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

• Conditions: Carcinoma, Pancreatic Ductal
• Interventions: Procedure: No Resection; Procedure: Resection

• Registration Number: NCT05489458
• Lead Sponsor: BUSQUETS, JULI

Brief Summary

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.

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 Timeline

• Status Verified: 2022-08
• Study First Submitted: 2022-08-01
• Study First Submitted QC: 2022-08-03
• Last Update Submitted: 2022-08-03
• Study First Posted: 2022-08-05
• Last Update Posted: 2022-08-05
• Study Start: 2022-09
• Primary Completion: 2022-10
• Study Completion: 2023-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Exploratory Surgery without Resection	No Resection	Type A BR-PDAC patients that underwent surgical exploration after neoadjuvant therapy and did not have their tumors resected.
Exploratory Surgery with Resection	Resection	Type A BR-PDAC patients that underwent surgical exploration after neoadjuvant therapy and had their tumors resected.

Primary Outcome Measures

Name	Time	Method
Overall survival	From starting NAT until the end of the observation period (December 2019) or death (whichever occurs first).	Time until death (from any cause)
The number of type A BR-PDAC patients who, after receiving NAT (≥3 cycles), undergo resection.	From 6 weeks until the end of the observation period (December 2019) or death (whichever occurs first)	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.
The evolution of the degree of vascular involvement in 64-MDCT scans from starting NAT until the surgical exploration.	Up to 16 weeks	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.
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).
Progression-Free Survival	From starting NAT until end of the observation period (December 2019) or disease progression (whichever occurs first).	Time until disease progression
The evolution of the plasmatic levels of CA 19-9 from starting NAT until the surgical exploration.	Up to 16 weeks	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.
The evolution of the degree of vascular involvement in 64-MDCT scans	From starting NAT until end of the observation period (December 2019) or disease progression (whichever occurs first).	The tumor's anatomical relationship with neighboring vascular structures; measured with 64-MDCT scans.

Secondary Outcome Measures

Name	Time	Method
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.	From starting NAT until end of the observation period (December 2019)	The Resection Rate will be calculated by dividing the total number of resections performed by the total number of patients treated with NAT.
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.	From starting NAT until end of the observation period (December 2019)	Disease progression will be considered as the development of metastatic disease and/or an increase in the primary tumor size.
The number (percentage) of patients presenting stable disease at the end of the observation period.	From starting NAT until end of the observation period (December 2019)	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).
The number (percentage) of patients considered responders at the end of the observation period.	From starting NAT until end of the observation period (December 2019)	Patients will be considered responders when the primary tumor presents a reduction in size and/or in its relationship with neighboring vascular structures.