<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/NCT03273647</url>
  </required_header>
  <id_info>
    <org_study_id>ESO-CRM</org_study_id>
    <nct_id>NCT03273647</nct_id>
  </id_info>
  <brief_title>Adjuvant Radiotherapy for Esophageal Squamous Cell Carcinoma With Positive Circumstantial Resection Margin</brief_title>
  <official_title>Adjuvant Radiotherapy for T3N0M0 Esophageal Squamous Cell Carcinoma With Positive Circumstantial Resection Margin(a Randomized Controlled Trial)</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 determine the efficacy of adjuvant radiotherapy for&#xD;
      esophageal squamous cell carcinoma with positive circumstantial resection margin.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Although preoperative chemoradiation therapy followed by surgery is the most common approach&#xD;
      for patients with resectable esophageal cancer, the considerable number of esophageal cancer&#xD;
      patients received operation as the first treatment modality. Accordingly, postoperative&#xD;
      treatments have been playing an important role because of the poor survival rates of the&#xD;
      patients who have been treated with resection alone. The existing data shows that the 5-yeal&#xD;
      survival rate of stage T2-3N0M0(UICC 7th edition) of thoracic esophageal squamous cell&#xD;
      carcinoma(TESCC) after surgery is about 50% ,and locoregional lymph nodes metastases is&#xD;
      responsible for the main cause of failure while distal metastases account for relatively less&#xD;
      ratio. Therefore, the subclinical residual tumor is affirmative even if the early disease has&#xD;
      been undergone curable excision and local adjuvant treatment may be essential. In rectal&#xD;
      cancer, the involvement of the circumferential resection margin (CRM) is one of the key&#xD;
      factors for local recurrence and poor prognosis,based on reports in which CRM with &lt; 1mm was&#xD;
      found to be prognostically significant, whereas the clinical and prognostic significance of&#xD;
      the CRM involvement in EC has been investigated only in a few series showing conflicting&#xD;
      results, as some studies suggest a significant influence of CRM. There is lack of clear&#xD;
      evidence for prophylactic radiation therapy in positive Circumferential Resection Margin(CRM)&#xD;
      patients of TESCC now. In view of this, the randomized controlled trial will determine the&#xD;
      clinical efficacy and toxicity of adjuvant radiotherapy in positive Circumferential Resection&#xD;
      Margin(CRM) for thoracic esophageal squamous cell carcinoma.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">December 1, 2017</start_date>
  <completion_date type="Anticipated">December 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2019</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>Disease-free survival time</measure>
    <time_frame>up to 3 years</time_frame>
    <description>including survival time from randomization to locoregional recurrence and to distal metastasis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>overall survival time</measure>
    <time_frame>up to 3 years</time_frame>
    <description>survival time from randomization to death</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Esophageal Squamous Cell Carcinoma</condition>
  <condition>Positive Circumferential Resection Margin</condition>
  <arm_group>
    <arm_group_label>surgery plus radiation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>adjuvant radiotherapy is developed in this arm</description>
  </arm_group>
  <arm_group>
    <arm_group_label>surgery alone</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No adjuvant radiotherapy,that is surgery alone is developed in this arm</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>radiation</intervention_name>
    <description>A total dose of 40Gy will be delivered in 20 fractions at 2.0Gy/fraction, 5 fractions per week in 4 weeks.&#xD;
The CTV encompassed the bilateral supraclavicular region, all mediastinal lymph nodes, the anastomosis site, and the left gastric and Celiac nodes.</description>
    <arm_group_label>surgery plus radiation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients with esophageal cancer who received R0 operations in Fudan University Shanghai&#xD;
        Cancer Center and postoperative pathology: squamous cell cancer,positive Circumferential&#xD;
        Resection Margin(CRM)+&#xD;
&#xD;
          -  KPS≥70 before radiotherapy;&#xD;
&#xD;
          -  Did not receive neoadjuvant or adjuvant treatment;&#xD;
&#xD;
          -  No clear recurrent or metastatic lesions before radiotherapy;&#xD;
&#xD;
          -  Intensity modulated radiation therapy(IMRT) is accepted;&#xD;
&#xD;
          -  Regular follow-up.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exploratory thoracotomy or palliative surgery;&#xD;
&#xD;
          -  No clear recurrent or metastatic sites;&#xD;
&#xD;
          -  Recurrence or metastasis is not certain;&#xD;
&#xD;
          -  death of no definite cause.&#xD;
&#xD;
          -  Irregular follow-up;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jiaqing Xiang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>professor of Department of Thoracic Surgery, Fudan University Shanghai Cancer Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jiaqing Xiang, MD</last_name>
    <phone>+86 13901992249</phone>
    <email>j.q.xiang@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yiliang Zhang, MD</last_name>
    <phone>+86 18017317284</phone>
    <email>ilya616@126.com</email>
  </overall_contact_backup>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>September 4, 2017</study_first_submitted>
  <study_first_submitted_qc>September 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>October 18, 2017</last_update_submitted>
  <last_update_submitted_qc>October 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 19, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fudan University</investigator_affiliation>
    <investigator_full_name>Jiaqing Xiang</investigator_full_name>
    <investigator_title>Professor of Department of Thoracic Surgery, Fudan University Shanghai Cancer Center</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Squamous Cell</mesh_term>
    <mesh_term>Esophageal Squamous Cell Carcinoma</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/NCT03273647
org study id: ESO-CRM
nct id: NCT03273647
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to determine the efficacy of adjuvant radiotherapy for
      esophageal squamous cell carcinoma with positive circumstantial resection margin.
