UMIN-CTR Clinical Trial

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
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Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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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
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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
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Results
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Results Delayed
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Baseline Characteristics
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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
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Research case data
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