NCT06129812

Brief Summary

An Exploration of Candidates for Neoadjuvant Treatment in Resectable Pancreatic Cancer

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,132

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2007

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
14.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

October 27, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 13, 2023

Completed
Last Updated

November 13, 2023

Status Verified

September 1, 2023

Enrollment Period

14.9 years

First QC Date

October 27, 2023

Last Update Submit

November 9, 2023

Conditions

Pancreatic CancerNeoadjuvant

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    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

Study Arms (3)

resectable PDAC with no contact to major vessels (R-no contact)

Drug: Neoadjuvant treatment

resectable PDAC with contact PV/SMV of ≤180° (R-contact)

Drug: Neoadjuvant treatment

borderline resectable PDAC with PV/SMV contact >180° and without arterial involvement (BR-V)

Drug: Neoadjuvant treatment

Interventions

Neoadjuvant treatmentDRUG

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)resectable PDAC with contact PV/SMV of ≤180° (R-contact)resectable PDAC with no contact to major vessels (R-no contact)

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeutics

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2023

First Posted

November 13, 2023

Study Start

January 1, 2007

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

November 13, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share