<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/NCT03244566</url>
  </required_header>
  <id_info>
    <org_study_id>PETCLM</org_study_id>
    <nct_id>NCT03244566</nct_id>
  </id_info>
  <brief_title>PET in Guiding Cervical Lymphadenectomy (ECTOP-2003)</brief_title>
  <official_title>The Utility of Positron Emission Tomography (PET) in Predicting Cervical Lymphatic Metastasis for Mid-lower Thoracic Esophageal Squamous Cell Carcinoma</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Esophageal cancer is the eighth most common cancer around the world, with more than 450000&#xD;
      new cases per year. Esophagectomy with radical lymphadenectomy (2-field lymphadenectomy) is&#xD;
      the mainstay of treatment in many countries for patients with esophageal cancer. To improve&#xD;
      the survival, 3-field lymphadenectomy combined with cervical lymphadenectomy was started in&#xD;
      1980s. More potential positive lymph nodes were found during more extended lymphadenectomy,&#xD;
      offering more accurate TNM staging, affecting consequent treatment.&#xD;
      However，3-field-lymphadenectomy was associated with increased surgical morbidity and&#xD;
      mortality. Positron emission tomography (PET) is used for detecting distant metastases and&#xD;
      lymphatic involvement. The aim of the study is to evaluate the role of PET in predicting&#xD;
      cervical lymph metastases of patients with thoracic esophageal squamous cell carcinoma, and&#xD;
      to determine if investigators can use PET to guide future cervical lymphadenectomy. (Eastern&#xD;
      Cooperative Thoracic Oncology Projects 2003, ECTOP-2003)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      From June, 2018, a total of 110 patients with thoracic esophageal carcinoma will be recruited&#xD;
      in 4 hospital in China. Participants with resectable esophageal cancer will have PET/CT scan&#xD;
      before three-field lymphadenectomy. Lymph nodes will be recored according to the anatomy&#xD;
      site. Lymph nodes metastasis diagnosed by PET/CT and by postoperation pathological&#xD;
      examination will be compared to evaluate the role of PET/CT in guiding the extent of&#xD;
      lymphadenecomy and surgical approach.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 26, 2018</start_date>
  <completion_date type="Actual">July 1, 2021</completion_date>
  <primary_completion_date type="Actual">November 28, 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>cervical lymph node metastasis</measure>
    <time_frame>Decembear 2018</time_frame>
    <description>postoperative pathological examination</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>mediastinal and abdonimal lymph nodes metastasis</measure>
    <time_frame>Novermber 2018</time_frame>
    <description>postoperative pathological examination</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>postoperative complications</measure>
    <time_frame>March 2019</time_frame>
    <description>surgical morbidity and mortality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>diseases-free survival</measure>
    <time_frame>November 2021</time_frame>
    <description>from the time of surgery to the time of first recurrence or death</description>
  </secondary_outcome>
  <enrollment type="Actual">110</enrollment>
  <condition>Esophageal Cancer</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>positron emission tomography</intervention_name>
    <description>patients who had esophagectomy with 3-field lymphadenectomy underwent examination of positron emission tomography prior to surgery within 2 weeks.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients had resectable thoracic esophageal squamous cell carcinoma.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Histologically proven esophageal cancer&#xD;
&#xD;
          2. Resectable cT1-T3/N0-N1 thoracic，operable esophageal lesion. Staging investigations&#xD;
             including esophagogastroscopy, chest and abdominal CT scan, and barium swallow&#xD;
&#xD;
          3. Karnofsky performance status greater than or equal to 80%&#xD;
&#xD;
          4. Acceptable pulmonary and cardiac function.&#xD;
&#xD;
          5. Acceptable hepatic, renal and bone marrow function&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Low performance status(Karnofsky score &lt;80%)&#xD;
&#xD;
          2. Past history of malignancy&#xD;
&#xD;
          3. Unresectable advanced disease(T4 or M1a,M1b)&#xD;
&#xD;
          4. Patients with any other serious underlying medical condition that would impair the&#xD;
             ability of the patient to receive or comply with protocol treatment&#xD;
&#xD;
          5. Medically unfit for surgical resection&#xD;
&#xD;
          6. Pulmonary reserve inadequate to undergo thoracotomy and extensive mediastinal&#xD;
             lymphadenectomy.&#xD;
&#xD;
          7. A significant history of unstable cardiovascular disease that in the opinion of the&#xD;
