<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/NCT03022734</url>
  </required_header>
  <id_info>
    <org_study_id>4-2016-0410</org_study_id>
    <nct_id>NCT03022734</nct_id>
  </id_info>
  <brief_title>Short Course Radiotherapy, Unresectable Rectal Cancer, Liver Metastasis</brief_title>
  <official_title>A Phase II Study of Neoadjuvant Systemic Chemotherapy With Short Course Radiotherapy in Patients With Unresectable Rectal Cancer and Liver Metastasis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is the increase of resection rate of primary cancer in rectal after&#xD;
      short course radiotherapy without interrupt chemotherapy schedule during the period of&#xD;
      chemotherapy. Radiation therapy is followed by additional chemotherapy to prevent the&#xD;
      progression of systemic metastasis, and to reduce the incidence of rectal carcinoma including&#xD;
      metastasis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2016</start_date>
  <completion_date type="Anticipated">June 2021</completion_date>
  <primary_completion_date type="Anticipated">January 2021</primary_completion_date>
  <phase>Phase 2</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>complete resection (R0) rate for rectal and liver lesions</measure>
    <time_frame>after surgical resection, an average of 24 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Response rate (RECIST V1.1)</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Rectal Cancer, Metastatic</condition>
  <arm_group>
    <arm_group_label>chemotherapy with radiotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cetuximab or Bevacizumab, FOLFOX or FOLFIRI, radiotherapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>chemotherapy</intervention_name>
    <description>cetuximab 250mg/m2 or bevacizumab 5mg/kg, FOLFOX (oxaliplatin 85mg/m2, leucovorin 200mg/m2, 5-FU 400mg/m2, 5-FU continuous 1200mg/m2) or FOLFIRI (irinotecan 180mg/m2, leucovorin 200mg/m2, 5-FU 400mg/m2, 5-FU continuous 1200mg/m2)</description>
    <arm_group_label>chemotherapy with radiotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>radiotherapy</intervention_name>
    <description>After FOLFOX 4cycle, subject have short course radiotherapy 5Gy for 5 days.</description>
    <arm_group_label>chemotherapy with radiotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  pathologically confirmed for unresectable (impossible to try Total mesorectal&#xD;
             excision) rectal cancer with liver metastasis&#xD;
&#xD;
          -  over 19 years&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group 0-1&#xD;
&#xD;
          -  Proper organ function&#xD;
&#xD;
          -  more than one target lesion (standard by Response Evaluation Criteria in Solid Tumors&#xD;
             1.1)&#xD;
&#xD;
          -  Who should sign on the Informed consent form before participate the trial.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Metastasis in other organ except liver&#xD;
&#xD;
          -  Chronic active hepatitis or cirrhosis&#xD;
&#xD;
          -  History of treatment for metastatic colorectal cancer&#xD;
&#xD;
          -  Subject pregnant or breast feeding&#xD;
&#xD;
          -  Uncontrolled disease&#xD;
&#xD;
          -  Have had adjuvant therapy&#xD;
&#xD;
          -  Uncontrolled peripheral nerve infection&#xD;
&#xD;
          -  Alcoholic or drug addict&#xD;
&#xD;
          -  Subject currently is enrolled in or ≤30 days from ending other clinical trial.&#xD;
&#xD;
          -  History of other type of cancer except resolved from skin cancer and cervical cancer.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Sang Joon Shin</last_name>
    <phone>82-2-2228-8130</phone>
  </overall_contact>
  <location>
    <facility>
      <name>Severance Hospital, Yonsei University Health System</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sang Joon Shin</last_name>
      <phone>82-2-2228-8130</phone>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 16, 2017</study_first_posted>
  <last_update_submitted>January 10, 2020</last_update_submitted>
  <last_update_submitted_qc>January 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Yonsei University</investigator_affiliation>
    <investigator_full_name>Sang Joon Shin</investigator_full_name>
    <investigator_title>Professor</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/NCT03022734
org study id: 4-2016-0410
nct id: NCT03022734
lead sponsor: 
has dmc: No
The purpose of this study is the increase of resection rate of primary cancer in rectal after
      short course radiotherapy without interrupt chemotherapy schedule during the period of
      chemotherapy. Radiation therapy is followed by additional chemotherapy to prevent the
      progression of systemic metastasis, and to reduce the incidence of rectal carcinoma including
      metastasis.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: complete resection (R0) rate for rectal and liver lesions
time frame: after surgical resection, an average of 24 weeks
measure: Response rate (RECIST V1.1)
time frame: 8 weeks
arm group label: chemotherapy with radiotherapy
arm group type: Experimental
description: Cetuximab or Bevacizumab, FOLFOX or FOLFIRI, radiotherapy
intervention type: Drug
intervention name: chemotherapy
description: cetuximab 250mg/m2 or bevacizumab 5mg/kg, FOLFOX (oxaliplatin 85mg/m2, leucovorin 200mg/m2, 5-FU 400mg/m2, 5-FU continuous 1200mg/m2) or FOLFIRI (irinotecan 180mg/m2, leucovorin 200mg/m2, 5-FU 400mg/m2, 5-FU continuous 1200mg/m2)
arm group label: chemotherapy with radiotherapy
intervention type: Radiation
intervention name: radiotherapy
description: After FOLFOX 4cycle, subject have short course radiotherapy 5Gy for 5 days.
arm group label: chemotherapy with radiotherapy
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Sang Joon Shin
phone: 82-2-2228-8130
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Yonsei University
investigator full name: Sang Joon Shin
investigator title: Professor
mesh term: Rectal Neoplasms
sharing ipd: No