UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010666 |
|---|---|
| Receipt number | 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 | 2021/05/14 19:36:13 |
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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 | Junji |
| Middle name | |
| Last name | Furuse |
Organization
Kyorin University
Division name
Department of Internal Medicine, Medical Oncology
Zip code
181-8611
Address
6-20-2, Shinkawa, Mitaka-shi, Tokyo, Japan
TEL
0422-47-5511
hkitamura3539@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | Institute of Medical ethics |
| Middle name | |
| Last name | Kyorin University, Faculty of Medicine |
Organization
Kyorin University School of Medecine
Division name
Department of Internal Medicine, Medical Oncology
Zip code
181-8611
Address
6-20-2, Shinkawa, Mitaka-shi, Tokyo, Japan
TEL
0422-47-5511(3220)
Homepage URL
info@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Department of Medical Oncology. kyorin University Faculty of Medicine,
Institute
Department
Personal name
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
Kagoshima University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institute of medical ethics, Kyorin University
Address
6-20-2, Shinkawa, Mitaka-shi, Tokyo, JAPAN
Tel
0422-47-5511(3220)
irb@ks.kyorin-u.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
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
Main results already published
Date of protocol fixation
| 2013 | Year | 05 | Month | 08 | Day |
Date of IRB
| 2013 | Year | 04 | Month | 01 | Day |
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
| 2021 | Year | 05 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012475
