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Failure to Adjuvant Therapy After Pancreatic Resection for Pancreatic Cancer


2019-01-01


2024-02-28


2024-02-28


317

Study Overview

Failure to Adjuvant Therapy After Pancreatic Resection for Pancreatic Cancer

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.

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.

  • Pancreatic Malignant Neoplasm Primary
    • FOUNTAIN

    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 Registration Dates Results Reporting Dates Study Record Updates

    2018-12-21  

    N/A  

    2024-05-06  

    2018-12-25  

    N/A  

    2024-05-07  

    2018-12-27  

    N/A  

    2024-05  

    Study Plan

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

    Design Details

    Primary Purpose:
    N/A


    Allocation:
    N/A


    Interventional Model:
    N/A


    Masking:
    N/A


    Arms and Interventions

    Participant Group/ArmIntervention/Treatment
    Primary Outcome MeasuresMeasure DescriptionTime Frame
    Rate of patients who fail to receive adjuvant therapy and reasons for thatThe amount of patients who will not receive adjuvant therapy after pancreatic resection for malignancy (when do indication exists) will be recorded6 months
    Rate of patients who fail to complete adjuvant therapy and reasons for thatThe amount of patients who will not complete adjuvant therapy after pancreatic resection for malignancy will be recorded9 months
    Secondary Outcome MeasuresMeasure DescriptionTime Frame
    Disease free survival of patients enrolled18 months

    Contacts and Locations

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

    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.

    Ages Eligible for Study:
    ALL

    Sexes Eligible for Study:
    18 Years

    Accepts Healthy Volunteers:

      Inclusion Criteria:

    • Histologic diagnosis of pancreatic cancer

    • Exclusion Criteria:

    • Non exocrine pancreatic tumors
    • Periampullary malignancies

    Collaborators and Investigators

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

    Publications

    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