Pancreatic Cancer MetastaticNCT06921252
Does Recurrent Pancreatic Cancer Really Have Similar Outcome Compared With Primary Metastatic Pancreatic Cancer?
An observational study of Pancreatic Cancer Metastatic, run by Kochi University.
Trial summary
The recurrent pancreatic cancer (Rec-PC) after radical surgery is sometimes eligible to clinical trial of chemotherapy for unresectable pancreatic cancer. However, the difference between Rec-PC and primary metastatic pancreatic cancer (PM-PC) did not know well. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pancreatic Cancer Metastatic
- What is being tested?
- chemotherapy agents
- How many people
- 276 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2010to 1 Mar 2025
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: A retrospective database review of patients with recurrent or primary metastatic pancreatic cancer at a single institution, from 2010 to 2023, was conducted.
Who may be able to join
- unresectable pancreatic cancer
Who cannot join
- Patients expected to survive for less than three months
About this study
The recurrent pancreatic cancer (Rec-PC) after radical surgery is sometimes eligible to clinical trial of chemotherapy for unresectable pancreatic cancer. However, the difference between Rec-PC and primary metastatic pancreatic cancer (PM-PC) did not know well. Thus, whether Rec-PC and PM-PC should be included in the same category when conducting clinical trials evaluating chemotherapy remains controversial. The purpose of this study is to investigate the difference of overall survival (OS) between Rec-PC and PM-PC, and analyze their impact on prognosis.
- Conditions
- Pancreatic Cancer Metastatic
- Being tested
- chemotherapy agents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chemotherapy agentsDrug
Overall, data of 276 patients (144 men and 132 women, 224 Rec-PC and 51 PM-PC) were retrospectively analyzed. The median patient age was 70 (range; 29-91) years. Serum carbohydrate antigen (CA) 19-9 among Rec-PC group (median; 207 U/mL) and PM-PC group (median; 1680 U/mL) was statistically different. Rec-PC patients received gemcitabine plus nab-paclitaxel (106), S-1 (37), gemcitabine (22), FOLRIFINOX (18) and other (8) regimen as a first line chemotherapy. 67 Rec-PC patients underwent any local treatment. PM-PC patients received gemcitabine plus nab-paclitaxel (34), FOLRIFINOX (8), gemcitabine (5), S-1 (2) and other (2) regimen as a first line chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| chemotherapy for metastatic pancreatic cancer | chemotherapy Receives: Drug: chemotherapy agents | |
| chemotherapy for recurrent pancreatic cancer | postoperative chemotherapy Receives: Drug: chemotherapy agents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: From date of evaluation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start1 Jan 2010
- Primary completion1 Mar 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic Cancer MetastaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 276 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Kochi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Takehiro Okabayashi, Kochi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06921252
- Sponsor's protocol ID
- Kochi University
- Status last verified
- Apr 2025
- First submitted
- 13 Mar 2025
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sakamoto S, Tabuchi M, Tokumaru T, Uemura S, Tamura S, Yoshimatsu R, Matsumoto M, Iwata J, Iiyama T, Okabayashi T. Does Recurrent Pancreatic Cancer Have Similar Outcomes Compared With Primary Metastatic Pancreatic Cancer? J Surg Oncol. 2026 May;133(6):763-772. doi: 10.1002/jso.70222. Epub 2026 Mar 1.
PubMed 41766110
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Recurrent Pancreatic Cancer Really Have Similar Outcome Compared With Primary Metastatic Pancreatic Cancer?
- ClinicalTrials.gov ID
- NCT06921252
- Acronym / sponsor ID
- Kochi University
- Conditions
- Pancreatic Cancer Metastatic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 276 participants (actual)
- Lead sponsor
- Kochi UniversityUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 10 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The recurrent pancreatic cancer (Rec-PC) after radical surgery is sometimes eligible to clinical trial of chemotherapy for unresectable pancreatic cancer. However, the difference between Rec-PC and primary metastatic pancreatic cancer (PM-PC) did not know well. Thus, whether Rec-PC and PM-PC should be included in the same category when conducting clinical trials evaluating chemotherapy remains controversial. The purpose of this study is to investigate the difference of overall survival (OS) between Rec-PC and PM-PC, and analyze their impact on prognosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| chemotherapy for metastatic pancreatic cancer | – | Drug: chemotherapy agentschemotherapy |
| chemotherapy for recurrent pancreatic cancer | – | Drug: chemotherapy agentspostoperative chemotherapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A retrospective database review of patients with recurrent or primary metastatic pancreatic cancer at a single institution, from 2010 to 2023, was conducted.
Key inclusion criteria (1 listed)
- unresectable pancreatic cancer
Key exclusion criteria (1 listed)
- Patients expected to survive for less than three months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| chemotherapy agentsOverall, data of 276 patients (144 men and 132 women, 224 Rec-PC and 51 PM-PC) were retrospectively analyzed. The median patient age was 70 (range; 29-91) years. Serum carbohydrate antigen (CA) 19-9 among Rec-PC group (median; 207 U/mL) and PM-PC group (median; 1680 U/mL) was statistically different. Rec-PC patients received gemcitabine plus nab-paclitaxel (106), S-1 (37), gemcitabine (22), FOLRIFINOX (18) and other (8) regimen as a first line chemotherapy. 67 Rec-PC patients underwent any local treatment. PM-PC patients received gemcitabine plus nab-paclitaxel (34), FOLRIFINOX (8), gemcitabine (5), S-1 (2) and other (2) regimen as a first line chemotherapy. | Drug | chemotherapy for metastatic pancreatic cancer, chemotherapy for recurrent pancreatic cancer |
Primary outcome
Overall survival
Time frame: From date of evaluation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Derived from this study: PubMed 41766110Sakamoto S, Tabuchi M, Tokumaru T, Uemura S, Tamura S, Yoshimatsu R, Matsumoto M, Iwata J, Iiyama T, Okabayashi T. Does Recurrent Pancreatic Cancer Have Similar Outcomes Compared With Primary Metastatic Pancreatic Cancer? J Surg Oncol. 2026 May;133(6):763-772. doi: 10.1002/jso.70222. Epub 2026 Mar 1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer Metastatic, run by Kochi University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: From date of evaluation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06921252, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.