UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044245 |
|---|---|
| Receipt number | R000050530 |
| Scientific Title | An assessment of quality of life using electronic patient-reported outcome (ePRO) in patients receiving second-line chemotherapy for unresectable pancreatic cancer |
| Date of disclosure of the study information | 2021/05/21 |
| Last modified on | 2022/02/07 11:46:59 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
csp-qol@csp.or.jp
Sponsor or person
Institute
Public Health Research Foundation
Institute
Department
Personal name
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)
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050530
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
