UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013206 |
|---|---|
| Receipt number | R000015333 |
| Scientific Title | efficacy and safety of Gemcitabine plus nab-paclitaxel in unresectable pancreas cancer |
| Date of disclosure of the study information | 2014/02/20 |
| Last modified on | 2022/02/26 10:37:05 |
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Basic information
Public title
efficacy and safety of Gemcitabine plus nab-paclitaxel in unresectable pancreas cancer
Acronym
Gemcitabine plus nab-paclitaxel treatment for pancreas cancer
Scientific Title
efficacy and safety of Gemcitabine plus nab-paclitaxel in unresectable pancreas cancer
Scientific Title:Acronym
Gemcitabine plus nab-paclitaxel treatment for pancreas cancer
Region
| Japan |
Condition
Condition
unresectable pancreas cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
efficacy
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
response rate
Key secondary outcomes
progression free survival
overall survival
classification of elastography
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 | Device,equipment |
Interventions/Control_1
Gemcitabine nab-Paclitaxel
endoscopic elastography
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
unresectable pancreas cancer
alive more than three months
EUS-elastgraphy was performed before the chemotheraphy.
pathological diagnosis is invasive ductal carcinoma.
GEM+nabPTX regimen is planning as first line chemotherapy.
Key exclusion criteria
other malignant diseases
Paformance status 3,4
uncontrolable pleural effusion and/or ascites
uncontrolable infection
uncontrolable DM
past treatment history to pancreas cancer
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Noritoshi |
| Middle name | |
| Last name | Kobayashi |
Organization
Yokohama City University Hospital
Division name
Clinical Oncology
Zip code
2360004
Address
3-9 Fukuura Kanazawa-Ku Yokohama
TEL
045-787-2623
norikoba@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Noritoshi |
| Middle name | |
| Last name | Kobayashi |
Organization
Yokohama City University Hospital
Division name
Clinical Oncology
Zip code
2360004
Address
3-9 Fukuura Kanazawa-Ku Yokohama
TEL
045-787-2623
Homepage URL
norikoba@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Hospital
Oncology
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Yokohama City University Hospital Oncology Division
Address
3-9 Fukuura Kanazawa-ku Yokohama-shi Kanagawa
Tel
+81457872623
norikoba@yokohama-cu.ac.jp
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
| 2014 | Year | 02 | 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
0
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
Terminated
Date of protocol fixation
| 2014 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 01 | Month | 10 | Day |
Anticipated trial start date
| 2014 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 02 | Month | 20 | Day |
Last modified on
| 2022 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015333
