UMIN-CTR Clinical Trial

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
Email	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
Email	info@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	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)
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012475