UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058482 |
|---|---|
| Receipt number | R000066138 |
| Scientific Title | A nationwide multi-institutional retrospective study to examine predictors of early postoperative recurrence in anatomically resectable pancreatic cancer treated with neoadjuvant chemotherapy (NAC-GS) |
| Date of disclosure of the study information | 2025/08/01 |
| Last modified on | 2025/07/15 21:41:53 |
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Basic information
Public title
A nationwide multi-institutional retrospective study to examine predictors of early postoperative recurrence in anatomically resectable pancreatic cancer treated with neoadjuvant chemotherapy (NAC-GS) (NAC-PIONEER trial)
Acronym
A nationwide multi-institutional retrospective study to examine predictors of early postoperative recurrence in anatomically resectable pancreatic cancer treated with neoadjuvant chemotherapy (NAC-GS) (NAC-PIONEER trial)
Scientific Title
A nationwide multi-institutional retrospective study to examine predictors of early postoperative recurrence in anatomically resectable pancreatic cancer treated with neoadjuvant chemotherapy (NAC-GS)
Scientific Title:Acronym
NAC-PIONEER trial
Region
| Japan |
Condition
Condition
Resectable pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To identify predictors of early recurrence within 6 months after surgery in patients with resectable pancreatic cancer who underwent NAC-GS.
Basic objectives2
Others
Basic objectives -Others
Determining the appropriateness of a treatment plan
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of recurrence within 6 months after surgery among patients with anatomically resectable pancreatic cancer who underwent radical resection after NAC-GS
Key secondary outcomes
Recurrence-free survival rate
Cumulative recurrence rate
Overall survival rate
Site of recurrence
Form of recurrence
Exploration of factors involved in early 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
Invasive pancreatic ductal adenocarcinoma
Resectable pancreatic cancer
Cases of initial treatment with NAC-GS
Cases with measurable lesions
Key exclusion criteria
Cases in which NAC was introduced with a regimen other than GS
Patients who could not undergo contrast-enhanced CT imaging due to allergy
Patients who refused to participate in this study by opting out
Target sample size
5500
Research contact person
Name of lead principal investigator
| 1st name | Tsutomu |
| Middle name | |
| Last name | Fujii |
Organization
University of Toyama
Division name
Department of Surgery and Science, Faculty of Medicine, Academic Assembly,
Zip code
930-0194
Address
2630 Sugitani, Toyama
TEL
076-434-7331
fjt@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Yuuko |
| Middle name | |
| Last name | Tohmatsu |
Organization
University of Toyama
Division name
Department of Surgery and Science, Faculty of Medicine, Academic Assembly,
Zip code
930-0194
Address
2630 Sugitani, Toyama
TEL
076-434-7331
Homepage URL
yuukot@med.u-toyama.ac.jp
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
Funding Source
Organization
Japanese Society of Hepato-Biliary-Pancreatic Surgery
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
Center for Clinical Research, Toyama University Hospital
Address
2630, Sugitani, Toyama
Tel
076-434-7331
rinri@adm.u-toyama.ac.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 08 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 07 | Month | 11 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 09 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2025 | Year | 07 | Month | 15 | Day |
Last modified on
| 2025 | Year | 07 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066138
