<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/NCT01697917</url>
  </required_header>
  <id_info>
    <org_study_id>2012-44-562</org_study_id>
    <nct_id>NCT01697917</nct_id>
  </id_info>
  <brief_title>Impact on Quality of Life in Patients Undergoing Total Gastrectomy or Proximal Gastrectomy for Adenocarcinoma of Esophagogastric Junction</brief_title>
  <acronym>GCQOL01</acronym>
  <official_title>A Pilot Randomized Controlled Trial Examining the Differences of Quality of Life of Patients Undergoing Total Gastrectomy or Proximal Gastrectomy for Adenocarcinoma of Esophagogastric Junction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fudan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fudan University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to find out more about differences of the quality of life in&#xD;
      patients undergoing total gastrectomy or proximal gastrectomy for adenocarcinoma of&#xD;
      esophagogastric junction. To find a better reconstruction for patients who received total&#xD;
      gastrectomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Overall, the incidence of stomach cancer worldwide is declining with geographical variation.&#xD;
      However, an increase in the incidence rate of adenocarcinoma of esophagogastric junction,&#xD;
      called cardia or AEG has been observed in recent years. AEG may represent a specific&#xD;
      histopathological and biologic entity. In the treatment AEG there is argument over whether&#xD;
      proximal gastractomy(PG) or total gastractomy (TG) should be done. The quality of life (QOL)&#xD;
      of the patients following TG or PG arouses people's attention. The purpose of this study was&#xD;
      to evaluate differences of the quality of life in patients undergoing total gastrectomy or&#xD;
      proximal gastrectomy for adenocarcinoma of esophagogastric junction.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>May 2012</start_date>
  <completion_date type="Anticipated">May 2017</completion_date>
  <primary_completion_date type="Anticipated">May 2015</primary_completion_date>
  <phase>Phase 3</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in QOL (Quality of Life)</measure>
    <time_frame>5years</time_frame>
    <description>From preoperative following gastrectomy, as measured with the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and QLQ-STO22 questionnaires.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Nutritional status of patients</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">140</enrollment>
  <condition>Adenocarcinoma of Esophagogastric Junction.</condition>
  <arm_group>
    <arm_group_label>Total Gastrectomy or Proximal Gastrectomy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Total Gastrectomy or Proximal Gastrectomy</intervention_name>
    <arm_group_label>Total Gastrectomy or Proximal Gastrectomy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Pathologically confirmed gastric malignant tumor at FUSCC (biopsy may be performed&#xD;
             at other institutions but slides must be confirmed at FUSCC, as is routine care at our&#xD;
             institution), and the patients be assessed can achieve R0 radical dissection through&#xD;
             total gastrectomy or proximal gastrectomy by three specialists.&#xD;
&#xD;
               -  Patients 20-75 years old&#xD;
&#xD;
               -  Normal organ function, able to tolerate surgery, no clear contraindication for&#xD;
                  surgery&#xD;
&#xD;
               -  No evidence of metastases of adjacent organs&#xD;
&#xD;
               -  be able to provide follow-up over 2 years&#xD;
&#xD;
               -  No specific treatment for gastric cancer before surgery&#xD;
&#xD;
               -  In line with the Declaration of Helsinki and the requirements of the hospital&#xD;
                  ethics committee.&#xD;
&#xD;
               -  The subjects were able to understand and comply with the trial protocol, and&#xD;
                  signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • AEG SiewertⅠtype patients&#xD;
&#xD;
               -  Synchronous or metachronous (less than five years) and patients with other&#xD;
                  malignancies.&#xD;
&#xD;
               -  Cirrhosis and portal hypertension&#xD;
&#xD;
               -  Associated with blood diseases&#xD;
&#xD;
               -  Serious heart/ lung and kidney dysfunction or with metabolic diseases such as&#xD;
                  diabetes, hyperthyroidism.&#xD;
&#xD;
               -  Suffering from a serious neurological disease or psychological diseases affecting&#xD;
                  the life.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Wang Ya Nong, MD, PhD</last_name>
    <phone>+86-21 64175590</phone>
    <phone_ext>1208</phone_ext>
    <email>huahuang@fudan.edu.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Huang Hua, MD,PhD</last_name>
    <phone>+86-21 64175590</phone>
    <phone_ext>1205</phone_ext>
    <email>huahuang@fudan.edu.cn</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Fudan University Shanghai Cancer Center</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ya Nong Wang, MD,PhD</last_name>
      <phone>+86-21 64175590</phone>
      <phone_ext>1208</phone_ext>
      <email>huahuang@fudan.edu.cn</email>
    </contact>
    <contact_backup>
      <last_name>Hua Huang, MD,PhD</last_name>
      <phone>+86-21 64175590</phone>
      <phone_ext>1205</phone_ext>
      <email>huahuang@fudan.edu.cn</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 29, 2012</study_first_submitted>
  <study_first_submitted_qc>October 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <last_update_submitted>October 1, 2012</last_update_submitted>
  <last_update_submitted_qc>October 1, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 2, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fudan University</investigator_affiliation>
    <investigator_full_name>Yanong Wang</investigator_full_name>
    <investigator_title>Director of Department of Abdominal Surgery</investigator_title>
  </responsible_party>
  <keyword>Adenocarcinoma of Esophagogastric Junction</keyword>
  <keyword>Total Gastrectomy</keyword>
  <keyword>Proximal Gastrectomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenocarcinoma</mesh_term>
    <mesh_term>Esophageal 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/NCT01697917
org study id: 2012-44-562
nct id: NCT01697917
lead sponsor: 
has dmc: No
The purpose of this study is to find out more about differences of the quality of life in
      patients undergoing total gastrectomy or proximal gastrectomy for adenocarcinoma of
      esophagogastric junction. To find a better reconstruction for patients who received total
      gastrectomy.
Overall, the incidence of stomach cancer worldwide is declining with geographical variation.
      However, an increase in the incidence rate of adenocarcinoma of esophagogastric junction,
      called cardia or AEG has been observed in recent years. AEG may represent a specific
      histopathological and biologic entity. In the treatment AEG there is argument over whether
      proximal gastractomy(PG) or total gastractomy (TG) should be done. The quality of life (QOL)
      of the patients following TG or PG arouses people's attention. The purpose of this study was
      to evaluate differences of the quality of life in patients undergoing total gastrectomy or
      proximal gastrectomy for adenocarcinoma of esophagogastric junction.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in QOL (Quality of Life)
time frame: 5years
description: From preoperative following gastrectomy, as measured with the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and QLQ-STO22 questionnaires.
measure: Nutritional status of patients
time frame: 5 years
arm group label: Total Gastrectomy or Proximal Gastrectomy
arm group type: Other
intervention type: Other
intervention name: Total Gastrectomy or Proximal Gastrectomy
arm group label: Total Gastrectomy or Proximal Gastrectomy
criteria: 
gender: All
minimum age: 20 Years
maximum age: 75 Years
healthy volunteers: No
last name: Wang Ya Nong, MD, PhD
phone: +86-21 64175590
phone ext: 1208
email: huahuang@fudan.edu.cn
last name: Huang Hua, MD,PhD
phone: +86-21 64175590
phone ext: 1205
email: huahuang@fudan.edu.cn
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Fudan University
investigator full name: Yanong Wang
investigator title: Director of Department of Abdominal Surgery
mesh term: Adenocarcinoma
mesh term: Esophageal Neoplasms