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

Sponsor
Asan Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT05888129
Collaborator
(none)
1
1
72
0

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
1 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
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?
Actual Study Start Date :
Jan 1, 2017
Actual Primary Completion Date :
Dec 31, 2020
Actual Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. oncologic outcome [3 - 5 years after surgery]

    overall survival and recurrence free survival according to the groups

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • The study population consists of patients who underwent pancreatectomy for pancreatic adenocarcinoma between January 2017 and December 2020
Exclusion Criteria:
  • None

Contacts and Locations

Locations

Site City State Country Postal Code
1 Asan medical center Seoul Korea, Republic of 05505

Sponsors and Collaborators

  • Asan Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Song Cheol Kim, Professor, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT05888129
Other Study ID Numbers:
  • 2016-0902
First Posted:
Jun 5, 2023
Last Update Posted:
Jun 5, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 5, 2023