Although preoperative chemoradiation therapy followed by surgery is the most common approach
      for patients with resectable esophageal cancer, the considerable number of esophageal cancer
      patients received operation as the first treatment modality. Accordingly, postoperative
      treatments have been playing an important role because of the poor survival rates of the
      patients who have been treated with resection alone. The existing data shows that the 5-yeal
      survival rate of stage T2-3N0M0(UICC 7th edition) of thoracic esophageal squamous cell
      carcinoma(TESCC) after surgery is about 50% ,and locoregional lymph nodes metastases is
      responsible for the main cause of failure while distal metastases account for relatively less
      ratio. Therefore, the subclinical residual tumor is affirmative even if the early disease has
      been undergone curable excision and local adjuvant treatment may be essential. In rectal
      cancer, the involvement of the circumferential resection margin (CRM) is one of the key
      factors for local recurrence and poor prognosis,based on reports in which CRM with < 1mm was
      found to be prognostically significant, whereas the clinical and prognostic significance of
      the CRM involvement in EC has been investigated only in a few series showing conflicting
      results, as some studies suggest a significant influence of CRM. There is lack of clear
      evidence for prophylactic radiation therapy in positive Circumferential Resection Margin(CRM)
      patients of TESCC now. In view of this, the randomized controlled trial will determine the
      clinical efficacy and toxicity of adjuvant radiotherapy in positive Circumferential Resection
      Margin(CRM) for thoracic esophageal squamous cell carcinoma.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Disease-free survival time
time frame: up to 3 years
description: including survival time from randomization to locoregional recurrence and to distal metastasis
measure: overall survival time
time frame: up to 3 years
description: survival time from randomization to death
arm group label: surgery plus radiation
arm group type: Experimental
description: adjuvant radiotherapy is developed in this arm
arm group label: surgery alone
arm group type: No Intervention
description: No adjuvant radiotherapy,that is surgery alone is developed in this arm
intervention type: Radiation
intervention name: radiation
description: A total dose of 40Gy will be delivered in 20 fractions at 2.0Gy/fraction, 5 fractions per week in 4 weeks.
The CTV encompassed the bilateral supraclavicular region, all mediastinal lymph nodes, the anastomosis site, and the left gastric and Celiac nodes.
arm group label: surgery plus radiation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jiaqing Xiang, MD
role: Principal Investigator
affiliation: professor of Department of Thoracic Surgery, Fudan University Shanghai Cancer Center
last name: Jiaqing Xiang, MD
phone: +86 13901992249
email: j.q.xiang@hotmail.com
last name: Yiliang Zhang, MD
phone: +86 18017317284
email: ilya616@126.com
responsible party type: Principal Investigator
investigator affiliation: Fudan University
investigator full name: Jiaqing Xiang
investigator title: Professor of Department of Thoracic Surgery, Fudan University Shanghai Cancer Center
mesh term: Carcinoma
mesh term: Carcinoma, Squamous Cell
mesh term: Esophageal Squamous Cell Carcinoma
sharing ipd: No