UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043939 |
|---|---|
| Receipt number | R000050179 |
| Scientific Title | A multicenter observational study of Liposomal Irinotecan and fluorouracil/leucovorin in patients with unresectable or recurrent pancreatic cancer (NAPOLEON 2) (Prospective part) |
| Date of disclosure of the study information | 2021/06/01 |
| Last modified on | 2024/04/17 09:25:06 |
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Basic information
Public title
A multicenter observational study of Liposomal Irinotecan and fluorouracil/leucovorin in patients with unresectable or recurrent pancreatic cancer (NAPOLEON 2) (Prospective part)
Acronym
NAPOLEON 2 study
Scientific Title
A multicenter observational study of Liposomal Irinotecan and fluorouracil/leucovorin in patients with unresectable or recurrent pancreatic cancer (NAPOLEON 2) (Prospective part)
Scientific Title:Acronym
NAPOLEON 2 study
Region
| Japan |
Condition
Condition
Pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hematology and clinical oncology | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Effectiveness and safety analyses for Liposomal Irinotecan and fluorouracil/leucovorin in patients with unresectable or recurrent pancreatic cancer.
Basic objectives2
Others
Basic objectives -Others
Analysis for prognostic or predictive markers
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
Response rate, disease control rate, progression-free survival
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
Patients
1. whose unresectable or recurrent pancreatic cancer are judged by abdominal CT.
2. who are going to receive NAL-IRI/FU/LV after at least one regimen.
3. whose tumors are not NET.
4. who submitted ICs.
5. of greater than or equal to 20 years old.
6. with adequate organ functions.
7. with ECOG PS 0-2.
Key exclusion criteria
Patients
1. with active double cancers.
2. whom the doctor in-chief judged not to be indicated for this study.
3. who cannot submit ICs.
4. who have allergy for NAL-IRI.
5. who are contraindicated for NAL-IRI.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Shirakawa |
Organization
Karatsu Higashi-Matsuura Medical Association Center
Division name
Medical Office
Zip code
847-0041
Address
2566-11, Chiyoda-machi, Karatsu-shi, Saga
TEL
0955-75-5170
twriver1979@gmail.com
Public contact
Name of contact person
| 1st name | Taiga |
| Middle name | |
| Last name | Otsuka |
Organization
Minato Medical Clinic
Division name
Department of Internal Medicine
Zip code
810-0072
Address
3-11-3 Nagahama, Chuo-ku, Fukuoka-shi, Fukuoka
TEL
092-711-6900
Homepage URL
otsuka-t@umin.ac.jp
Sponsor or person
Institute
Sasebo Kyosai Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sasebo Kyosai Hospital
Address
10-17, Simanji-cho, Sasebo-shi, Nagasaki
Tel
0956-22-5136
kenji.mitsugi@sb.kkr.or.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
朝倉医師会病院 肝胆膵内科(福岡県)，出水総合医療センター 消化器内科(鹿児島県)，今村総合病院 消化器内科(鹿児島県)，大分県厚生連鶴見病院 腫瘍内科(大分県)，大分大学医学部附属病院 腫瘍・血液内科(大分県)，鹿児島市立病院 消化器内科(鹿児島県)，鹿児島大学病院 消化器内科(鹿児島県)，唐津赤十字病院 内科(佐賀県)，岐阜大学医学部附属病院 がんセンター(岐阜県)，君津中央病院 腫瘍内科(千葉県)，熊本赤十字病院 血液腫瘍内科(熊本県)，久留米大学病院 がん集学治療センター・消化器内科部門(福岡県)，国立病院機構熊本医療センター 腫瘍内科(熊本県)，国立病院機構佐賀病院 内科(佐賀県)，国家公務員共済組合連合佐世保共済病院 腫瘍内科(長崎県)，国家公務員共済組合連合浜の町病院 腫瘍内科(福岡県)，済生会川内病院 消化器内科(鹿児島県)，済生会熊本病院 腫瘍内科(熊本県)，佐賀県医療センター好生館 肝胆膵内科(佐賀県)，地域医療機能推進機構九州病院 腫瘍内科(福岡県)，長崎原爆病院 消化器内科(長崎県)，長崎大学病院 消化器内科(長崎県)，福岡大学病院 腫瘍・血液・感染症内科(福岡県)，宮崎県立宮崎病院 化学療法科・外科(宮崎県)，宮崎大学医学部附属病院 がん診療部(宮崎県)，山口大学大学院医学系研究科 医学統計学分野(山口県)
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 06 | Month | 01 | 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 | 04 | Month | 05 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 17 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
| 2024 | Year | 04 | Month | 26 | Day |
Date analysis concluded
Other
Other related information
We will analyze post-hoc studies.
Management information
Registered date
| 2021 | Year | 04 | Month | 15 | Day |
Last modified on
| 2024 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050179
