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

Completed

• Conditions: Pancreatic Cancer; Neoadjuvant Therapy; Pathological Complete Response
• Interventions: Drug: neoadjuvant therapy

• Registration Number: NCT06630481
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-01
• Primary Completion: 2023-12-31
• Status Verified: 2024-08
• Study Completion: 2024-09-01
• Study First Submitted: 2024-10-02
• Study First Submitted QC: 2024-10-05
• Last Update Submitted: 2024-10-05
• Study First Posted: 2024-10-08
• Last Update Posted: 2024-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 462

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CAP grade 0	neoadjuvant therapy	No viable cancer cells in pancreatic resection specimen with neoadjuvant therapy.
CAP grade 1	neoadjuvant therapy	Single cells or rare small groups of cancer cells in pancreatic resection specimen with neoadjuvant therapy.
CAP grade 2	neoadjuvant therapy	Residual cancer with evident tumor regression in pancreatic resection specimen with neoadjuvant therapy.
CAP grade 3	neoadjuvant therapy	Extensive residual cancer with no evident tumor regression in pancreatic resection specimen with neoadjuvant therapy.
pathological complete response	neoadjuvant therapy	No viable cancer cells in pancreatic resection specimen with neoadjuvant therapy.

Primary Outcome Measures

Name	Time	Method
5-year overall survival	assessed up to 60months	from diagnosis to any cause of death
5-year disease-free survival	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.