<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/NCT03790553</url>
  </required_header>
  <id_info>
    <org_study_id>ESO-Shanghai 12</org_study_id>
    <nct_id>NCT03790553</nct_id>
  </id_info>
  <brief_title>Comparing 61.2 Gy Radiotherapy Dose Versus 50.4 Gy Radiotherapy Dose for Locally Advanced Esophageal Carcinoma</brief_title>
  <official_title>A Phase III Study of Comparing 61.2 Gy Radiotherapy Dose Versus 50.4 Gy Radiotherapy Dose for Locally Advanced Esophageal Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fudan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fudan University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determined the best definitive radiotherapy dosage for&#xD;
      patients with locally advanced esophageal squamous cell carcinoma.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 15, 2018</start_date>
  <completion_date type="Anticipated">October 15, 2025</completion_date>
  <primary_completion_date type="Anticipated">October 15, 2023</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>Overall survival in PET/CT non-responders</measure>
    <time_frame>2 years</time_frame>
    <description>The time between the start of the study treatment (Day 1) and death from any cause or last follow-up for patients alive at the end of the study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall survival in ITT population</measure>
    <time_frame>2 years</time_frame>
    <description>The time between the start of the study treatment (Day 1) and death from any cause or last follow-up for patients alive at the end of the study.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Local control rate</measure>
    <time_frame>2 years</time_frame>
    <description>The time between the start of the study treatment (Day 1) and local reccurence (included the primary tumor and regional lymph node failure)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival</measure>
    <time_frame>2 years</time_frame>
    <description>(defined as the time between Day 1 and the first event of local failure, metastatic recurrence, progression or death)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival in PET/CT responders</measure>
    <time_frame>2 years</time_frame>
    <description>Overall survival in patients who have SUV ≤ 4 in PET/CT analysis in 25-28 radiotherapy fractions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Questionnaire EORTC-QLQ-C30</measure>
    <time_frame>2 years</time_frame>
    <description>A quality of life score is obtained according to the answers to the questionnaires.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Questionnaire EORTC-QLQ-OES18</measure>
    <time_frame>2 years</time_frame>
    <description>A quality of life score is obtained according to the answers to the questionnaires.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">646</enrollment>
  <condition>Esophageal Squamous Cell Carcinoma</condition>
  <arm_group>
    <arm_group_label>50.4Gy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Total radiotherapy dose of 50.4Gy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>61.2Gy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Total radiotherapy dose of 61.2Gy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Radiotherapy</intervention_name>
    <description>Different total radiotherapy dose between two arms.</description>
    <arm_group_label>50.4Gy</arm_group_label>
    <arm_group_label>61.2Gy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Joined the study voluntarily and signed informed consent form;&#xD;
&#xD;
          -  Age 18-75 years; both genders&#xD;
&#xD;
          -  Esophageal squamous cell carcinoma confirmed by pathology.&#xD;
&#xD;
          -  No radiotherapy, chemotherapy or other treatments prior to enrollment&#xD;
&#xD;
          -  Locally advanced esophageal squamous cell carcinoma (T1N1-3M0, T2-4NxM0, TxNxM1&#xD;
             (supraclavicular lymph node metastasis only) (AJCC 8th)&#xD;
&#xD;
          -  Use of an effective contraceptive for adults to prevent pregnancy.&#xD;
&#xD;
          -  No severely abnormal hematopoietic, cardiac, pulmonary, renal, or hepatic function. No&#xD;
             immunodeficiency.&#xD;
&#xD;
          -  WBC ≥ 3.5*109/L, Hemoglobin ≥ 9 g/dL, Neutrophils ≥ 1·5*109/L, Platelet count ≥&#xD;
             100*109/L, ALAT and ASAT &lt; 2·5 * ULN, TBIL &lt; 1·5 * ULN, and Creatinine &lt; 1·5 *ULN.&#xD;
&#xD;
          -  ECOG 0-2.&#xD;
&#xD;
          -  Life expectancy of more than 3 months.&#xD;
&#xD;
          -  Agreement of PET/CT accessment at 25-28 radiotherapy fraction.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Total radiotherapy dose cannot reach 61.2Gy/34Fx in the condition of the nomal tissue&#xD;
             dose complying to the standard criteria.&#xD;
&#xD;
          -  Esophageal perforation, or hematemesis.&#xD;
&#xD;
