<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03788382</url>
  </required_header>
  <id_info>
    <org_study_id>FOUNTAIN</org_study_id>
    <nct_id>NCT03788382</nct_id>
  </id_info>
  <brief_title>Failure to Adjuvant Therapy After Pancreatic Resection for Pancreatic Cancer</brief_title>
  <acronym>FOUNTAIN</acronym>
  <official_title>Failure to Adjuvant Therapy After Pancreatic Resection for Pancreatic Cancer: a Real Life Scenario</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universita di Verona</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universita di Verona</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to evaluate the rate of patients submitted to pancreatic resection for&#xD;
      pancreatic cancer, who fail to access to adjuvant therapy or do not complete adjuvant&#xD;
      therapy. The purpose is to give an overview concerning the most frequent conditions and/or&#xD;
      reasons associated with failure or omission of adjuvant therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This prospective observational study will evaluate all patients submitted to pancreatic&#xD;
      resection for pancreatic cancer.&#xD;
&#xD;
      The rate of omission to adjuvant therapy and rate of failure of completion of adjuvant&#xD;
      therapy will be evaluated as primary outcomes. As secondary outcomes, survival analyses will&#xD;
      be performed to investigate whether these factors influence prognosis, that will be evaluated&#xD;
      through a disease free survival analysis at 18-months. Epidemiological and perioperative data&#xD;
      will be analyzed to identify conditions associated with the primary outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Anticipated">June 30, 2023</completion_date>
  <primary_completion_date type="Actual">July 30, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of patients who fail to receive adjuvant therapy and reasons for that</measure>
    <time_frame>6 months</time_frame>
    <description>The amount of patients who will not receive adjuvant therapy after pancreatic resection for malignancy (when do indication exists) will be recorded</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of patients who fail to complete adjuvant therapy and reasons for that</measure>
    <time_frame>9 months</time_frame>
    <description>The amount of patients who will not complete adjuvant therapy after pancreatic resection for malignancy will be recorded</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Disease free survival of patients enrolled</measure>
    <time_frame>18 months</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">316</enrollment>
  <condition>Pancreatic Malignant Neoplasm Primary</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients submitted to Pancreatic Resection for Pancreatic Cancer&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologic diagnosis of pancreatic cancer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non exocrine pancreatic tumors&#xD;
&#xD;
          -  Periampullary malignancies&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Verona Hospital</name>
      <address>
        <city>Verona</city>
        <zip>37134</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Salvatore Paiella, MD</last_name>
      <phone>00390458126009</phone>
      <email>salvatore.paiella@univr.it</email>
    </contact>
    <investigator>
      <last_name>Salvatore Paiella, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Giuseppe Malleo, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Claudio Bassi, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Roberto Salvia, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Alice Cattelani, Med Stud</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>December 21, 2018</study_first_submitted>
  <study_first_submitted_qc>December 25, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 27, 2018</study_first_posted>
  <last_update_submitted>May 8, 2023</last_update_submitted>
  <last_update_submitted_qc>May 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universita di Verona</investigator_affiliation>
    <investigator_full_name>Salvatore Paiella, MD</investigator_full_name>
    <investigator_title>Salvatore Paiella, MD, Università di Verona</investigator_title>
  </responsible_party>
  <keyword>Failure Adjuvant Therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03788382
org study id: FOUNTAIN
nct id: NCT03788382
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Cohort
time perspective: Prospective
measure: Rate of patients who fail to receive adjuvant therapy and reasons for that
time frame: 6 months
description: The amount of patients who will not receive adjuvant therapy after pancreatic resection for malignancy (when do indication exists) will be recorded
measure: Rate of patients who fail to complete adjuvant therapy and reasons for that
time frame: 9 months
description: The amount of patients who will not complete adjuvant therapy after pancreatic resection for malignancy will be recorded
measure: Disease free survival of patients enrolled
time frame: 18 months
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Universita di Verona
investigator full name: Salvatore Paiella, MD
investigator title: Salvatore Paiella, MD, Università di Verona
mesh term: Neoplasms