Predictive Factors for Resection and Survival in Type A Borderline Resectable Pancreatic Ductal Adenocarcinoma Patients After Neoadjuvant Therapy (PF-BARNA)

Predictive Factors for Resection and Survival in Type A Borderline Resectable Pancreatic Ductal Adenocarcinoma Patients After Neoadjuvant Therapy: A Retrospective Cohort Study

Radical surgical resection is the only curative treatment option for pancreatic cancer, but borderline resectable tumors have a high probability of incomplete exeresis. Although neoadjuvant therapy can improve the chances of complete exeresis, not all patients respond as expected.

Study Overview

• Status: Not yet recruiting
• Conditions: Carcinoma, Pancreatic Ductal
• Intervention / Treatment: Procedure: Resection; Procedure: No Resection

Detailed Description

Pancreatic cancer is an important cause of cancer-related death worldwide. Radical surgical resection still is the only curative treatment option today, but not all tumors are considered resectable. Among resectable tumors, some are deemed borderline and have a high probability of incomplete exeresis. Neoadjuvant therapy (NAT) can be a game-changer for borderline cases, and there is a lack of evidence on the predictive factors associated with resectability after neoadjuvant treatment.

This study aims to assess the prognostic factors for resectability and survival after NAT in type A borderline resectable pancreatic ductal adenocarcinoma patients.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Juli Busquets, MD, PhD; Phone Number: 034932607623; Email: jbusquets@bellvitgehospital.cat
• Study Contact Backup: Name: Luis Secanella, MD; Phone Number: 034932607623; Email: lsecanella@bellvitgehospital.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All BR-PDAC patients that required an evaluation by the Digestive and General Surgery Department from January 2010 to December 2019 were assessed for eligibility. These patients live within the Bellvitge University Hospital (tertiary level hospital) service area.

Description

Inclusion Criteria:

• Patients ≥18 years old.
• Both sexes.
• Diagnosed with a type A BR-PDAC between January 2010 and December 2019.
• Minimum follow-up period of 12 months.

Exclusion Criteria:

• Patients diagnosed with a type B or type C BR-PDAC.
• Patients diagnosed with a type A BR-PDAC who had disease progression prior to receiving NAT.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Exploratory Surgery with Resection; Type A BR-PDAC patients that underwent surgical exploration after neoadjuvant therapy and had their tumors resected.	Procedure: Resection; Type A BR-PDAC patients who had a favorable tumor/vascular structures relationship confirmed during surgical exploration underwent resection.
Exploratory Surgery without Resection; Type A BR-PDAC patients that underwent surgical exploration after neoadjuvant therapy and did not have their tumors resected.	Procedure: No Resection; Type A BR-PDAC patients who did not have a favorable tumor/vascular structures relationship confirmed during surgical exploration did not undergo resection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of type A BR-PDAC patients who, after receiving NAT (≥3 cycles), undergo resection.	NAT was administered up to 6 cycles, and cycles were administered every 2 weeks. The minimum time interval between the last NAT session and surgery was 4 weeks.	From 6 weeks until the end of the observation period (December 2019) or death (whichever occurs first)
The evolution of the plasmatic levels of CA 19-9 from starting NAT until the surgical exploration.	NAT was administered up to 6 cycles, and cycles were administered every 2 weeks. The minimum time interval between the last NAT session and surgery was 4 weeks.	Up to 16 weeks
The evolution of the degree of vascular involvement in 64-MDCT scans from starting NAT until the surgical exploration.	We will evaluate the tumor's anatomical relationship with neighboring vascular structures before and after NAT, measured with 64-MDCT (multidetector computerized tomography) scans. NAT was administered up to 6 cycles, and cycles were administered every 2 weeks. The minimum time interval between the last NAT session and surgery was 4 weeks.	Up to 16 weeks
Overall survival	Time until death (from any cause)	From starting NAT until the end of the observation period (December 2019) or death (whichever occurs first).
The evolution of the plasmatic levels of CA 19-9		From starting NAT until end of the observation period (December 2019) or death (whichever occurs first).
The evolution of the degree of vascular involvement in 64-MDCT scans	The tumor's anatomical relationship with neighboring vascular structures; measured with 64-MDCT scans.	From starting NAT until end of the observation period (December 2019) or death (whichever occurs first).
Progression-Free Survival	Time until disease progression	From starting NAT until end of the observation period (December 2019) or disease progression (whichever occurs first).
The evolution of the plasmatic levels of CA 19-9		From starting NAT until end of the observation period (December 2019) or disease progression (whichever occurs first).
The evolution of the degree of vascular involvement in 64-MDCT scans	The tumor's anatomical relationship with neighboring vascular structures; measured with 64-MDCT scans.	From starting NAT until end of the observation period (December 2019) or disease progression (whichever occurs first).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number (percentage) of deaths at the end of the observation period.		From starting NAT until end of the observation period (December 2019)
The number (percentage) of patients presenting disease progression at the end of the observation period.	Disease progression will be considered as the development of metastatic disease and/or an increase in the primary tumor size.	From starting NAT until end of the observation period (December 2019)
The number (percentage) of patients presenting stable disease at the end of the observation period.	Stable disease will be considered as an insufficient increase or reduction in the primary tumor size or in its relationship with neighboring vascular structures (i.e., cases that cannot be classified as responders).	From starting NAT until end of the observation period (December 2019)
The number (percentage) of patients considered responders at the end of the observation period.	Patients will be considered responders when the primary tumor presents a reduction in size and/or in its relationship with neighboring vascular structures.	From starting NAT until end of the observation period (December 2019)
The number (percentage) of patients surgically explored at the end of the observation period.		From starting NAT until end of the observation period (December 2019)
The Resection Rate at the end of the observation period.	The Resection Rate will be calculated by dividing the total number of resections performed by the total number of patients treated with NAT.	From starting NAT until end of the observation period (December 2019)

Collaborators and Investigators

• Sponsor: BUSQUETS, JULI
• Investigators: Principal Investigator: Luis Secanella, MD, Bellvitge University Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): January 1, 2023

Study Registration Dates

• First Submitted: August 1, 2022
• First Submitted That Met QC Criteria: August 3, 2022
• First Posted (Actual): August 5, 2022

Study Record Updates

• Last Update Posted (Actual): August 5, 2022
• Last Update Submitted That Met QC Criteria: August 3, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Pancreatic Ductal Adenocarcinoma; Borderline Resectable; CA 19-9; Anatomical; BR-PDAC
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Neoplasms, Ductal, Lobular, and Medullary; Pancreatic Neoplasms; Carcinoma, Ductal; Adenocarcinoma; Carcinoma, Pancreatic Ductal
• Other Study ID Numbers: HUB-BR-PDAC-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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