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NCT05888129 Clinical Trial

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

Postoperative Complications Clinical Trial

— COSNALAP  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05888129
Other study ID # 2016-0902
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2017
Est. completion date December 31, 2022

Study information
Verified date June 2023
Source Asan Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 1
Est. completion date December 31, 2022
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - The study population consists of patients who underwent pancreatectomy for pancreatic adenocarcinoma between January 2017 and December 2020 Exclusion Criteria: - None

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• surgery after neoadjuvant chemotherapy
surgery after neoadjuvant chemotherapy

Locations
Country Name City State
Korea, Republic of Asan medical center Seoul

Sponsors (1)
Lead Sponsor Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary oncologic outcome overall survival and recurrence free survival according to the groups 3 - 5 years after surgery
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