Long-term Survival Outcomes According to the Pathologic Response After Neoadjuvant Treatment in PDAC and the Fate of the Patients with Good CAP Grade (CAP with NAT)

October 5, 2024 updated by: Jin-Young Jang, Seoul National University Hospital
  1. Neoadjuvant treatment (NAT) is increasingly used in managing pancreatic ductal adenocarcinoma (PDAC), necessitating dependable methods to evaluate tumor response.
  2. Among various pathological tumor regression grading systems, the College of American Pathologists (CAP) system is commonly used to predict chemo-responsiveness and survival.
  3. This study aimed to analyze long-term survival outcomes based on pathologic response using the CAP grade after NAT in PDAC and to identify clinicopathologic factors that influence a favorable pathologic response.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

462

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All consecutive adult patients (aged >18 years) who underwent pancreatic resection after NAT at Seoul National University Hospital between January 2009 and December 2023 were included. Patients were initiated on NAT after confirming PDAC diagnosis based on pathological examination.

Description

Inclusion Criteria:

  • Adult patients (aged >18 years) who underwent pancreatic resection after NAT at a single center between January 2009 and December 2023.
  • Patients were initiated on NAT after confirming PDAC diagnosis based on pathological examination.

Exclusion Criteria:

  • Patients without a reported CAP grade
  • Patients who underwent palliative surgery
  • Patients who received NAT outside the specified protocol due to incomplete information.

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
CAP grade 0
No viable cancer cells in pancreatic resection specimen with neoadjuvant therapy.
Drug: neoadjuvant therapy
Neoadjuvant chemotherapy, neoadjuvant radiotherapy, or both.
CAP grade 1
Single cells or rare small groups of cancer cells in pancreatic resection specimen with neoadjuvant therapy.
Drug: neoadjuvant therapy
Neoadjuvant chemotherapy, neoadjuvant radiotherapy, or both.
CAP grade 2
Residual cancer with evident tumor regression in pancreatic resection specimen with neoadjuvant therapy.
Drug: neoadjuvant therapy
Neoadjuvant chemotherapy, neoadjuvant radiotherapy, or both.
CAP grade 3
Extensive residual cancer with no evident tumor regression in pancreatic resection specimen with neoadjuvant therapy.
Drug: neoadjuvant therapy
Neoadjuvant chemotherapy, neoadjuvant radiotherapy, or both.
pathological complete response
No viable cancer cells in pancreatic resection specimen with neoadjuvant therapy.
Drug: neoadjuvant therapy
Neoadjuvant chemotherapy, neoadjuvant radiotherapy, or both.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
5-year overall survival
Time Frame: assessed up to 60months
from diagnosis to any cause of death
assessed up to 60months
5-year disease-free survival
Time Frame: assessed up to 60months
defined as the duration between the date of surgery and the occurrence of the first instance of recurrence, death, or the last follow-up date.
assessed up to 60months

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, 2009

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

September 1, 2024

Study Registration Dates

First Submitted

October 2, 2024

First Submitted That Met QC Criteria

October 5, 2024

First Posted (Actual)

October 8, 2024

Study Record Updates

Last Update Posted (Actual)

October 8, 2024

Last Update Submitted That Met QC Criteria

October 5, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2407-036-1558

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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