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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000010666
Receipt No. R000012475
Scientific Title Examination of change about comprehensive functional assessment before and while chemotherapy for pancreatic cancer in elderly patients using Cancer-Specific Geriatric Assessment(CSGA)
Date of disclosure of the study information 2013/05/08
Last modified on 2020/05/15

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Basic information
Public title Examination of change about comprehensive functional assessment before and while chemotherapy for pancreatic cancer in elderly patients using Cancer-Specific Geriatric Assessment(CSGA)
Acronym A prospective study of functional assessments by CSGA for elderly pancreatic cancer patients
Scientific Title Examination of change about comprehensive functional assessment before and while chemotherapy for pancreatic cancer in elderly patients using Cancer-Specific Geriatric Assessment(CSGA)
Scientific Title:Acronym A prospective study of functional assessments by CSGA for elderly pancreatic cancer patients
Region
Japan

Condition
Condition Pancreatic cancer
Classification by specialty
Medicine in general Hepato-biliary-pancreatic medicine Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To observe and evaluate of comprehensive functional assessments containing cognitive function, higher brain function, with CSGA(Japanese version) for pancreatic cancer patients aged 70 years or older, before and while treatment with gemcitabine
Basic objectives2 Others
Basic objectives -Others To assess the relevance of the continuity of gemcitabine and prognosis by CSGA scores before treatment, 2, 4 and 6 months while treatment with gemcitabine
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Relation to overall survival(OS) and scores of comprehensive geriatric assessments by CSGA
Key secondary outcomes Relation to the scores of comprehensive geriatric assessments by CSGA and as follows; Progression-free survival(PFS),
Time to treatment failure of primary treatment(TTF),
Non-hospital stay,
Adverse events rate

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
70 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria 1) Patients with pancreatic cancer that is diagnosed adenocarcinoma was confirmed histologically
2) Patients aged 70 years or older at the first chemotherapy
3) Patients of 0-2 Performance Status in ECOG
4) Patients expected to be capable of surviving at least 3 months
Key exclusion criteria 1)Cases with moderate to severe delirium and dementia at the time of initial diagnosis and not expected help from caregivers and/or family surrounding
2)Patients impossible for evaluation by CSGA because of the merger of significant psychiatric and neurological disorders
3)Patients that attending doctors judge to be inappropriate to perform this study safely
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Junji Furuse
Organization Kyorin University
Division name Department of Internal Medicine, Medical Oncology
Zip code
Address 6-20-2, Shinkawa, Mitaka-shi, Tokyo, Japan
TEL 0422-47-5511
Email hkitamura3539@ks.kyorin-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Institution of Review Board in Kyorin University School of Medicine
Organization Kyorin University School of Medecine
Division name Department of Internal Medicine, Medical Oncology
Zip code
Address 6-20-2, Shinkawa, Mitaka-shi, Tokyo, Japan
TEL 0422-47-5511(3220)
Homepage URL
Email irb@ks.kyorin-u.ac.jp

Sponsor
Institute Department of Medical Oncology. kyorin University Faculty of Medicine,
Institute
Department

Funding Source
Organization 1.Health and Labour Sciences Research Grant cancer clinical research business
2.Ministry of Education private university strategic research infrastructure development support business
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

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 杏林大学病院(東京都)、立正佼成会附属佼成病院(東京都)、鹿児島大学医学部附属病院(鹿児島県)、鹿児島市民病院(鹿児島県)

Other administrative information
Date of disclosure of the study information
2013 Year 05 Month 08 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 50
Results
The total number of entries is 52. But 2 patients were dead before treatment.
Results date posted
2020 Year 05 Month 15 Day
Results Delayed
Delay expected
Results Delay Reason Because we are currently submitting a paper.
Date of the first journal publication of results
Baseline Characteristics
Patients with advanced pancreatic cancer who were in stage 4 or inoperable, capable of standard chemotherapy.
Participant flow
Cancer-specific geriatric assessments (CSGA) were performed before the start of treatment and two or four months after the start of treatment, and were followed until the end of treatment and death.
Adverse events
This study is an observational study, with adverse events from standard chemotherapy, most of which were grade 1 or 2.
Outcome measures
The primary endpoint of this study is the correlation between OS and GA score
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2013 Year 05 Month 08 Day
Date of IRB
Anticipated trial start date
2013 Year 06 Month 01 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
2018 Year 03 Month 31 Day
Date trial data considered complete
2018 Year 12 Month 01 Day
Date analysis concluded
2019 Year 03 Month 30 Day

Other
Other related information As prospected study, 1)-5) are conducted before and after two months of chemotherapy. 2)-5) are conducted continuously after4,6 months.
1)CSGA
2)MMSE
3)FAB
4)VES-13
5)CGA7
6)EQ-5D-3L

Management information
Registered date
2013 Year 05 Month 08 Day
Last modified on
2020 Year 05 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012475

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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