<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/NCT02988921</url>
  </required_header>
  <id_info>
    <org_study_id>16-161/1240</org_study_id>
    <nct_id>NCT02988921</nct_id>
  </id_info>
  <brief_title>MRI and CT Simulation in the Evaluation of Tumor Response and Target Volume Definition for Esophageal or Esophagogastric Cancer Patients Undergoing Chemoradiotherapy</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</source>
  <brief_summary>
    <textblock>
      Magnetic resonance imaging (MRI) with functional features of diffusion weighted imaging (DWI)&#xD;
      are advancing imaging technologies that have potential to overcome limitations of&#xD;
      conventional staging methods, radiation treatment planning and the assessment of tumor&#xD;
      response in esophageal or esophagogastric cancer. This study aimed to explore the value of&#xD;
      MRI for the prediction of tumor response to chemoradiotherapy and accurate target volume&#xD;
      delineation as compared to CT simulation for patients with unresectable or potentially&#xD;
      resectable esophageal or esophagogastric cancer undergoing chemoradiotherapy. The average CT&#xD;
      texture features are also extracted before and during treatment to establish a model to&#xD;
      predict the prognosis or side effects (e.g. radiation pneumonitis or esophagitis) of&#xD;
      patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Both DW-MRI and CT simulation will be performed before chemoradiotherapy and after 18-22&#xD;
           fractions. Also MRI will be performed after treatment. The investigators will contour&#xD;
           based on the MRI image and compare this with the standard CT plan before and during&#xD;
           treatment.&#xD;
&#xD;
        2. The predictive potential of initial tumor ADC, and change in ADC during and after&#xD;
           treatment for tumor response will be assessed.&#xD;
&#xD;
        3. The average CT texture features not only in the present study but also of those who&#xD;
           treated previously in our department (since 2014) will be extracted before and during&#xD;
           chemoradiotherapy to establish a model to predict the prognosis of patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2016</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">January 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Tumor response based on MRI and CT simulation</measure>
    <time_frame>up to 8 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Radiotherapy target volume assessment with pre- and post-chemoradiotherapy based on MRI and CT simulation</measure>
    <time_frame>up to 8 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluation of tumor heterogeneity with IBEX software</measure>
    <time_frame>up to 8 weeks</time_frame>
    <description>Using the average CT images for texture extraction. Histogram, gradient, cooccurrence, gray-tone difference, and filtration-based techniques are used for texture feature extraction. Models incorporating texture features are established to compare to models incorporating clinical prognostic factors alone.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progress free survival</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reduction in acute and late side effects based on modified RT treatment volumes with pre- and post-chemoradiotherapy based on MRI and CT simulation</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Esophagus Cancer</condition>
  <condition>Esophagogastric Junction Cancer</condition>
  <arm_group>
    <arm_group_label>Esophageal or esophagogastric cancer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MRI and CT</intervention_name>
    <arm_group_label>Esophageal or esophagogastric cancer</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Ratiotherapy</intervention_name>
    <arm_group_label>Esophageal or esophagogastric cancer</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paclitaxel, platinum-based drug</intervention_name>
    <arm_group_label>Esophageal or esophagogastric cancer</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically confirmed squamous cell carcinoma, adenocarcinoma of the esophageal or&#xD;
             esophagogastric junction&#xD;
&#xD;
          -  Unresectable or potentially resectable tumor (cT3-4N0-1M0-M1a, according to AJCC 6th)&#xD;
             based on 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 or chemotherapy&#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;
          -  Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindication for MRI scanning&#xD;
&#xD;
          -  Patients with other cancer history except cervical carcinoma in situ and non-malignant&#xD;
             melanoma skin 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>
  <overall_contact>
    <last_name>Xin Wang, MD</last_name>
    <phone>+861013311583220</phone>
    <email>beryl_wx2000@163.com</email>
  </overall_contact>
  <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>
    <status>Recruiting</status>
    <contact>
      <last_name>Xin Wang, MD</last_name>
      <phone>+861013311583220</phone>
      <email>beryl_wx2000@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 5, 2016</study_first_submitted>
  <study_first_submitted_qc>December 7, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 12, 2016</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>Wang Xin</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paclitaxel</mesh_term>
  </intervention_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/NCT02988921
org study id: 16-161/1240
nct id: NCT02988921
lead sponsor: 
Magnetic resonance imaging (MRI) with functional features of diffusion weighted imaging (DWI)
      are advancing imaging technologies that have potential to overcome limitations of
      conventional staging methods, radiation treatment planning and the assessment of tumor
      response in esophageal or esophagogastric cancer. This study aimed to explore the value of
      MRI for the prediction of tumor response to chemoradiotherapy and accurate target volume
      delineation as compared to CT simulation for patients with unresectable or potentially
      resectable esophageal or esophagogastric cancer undergoing chemoradiotherapy. The average CT
      texture features are also extracted before and during treatment to establish a model to
      predict the prognosis or side effects (e.g. radiation pneumonitis or esophagitis) of
      patients.
1. Both DW-MRI and CT simulation will be performed before chemoradiotherapy and after 18-22
           fractions. Also MRI will be performed after treatment. The investigators will contour
           based on the MRI image and compare this with the standard CT plan before and during
           treatment.

        2. The predictive potential of initial tumor ADC, and change in ADC during and after
           treatment for tumor response will be assessed.

        3. The average CT texture features not only in the present study but also of those who
           treated previously in our department (since 2014) will be extracted before and during
           chemoradiotherapy to establish a model to predict the prognosis of patients.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Tumor response based on MRI and CT simulation
time frame: up to 8 weeks
measure: Radiotherapy target volume assessment with pre- and post-chemoradiotherapy based on MRI and CT simulation
time frame: up to 8 weeks
measure: Evaluation of tumor heterogeneity with IBEX software
time frame: up to 8 weeks
description: Using the average CT images for texture extraction. Histogram, gradient, cooccurrence, gray-tone difference, and filtration-based techniques are used for texture feature extraction. Models incorporating texture features are established to compare to models incorporating clinical prognostic factors alone.
measure: Overall survival
time frame: 1 year
measure: Progress free survival
time frame: 1 year
measure: Reduction in acute and late side effects based on modified RT treatment volumes with pre- and post-chemoradiotherapy based on MRI and CT simulation
time frame: 1 year
arm group label: Esophageal or esophagogastric cancer
arm group type: Experimental
intervention type: Device
intervention name: MRI and CT
arm group label: Esophageal or esophagogastric cancer
intervention type: Radiation
intervention name: Ratiotherapy
arm group label: Esophageal or esophagogastric cancer
intervention type: Drug
intervention name: Paclitaxel, platinum-based drug
arm group label: Esophageal or esophagogastric cancer
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Xin Wang, MD
phone: +861013311583220
email: beryl_wx2000@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
investigator full name: Wang Xin
investigator title: MD
mesh term: Esophageal Neoplasms
mesh term: Paclitaxel