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

NCT06630481 | Completed

• 1 other identifier: 2407-036-1558
• Study Type: observational
• Target: 462
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 1.Neoadjuvant treatment (NAT) is increasingly used in managing pancreatic ductal adenocarcinoma (PDAC), necessitating dependable methods to evaluate tumor response.
2. 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. 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.

Conditions

Pancreatic Cancer; Neoadjuvant Therapy; Pathological Complete Response

Keywords

CAP grade; tumor response grading system

Outcome Measures

Primary Outcomes (2)

• 5-year overall survival

  from diagnosis to any cause of death

  assessed up to 60months

• 5-year disease-free survival

  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

Study Arms (5)

CAP grade 0

No viable cancer cells in pancreatic resection specimen with neoadjuvant therapy.

Drug: neoadjuvant therapy

CAP grade 1

Single cells or rare small groups of cancer cells in pancreatic resection specimen with neoadjuvant therapy.

Drug: neoadjuvant therapy

CAP grade 2

Residual cancer with evident tumor regression in pancreatic resection specimen with neoadjuvant therapy.

Drug: neoadjuvant therapy

CAP grade 3

Extensive residual cancer with no evident tumor regression in pancreatic resection specimen with neoadjuvant therapy.

Drug: neoadjuvant therapy

pathological complete response

No viable cancer cells in pancreatic resection specimen with neoadjuvant therapy.

Drug: neoadjuvant therapy

Interventions

neoadjuvant therapy DRUG

Neoadjuvant chemotherapy, neoadjuvant radiotherapy, or both.

CAP grade 0; CAP grade 1; CAP grade 2; CAP grade 3; pathological complete response

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Seoul National University Hospital: lead

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 2, 2024
• First Posted: October 8, 2024
• Study Start: January 1, 2009
• Primary Completion: December 31, 2023
• Study Completion: September 1, 2024
• Last Updated: October 8, 2024

Record last verified: 2024-08