UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021330 |
|---|---|
| Receipt number | R000024596 |
| Scientific Title | The efficiency of Ramucirumab therapy for advanced gastric cancer after chemotherapy |
| Date of disclosure of the study information | 2016/06/01 |
| Last modified on | 2016/03/04 09:25:50 |
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Basic information
Public title
The efficiency of Ramucirumab therapy for advanced gastric cancer after chemotherapy
Acronym
Ramuciru-AC
Scientific Title
The efficiency of Ramucirumab therapy for advanced gastric cancer after chemotherapy
Scientific Title:Acronym
Ramuciru-AC
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Objective is to examine the efficiency for the treatment of gastric cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
PSF,RR,OS
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
Try Ramucirumab monotherapy for gastric cancer.
Over a period of 60 minutes once Ramucirumab 8mg / kg for intravenous infusion every two weeks.
Administration of Ramucirumab will continue until worsen of disease.
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
| 95 | years-old | > |
Gender
Female
Key inclusion criteria
Patients who were received all kind of chemotherapy as much as possible
Key exclusion criteria
serious underlying disease
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoyuki Shibata |
Organization
Fujita Health University
Division name
Gastroenterology
Zip code
Address
1-98 Denagakugakubo, Kutsukake-cho, Toyoake 470-1192, Japan
TEL
+81-562-93-9240
tshibata-04@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoyuki Shibata |
Organization
Fujita Health University
Division name
Gastroenterology
Zip code
Address
1-98 Denagakugakubo, Kutsukake-cho, Toyoake 470-1192, Japan
TEL
+81-562-93-9240
Homepage URL
tshibata-04@umin.ac.jp
Sponsor or person
Institute
Fujita Health University Hospital
Institute
Department
Personal name
Funding Source
Organization
Fujita Health University Hospital
Organization
Division
Category of Funding Organization
Other
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
| 2016 | Year | 06 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2015 | Year | 10 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2016 | 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
| 2016 | Year | 03 | Month | 04 | Day |
Last modified on
| 2016 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024596
