Carcinoma, Pancreatic DuctalPF-BARNANCT05489458
Predictive Factors for Resection and Survival in Type A Borderline Resectable Pancreatic Ductal Adenocarcinoma Patients After Neoadjuvant Therapy
An observational study of Carcinoma, Pancreatic Ductal, run by BUSQUETS, JULI.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Pancreatic Ductal
- What is being tested?
- Resection and No Resection
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Sep 2022to Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Carcinoma, Pancreatic Ductal
- Being tested
- Resection, No Resection
- Keywords
- BR-PDAC, Pancreatic Ductal Adenocarcinoma, Borderline Resectable, CA 19-9, Anatomical
- Medical subject headings
- Carcinoma, Pancreatic Ductal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResectionProcedure or surgery
Type A BR-PDAC patients who had a favorable tumor/vascular structures relationship confirmed during surgical exploration underwent resection.
No ResectionProcedure or surgery
Type A BR-PDAC patients who did not have a favorable tumor/vascular structures relationship confirmed during surgical exploration did not undergo resection.
| Study group | Role | What they receive |
|---|---|---|
| Exploratory Surgery with Resection | Type A BR-PDAC patients that underwent surgical exploration after neoadjuvant therapy and had their tumors resected. Receives: 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. Receives: Procedure: No Resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Up to 16 weeks
Overall survival
Time until death (from any cause)
Measured: 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
Measured: 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.
Measured: From starting NAT until end of the observation period (December 2019) or death (whichever occurs first).
Progression-Free Survival
Time until disease progression
Measured: 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
Measured: 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.
Measured: From starting NAT until end of the observation period (December 2019) or disease progression (whichever occurs first).
Secondary outcomes (6)
The number (percentage) of deaths at the end of the observation period.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From starting NAT until end of the observation period (December 2019)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2022
- Study startSep 2022 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Pancreatic DuctalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BUSQUETS, JULI
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, BUSQUETS, JULI, Hospital Universitari de Bellvitge
- Investigators
- Luis Secanella, MD, Principal investigator, Hospital Universitari de Bellvitge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05489458
- Sponsor's protocol ID
- HUB-BR-PDAC-2022
- Acronym
- PF-BARNA
- Status last verified
- Aug 2022
- First submitted
- 1 Aug 2022
- Last updated
- 5 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Factors for Resection and Survival in Type A Borderline Resectable Pancreatic Ductal Adenocarcinoma Patients After Neoadjuvant Therapy: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT05489458
- Acronym / sponsor ID
- PF-BARNA / HUB-BR-PDAC-2022
- Conditions
- Carcinoma, Pancreatic Ductal
- Keywords
- BR-PDAC, Pancreatic Ductal Adenocarcinoma, Borderline Resectable, CA 19-9, Anatomical
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- BUSQUETS, JULIUniversity, hospital or other
- Study start
- Sep 2022 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 5 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exploratory Surgery with Resection | – | Procedure: ResectionType A BR-PDAC patients that underwent surgical exploration after neoadjuvant therapy and had their tumors resected. |
| Exploratory Surgery without Resection | – | Procedure: No ResectionType A BR-PDAC patients that underwent surgical exploration after neoadjuvant therapy and did not have their tumors resected. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ResectionType A BR-PDAC patients who had a favorable tumor/vascular structures relationship confirmed during surgical exploration underwent resection. | Procedure or surgery | Exploratory Surgery with Resection |
| No ResectionType A BR-PDAC patients who did not have a favorable tumor/vascular structures relationship confirmed during surgical exploration did not undergo resection. | Procedure or surgery | Exploratory Surgery without Resection |
Primary outcome
The number of type A BR-PDAC patients who, after receiving NAT (≥3 cycles), undergo resection.
Time frame: 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 plasmatic levels of CA 19-9 from starting NAT until the surgical exploration.
Time frame: 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 the surgical exploration.
Time frame: 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.
Overall survival
Time frame: From starting NAT until the end of the observation period (December 2019) or death (whichever occurs first).
Time until death (from any cause)
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
Time frame: From starting NAT until end of the observation period (December 2019) or death (whichever occurs first).
The tumor's anatomical relationship with neighboring vascular structures; measured with 64-MDCT scans.
Progression-Free Survival
Time frame: 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
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
Time frame: 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.
6 secondary outcomes
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.
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.
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.
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.
Time frame: From starting NAT until end of the observation period (December 2019)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luis Secanella, MD principal investigator
Hospital Universitari de Bellvitge
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Pancreatic Ductal, run by BUSQUETS, JULI.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juli Busquets, MD, PhD (034932607623, jbusquets@bellvitgehospital.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of type A BR-PDAC patients who, after receiving NAT (≥3 cycles), undergo resection. (time frame: From 6 weeks until the end of the observation period (December 2019) or death (whichever occurs first)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2022.