Does Recurrent Pancreatic Cancer Really Have Similar Outcome Compared With Primary Metastatic Pancreatic Cancer?

April 3, 2025 updated by: Takehiro Okabayashi, Kochi University
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

276

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • unresectable pancreatic cancer

Exclusion Criteria:

  • Patients expected to survive for less than three months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
chemotherapy for metastatic pancreatic cancer
chemotherapy
Drug: chemotherapy agents
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.
chemotherapy for recurrent pancreatic cancer
postoperative chemotherapy
Drug: chemotherapy agents
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kochi University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2010

Primary Completion (Actual)

March 1, 2025

Study Completion (Actual)

March 1, 2025

Study Registration Dates

First Submitted

March 13, 2025

First Submitted That Met QC Criteria

April 3, 2025

First Posted (Actual)

April 10, 2025

Study Record Updates

Last Update Posted (Actual)

April 10, 2025

Last Update Submitted That Met QC Criteria

April 3, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Kochi University

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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