<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/NCT03031444</url>
  </required_header>
  <id_info>
    <org_study_id>PX2016002</org_study_id>
    <nct_id>NCT03031444</nct_id>
  </id_info>
  <brief_title>Perioperative Chemotherapy Plus Cetuximab Versus Chemotherapy Alone for High Risk Resectable Colorectal Liver Metastasis</brief_title>
  <acronym>PARECEC</acronym>
  <official_title>A Multicenter Study of Prognosis and the Efficacy Comparison of Perioperative Chemotherapy Plus Cetuximab Versus Chemotherapy Alone for High Risk Patients(Clinical Risk Score≥3) of Resectable Colorectal Liver Metastasis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University Cancer Hospital &amp; Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Beijing Municipal Administration of Hospitals</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>West China Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Zhejiang Cancer Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>First Affiliated Hospital of Kunming Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Peking University Cancer Hospital &amp; Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study was designed to analyze the prognosis and recurrence predictive factors of high&#xD;
      risk patients (Clinical Risk Score≥3) of resectable colorectal liver metastasis.&#xD;
&#xD;
      The efficacy of perioperative chemotherapy plus cetuximab and chemotherapy alone was compared&#xD;
      for these patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Resection could prolong the survival of colorectal liver metastasis patients, however,the&#xD;
      curative resection rate was still low and more than 2/3 of the patients would experience&#xD;
      tumor recurrence.This study was designed to formulate a more accurate and individual&#xD;
      evaluation system via the multivariate analysis.&#xD;
&#xD;
      Up to now, there was no data to demonstrate the addition of cetuximab to perioperative&#xD;
      chemotherapy could decrease recurrence and prolong survival for RAS wild-type, high&#xD;
      risk(Clinical Risk Score≥3) resectable colorectal liver metastasis patients. This study was&#xD;
      also designed to elucidate this question and to observe the objective response rate(ORR) and&#xD;
      the safety data of the regime.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2016</start_date>
  <completion_date type="Actual">December 30, 2020</completion_date>
  <primary_completion_date type="Actual">December 30, 2020</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>disease free survival</measure>
    <time_frame>From date of hepatectomy until the date of first documented recurrence or metastasis or date of death from any cause, whichever came first, assessed up to 60 months</time_frame>
    <description>months the patient lived from the date of liver resection to the date of disease recurrence or metastasis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>overall survival</measure>
    <time_frame>From date of hepatectomy until the date of first documented death from any cause or the last follow-up if no death happened, assessed up to 60 months</time_frame>
    <description>months the patient lived from the date of liver resection to the date of patient death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>objective response rate</measure>
    <time_frame>from the date of the first chemotherapy until the date two weeks after the completion of the last preoperative chemotherapy, assessed up to 6 weeks</time_frame>
    <description>percent of the number of patients who showed partial response(PR) or complete response(CR) who received preoperative chemotherapy to the number of all the patients enrolled.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">135</enrollment>
  <condition>Colorectal Cancer Stage IV</condition>
  <condition>Metastasis</condition>
  <arm_group>
    <arm_group_label>chemotherapy plus cetuximab</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Cetuximab plus FOLFIRI/FOLFOX:FOLFIRI plus cetuximab [Irinotecan 180 mg/m2 IV over 30-90 minutes, day 1;Leucovorin 400 mg/m2 IV infusion to match duration of irinotecan infusion, day 1;5-fluoruracil(5-FU) 400 mg/m2 IV bolus day 1, then 1200 mg/m2/day x 2 days (total 2400 mg/m2 over 46-48 hours) IV continuous infusion.Repeat every 2 weeks.Cetuximab 500 mg/m2 IV over 2 hours, day 1, every 2 weeks] or FOLFOX plus Cetuximab [Oxaliplatin 85 mg/m2 IV over 2 hours, day 1 Leucovorin 400 mg/m2 IV over 2 hours, day 1 5-FU 400 mg/m2 IV bolus on day 1, then 1200 mg/m2/day x 2 days (total 2400 mg/m2 over 46-48 hours) IV continuous infusion Repeat every 2 weeks;Cetuximab 500 mg/m2 IV over 2 hours, day 1, every 2 weeks]</description>
  </arm_group>
  <arm_group>