             treating physician should preclude the patient from protocol treatment.&#xD;
&#xD;
          8. Uncontrolled diabetes mellitus or uncontrolled infection, including HIV or&#xD;
             interstitial pneumonia or interstitial fibrosis.&#xD;
&#xD;
          9. Significant psychiatric illness that would interfere with patient compliance&#xD;
&#xD;
         10. Severe hepatic cirrhosis or with serious renal disease unacceptable for surgery&#xD;
&#xD;
         11. Salvage surgery after definitive chemoradiotherapy&#xD;
&#xD;
         12. Patients have neoadjuvant chemoradiotherapy&#xD;
&#xD;
         13. Above the age of 80 years&#xD;
&#xD;
         14. Unreliable for follow up&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Haiquan Chen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fudan University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100021</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fujian Medical University Cancer Hospital</name>
      <address>
        <city>Fuzhou</city>
        <state>Fujian</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jiangdu people's hospital of Yangzhou</name>
      <address>
        <city>Yangzhou</city>
        <state>Jiangsu</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fudan University Shanghai Cancer Center</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>August 6, 2017</study_first_submitted>
  <study_first_submitted_qc>August 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 9, 2017</study_first_posted>
  <last_update_submitted>July 12, 2023</last_update_submitted>
  <last_update_submitted_qc>July 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fudan University</investigator_affiliation>
    <investigator_full_name>Haiquan Chen</investigator_full_name>
    <investigator_title>Chief,department of thoracic surgery, Fudan University Shanghai Cancer Center</investigator_title>
  </responsible_party>
  <keyword>positron emission tomography</keyword>
  <keyword>cervical lymphatic metastasis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphatic Metastasis</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/NCT03244566
org study id: PETCLM
nct id: NCT03244566
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Esophageal cancer is the eighth most common cancer around the world, with more than 450000
      new cases per year. Esophagectomy with radical lymphadenectomy (2-field lymphadenectomy) is
      the mainstay of treatment in many countries for patients with esophageal cancer. To improve
      the survival, 3-field lymphadenectomy combined with cervical lymphadenectomy was started in
      1980s. More potential positive lymph nodes were found during more extended lymphadenectomy,
      offering more accurate TNM staging, affecting consequent treatment.
      However，3-field-lymphadenectomy was associated with increased surgical morbidity and
      mortality. Positron emission tomography (PET) is used for detecting distant metastases and
      lymphatic involvement. The aim of the study is to evaluate the role of PET in predicting
      cervical lymph metastases of patients with thoracic esophageal squamous cell carcinoma, and
      to determine if investigators can use PET to guide future cervical lymphadenectomy. (Eastern
      Cooperative Thoracic Oncology Projects 2003, ECTOP-2003)
From June, 2018, a total of 110 patients with thoracic esophageal carcinoma will be recruited
      in 4 hospital in China. Participants with resectable esophageal cancer will have PET/CT scan
      before three-field lymphadenectomy. Lymph nodes will be recored according to the anatomy
      site. Lymph nodes metastasis diagnosed by PET/CT and by postoperation pathological
      examination will be compared to evaluate the role of PET/CT in guiding the extent of
      lymphadenecomy and surgical approach.
observational model: Cohort
time perspective: Prospective
measure: cervical lymph node metastasis
time frame: Decembear 2018
description: postoperative pathological examination
measure: mediastinal and abdonimal lymph nodes metastasis
time frame: Novermber 2018
description: postoperative pathological examination
measure: postoperative complications
time frame: March 2019
description: surgical morbidity and mortality
measure: diseases-free survival
time frame: November 2021
description: from the time of surgery to the time of first recurrence or death
intervention type: Diagnostic Test
intervention name: positron emission tomography
description: patients who had esophagectomy with 3-field lymphadenectomy underwent examination of positron emission tomography prior to surgery within 2 weeks.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Haiquan Chen, MD
role: Principal Investigator
affiliation: Fudan University
facility: 
facility: 
facility: 
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Fudan University
investigator full name: Haiquan Chen
investigator title: Chief,department of thoracic surgery, Fudan University Shanghai Cancer Center
mesh term: Lymphatic Metastasis