Failure to Adjuvant Therapy After Pancreatic Resection for Pancreatic Cancer (FOUNTAIN)

Failure to Adjuvant Therapy After Pancreatic Resection for Pancreatic Cancer: a Real Life Scenario

This study aims to evaluate the rate of patients submitted to pancreatic resection for pancreatic cancer, who fail to access to adjuvant therapy or do not complete adjuvant therapy. The purpose is to give an overview concerning the most frequent conditions and/or reasons associated with failure or omission of adjuvant therapy.

Study Overview

• Status: Completed
• Conditions: Pancreatic Malignant Neoplasm Primary

Detailed Description

This prospective observational study will evaluate all patients submitted to pancreatic resection for pancreatic cancer.

The rate of omission to adjuvant therapy and rate of failure of completion of adjuvant therapy will be evaluated as primary outcomes. As secondary outcomes, survival analyses will be performed to investigate whether these factors influence prognosis, that will be evaluated through a disease free survival analysis at 18-months. Epidemiological and perioperative data will be analyzed to identify conditions associated with the primary outcomes.

• Study Type: Observational
• Enrollment (Actual): 317

Contacts and Locations

Study Locations

• Italy
  • Verona, Italy, 37134
    • University of Verona Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients submitted to Pancreatic Resection for Pancreatic Cancer

Description

Inclusion Criteria:

• Histologic diagnosis of pancreatic cancer

Exclusion Criteria:

• Non exocrine pancreatic tumors
• Periampullary malignancies

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of patients who fail to receive adjuvant therapy and reasons for that	The amount of patients who will not receive adjuvant therapy after pancreatic resection for malignancy (when do indication exists) will be recorded	6 months
Rate of patients who fail to complete adjuvant therapy and reasons for that	The amount of patients who will not complete adjuvant therapy after pancreatic resection for malignancy will be recorded	9 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Disease free survival of patients enrolled	18 months

Collaborators and Investigators

• Sponsor: Universita di Verona

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): February 28, 2024
• Study Completion (Actual): February 28, 2024

Study Registration Dates

• First Submitted: December 21, 2018
• First Submitted That Met QC Criteria: December 25, 2018
• First Posted (Actual): December 27, 2018

Study Record Updates

• Last Update Posted (Actual): May 7, 2024
• Last Update Submitted That Met QC Criteria: May 6, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Failure Adjuvant Therapy
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: FOUNTAIN

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No