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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000048143
Receipt No. R000054863
Scientific Title Comparison between nanoliposomal irinotecan plus 5-FU/ folinic acid and S-1 monotherapy in metastatic pancreatic cancer: A propensity score-matched retrospective cohort study.
Date of disclosure of the study information 2022/06/23
Last modified on 2022/06/23

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Basic information
Public title Comparison between nanoliposomal irinotecan plus 5-FU/ folinic acid and S-1 monotherapy in metastatic pancreatic cancer: A propensity score-matched retrospective cohort study.
Acronym Comparison between nanoliposomal irinotecan plus 5-FU/ folinic acid and S-1 monotherapy in metastatic pancreatic cancer: A propensity score-matched retrospective cohort study.
Scientific Title Comparison between nanoliposomal irinotecan plus 5-FU/ folinic acid and S-1 monotherapy in metastatic pancreatic cancer: A propensity score-matched retrospective cohort study.
Scientific Title:Acronym Comparison between nanoliposomal irinotecan plus 5-FU/ folinic acid and S-1 monotherapy in metastatic pancreatic cancer: A propensity score-matched retrospective cohort study.
Region
Japan

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

Objectives
Narrative objectives1 To compare the outcomes of the NAPOLI-1 regimen and S-1 monotherapy for recurrent or metastatic pancreatic cancer after gemcitabine-based first-line therapy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Overall survival
Key secondary outcomes Progression-free survival, Objective response rate, Disease control 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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) NAPOLI-1 regimen or S-1 monotherapy is initiated as second-line therapy after failure of gemcitabine=based first-line therapy.
2) Therapy is introduced between September 1, 2019 and February 28, 2021
3) Diagnosis of adenocarcinoma by histological or cytological diagnosis of primary or metastatic lesions.
4) Pancreatic cancer with distant metastasis or recurrent pancreatic cancer by chest CT and abdominal/pelvic contrast-enhanced CT or abdominal/pelvic contrast-enhanced MRI.
In the case of recurrent pancreatic cancer, the following items should be followed:
a) The first treatment regimen after the diagnosis of recurrence is considered as the primary treatment.
b) If postoperative adjuvant chemotherapy was administered, patients are eligible if at least 6 months have elapsed between the last administration of postoperative adjuvant chemotherapy and the recurrence (patients are eligible if the recurrence occurs on the same date 6 months after the last administration of postoperative adjuvant chemotherapy).
c) The first treatment regimen after the diagnosis of recurrence is defined as first-line treatment.
5) Patients must not have used irinotecan (including nanoliposomal irinotecan) or fluoropyrimidines.
6) Patients must be at least 20 years of age at the time of enrollment.
Key exclusion criteria None
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Masafumi
Middle name
Last name Ikeda
Organization National Cancer Center Hospital East
Division name Hepatobiliary and Pancreatic Oncology
Zip code 277-8577
Address 6-5-1, Kashiwanoha, Kashiwa
TEL +81-4-7133-1111
Email masikeda@east.ncc.go.jp

Public contact
Name of contact person
1st name Hiroshi
Middle name
Last name Imaoka
Organization National Cancer Center Hospital East
Division name Hepatobiliary and Pancreatic Oncology
Zip code 277-8577
Address 6-5-1, Kashiwanoha, Kashiwa
TEL +81-4-7133-1111
Homepage URL
Email hiimaoka@east.ncc.go.jp

Sponsor
Institute Japan Oncology Network in Hepatobiliary and Pancreas
Institute
Department

Funding Source
Organization Japan Oncology Network in Hepatobiliary and Pancreas
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Ethics Review Board of National Cancer Center
Address 5-1-1, Tsukiji, Chuo-ku
Tel +81-3-3542-2511
Email NCC_IRBoffice@ml.res.ncc.go.jp

Secondary IDs
Secondary IDs YES
Study ID_1 2022-045
Org. issuing International ID_1 Ethics Review Board of National Cancer Center
Study ID_2 JON2109-P
Org. issuing International ID_2 Japan Oncology Network in Hepatobiliary and Pancreas
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2022 Year 06 Month 23 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 Open public recruiting
Date of protocol fixation
2022 Year 04 Month 21 Day
Date of IRB
2022 Year 06 Month 23 Day
Anticipated trial start date
2022 Year 06 Month 23 Day
Last follow-up date
2024 Year 04 Month 21 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Retrospective cohort study

Management information
Registered date
2022 Year 06 Month 23 Day
Last modified on
2022 Year 06 Month 23 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054863

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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