Clincosm LogoSign in Get a demo

An Exploration of Candidates for Neoadjuvant Treatment in Resectable Pancreatic Cancer

Sponsor
Seoul National University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT06129812
Collaborator
(none)
1,132
Enrollment
179
Actual Duration (Months)

Study Details

Study Description

Brief Summary

An Exploration of Candidates for Neoadjuvant Treatment in Resectable Pancreatic Cancer

Condition or Disease Intervention/Treatment Phase
  • Drug: Neoadjuvant 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 Design

Study Type:
Observational
Actual Enrollment :
1132 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
An Exploration of Candidates for Neoadjuvant Treatment in Resectable Pancreatic Cancer According to Tumor-vessel Relationship and CA 19-9 Levels
Actual Study Start Date :
Jan 1, 2007
Actual Primary Completion Date :
Dec 1, 2021
Actual Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Overall survival [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Seoul National University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT06129812
Other Study ID Numbers:
  • NAT in resectable PDAC
First Posted:
Nov 13, 2023
Last Update Posted:
Nov 13, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Pancreatic Neoplasms

Study Results

No Results Posted as of Nov 13, 2023