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

May 6, 2024 updated by: Salvatore Paiella, MD, Universita di Verona

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

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Time Frame: 6 months
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
Time Frame: 9 months
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
Time Frame: 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universita di Verona

Study record dates

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 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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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