<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/NCT02209415</url>
  </required_header>
  <id_info>
    <org_study_id>2011-41-5702</org_study_id>
    <nct_id>NCT02209415</nct_id>
  </id_info>
  <brief_title>EUFURO - EUS-based Follow-Up on R0-resected Patients for Esophageal, Gastric and Pancreatic Cancer</brief_title>
  <acronym>EUFURO</acronym>
  <official_title>Endoscopic Ultrasound (EUS) and PET-CT Based Follow-up of Patients Radically Resected for Cancer of the Oesophagus, Stomach or Pancreas.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Michael Bau Mortensen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Odense University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Odense University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Follow-up after successful operative treatment of cancer in the esophagus, stomach or&#xD;
      pancreas in order to detect recurrent disease is a controversial topic.&#xD;
&#xD;
      This is because the methods and the consequence of following these patients is unknown.&#xD;
&#xD;
      Therefore the investigators will randomize these patients in to two groups:&#xD;
&#xD;
        1. One group of patients will be offered visits with a specialist surgeon in a outpatient&#xD;
           setting for a clinical evaluation every 3,6,9,12,18 and 24 months after surgery, as is&#xD;
           the current standard at our department.&#xD;
&#xD;
        2. The other group will be offered Endoscopic UltraSound, EUS, and PET/CT with the same&#xD;
           intervals as the first group.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>April 2011</start_date>
  <completion_date type="Anticipated">August 2016</completion_date>
  <primary_completion_date type="Anticipated">January 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients eligible for treatment</measure>
    <time_frame>2 years</time_frame>
    <description>Does early detection of recurrent disease translate in to more patients being eligible for oncologic treatment?</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">182</enrollment>
  <condition>Esophageal Cancer</condition>
  <condition>Stomach Cancer</condition>
  <condition>Pancreatic Cancer</condition>
  <arm_group>
    <arm_group_label>Standard outpatient follow-up</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Outpatient clinic visits 3,6,9,12,18 and 24 mths after surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention PET/CT and EUS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PET/CT and EUS at 3,6,9,12,18 and 24 months after surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>standard follow-up</intervention_name>
    <description>Outpatient clinic visits</description>
    <arm_group_label>Standard outpatient follow-up</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>PET/CT and EUS</intervention_name>
    <description>PET/CT and EUS</description>
    <arm_group_label>Intervention PET/CT and EUS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  R0- resection for primary adenocarcinoma or squamous cell carcinoma of the esophagus,&#xD;
             stomach or pancreas.&#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>Center for Surgical Ultrasound, Department of upper surgical gastroenterology</name>
      <address>
        <city>Odense</city>
        <state>Region of Southern Denmark</state>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>November 28, 2011</study_first_submitted>
  <study_first_submitted_qc>August 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 5, 2014</study_first_posted>
  <last_update_submitted>August 4, 2014</last_update_submitted>
  <last_update_submitted_qc>August 4, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 5, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Odense University Hospital</investigator_affiliation>
    <investigator_full_name>Michael Bau Mortensen</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatic Neoplasms</mesh_term>
    <mesh_term>Stomach 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/NCT02209415
org study id: 2011-41-5702
nct id: NCT02209415
lead sponsor: 
collaborator: 
has dmc: Yes
Follow-up after successful operative treatment of cancer in the esophagus, stomach or
      pancreas in order to detect recurrent disease is a controversial topic.

      This is because the methods and the consequence of following these patients is unknown.

      Therefore the investigators will randomize these patients in to two groups:

        1. One group of patients will be offered visits with a specialist surgeon in a outpatient
           setting for a clinical evaluation every 3,6,9,12,18 and 24 months after surgery, as is
           the current standard at our department.

        2. The other group will be offered Endoscopic UltraSound, EUS, and PET/CT with the same
           intervals as the first group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Number of patients eligible for treatment
time frame: 2 years
description: Does early detection of recurrent disease translate in to more patients being eligible for oncologic treatment?
arm group label: Standard outpatient follow-up
arm group type: Active Comparator
description: Outpatient clinic visits 3,6,9,12,18 and 24 mths after surgery
arm group label: Intervention PET/CT and EUS
arm group type: Experimental
description: PET/CT and EUS at 3,6,9,12,18 and 24 months after surgery
intervention type: Behavioral
intervention name: standard follow-up
description: Outpatient clinic visits
arm group label: Standard outpatient follow-up
intervention type: Procedure
intervention name: PET/CT and EUS
description: PET/CT and EUS
arm group label: Intervention PET/CT and EUS
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Denmark
responsible party type: Sponsor-Investigator
investigator affiliation: Odense University Hospital
investigator full name: Michael Bau Mortensen
investigator title: MD, PhD
mesh term: Pancreatic Neoplasms
mesh term: Stomach Neoplasms