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 2023/12/12 19:08:43

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

Email

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


Email

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

Email

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 05 Month 31 Day

Date of closure to data entry


Date trial data considered complete

2024 Year 04 Month 28 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

2023 Year 12 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050179


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name