          -  History of radiotherapy or chemotherapy for esophageal cancer.&#xD;
&#xD;
          -  History of surgery within 28 days before Day 1.&#xD;
&#xD;
          -  History of prior malignancies (other than skin basal cell carcinoma or cervical&#xD;
             carcinoma in situ with a disease-free survival of at least 3 years).&#xD;
&#xD;
          -  Participation in other interventional clinical trials within 30 days.&#xD;
&#xD;
          -  Pregnant or breast-feeding women or fertile patients who refused to use&#xD;
             contraceptives.&#xD;
&#xD;
          -  Drug addiction, alcoholism or AIDS.&#xD;
&#xD;
          -  Uncontrolled seizures or psychiatric disorders.&#xD;
&#xD;
          -  Any other condition which in the investigator's opinion would not make the patient a&#xD;
             good candidate for the clinical trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Jiangsu Cancer Hospital</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jinjun C Ye, M.D.</last_name>
      <phone>13585175433</phone>
      <phone_ext>13585175433</phone_ext>
      <email>jjye2004@163.com</email>
    </contact>
    <investigator>
      <last_name>Jinjun C Ye, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Huadong Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiangpeng Zheng, M.D.</last_name>
      <phone>8621-62483180</phone>
      <phone_ext>862162483180</phone_ext>
      <email>zhengxp@fudan.edu.cn</email>
    </contact>
    <contact_backup>
      <last_name>Xiangpeng Zheng</last_name>
      <phone>862162483180</phone>
      <phone_ext>862162483180</phone_ext>
      <email>zhengxp@fudan.edu.cn</email>
    </contact_backup>
    <investigator>
      <last_name>Xiangpeng Zheng</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Fudan Universtiy 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>Kuaile Zhao, MD.</last_name>
      <phone>+8618017312534</phone>
      <email>kuaile_z@sina.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>October 17, 2018</study_first_submitted>
  <study_first_submitted_qc>December 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 31, 2018</study_first_posted>
  <last_update_submitted>August 1, 2023</last_update_submitted>
  <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fudan University</investigator_affiliation>
    <investigator_full_name>Kuai Le Zhao, MD</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>chemoradiotherapy</keyword>
  <keyword>esophageal cancer</keyword>
  <keyword>PET/CT</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Esophageal Squamous Cell Carcinoma</mesh_term>
    <mesh_term>Esophageal Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03790553
org study id: ESO-Shanghai 12
nct id: NCT03790553
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to determined the best definitive radiotherapy dosage for
      patients with locally advanced esophageal squamous cell carcinoma.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall survival in PET/CT non-responders
time frame: 2 years
description: The time between the start of the study treatment (Day 1) and death from any cause or last follow-up for patients alive at the end of the study.
measure: Overall survival in ITT population
time frame: 2 years
description: The time between the start of the study treatment (Day 1) and death from any cause or last follow-up for patients alive at the end of the study.
measure: Local control rate
time frame: 2 years
description: The time between the start of the study treatment (Day 1) and local reccurence (included the primary tumor and regional lymph node failure)
measure: Progression-free survival
time frame: 2 years
description: (defined as the time between Day 1 and the first event of local failure, metastatic recurrence, progression or death)
measure: Overall survival in PET/CT responders
time frame: 2 years
description: Overall survival in patients who have SUV ≤ 4 in PET/CT analysis in 25-28 radiotherapy fractions.
measure: Questionnaire EORTC-QLQ-C30
time frame: 2 years
description: A quality of life score is obtained according to the answers to the questionnaires.
measure: Questionnaire EORTC-QLQ-OES18
time frame: 2 years
description: A quality of life score is obtained according to the answers to the questionnaires.
arm group label: 50.4Gy
arm group type: Active Comparator
description: Total radiotherapy dose of 50.4Gy.
arm group label: 61.2Gy
arm group type: Experimental
description: Total radiotherapy dose of 61.2Gy.
intervention type: Radiation
intervention name: Radiotherapy
description: Different total radiotherapy dose between two arms.
arm group label: 50.4Gy
arm group label: 61.2Gy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Fudan University
investigator full name: Kuai Le Zhao, MD
investigator title: Professor
mesh term: Carcinoma
mesh term: Esophageal Squamous Cell Carcinoma
mesh term: Esophageal Neoplasms
sharing ipd: Undecided