<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/NCT01677728</url>
  </required_header>
  <id_info>
    <org_study_id>ZSTCC</org_study_id>
    <secondary_id>Xjianmin</secondary_id>
    <nct_id>NCT01677728</nct_id>
  </id_info>
  <brief_title>Effect of Target Therapy on Patients Undergoing Synchronic Hepatectomy for Colorectal Liver Metastases</brief_title>
  <official_title>A Randomized, Controlled Trial of Target Therapy Plus Chemotherapy in Patients Undergoing Liver Resection for Colorectal Liver Metastases</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xu jianmin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fudan University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fudan University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to explore whether target therapy in combination with chemotherapy&#xD;
      as treatment could improve survival or tumor response in patients undergoing Synchronic&#xD;
      Hepatectomy for Colorectal Liver Metastases.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In patients with colorectal cancer (CRC), the liver is the most common site of hematogenous&#xD;
      metastases. Approximately half of patients develop hepatic metastases during the course of&#xD;
      the disease, and hepatic metastases are responsible for death in at least two thirds of CRC&#xD;
      patients.&#xD;
&#xD;
      Over the past decade, due to the introduction of irinotecan-based or oxaliplatin-based&#xD;
      combination chemotherapy, the median survival among patients with colorectal liver metastases&#xD;
      (CLM) has increased from 6 ~8 months to more than 20 months5.In recent years, target therapy&#xD;
      has rapidly gained attention for the treatment of CLM and is under active investigation.&#xD;
&#xD;
      Although numerous publications have reported the efficacy of target therapy in combination&#xD;
      treatment for CLM patients, most of these studies focused solely on those patients without&#xD;
      undergoing resection of liver metastases. In contrast, little work has concentrated on&#xD;
      exploring the effection of target therapy for CLM patients undergoing Synchronic Hepatectomy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2007</start_date>
  <completion_date type="Anticipated">December 2014</completion_date>
  <primary_completion_date type="Anticipated">December 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Colorectal Cancer</condition>
  <condition>Liver Tumor</condition>
  <arm_group>
    <arm_group_label>arm A</arm_group_label>
    <description>patients received chemotherapy alone</description>
  </arm_group>
  <arm_group>
    <arm_group_label>arm B</arm_group_label>
    <description>patients received target therapy combined with chemotherapy</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        From Zhongshan hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age between 18 - 75 years old&#xD;
&#xD;
          -  Performance status (ECOG) 0~1&#xD;
&#xD;
          -  colorectal adenocarcinoma pathologically&#xD;
&#xD;
          -  without any chemotherapy or radiotherapy&#xD;
&#xD;
          -  liver metastases undergoing radical resection&#xD;
&#xD;
          -  colorectal cancer undergoing radical resection&#xD;
&#xD;
          -  no other metastases&#xD;
&#xD;
          -  suitable for chemotherapy&#xD;
&#xD;
          -  agreed by patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age below 18 years old or greater than 75 years old&#xD;
&#xD;
          -  haven't pathological diagnosis of colorectal adenocarcinoma with liver metastase&#xD;
&#xD;
          -  with any chemotherapy or radiotherapy&#xD;
&#xD;
          -  with other metastasis&#xD;
&#xD;
          -  unresectable colorectal cancer or liver metastases&#xD;
&#xD;
          -  unsuitable for chemotherapy or target therapy&#xD;
&#xD;
          -  not agreed by patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xu Jianmin, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Shanghai Zhongshan Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xu Jianmin, MD</last_name>
    <phone>+86-13501984869</phone>
    <email>xujmin@yahoo.com.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Zhongshan Hospital, Fudan University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jianmin Xu, M.D.,Ph.D.</last_name>
      <phone>86-13501984869</phone>
      <email>xujmin@yahoo.com.cn</email>
    </contact>
    <investigator>
      <last_name>Jianmin Xu, M.D.,Ph.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 30, 2012</study_first_submitted>
  <study_first_submitted_qc>August 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2012</study_first_posted>
  <last_update_submitted>August 30, 2012</last_update_submitted>
  <last_update_submitted_qc>August 30, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 3, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Fudan University</investigator_affiliation>
    <investigator_full_name>Xu jianmin</investigator_full_name>
    <investigator_title>Zhongshan hospital</investigator_title>
  </responsible_party>
  <keyword>colorectal liver metastases</keyword>
  <keyword>chemotherapy</keyword>
  <keyword>cetuximab</keyword>
  <keyword>bevacizumab</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasm Metastasis</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/NCT01677728
org study id: ZSTCC
secondary id: Xjianmin
nct id: NCT01677728
lead sponsor: 
collaborator: 
has dmc: No
The aim of this study is to explore whether target therapy in combination with chemotherapy
      as treatment could improve survival or tumor response in patients undergoing Synchronic
      Hepatectomy for Colorectal Liver Metastases.
In patients with colorectal cancer (CRC), the liver is the most common site of hematogenous
      metastases. Approximately half of patients develop hepatic metastases during the course of
      the disease, and hepatic metastases are responsible for death in at least two thirds of CRC
      patients.

      Over the past decade, due to the introduction of irinotecan-based or oxaliplatin-based
      combination chemotherapy, the median survival among patients with colorectal liver metastases
      (CLM) has increased from 6 ~8 months to more than 20 months5.In recent years, target therapy
      has rapidly gained attention for the treatment of CLM and is under active investigation.

      Although numerous publications have reported the efficacy of target therapy in combination
      treatment for CLM patients, most of these studies focused solely on those patients without
      undergoing resection of liver metastases. In contrast, little work has concentrated on
      exploring the effection of target therapy for CLM patients undergoing Synchronic Hepatectomy.
observational model: Case-Control
time perspective: Prospective
arm group label: arm A
description: patients received chemotherapy alone
arm group label: arm B
description: patients received target therapy combined with chemotherapy
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Xu Jianmin, MD
role: Study Chair
affiliation: Shanghai Zhongshan Hospital
last name: Xu Jianmin, MD
phone: +86-13501984869
email: xujmin@yahoo.com.cn
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Fudan University
investigator full name: Xu jianmin
investigator title: Zhongshan hospital
mesh term: Neoplasm Metastasis