UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057694 |
|---|---|
| Receipt number | R000065921 |
| Scientific Title | Reevaluation of Treatment Outcomes Following Conversion Surgery After Introduction of New Chemotherapy for Unresectable Locally Advanced Pancreatic Cancer |
| Date of disclosure of the study information | 2025/04/24 |
| Last modified on | 2025/04/23 13:36:13 |
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Basic information
Public title
Reevaluation of Treatment Outcomes Following Conversion Surgery for Unresectable Locally Advanced Pancreatic Cancer
Acronym
Reevaluating Conversion Surgery for Locally Advanced Pancreatic Cancer
Scientific Title
Reevaluation of Treatment Outcomes Following Conversion Surgery After Introduction of New Chemotherapy for Unresectable Locally Advanced Pancreatic Cancer
Scientific Title:Acronym
Reevaluating Conversion Surgery for Locally Advanced Pancreatic Cancer
Region
| Japan |
Condition
Condition
Unresectable Locally Advanced Pancreatic Cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To reevaluate the results of Conversion Surgery after new chemotherapy (FOLFIRINOX, GnP, etc.) and to identify clinical factors and biomarkers that can contribute to the development of optimal treatment strategies.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Overall Survival from the start of initial treatment
Key secondary outcomes
Overall survival after CS, recurrence-free survival after CS, preoperative treatment period, postoperative short-term outcomes (complications, postoperative mortality), recurrence patterns, and factors contributing to 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Cases diagnosed as invasive pancreatic ductal carcinoma on postoperative pathology (however, if the case achieved complete response [CR], it must have been diagnosed as adenocarcinoma on preoperative cytology or histology).
2. Cases diagnosed at initial diagnosis as unresectable locally advanced pancreatic cancer (based on the definition of locally advanced pancreatic cancer in the NCCN Guidelines 2022 Edition Version 2). pancreatic head cancer with >180 degree contact with the superior mesenteric artery (SMA) or celiac artery (CA); pancreatic body/tail cancer with >180 degree contact with the SMA or CA, or CA involvement with aortic invasion; and unreconstructable superior mesenteric vein/portal vein invasion or occlusion.
3. Patients who underwent FOLFIRINOX therapy, GnP therapy, or its variants (mFOLFIRINOX, SOXIRI, GAS, etc.) as first-line treatment between January 2015 and December 2020, followed by CS. The presence or absence of radiotherapy is not a criterion.
4. Patients with no macroscopic peritoneal dissemination but microscopic peritoneal dissemination (CY) are eligible.
5. The types of pancreatic resection included are pancreaticoduodenectomy, pancreatic tail resection (including DP-CAR), total pancreatectomy, and others.
Key exclusion criteria
Distant metastasis at initial diagnosis
Invasive intraductal papillary mucinous carcinoma
Active multiple primary cancers
Cases deemed inappropriate by the multidisciplinary team.
Target sample size
950
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Yasuda |
Organization
Nara Medical University
Division name
Department of Surgery
Zip code
6348522
Address
840 Shijo-cho, Kashihara, Nara
TEL
0744-29-8863
hi22zd@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Yasuda |
Organization
Nara Medical University
Division name
Department of Sugery
Zip code
6348522
Address
840 Shijo-cho, Kashihara, Nara
TEL
0744298863
Homepage URL
hi22zd@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
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
Accredited Institutions of the Japanese Society of Hepato-Biliary-Pancreatic Surgery
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Nara Medical University
Address
840 Shijo-cho, Kashihara, Nara 634-8522, Japan
Tel
0744298863
hi22zd@naramed-u.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
奈良県立医科大学附属病院（奈良県）
ほか、日本肝胆膵外科学会 高度技能専門医修練施設（全国各地）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 24 | 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
950
Results
Currently under analysis. Results will be presented at academic meetings and submitted for publication.
Results date posted
| 2025 | Year | 04 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients initially diagnosed with unresectable locally advanced pancreatic cancer who received chemotherapy followed by conversion surgery were included.
Participant flow
Adverse events
No new interventions are conducted in this observational study; therefore, no adverse events are expected from the study itself.
Outcome measures
The primary outcome is overall survival from initiation of first-line treatment. Secondary outcomes include recurrence-free survival after conversion surgery, recurrence patterns, and short-term surgical outcomes.
Plan to share IPD
No plan to share individual participant data.
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2023 | Year | 03 | Month | 30 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 26 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 27 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2024 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 12 | Month | 31 | Day |
Other
Other related information
This study is a retrospective multicenter observational study of patients who underwent conversion surgery following chemotherapy for unresectable locally advanced pancreatic cancer.
Management information
Registered date
| 2025 | Year | 04 | Month | 23 | Day |
Last modified on
| 2025 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065921
