Clinical Outcomes of Surgery After Neoadjuvant Chemotherapy in Locally Advanced Pancreatic Cancer (COSNALAP)
June 1, 2023 updated by: Song Cheol Kim, Asan Medical Center
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
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of, 05505
- Asan Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
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. |
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. |
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
Time Frame: 3 - 5 years after surgery
|
overall survival and recurrence free survival according to the groups
|
3 - 5 years after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Song Cheol Kim, MD. PhD, Asan Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.