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.
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
100
Type A BR-PDAC patients who had a favorable tumor/vascular structures relationship confirmed during surgical exploration underwent resection.
Type A BR-PDAC patients who did not have a favorable tumor/vascular structures relationship confirmed during surgical exploration did not undergo resection.
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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 16 weeks
Overall survival
Time until death (from any cause)
Time frame: 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
Time frame: 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.
Time frame: From starting NAT until end of the observation period (December 2019) or death (whichever occurs first).
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Progression-Free Survival
Time until disease progression
Time frame: 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
Time frame: 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.
Time frame: From starting NAT until end of the observation period (December 2019) or disease progression (whichever occurs first).
The number (percentage) of deaths at the end of the observation period.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From starting NAT until end of the observation period (December 2019)