UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060823 |
|---|---|
| Receipt number | R000069601 |
| Scientific Title | POTE-CON Study: A Prospective Observational Study Evaluating the Indications, Efficacy, and Safety of Conversion Surgery Following Non-Surgical Treatment for Locally Advanced or Metastatic Pancreatic Cancer |
| Date of disclosure of the study information | 2026/03/05 |
| Last modified on | 2026/03/05 00:22:59 |
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Basic information
Public title
Prospective Observational Study on the Indications, Efficacy, and Safety of Conversion Surgery After Non-Surgical Treatment for Locally Advanced or Metastatic Pancreatic Cancer (JG Project-01)
Acronym
POTE-CON study (POTEntially CONvertible pancreatic cancer study)
Scientific Title
POTE-CON Study: A Prospective Observational Study Evaluating the Indications, Efficacy, and Safety of Conversion Surgery Following Non-Surgical Treatment for Locally Advanced or Metastatic Pancreatic Cancer
Scientific Title:Acronym
POTE-CON Study
Region
| Japan |
Condition
Condition
Unresectable Pancreatic Cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To prospectively evaluate the feasibility, safety, and efficacy of conversion surgery (CS) in patients with locally advanced pancreatic cancer (UR-LA or BR-A) and metastatic pancreatic cancer (UR-M) considered to fall within the criteria for potentially convertible disease.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Conversion rate and R0 resection rate
Key secondary outcomes
a. Postoperative in-hospital mortality
b. Postoperative perioperative complication rate
c. Overall survival after initiation of treatment
d. Patterns of recurrence
e. Changes in serum tumor marker levels
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
1. Patients aged over 20 years at the time of informed consent.
2. Patients diagnosed with unresectable pancreatic cancer at the initial presentation, defined by major arterial involvement and/or distant metastasis.
3. Borderline resectable pancreatic cancer (BRA): Tumor contact or invasion of under 180 degrees with the celiac axis (CA) and/or common hepatic artery (CHA), and/or under 180 degrees contact with the superior mesenteric artery (SMA) without definite arterial encasement.
4. Potentially convertible pancreatic cancer, defined as follows:
(a) Potentially convertible locally advanced pancreatic cancer (URLAPC): Tumor contact or invasion of 180 to 360 degrees with the celiac axis (CA) and/or common hepatic artery (CHA), and/or 180 to 360 degrees contact with the superior mesenteric artery (SMA) without definite encasement; or invasion of the portal vein (PV) deemed unreconstructable.
(b) Potentially convertible metastatic pancreatic cancer (URMPC): (1) Patients meeting any of the following conditions: Up to three liver metastases (2) Metastatic involvement in up to two sites among liver metastasis, lung metastasis, and para-aortic lymph node metastasis (multiple organs allowed) (3) Positive peritoneal cytology (CY1) without macroscopic peritoneal dissemination, confirmed by staging laparoscopy.
5. Patients planned to undergo non-surgical treatment and who understand and agree to the possibility of conversion surgery (CS) thereafter.
6. Adequate organ function and general condition judged sufficient to tolerate surgical resection.
7. Written informed consent obtained from the patient after receiving a full explanation of the study and demonstrating adequate understanding.
Key exclusion criteria
1. Patients younger than 20 years of age at the time of informed consent.
2. Patients with resectable pancreatic cancer at the initial diagnosis.
3. Tumor conditions exceeding the above eligibility criteria, such as definite encasement or severe narrowing of the superior mesenteric artery (SMA) or peritoneal dissemination.
4. Patients for whom conversion surgery (CS) is not intended at the time of enrollment, or those who do not agree to the possibility of CS after non-surgical treatment.
5. Patients judged unable to tolerate surgical resection due to poor general condition.
6. Patients with recurrent pancreatic cancer.
7. Patients deemed inappropriate for participation in the study by the principal investigator for any other reason.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yu |
| Middle name | |
| Last name | Takahashi |
Organization
Cancer Institute Hospital of JFCR
Division name
Hepatobiliary and Pancreatic Surgery Division
Zip code
135-8550
Address
Tokyo, Ko-to ku, Ariake, 3-8-31
TEL
0335200111
sho.kiritani@jfcr.or.jp
Public contact
Name of contact person
| 1st name | Sho |
| Middle name | |
| Last name | Kiritani |
Organization
Cancer Institute Hospital of JFCR
Division name
Hepatobiliary and Pancreatic Surgery Division
Zip code
135-8550
Address
Tokyo, Koto-ku, Ariake, 3-8-31
TEL
0335200111
Homepage URL
sho.kiritani@gmail.com
Sponsor or person
Institute
Cancer Institute Hospital of JFCR
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
Cancer Institute Hospital of JFCR
Address
Tokyo, Koto-ku, Ariake, 3-8-31
Tel
0335200111
sho.kiritani@jfcr.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
東京都
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 05 | 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
58
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
| 2020 | Year | 04 | Month | 30 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 15 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The enrollment and observation periods have been completed, and data analysis is currently underway.
Management information
Registered date
| 2026 | Year | 03 | Month | 05 | Day |
Last modified on
| 2026 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069601
