UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030070 |
|---|---|
| Receipt number | 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 | 2022/05/26 09:51:31 |
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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
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
maeda-o@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2018 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 22 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 22 | Day |
Last follow-up date
| 2022 | Year | 05 | 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
| 2017 | Year | 11 | Month | 21 | Day |
Last modified on
| 2022 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034322
