<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/NCT02979795</url>
  </required_header>
  <id_info>
    <org_study_id>CMUH105-REC2-072</org_study_id>
    <nct_id>NCT02979795</nct_id>
  </id_info>
  <brief_title>Translational Research in Identifying Molecular Mechanisms for Rectal Cancer Metastasis</brief_title>
  <official_title>Translational Research in Identifying Molecular Mechanisms for Rectal Cancer Metastasis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>China Medical University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>China Medical University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Rectal cancer, comprised of 30% of overall colorectal cancer cohort, is one of the leading&#xD;
      cancers of Taiwan. In patients with advanced disease, the standard of care is concurrent&#xD;
      chemoradiotherapy (CCRT) before surgery. After CCRT, the abscopal effect, a phenomenon that&#xD;
      localized radiation not only destroys local tumor but also inhibits the growth of tumor at&#xD;
      the remote site, has been observed. This effect is believed to be associated with tumor&#xD;
      immune response. In addition, other immune checkpoint molecules, such as Programmed cell&#xD;
      death-1(PD-1), Programmed cell death ligand-1 (PD-L1), and Cytotoxic T-Lymphocyte Associated&#xD;
      Protein 4 (CTLA-4), have been reported associated with therapeutic outcome. However, after&#xD;
      CCRT, more than 50% of patients were still either having persistent disease or developed&#xD;
      distant metastasis. To improve therapeutic outcome of patients with rectal cancer, this&#xD;
      project, thus, aims at exploring the evolution of factors that may affect the abscopal effect&#xD;
      and immune checkpoint functions in tissues and in blood before and after CCRT.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      For most patients, preoperative chemoradiotherapy results in clinically tumor regression, but&#xD;
      the degree of response varies among patients. There are approximately 40-60% of LARC patients&#xD;
      treated with CCRT achieve some degree of pathologic response. However, there is yet an&#xD;
      effective method before the commencement of CCRT that can predict how patients will respond&#xD;
      to CCRT and can subsequently render better survival. Identify patents who will benefit most&#xD;
      from CCRT is crucial not only in lowering treatment-related morbidity and sustaining local&#xD;
      control but also to improve survival rate in LARC.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">November 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>5 Years</target_duration>
  <primary_outcome>
    <measure>Tumor regression rate</measure>
    <time_frame>within 8 weeks after completion of chemoradiotherapy</time_frame>
    <description>complete tumor regression rate(TRG) with tumor regression graded at at surgical resection at 8 weeks after completion of chemoradiotherapy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Disease free survival</measure>
    <time_frame>5 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>5 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Local recurrence</measure>
    <time_frame>5 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distant metastasis</measure>
    <time_frame>5 year</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Rectal Cancer</condition>
  <condition>Chemoradiation</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Preoperative chemoradiotherapy</intervention_name>
    <description>Preoperative chemoradiotherapy. 2.5 Gray/fraction (Total in 45-54 Gray)</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Rectal cancer patients in China Medical University Hospital (Age: 20 yrs and older)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Rectal cancer patients in China Medical University Hospital (Age limit: 20 yrs and&#xD;
             older)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy, Disabilities&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kan Sun Clifford Chao, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>China Medical University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kan Sun Clifford Chao, MD</last_name>
    <phone>886422052121</phone>
    <phone_ext>2976</phone_ext>
    <email>D94032@mail.cmuh.org.tw</email>
  </overall_contact>
  <location>
    <facility>
      <name>China Medical University Hospital</name>
      <address>
        <city>Taichung</city>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Huang Chih-Yang, Ph.D</last_name>
      <phone>886422052121</phone>
      <phone_ext>3677</phone_ext>
      <email>T96752@mail.cmuh.org.tw</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 30, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <last_update_submitted>November 30, 2016</last_update_submitted>
  <last_update_submitted_qc>November 30, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 2, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>China Medical University Hospital</investigator_affiliation>
    <investigator_full_name>Kun-San Clifford Chao</investigator_full_name>
    <investigator_title>Cancer center</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>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/NCT02979795
org study id: CMUH105-REC2-072
nct id: NCT02979795
lead sponsor: 
has dmc: Yes
Rectal cancer, comprised of 30% of overall colorectal cancer cohort, is one of the leading
      cancers of Taiwan. In patients with advanced disease, the standard of care is concurrent
      chemoradiotherapy (CCRT) before surgery. After CCRT, the abscopal effect, a phenomenon that
      localized radiation not only destroys local tumor but also inhibits the growth of tumor at
      the remote site, has been observed. This effect is believed to be associated with tumor
      immune response. In addition, other immune checkpoint molecules, such as Programmed cell
      death-1(PD-1), Programmed cell death ligand-1 (PD-L1), and Cytotoxic T-Lymphocyte Associated
      Protein 4 (CTLA-4), have been reported associated with therapeutic outcome. However, after
      CCRT, more than 50% of patients were still either having persistent disease or developed
      distant metastasis. To improve therapeutic outcome of patients with rectal cancer, this
      project, thus, aims at exploring the evolution of factors that may affect the abscopal effect
      and immune checkpoint functions in tissues and in blood before and after CCRT.
For most patients, preoperative chemoradiotherapy results in clinically tumor regression, but
      the degree of response varies among patients. There are approximately 40-60% of LARC patients
      treated with CCRT achieve some degree of pathologic response. However, there is yet an
      effective method before the commencement of CCRT that can predict how patients will respond
      to CCRT and can subsequently render better survival. Identify patents who will benefit most
      from CCRT is crucial not only in lowering treatment-related morbidity and sustaining local
      control but also to improve survival rate in LARC.
observational model: Case-Only
time perspective: Prospective
measure: Tumor regression rate
time frame: within 8 weeks after completion of chemoradiotherapy
description: complete tumor regression rate(TRG) with tumor regression graded at at surgical resection at 8 weeks after completion of chemoradiotherapy
measure: Disease free survival
time frame: 5 year
measure: Overall survival
time frame: 5 year
measure: Local recurrence
time frame: 5 year
measure: Distant metastasis
time frame: 5 year
intervention type: Procedure
intervention name: Preoperative chemoradiotherapy
description: Preoperative chemoradiotherapy. 2.5 Gray/fraction (Total in 45-54 Gray)
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Kan Sun Clifford Chao, MD
role: Principal Investigator
affiliation: China Medical University Hospital
last name: Kan Sun Clifford Chao, MD
phone: 886422052121
phone ext: 2976
email: D94032@mail.cmuh.org.tw
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: China Medical University Hospital
investigator full name: Kun-San Clifford Chao
investigator title: Cancer center
mesh term: Rectal Neoplasms
sharing ipd: Undecided