Clinical trial NCT05489458: Predictive Factors for Resection and Survival in Type A Borderline Resectable Pancreatic Ductal Adenocarcinoma Patients After Neoadjuvant Therapy
Official title: Predictive Factors for Resection and Survival in Type A Borderline Resectable Pancreatic Ductal Adenocarcinoma Patients After Neoadjuvant Therapy: A Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Carcinoma, Pancreatic Ductal
Keywords: BR-PDAC
Pancreatic Ductal Adenocarcinoma
Borderline Resectable
CA 19-9
Anatomical
Lead sponsor: Hospital Universitari de Bellvitge
Sponsor class: OTHER
First posted: 2022-08-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The number of type A BR-PDAC patients who, after receiving NAT (≥3 cycles), undergo resection.
timeFrame: From 6 weeks until the end of the observation period (December 2019) or death (whichever occurs first)
measure: The evolution of the plasmatic levels of CA 19-9 from starting NAT until the surgical exploration.
timeFrame: Up to 16 weeks
measure: The evolution of the degree of vascular involvement in 64-MDCT scans from starting NAT until the surgical exploration.
timeFrame: Up to 16 weeks
measure: Overall survival
timeFrame: From starting NAT until the end of the observation period (December 2019) or death (whichever occurs first).
measure: The evolution of the plasmatic levels of CA 19-9
timeFrame: From starting NAT until end of the observation period (December 2019) or death (whichever occurs first).
measure: The evolution of the degree of vascular involvement in 64-MDCT scans
timeFrame: From starting NAT until end of the observation period (December 2019) or death (whichever occurs first).
measure: Progression-Free Survival
timeFrame: From starting NAT until end of the observation period (December 2019) or disease progression (whichever occurs first).
measure: The evolution of the plasmatic levels of CA 19-9
timeFrame: From starting NAT until end of the observation period (December 2019) or disease progression (whichever occurs first).
measure: The evolution of the degree of vascular involvement in 64-MDCT scans
timeFrame: From starting NAT until end of the observation period (December 2019) or disease progression (whichever occurs first).
Secondary outcomes:
measure: The number (percentage) of deaths at the end of the observation period.
timeFrame: From starting NAT until end of the observation period (December 2019)
measure: The number (percentage) of patients presenting disease progression at the end of the observation period.
timeFrame: From starting NAT until end of the observation period (December 2019)
measure: The number (percentage) of patients presenting stable disease at the end of the observation period.
timeFrame: From starting NAT until end of the observation period (December 2019)
measure: The number (percentage) of patients considered responders at the end of the observation period.
timeFrame: From starting NAT until end of the observation period (December 2019)
measure: The number (percentage) of patients surgically explored at the end of the observation period.
timeFrame: From starting NAT until end of the observation period (December 2019)
measure: The Resection Rate at the end of the observation period.
timeFrame: From starting NAT until end of the observation period (December 2019)
Other outcomes:
Locations:
Study officials:
affiliation: Bellvitge University Hospital
name: Luis Secanella, MD
role: PRINCIPAL_INVESTIGATOR
References: