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

NCT05489458 | Unknown

• 1 other identifier: HUB-BR-PDAC-2022
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Carcinoma, Pancreatic Ductal

Keywords

BR-PDAC; Pancreatic Ductal Adenocarcinoma; Borderline Resectable; CA 19-9; Anatomical

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (6)

• 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)

• 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)

• 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)

• 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)

Study Arms (2)

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

Interventions

Resection PROCEDURE

Type A BR-PDAC patients who had a favorable tumor/vascular structures relationship confirmed during surgical exploration underwent resection.

Exploratory Surgery with Resection

No Resection PROCEDURE

Type A BR-PDAC patients who did not have a favorable tumor/vascular structures relationship confirmed during surgical exploration did not undergo resection.

Exploratory Surgery without Resection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• BUSQUETS, JULI: lead

MeSH Terms

Conditions

Carcinoma, Pancreatic Ductal

Condition Hierarchy (Ancestors)

Carcinoma, Ductal; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Ductal, Lobular, and Medullary; Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Luis Secanella, MD

  Bellvitge University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juli Busquets, MD, PhD

CONTACT

034932607623; jbusquets@bellvitgehospital.cat

Luis Secanella, MD

CONTACT

034932607623; lsecanella@bellvitgehospital.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 1, 2022
• First Posted: August 5, 2022
• Study Start: September 1, 2022
• Primary Completion: October 1, 2022
• Study Completion: January 1, 2023
• Last Updated: August 5, 2022

Record last verified: 2022-08