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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | Pancreatic cancer | |
Classification by specialty |
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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 | |
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Randomization | |
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Control | |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | |
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Eligibility | ||||
Age-lower limit |
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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. |
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Key exclusion criteria | None | |||
Target sample size | 500 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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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 |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
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Baseline Characteristics | |
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IPD sharing Plan description |
Progress | |||||||
Recruitment status | Open public recruiting | ||||||
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Other | |
Other related information | Retrospective cohort study |
Management information | |||||||
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Last modified on |
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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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