<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/NCT01671891</url>
  </required_header>
  <id_info>
    <org_study_id>SCRC-NM-1001</org_study_id>
    <nct_id>NCT01671891</nct_id>
  </id_info>
  <brief_title>Detection and Enumeration of Circulating Tumor Cells in Rectal Cancer</brief_title>
  <official_title>Detection and Enumeration of Circulating Tumor Cells in Rectal Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fudan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fudan University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Rectal cancer is one of the most common malignant tumors in the world. However, there's also&#xD;
      no reliable and sensitive method to monitor diseases and evaluate therapy responses till now.&#xD;
      Circulating tumor cells, which could reflect tumor's status correctly and reliably, may be a&#xD;
      promising method in this field. This study is to investigate the role of circulating tumor&#xD;
      cells in evaluating and predicting the responses of chemoradiotherapy in rectal cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>February 2012</start_date>
  <completion_date type="Anticipated">February 2013</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>circulating tumor cells level changes after radiotherapy</measure>
    <time_frame>3 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>overall survival</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>disease-free survival</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>serum carcinoembryonic antigen (CEA) level</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pathological response (tumor regression grade)if surgery</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>RECIST-based tumor response at 10 week after radiotherapy</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Rectal Cancer</condition>
  <arm_group>
    <arm_group_label>rectal cancer with stage II-IV</arm_group_label>
    <description>rectal cancer with stage II-IV intervention: pelvic radiotherapy (45-55Gy) concurrent chemotherapy using capecitabine and oxaliplatin</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>radiation therapy</intervention_name>
    <description>45-55Gy</description>
    <arm_group_label>rectal cancer with stage II-IV</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>capecitabine (625mg/m2,bid,d1-5 qw)and oxaliplatin (85mg/m2 d1 qw)</intervention_name>
    <description>radiotherapy concurrent chemotherapy(capecitabine+oxaliplatin)</description>
    <arm_group_label>rectal cancer with stage II-IV</arm_group_label>
    <other_name>Xeloda</other_name>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      whole blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        rectal cancer diagnosed with stage II-IV&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically verified rectal carcinoma&#xD;
&#xD;
          -  Locally advanced tumor (cT3-4 and/or N+ by transrectal ultrasound and/or pelvic&#xD;
             magnetic resonance imaging)&#xD;
&#xD;
          -  the distance from anal verge &lt;= 12cm&#xD;
&#xD;
          -  with or without metastasis&#xD;
&#xD;
          -  Age 18-75 years old&#xD;
&#xD;
          -  ECOG PS 0-2&#xD;
&#xD;
          -  No previous chemotherapy or radiotherapy for rectal carcinoma&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  no histologically verified rectal carcinoma&#xD;
&#xD;
          -  rectal cancer with stage I&#xD;
&#xD;
          -  distance from verge &gt;12cm&#xD;
&#xD;
          -  age &lt;=18 or &gt;=75 years old&#xD;
&#xD;
          -  performed previously chemotherapy or radiotherapy&#xD;
&#xD;
          -  infection diseases within three months&#xD;
&#xD;
          -  serious other diseases&#xD;
&#xD;
          -  no written informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Wenjie Sun, Master</last_name>
    <phone>86-21-64175590-1600</phone>
    <email>ganjumedecin@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Fudan University Shanghai Cancer Center</name>
      <address>
        <city>Shanghai</city>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wenjie Sun, Master</last_name>
      <phone>86-21-64175590</phone>
      <email>ganjumedecin@hotmail.com</email>
    </contact>
    <investigator>
      <last_name>Zhen Zhang, PhD,MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Wenjie Sun, Master,MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <link>
    <url>http://www.ncbi.nlm.nih.gov/pubmed/22230943</url>
    <description>circulating tumor cells in colorectal cancer</description>
  </link>
  <link>
    <url>http://www.ncbi.nlm.nih.gov/pubmed/22157288</url>
    <description>Circulating tumors cells as biomarkers: progress toward biomarker qualification</description>
  </link>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>July 19, 2012</study_first_submitted>
  <study_first_submitted_qc>August 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 24, 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 24, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fudan University</investigator_affiliation>
    <investigator_full_name>Zhen Zhang</investigator_full_name>
    <investigator_title>director of radiotherapy department in Fudan university shanghai cancer center</investigator_title>
  </responsible_party>
  <keyword>rectal cancer</keyword>
  <keyword>circulating tumor cells</keyword>
  <keyword>predict responses</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rectal Neoplasms</mesh_term>
    <mesh_term>Neoplastic Cells, Circulating</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Capecitabine</mesh_term>
    <mesh_term>Oxaliplatin</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/NCT01671891
org study id: SCRC-NM-1001
nct id: NCT01671891
lead sponsor: 
has dmc: Yes
Rectal cancer is one of the most common malignant tumors in the world. However, there's also
      no reliable and sensitive method to monitor diseases and evaluate therapy responses till now.
      Circulating tumor cells, which could reflect tumor's status correctly and reliably, may be a
      promising method in this field. This study is to investigate the role of circulating tumor
      cells in evaluating and predicting the responses of chemoradiotherapy in rectal cancer.
observational model: Cohort
time perspective: Prospective
measure: circulating tumor cells level changes after radiotherapy
time frame: 3 years
measure: overall survival
time frame: 3 years
measure: disease-free survival
time frame: 3 years
measure: serum carcinoembryonic antigen (CEA) level
time frame: 3 years
measure: pathological response (tumor regression grade)if surgery
time frame: 3 years
measure: RECIST-based tumor response at 10 week after radiotherapy
time frame: 3 years
arm group label: rectal cancer with stage II-IV
description: rectal cancer with stage II-IV intervention: pelvic radiotherapy (45-55Gy) concurrent chemotherapy using capecitabine and oxaliplatin
intervention type: Radiation
intervention name: radiation therapy
description: 45-55Gy
arm group label: rectal cancer with stage II-IV
intervention type: Drug
intervention name: capecitabine (625mg/m2,bid,d1-5 qw)and oxaliplatin (85mg/m2 d1 qw)
description: radiotherapy concurrent chemotherapy(capecitabine+oxaliplatin)
arm group label: rectal cancer with stage II-IV
other name: Xeloda
whole blood
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Wenjie Sun, Master
phone: 86-21-64175590-1600
email: ganjumedecin@hotmail.com
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: China
url: http://www.ncbi.nlm.nih.gov/pubmed/22230943
description: circulating tumor cells in colorectal cancer
url: http://www.ncbi.nlm.nih.gov/pubmed/22157288
description: Circulating tumors cells as biomarkers: progress toward biomarker qualification
responsible party type: Principal Investigator
investigator affiliation: Fudan University
investigator full name: Zhen Zhang
investigator title: director of radiotherapy department in Fudan university shanghai cancer center
mesh term: Rectal Neoplasms
mesh term: Neoplastic Cells, Circulating
mesh term: Capecitabine
mesh term: Oxaliplatin