Clinical Outcomes of Surgery After Neoadjuvant Chemotherapy in Locally Advanced Pancreatic Cancer (COSNALAP)

Clinical Outcomes of Surgery After Neoadjuvant Chemotherapy in Locally Advanced Pancreatic Ductal Adenocarcinoma: is it Really Comparable to Borderline Resectable or Resectable Pancreatic Adenocarcinoma?

The purpose of this study was to investigate the clinical outcomes of patients with locally advanced pancreatic cancer (LA-PC) who underwent surgery after neoadjuvant chemotherapy (NACT) at Asan Medical Center's Department of Hepato-Biliary-Pancreatic Surgery from 2017 to 2020.

Study Overview

• Status: Completed
• Conditions: Postoperative Complications
• Intervention / Treatment: Procedure: surgery after neoadjuvant chemotherapy

Detailed Description

Pancreatic cancer (PC) has a very low survival rate. Most PC patients have non-specific symptoms that are advanced enough to be contraindications for surgical treatment; therefore, surgery is often impossible by the time PC is diagnosed. According to the NCCN guidelines, PCs with no metastases can be divided into resectable, borderline resectable , and locally advanced cases. Patients with borderline resectable PC (BR-PC) and locally advanced PC (LA-PC) currently receive multimodal therapy before surgery. The goal of these neoadjuvant treatments, including chemotherapy and radiation therapy, is to ultimately reduce local recurrence after surgery in patients with BR-PC and further improve their survival time. Additionally, several recent studies have reported results on the prognosis when surgery is performed after neoadjuvant chemotherapy (NACT) in patients with LA-PC. In the patients with LA-PC, surgery technically difficult because of major vascular invasion before NACT. Therefore, this study investigated the clinical outcomes of patients with LA-PC who underwent surgery after NACT. Additionally, the investigators evaluated factors affecting the prognosis related to survival after surgery in patients with LA-PC.

• Study Type: Observational
• Enrollment (Actual): 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

We retrospectively reviewed records of patients who were diagnosed with resectable, borderline resectable, or locally advanced pancreatic adenocarcinoma between January 2017 and December 2020, at the Department of Surgery, Asan Medical Center, Seoul, South Korea. A total of 1,358 patients were diagnosed with pancreatic ductal adenocarcinoma and treated.

Description

Inclusion Criteria:

• The study population consists of patients who underwent pancreatectomy for pancreatic adenocarcinoma between January 2017 and December 2020

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
locally advanced pancreatic cancer; Locally advanced pancreatic cancer (LA-PC) is classified according to the National Comprehansive Cancer Networks (NCCN) guidelines. Patients with the above conditions underwent surgery after neoadjuvant chemotherapy.	Procedure: surgery after neoadjuvant chemotherapy; surgery after neoadjuvant chemotherapy
borderline resectable pancreatic cancer; Borderline resectable pancreatic cancer (BR-PC) is classified according to the NCCN guidelines. Patients with the above conditions underwent surgery after neoadjuvant chemotherapy.	Procedure: surgery after neoadjuvant chemotherapy; surgery after neoadjuvant chemotherapy
resectable pancreatic cancer; Resectable pancreatic cancer (PC) is classified according to the NCCN guidelines. There are no arterial and venous contact with tumor Patients with the above conditions underwent upfront surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
oncologic outcome	overall survival and recurrence free survival according to the groups	3 - 5 years after surgery

Collaborators and Investigators

• Sponsor: Asan Medical Center
• Investigators: Principal Investigator: Song Cheol Kim, MD. PhD, Asan Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: May 9, 2023
• First Submitted That Met QC Criteria: June 1, 2023
• First Posted (Actual): June 5, 2023

Study Record Updates

• Last Update Posted (Actual): June 5, 2023
• Last Update Submitted That Met QC Criteria: June 1, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: 2016-0902 (Other Identifier: M D Anderson Cancer Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No