<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/NCT02991547</url>
  </required_header>
  <id_info>
    <org_study_id>1611-55</org_study_id>
    <nct_id>NCT02991547</nct_id>
  </id_info>
  <brief_title>Surveillance of Patients With Adenocarcinoma of the Gastroesophageal Junction or Esophagus</brief_title>
  <acronym>SAGE</acronym>
  <official_title>Study on Outcomes of Active Surveillance Among Invasive Locoregional Adenocarcinoma of Esophagus and Gastroesophageal Junction (GEJ) With Complete Response After Neoadjuvant Combined Chemoradiotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Guthrie Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Guthrie Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to find out more information about patients who have cancer&#xD;
      (adenocarcinoma) of the esophagus or gastroesophageal junction (GEJ) who have been treated&#xD;
      with chemotherapy and radiation but have not had surgery. The study will follow patients for&#xD;
      5 years to monitor for their cancer and to see how the standard medical care affects the&#xD;
      daily life of patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Initial Principal Investigator no longer at institution.&#xD;
  </why_stopped>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">August 3, 2018</completion_date>
  <primary_completion_date type="Actual">August 3, 2018</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>Progression free survival</measure>
    <time_frame>5 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of complete remission</measure>
    <time_frame>8 weeks after completion of neoadjuvant chemoradiotherapy</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of local recurrence or mestastasis or both</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse effect profile</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life</measure>
    <time_frame>5 years</time_frame>
    <description>EORTC QLQ-C30</description>
  </secondary_outcome>
  <enrollment type="Actual">3</enrollment>
  <condition>Adenocarcinoma Esophagus</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Observational</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with adenocarcinoma of the esophageal and gastroesophageal junction&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adenocarcinoma of esophagus or gastroesophageal junction (nidus of the cancer within 5&#xD;
             cm from the gastroesophageal junction) confirmed by biopsy with clinical stage I, II,&#xD;
             or III. The superficial adenocarcinoma of the esophagus will be excluded.&#xD;
&#xD;
          -  Received no previous treatment for esophageal cancer.&#xD;
&#xD;
          -  Measurable or evaluable disease&#xD;
&#xD;
          -  ECOG performance status: 0 to 2 that is able to perform activities of daily living&#xD;
             with minimal assistance&#xD;
&#xD;
          -  Adequate bone marrow function (hemoglobulin ≥8 g/dl, neutrophil ≥1.5x109/L and&#xD;
             platelet ( ≥100x109/L)&#xD;
&#xD;
          -  Adequate liver function&#xD;
&#xD;
               -  Bilirubin normal, Meets 1 of the following criteria:&#xD;
&#xD;
               -  Alkaline phosphatase (AP) normal AND AST/ALT ≤ 5 times upper limit of normal&#xD;
                  (ULN)&#xD;
&#xD;
               -  AP ≤ 2.5 times ULN AND AST/ALT ≤ 1.5 times ULN&#xD;
&#xD;
               -  AP ≤ 5 times ULN AND AST/ALT normal&#xD;
&#xD;
          -  Adequate kidney function (creatinine ≤1.5 UNL and creatinine clearance ≥ 60 )&#xD;
&#xD;
          -  Be at least 4 weeks from recent major surgical procedures.&#xD;
&#xD;
          -  Patients must be able to understand the nature of the study and give written informed&#xD;
             consent&#xD;
&#xD;
          -  At least one measurable lesion on CT, MRI or esophageal barium exam.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 18 years and &gt;80 years&#xD;
&#xD;
          -  Contraindication for irradiation: complete obstruction of esophagus, deep esophageal&#xD;
             ulcer, fistula to mediastinum, or hematemesis&#xD;
&#xD;
          -  Participating in other clinical trials&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Clinically significant and uncontrolled major medical conditions including but not&#xD;
             limited to active uncontrolled infection, symptomatic congestive heart failure,&#xD;
             unstable angina pectoris or cardiac arrhythmia, psychiatric illness/ social situation&#xD;
             that would limit compliance with study requirements&#xD;
&#xD;
          -  any medical condition, which in the opinion of the study investigator places the&#xD;
             subject at an unacceptably high risk for toxicities&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Philip Lowry, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Guthrie Medical Group, PC/Robert Packer Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Guthrie Corning Hospital</name>
      <address>
        <city>Corning</city>
        <state>New York</state>
        <zip>14830</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guthrie Medical Group, PC/Robert Packer Hospital</name>
      <address>
        <city>Sayre</city>
        <state>Pennsylvania</state>
        <zip>18840</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>November 28, 2016</study_first_submitted>
  <study_first_submitted_qc>December 9, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>December 11, 2018</last_update_submitted>
  <last_update_submitted_qc>December 11, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 13, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenocarcinoma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02991547
org study id: 1611-55
nct id: NCT02991547
lead sponsor: 
has dmc: No
The purpose of this study is to find out more information about patients who have cancer
      (adenocarcinoma) of the esophagus or gastroesophageal junction (GEJ) who have been treated
      with chemotherapy and radiation but have not had surgery. The study will follow patients for
      5 years to monitor for their cancer and to see how the standard medical care affects the
      daily life of patients.
observational model: Cohort
time perspective: Prospective
measure: Progression free survival
time frame: 5 years
measure: Overall survival
time frame: 5 years
measure: Rate of complete remission
time frame: 8 weeks after completion of neoadjuvant chemoradiotherapy
measure: Occurrence of local recurrence or mestastasis or both
time frame: 5 years
measure: Adverse effect profile
time frame: 5 years
measure: Quality of Life
time frame: 5 years
description: EORTC QLQ-C30
intervention type: Other
intervention name: Observational
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Philip Lowry, MD
role: Principal Investigator
affiliation: Guthrie Medical Group, PC/Robert Packer Hospital
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Adenocarcinoma
sharing ipd: No