<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/NCT01671683</url>
  </required_header>
  <id_info>
    <org_study_id>CNUH 10</org_study_id>
    <nct_id>NCT01671683</nct_id>
  </id_info>
  <brief_title>Additional Chemotherapy After Neoadjuvant Chemoradiotherapy in Patients With Locally Advanced Rectal Cancer</brief_title>
  <official_title>A Phase II Study of Additional Four-week Chemotherapy With Capecitabine During the Resting Periods After Six-week Neoadjuvant Chemoradiotherapy in Patients With Locally Advanced Rectal Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chungnam National University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chungnam National University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to evaluate the efficacy and safety of additional neoadjuvant&#xD;
      chemotherapy with capecitabine during the resting periods in patients with locally advanced&#xD;
      rectal cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Neoadjuvant chemoradiotherapy (NCRT) has been used as standard treatment modality in patients&#xD;
      with locally advanced rectal cancer (LARC) because of increased local control, enhanced&#xD;
      sphincter preservation, and less toxicity.NCRT has enhanced down-staging of tumor and reduced&#xD;
      local recurrence. However, survival benefit of NCRT has not been demonstrated and the rate of&#xD;
      distant metastasis was still reported as high as 30%.&#xD;
&#xD;
      Patients with pathologic complete remission (pCR) after NCRT have shown excellent survival&#xD;
      benefit. We inferred that additional chemotherapy during the resting period could enhance the&#xD;
      pCR rate. The aim of the present study is to evaluate the safety and efficacy of an&#xD;
      additional 4-week chemotherapy with capecitabine after the conventional 6-week NCRT in&#xD;
      patients with LARC.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2010</start_date>
  <completion_date type="Actual">September 2011</completion_date>
  <study_type>Observational</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>
  <enrollment type="Actual">44</enrollment>
  <condition>Rectal Cancer</condition>
  <eligibility>
    <study_pop>
      <textblock>
        patients of our hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  histologically proven, locally advanced adenocarcinoma of the rectum&#xD;
&#xD;
          -  an Eastern Cooperative Oncology Group (ECOG) score of 0-2&#xD;
&#xD;
          -  adequate function of major organs&#xD;
&#xD;
          -  a signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  other co-existing malignancy or malignancy within the last 5 years prior to enrollment&#xD;
&#xD;
          -  severe concurrent medical or psychiatric disorders&#xD;
&#xD;
          -  prior RT to pelvis&#xD;
&#xD;
          -  pregnant or lactating patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ji Yeon Kim, MD., PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Surgical Oncology Research Lab</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chungnam National University Hospital</name>
      <address>
        <city>Daejeon</city>
        <zip>301-721</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 21, 2012</study_first_submitted>
  <study_first_submitted_qc>August 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 23, 2012</study_first_posted>
  <last_update_submitted>August 21, 2012</last_update_submitted>
  <last_update_submitted_qc>August 21, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 23, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chungnam National University</investigator_affiliation>
    <investigator_full_name>Ji Yeon Kim</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>rectal cancer</keyword>
  <keyword>neoadjuvant chemoradiotherapy</keyword>
  <keyword>Capecitabine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rectal Neoplasms</mesh_term>
  </condition_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/NCT01671683
org study id: CNUH 10
nct id: NCT01671683
lead sponsor: 
has dmc: No
The aim of this study is to evaluate the efficacy and safety of additional neoadjuvant
      chemotherapy with capecitabine during the resting periods in patients with locally advanced
      rectal cancer.
Neoadjuvant chemoradiotherapy (NCRT) has been used as standard treatment modality in patients
      with locally advanced rectal cancer (LARC) because of increased local control, enhanced
      sphincter preservation, and less toxicity.NCRT has enhanced down-staging of tumor and reduced
      local recurrence. However, survival benefit of NCRT has not been demonstrated and the rate of
      distant metastasis was still reported as high as 30%.

      Patients with pathologic complete remission (pCR) after NCRT have shown excellent survival
      benefit. We inferred that additional chemotherapy during the resting period could enhance the
      pCR rate. The aim of the present study is to evaluate the safety and efficacy of an
      additional 4-week chemotherapy with capecitabine after the conventional 6-week NCRT in
      patients with LARC.
observational model: Case-Only
time perspective: Prospective
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ji Yeon Kim, MD., PhD
role: Principal Investigator
affiliation: Surgical Oncology Research Lab
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Chungnam National University
investigator full name: Ji Yeon Kim
investigator title: Associate Professor
mesh term: Rectal Neoplasms