UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061995 |
|---|---|
| Receipt number | R000070936 |
| Scientific Title | A Multicenter Retrospective Study to Evaluate the Current Practice of Neoadjuvant Therapy for Biological Borderline Resectable Pancreatic Cancer |
| Date of disclosure of the study information | 2026/06/22 |
| Last modified on | 2026/06/22 07:10:06 |
* 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 Retrospective Study of Neoadjuvant Therapy for Biological Borderline Resectable Pancreatic Cancer
Acronym
A Multicenter Retrospective Study of Neoadjuvant Therapy for Biological Borderline Resectable Pancreatic Cancer
Scientific Title
A Multicenter Retrospective Study to Evaluate the Current Practice of Neoadjuvant Therapy for Biological Borderline Resectable Pancreatic Cancer
Scientific Title:Acronym
A Multicenter Retrospective Study to Evaluate the Current Practice of Neoadjuvant Therapy for Biological Borderline Resectable Pancreatic Cancer
Region
| Japan |
Condition
Condition
Pancreatic invasive ductal adenocarcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery | Operative medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the current practice of neoadjuvant therapy in patients with biological borderline resectable pancreatic cancer with elevated CA19-9 levels and to provide insights into the development of optimal neoadjuvant treatment strategies for this condition.
Basic objectives2
Others
Basic objectives -Others
To evaluate the impact of neoadjuvant therapy regimens and CA19-9 dynamics on postoperative outcomes in patients with biological borderline resectable pancreatic cancer with elevated CA19-9 levels.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
Postoperative overall survival according to neoadjuvant treatment regimen
Key secondary outcomes
Recurrence-free survival and patterns of recurrence according to neoadjuvant therapy regimen, and the association of CA19-9 dynamics during neoadjuvant therapy with prognosis and patterns of recurrence.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with biological borderline resectable pancreatic cancer with elevated CA19-9 levels (>500 U/mL) who underwent pancreatic resection following neoadjuvant therapy between January 1 2012 and December 31 2023.
Key exclusion criteria
Patients who opted out of participation in this study.
Target sample size
220
Research contact person
Name of lead principal investigator
| 1st name | Hirofumi |
| Middle name | |
| Last name | Akita |
Organization
Graduate School of Medicine, Osaka University, Osaka, Japan
Division name
Department of Gastroenterological Surgery
Zip code
565-0871
Address
2-2 Yamadaoka E-2, Suita, Osaka, Japan
TEL
06-6879-3251
hakita@gesurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasunari |
| Middle name | |
| Last name | Fukuda |
Organization
Osaka International Cancer Institute, Osaka, Japan
Division name
Department of Gastroenterological Surgery
Zip code
541-8567
Address
3-1-69 Otemae, Chuo-Ku, Osaka-shi, Osaka, Japan
TEL
06-6945-1181
Homepage URL
yasunari.fukuda@oici.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Osaka International Cancer Institute
Address
3-1-69 Otemae, Chuo-Ku, Osaka-shi, Osaka, Japan
Tel
06-6945-1181
oici@esct.bvits.com
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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 22 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 06 | Month | 09 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 10 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multicenter retrospective observational study
Management information
Registered date
| 2026 | Year | 06 | Month | 22 | Day |
Last modified on
| 2026 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070936
