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

NCT ID: NCT06630481

Last Updated: 2024-10-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 462 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-01-01
• Study Completion Date: 2024-09-01

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.

Conditions

Pancreatic Cancer; Neoadjuvant Therapy; Pathological Complete Response

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

CAP grade 0

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

neoadjuvant therapy

Intervention Type: DRUG

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.

neoadjuvant therapy

Intervention Type: DRUG

Neoadjuvant chemotherapy, neoadjuvant radiotherapy, or both.

CAP grade 2

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

neoadjuvant therapy

Intervention Type: DRUG

Neoadjuvant chemotherapy, neoadjuvant radiotherapy, or both.

CAP grade 3

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

neoadjuvant therapy

Intervention Type: DRUG

Neoadjuvant chemotherapy, neoadjuvant radiotherapy, or both.

pathological complete response

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

neoadjuvant therapy

Intervention Type: DRUG

Neoadjuvant chemotherapy, neoadjuvant radiotherapy, or both.

Interventions

neoadjuvant therapy

Neoadjuvant chemotherapy, neoadjuvant radiotherapy, or both.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jin-Young Jang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

2407-036-1558

Identifier Type: -

Identifier Source: org_study_id