<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/NCT03298204</url>
  </required_header>
  <id_info>
    <org_study_id>3JECROG R-01</org_study_id>
    <nct_id>NCT03298204</nct_id>
  </id_info>
  <brief_title>Definitive (Chemo)Radiotherapy for Patients With Esophageal Cancer - 3JECROG R-01</brief_title>
  <official_title>A Multicenter Analysis of Definitive (Chemo)Radiotherapy With or Without Chemotherapy for Patients With Esophageal Cancer - 3JECROG-R01</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hebei Medical University Fourth Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fujian Cancer Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Anyang Tumor Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First Affiliated Hospital with Nanjing Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Affiliated Hospital of Hebei University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tianjin Medical University Cancer Institute and Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beijing Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tengzhou Central People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>PLA Army General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The aim of this observational study is to retrospectively collect survival data for 3000&#xD;
      primary esophageal cancer patients from multicenter between January 2000 to present. Based on&#xD;
      a Cox model, we want to develope a nomogram that predicts local recurrence, distant&#xD;
      metastases, and survival for patients treated with radiotherapy or chemoradiotherapy with or&#xD;
      without chemotherapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2017</start_date>
  <completion_date type="Actual">February 28, 2018</completion_date>
  <primary_completion_date type="Actual">September 30, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Overall survival</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall survival</measure>
    <time_frame>2 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progress free survival</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progress free survival</measure>
    <time_frame>2 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Locoregional recurrence free survival</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Locoregional recurrence free survival</measure>
    <time_frame>2 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distant metastasis free survival</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distant metastasis free survival</measure>
    <time_frame>2 year</time_frame>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">2762</enrollment>
  <condition>Esophagus Cancer</condition>
  <condition>Chemoradiation</condition>
  <condition>Chemotherapy Effect</condition>
  <condition>Radiotherapy Side Effect</condition>
  <arm_group>
    <arm_group_label>Chemoradiotherapy</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Chemoradiotherapy following chemotherapy</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Chemoradiotherapy followed by chemotherapy</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with esophageal or esophagogastric junction cancer&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically confirmed squamous cell carcinoma, adenocarcinoma of the esophageal or&#xD;
             esophagogastric junction Unresectable or potentially resectable tumor&#xD;
             (cT3-4N0-1M0-M1b, without visceral metastasis, according to AJCC 6th) based on&#xD;
             standard primary staging by EUS and CT&#xD;
&#xD;
          -  Age&gt;18 years&#xD;
&#xD;
          -  No distant metastasis other than supraclavicular lymph nodes&#xD;
&#xD;
          -  No prior history of thoracic radiation&#xD;
&#xD;
          -  Patients must have normal organ and marrow function as defined below: Leukocytes:&#xD;
             greater than or equal to 3,500 G/L; Platelets: greater than or equal to 100,000/mm3&#xD;
             .Hemoglobin:greater than or equal to 10g/L .Total bilirubin: within normal&#xD;
             institutional limits; AST/ALT: less than or equal to 1.5 times the upper limit;&#xD;
             Creatinine within normal upper limits&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with other cancer history except cervical carcinoma in situ and non-malignant&#xD;
             melanoma skin cancer during 5 years before diagnosis of esophageal cancer&#xD;
&#xD;
          -  Pregnant or lactating females&#xD;
&#xD;
          -  Contraindication for radiotherapy or chemotherapy&#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>Department of Radiation Oncology, Cancer Hospital, National Cancer Center, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)</name>
      <address>
        <city>Beijing</city>
        <zip>100021</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>September 27, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 2, 2017</study_first_posted>
  <last_update_submitted>December 29, 2018</last_update_submitted>
  <last_update_submitted_qc>December 29, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 2, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Zefen Xiao</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT03298204
org study id: 3JECROG R-01
nct id: NCT03298204
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of this observational study is to retrospectively collect survival data for 3000
      primary esophageal cancer patients from multicenter between January 2000 to present. Based on
      a Cox model, we want to develope a nomogram that predicts local recurrence, distant
      metastases, and survival for patients treated with radiotherapy or chemoradiotherapy with or
      without chemotherapy.
observational model: Case-Control
time perspective: Retrospective
measure: Overall survival
time frame: 1 year
measure: Overall survival
time frame: 2 year
measure: Progress free survival
time frame: 1 year
measure: Progress free survival
time frame: 2 year
measure: Locoregional recurrence free survival
time frame: 1 year
measure: Locoregional recurrence free survival
time frame: 2 year
measure: Distant metastasis free survival
time frame: 1 year
measure: Distant metastasis free survival
time frame: 2 year
arm group label: Chemoradiotherapy
arm group label: Chemoradiotherapy following chemotherapy
arm group label: Chemoradiotherapy followed by chemotherapy
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
investigator full name: Zefen Xiao
investigator title: MD
mesh term: Esophageal Neoplasms