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2022-09
2022-10
2023-01
100
NCT05489458
Hospital Universitari de Bellvitge
Hospital Universitari de Bellvitge
OBSERVATIONAL
Predictive Factors for Resection and Survival in Type A Borderline Resectable Pancreatic Ductal Adenocarcinoma Patients After Neoadjuvant Therapy
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.
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 Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2022-08-01 | N/A | 2022-08-03 |
2022-08-03 | N/A | 2022-08-05 |
2022-08-05 | N/A | 2022-08 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | 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
|
| : 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
|
| Primary Outcome Measures | 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 | 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) |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
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 |
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.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
