An Exploration of Candidates for Neoadjuvant Treatment in Resectable Pancreatic Cancer

November 9, 2023 updated by: Seoul National University Hospital

An Exploration of Candidates for Neoadjuvant Treatment in Resectable Pancreatic Cancer According to Tumor-vessel Relationship and CA 19-9 Levels

An Exploration of Candidates for Neoadjuvant Treatment in Resectable Pancreatic Cancer

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The 1,132 patients with resectable or borderline resectable PDAC who underwent surgery between 2007 and 2021 were retrospectively reviewed. Patients with resectable PDAC without contact of major vessels (R-no contact) (n=651), with contact of portal vein or superior mesenteric vein (PV/SMV) ≤180° (R-contact) (n=306), and borderline resectable PDAC without arterial involvement (BR-V) (n=175) were analyzed.

Study Type

Observational

Enrollment (Actual)

1132

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

N/A

Sampling Method

Non-Probability Sample

Study Population

consecutive patients with resectable or borderline resectable pancreatic ductal adenocarcinoma (PDAC)

Description

Inclusion Criteria:

  • Patients diagnosed with resectable or borderline resectable pancreatic ductal adenocarcinoma (PDAC)
  • Between January 2007 and June 2021 at Seoul National University Hospital

Exclusion Criteria:

  • Patients who had borderline resectable PDAC with arterial invasion
  • Patients who received chemotherapy as initial treatment and did not undergo surgery
  • Incomplete follow-up data for analysis

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
resectable PDAC with no contact to major vessels (R-no contact)
Drug: Neoadjuvant treatment
Intravenous gemcitabine-based combination regimens or FOLFIRINOX were included in NAC.
resectable PDAC with contact PV/SMV of ≤180° (R-contact)
Drug: Neoadjuvant treatment
Intravenous gemcitabine-based combination regimens or FOLFIRINOX were included in NAC.
borderline resectable PDAC with PV/SMV contact >180° and without arterial involvement (BR-V)
Drug: Neoadjuvant treatment
Intravenous gemcitabine-based combination regimens or FOLFIRINOX were included in NAC.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: From the date when biopsy results came out until the date of death from any cause or the date of the last visit, whichever came first, assessed up to 60 months
the time from diagnosis to death from any cause or the date of the last visit
From the date when biopsy results came out until the date of death from any cause or the date of the last visit, whichever came first, assessed up to 60 months

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

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, 2007

Primary Completion (Actual)

December 1, 2021

Study Completion (Actual)

December 1, 2021

Study Registration Dates

First Submitted

October 27, 2023

First Submitted That Met QC Criteria

November 9, 2023

First Posted (Estimated)

November 13, 2023

Study Record Updates

Last Update Posted (Estimated)

November 13, 2023

Last Update Submitted That Met QC Criteria

November 9, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NAT in resectable PDAC

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

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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