan
TEL
076-424-1531
Homepage URL
york@mud.biglobe.ne.jp
Sponsor or person
Institute
Toyama Prefectural Central Hospital
Institute
Department
Personal name
Funding Source
Organization
Toyama Prefectural Central Hospital
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 09 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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 | 08 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
| 2018 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 09 | Month | 24 | Day |
Last modified on
| 2018 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007598
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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