UMIN-CTR Clinical Trial

Basic information
Public title	An assessment of quality of life using electronic patient-reported outcome (ePRO) in patients receiving second-line chemotherapy for unresectable pancreatic cancer
Acronym	QOL-ePAC
Scientific Title	An assessment of quality of life using electronic patient-reported outcome (ePRO) in patients receiving second-line chemotherapy for unresectable pancreatic cancer
Scientific Title:Acronym	QOL-ePAC
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the impact and difference of the below-listed second-line chemotherapy on quality of life in patients with unresectable pancreatic cancer: ･ Nal-IRI+5-FU/LV ･ GEM ･ GEM+NPTX
Basic objectives2	Others
Basic objectives -Others	To evaluate the impact of the second-line chemotherapy on quality adjusted life day (QALD) and cancer-specific QOL scores. Also this study aims to investigate the impact of patient-reported adverse events on the QOL scores.
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	EQ-5D-5L index values measured during 2 consecutive cycles of the second-line chemotherapy after enrolment, beginning at the first day of the 2nd cycle of the chemotherapy.
Key secondary outcomes	(1) QALD calculated from the EQ-5D-5L index value and EORTC QLQ C-30 global score in the study period. (2) EORTC QLQ-C30 global and domain scores during the study period. (3) Correlation between QOL scores and frequency and severity of adverse events as defined in PRO-CTCAE.

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	(1) Diagnosed with invasive pancreatic cancer in cytodiagnosis and biopsy (2) Scheduled to receive 2nd cycle of below-listed outpatient second-line chemotherapy for unresectable advanced or metastatic pancreatic cancer: ･ nal-IRI+5-FU/LV ･ GEM ･ GEM+NPTX (3) Aged 20 years or older at the time of consent (4) Able to handle electronic device by him-/herself or with a little help (5) Consent to participate in the study has been obtained from the patient
Key exclusion criteria	(1) Judged ineligible to enroll by principal or sub-investigator (2) Currently receiving 2nd cycle of second-line chemotherapy for unresectable advanced or metastatic pancreatic cancer
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Junji Middle name Last name Furuse
Organization	Kyorin University
Division name	School of Medicine, Dept of Medical Oncology
Zip code	181-8611
Address	6-20-2 Shinkawa, Mitaka, Tokyo
TEL	0422-47-5511
Email	jfuruse@ks.kyorin-u.ac.jp

Public contact
Name of contact person	1st name Akira Middle name Last name Yamao
Organization	Public Health Research Center
Division name	Comprehensive Support Project for Oncology Research
Zip code	169-0051
Address	1-1-7 Nishi-Waseda, Shinjyuku, Tokyo
TEL	03-5287-2636
Homepage URL
Email	csp-qol@csp.or.jp

Sponsor
Institute	Public Health Research Foundation
Institute
Department

Funding Source
Organization	National Institute of Public Health
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Faculty of Medicine Research Ethics Committee, Kyorin University
Address	6-20-2 Shinkawa, Mitaka City, Tokyo
Tel	0422-47-5511(Ext.3222)
Email	rec@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	札幌医科大学（北海道）、東北大学大学院（宮城県）、山形県立中央病院（山形県）、福島県立医科大学（福島県）、国立がん研究センター東病院（千葉県）、千葉県がんセンター（千葉県）、千葉大学医学部附属病院（千葉県）、杏林大学（東京都）、国立がん研究センター中央病院（東京都）、神奈川県立がんセンター（神奈川県）、新潟県立がんセンター新潟病院（新潟県）、金沢大学附属病院（石川県）、国際医療福祉大学熱海病院（静岡県）、聖隷浜松病院（静岡県）、愛知県がんセンター（愛知県）、三重大学医学部附属病院（三重県）、大阪国際がんセンター（大阪府）、近畿大学医学部（大阪府）、兵庫県立がんセンター（兵庫県）、香川大学医学部附属病院（香川県）、高知医療センター（高知県）、九州がんセンター（福岡県）、九州大学病院（福岡県）、鹿児島大学病院（鹿児島県）

Other administrative information
Date of disclosure of the study information	2021 Year 05 Month 21 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	No longer recruiting
Date of protocol fixation	2021 Year 05 Month 21 Day
Date of IRB	2021 Year 06 Month 29 Day
Anticipated trial start date	2021 Year 09 Month 24 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Observations that use electronic devices to evaluate QOL over time at the time of visit and at home for patients during the second-line chemotherapy period for pancreatic cancer, and to examine the effect of each chemotherapy on the QOL value during that period It is a study. The following three types of evaluation scales are used. ･ PRO-CTCAE ･ EORTC QLQ-C30 ･ EQ-5D-5L index score

Management information
Registered date	2021 Year 05 Month 18 Day
Last modified on	2022 Year 02 Month 07 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050530