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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030070
Receipt No. R000034322
Scientific Title Validation study of a comprehensive geriatric assessment for the management of elderly patients with advanced pancreatic cancer
Date of disclosure of the study information 2018/01/01
Last modified on 2018/05/23

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Basic information
Public title Validation study of a comprehensive geriatric assessment for the management of elderly patients with advanced pancreatic cancer
Acronym Validation study of a comprehensive geriatric assessment for the management of elderly patients with advanced pancreatic cancer
Scientific Title Validation study of a comprehensive geriatric assessment for the management of elderly patients with advanced pancreatic cancer
Scientific Title:Acronym Validation study of a comprehensive geriatric assessment for the management of elderly patients with advanced pancreatic cancer
Region
Japan

Condition
Condition Pancreatic cancer
Classification by specialty
Hepato-biliary-pancreatic medicine Geriatrics
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To optimize selection of chemotherapy regimen for pancreatic cancer of elderly patients using comprehensive geriatric assessment
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Time to treatment failure, TTF
Key secondary outcomes 1) overall survival
2) progression free survival
3) adverse events

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 Selection of chemotherapy regimen using comprehensive geriatric assessment
1. Fit -> Gemcitabine+Nab-paclitaxel
2. Vulnerabel -> Gemcitabine
3. Frail -> Best supportive care
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
75 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Chemotherapy is under consideration for advanced or recurrence pancreatic cancer
Key exclusion criteria Patients who are going to receive resection or chemoradiation.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Osamu Maeda
Organization Nagoya University Hospital
Division name Department of Clinical Oncology and Chemotherapy
Zip code
Address 65 Tsurumai-cho Showa-ku Nagoya
TEL 052-741-2111
Email maeda-o@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Osamu Maeda
Organization Nagoya University Hospital
Division name Department of Clinical Oncology and Chemotherapy
Zip code
Address 65 Tsurumai-cho Showa-ku Nagoya
TEL 052-741-2111
Homepage URL
Email maeda-o@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University
Institute
Department

Funding Source
Organization Nagoya University
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
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

Other administrative information
Date of disclosure of the study information
2018 Year 01 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 Open public recruiting
Date of protocol fixation
2018 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 01 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
2017 Year 11 Month 21 Day
Last modified on
2018 Year 05 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034322

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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