UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048143 |
|---|---|
| Receipt number | 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 | 2023/12/24 10:32:36 |
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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
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
hiimaoka@east.ncc.go.jp
Sponsor or person
Institute
Japan Oncology Network in Hepatobiliary and Pancreas
Institute
Department
Personal name
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
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
No longer 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
| 2023 | Year | 09 | Month | 25 | Day |
Date of closure to data entry
| 2023 | Year | 09 | Month | 25 | Day |
Date trial data considered complete
| 2023 | Year | 09 | Month | 25 | Day |
Date analysis concluded
| 2024 | Year | 04 | Month | 20 | Day |
Other
Other related information
Retrospective cohort study
Management information
Registered date
| 2022 | Year | 06 | Month | 23 | Day |
Last modified on
| 2023 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054863
