<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/NCT03238885</url>
  </required_header>
  <id_info>
    <org_study_id>RCpCR-MR-Radiomics</org_study_id>
    <nct_id>NCT03238885</nct_id>
  </id_info>
  <brief_title>Predicting Pathological Complete Response of Rectal Cancer With Magnetic Resonance(MR) Radiomics</brief_title>
  <official_title>Predicting Pathological Complete Response of Rectal Cancer to Neoadjuvant Chemoradiotherapy With MR Radiomics Method</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sun Ying-Shi</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking University Cancer Hospital &amp; Institute</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>
      This study plans to construct a MR radiomics model for predicting pathological complete&#xD;
      response(pCR) to neoadjuvant chemoradiotherapy(CRT) in locally advanced rectal cancer(LARC)&#xD;
      patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We propose to develop and validate a radiomics model for individualized pCR evaluation after&#xD;
      CRT in patients with LARC. We plan to use both pre- and post-CRT MRI data to construct the&#xD;
      predictive radiomics model for evaluating if LARC patients achieve pCR after CRT. The&#xD;
      ultimate aim is to select appropriate LARC patients for omission of surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2013</start_date>
  <completion_date type="Actual">January 21, 2019</completion_date>
  <primary_completion_date type="Actual">December 18, 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>Pathological complete response(pCR)</measure>
    <time_frame>within one week after surgery</time_frame>
    <description>Pathological complete response was defined as the absence of viable tumor cells in the primary tumor and lymph nodes.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">538</enrollment>
  <condition>Locally Advanced Rectal Cancer</condition>
  <arm_group>
    <arm_group_label>LARC-CRT</arm_group_label>
    <description>LARC patients who will receive neoadjuvant CRT before surgical resection.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>pelvic MR examination</intervention_name>
    <description>All patients will take pelvic MR examination within 1 week before CRT and within 1 week before surgery.Pre- and post-CRT MRI examinations will be performed using a 3.0 T unit (Discovery 750) using an 8-channel phased array body coil in the supine position. To reduce colonic motility, 20mg of scopolamine butylbromide will be injected intramuscularly 30 min before MRI.</description>
    <arm_group_label>LARC-CRT</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        LARC patients who will undergo neoadiuvant CRT before surgery.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  pathologically proved rectal cancer&#xD;
&#xD;
          -  locally advanced rectal cancer (≥T3 or N+)&#xD;
&#xD;
          -  a distance less than 12cm between the lower edge of tumor and the anal margin&#xD;
&#xD;
          -  no evidence of distant metastases&#xD;
&#xD;
          -  no prior anti-cancer therapy before treatment&#xD;
&#xD;
          -  scheduled to receive preoperative CRT&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history or concurrent of other malignancy&#xD;
&#xD;
          -  incomplete preoperative CRT&#xD;
&#xD;
          -  failed to receive surgery or unavailable pCR assessment&#xD;
&#xD;
          -  poor quality of MR images for measurement&#xD;
&#xD;
          -  patient quit&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ying-Shi Sun</last_name>
    <role>Study Chair</role>
    <affiliation>Peking University Cancer Hospital &amp; Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beijing Cancer Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100142</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>August 1, 2017</study_first_submitted>
  <study_first_submitted_qc>August 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2017</study_first_posted>
  <last_update_submitted>January 31, 2019</last_update_submitted>
  <last_update_submitted_qc>January 31, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Peking University Cancer Hospital &amp; Institute</investigator_affiliation>
    <investigator_full_name>Sun Ying-Shi</investigator_full_name>
    <investigator_title>Director</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rectal Neoplasms</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/NCT03238885
org study id: RCpCR-MR-Radiomics
nct id: NCT03238885
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study plans to construct a MR radiomics model for predicting pathological complete
      response(pCR) to neoadjuvant chemoradiotherapy(CRT) in locally advanced rectal cancer(LARC)
      patients.
We propose to develop and validate a radiomics model for individualized pCR evaluation after
      CRT in patients with LARC. We plan to use both pre- and post-CRT MRI data to construct the
      predictive radiomics model for evaluating if LARC patients achieve pCR after CRT. The
      ultimate aim is to select appropriate LARC patients for omission of surgery.
observational model: Cohort
time perspective: Prospective
measure: Pathological complete response(pCR)
time frame: within one week after surgery
description: Pathological complete response was defined as the absence of viable tumor cells in the primary tumor and lymph nodes.
arm group label: LARC-CRT
description: LARC patients who will receive neoadjuvant CRT before surgical resection.
intervention type: Diagnostic Test
intervention name: pelvic MR examination
description: All patients will take pelvic MR examination within 1 week before CRT and within 1 week before surgery.Pre- and post-CRT MRI examinations will be performed using a 3.0 T unit (Discovery 750) using an 8-channel phased array body coil in the supine position. To reduce colonic motility, 20mg of scopolamine butylbromide will be injected intramuscularly 30 min before MRI.
arm group label: LARC-CRT
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Ying-Shi Sun
role: Study Chair
affiliation: Peking University Cancer Hospital & Institute
facility: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Peking University Cancer Hospital & Institute
investigator full name: Sun Ying-Shi
investigator title: Director
mesh term: Rectal Neoplasms
sharing ipd: No