    <arm_group_label>perioperative chemotherapy alone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>FOLFIRI/FOLFOX/CapeOX:routine perioperative chemotherapy including FOLFIRI[Irinotecan 180 mg/m2 IV over 30-90 minutes, day 1 Leucovorin 400 mg/m2 IV infusion to match duration of irinotecan infusion, day 1 5-FU 400 mg/m2 IV bolus day 1, then 1200 mg/m2/day x 2 days (total 2400 mg/m2 over 46-48 hours) continuous infusion Repeat every 2 weeks] or FOLFOX[Oxaliplatin 85 mg/m2 IV over 2 hours, day 1;Leucovorin 400 mg/m2 IV over 2 hours, day 1 5-FU 400 mg/m2 IV bolus on day 1, then 1200 mg/m2/day x 2 days (total 2400 mg/m2 over 46-48 hours) IV continuous infusion Repeat every 2 weeks] or CapeOX[Oxaliplatin 130 mg/m2 IV over 2 hours, day 1 Capecitabine 850-1000mg/m2 twice daily PO for 14 days Repeat every 3 weeks] was adopted in this control arm.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cetuximab plus FOLFIRI/FOLFOX</intervention_name>
    <description>cetuximab was added into the routine perioperative chemotherapy(FOLFIRI/FOLFOX) to evaluate its safety and efficacy</description>
    <arm_group_label>chemotherapy plus cetuximab</arm_group_label>
    <other_name>Erbitux</other_name>
    <other_name>C225</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>FOLFIRI/FOLFOX/CapeOX</intervention_name>
    <description>to evaluate its safety and efficacy of routine perioperative chemotherapy(FOLFIRI/FOLFOX/CapeOX)</description>
    <arm_group_label>perioperative chemotherapy alone</arm_group_label>
    <other_name>XELOX</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  good performance status&#xD;
&#xD;
          -  pathologic diagnosis of colorectal cancer&#xD;
&#xD;
          -  Rat sarcoma viral oncogene homolog(RAS) wild-type&#xD;
&#xD;
          -  radiologic confirmation the resectability of liver metastases&#xD;
&#xD;
          -  enough future liver remnant&#xD;
&#xD;
          -  Clinical Risk Score≥3&#xD;
&#xD;
          -  treatment naive&#xD;
&#xD;
          -  extra-hepatic metastases could be resected completely, if exist&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  poor performance status, could not tolerate chemotherapy or operation&#xD;
&#xD;
          -  other malignancy history or synchronously&#xD;
&#xD;
          -  extra-hepatic metastases could not be resected completely, if exist&#xD;
&#xD;
          -  received other treatment previously&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Baocai Xing, MD</last_name>
    <role>Study Director</role>
    <affiliation>Beijing Cancer Hospital,Peking University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beijing Cancer Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100142</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West China Hospital, Sichuan University</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610041</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>First Affiliated Hospital of Kunming Medical University</name>
      <address>
        <city>Kunming</city>
        <state>Yunnan</state>
        <zip>650032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zhejiang Cancer Hospital</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310022</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <link>
    <url>http://ncbi.nlm.nih.gov</url>
    <description>test link</description>
  </link>
  <reference>
    <citation>Primrose J, Falk S, Finch-Jones M, Valle J, O'Reilly D, Siriwardena A, Hornbuckle J, Peterson M, Rees M, Iveson T, Hickish T, Butler R, Stanton L, Dixon E, Little L, Bowers M, Pugh S, Garden OJ, Cunningham D, Maughan T, Bridgewater J. Systemic chemotherapy with or without cetuximab in patients with resectable colorectal liver metastasis: the New EPOC randomised controlled trial. Lancet Oncol. 2014 May;15(6):601-11. doi: 10.1016/S1470-2045(14)70105-6. Epub 2014 Apr 7. Erratum In: Lancet Oncol. 2014 Jun;15(7):e253.</citation>
    <PMID>24717919</PMID>
  </reference>
  <results_reference>
    <citation>Fong Y, Fortner J, Sun RL, Brennan MF, Blumgart LH. Clinical score for predicting recurrence after hepatic resection for metastatic colorectal cancer: analysis of 1001 consecutive cases. Ann Surg. 1999 Sep;230(3):309-18; discussion 318-21. doi: 10.1097/00000658-199909000-00004.</citation>
    <PMID>10493478</PMID>
  </results_reference>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>December 4, 2016</study_first_submitted>
  <study_first_submitted_qc>January 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 25, 2017</study_first_posted>
  <last_update_submitted>January 29, 2021</last_update_submitted>
  <last_update_submitted_qc>January 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking University Cancer Hospital &amp; Institute</investigator_affiliation>
    <investigator_full_name>Wang Kun</investigator_full_name>
    <investigator_title>associate director</investigator_title>
  </responsible_party>
  <keyword>colorectal liver metastasis</keyword>
  <keyword>preoperative</keyword>
  <keyword>chemotherapy</keyword>
  <keyword>targeted therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasm Metastasis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leucovorin</mesh_term>
    <mesh_term>Cetuximab</mesh_term>
    <mesh_term>Fluorouracil</mesh_term>
    <mesh_term>Oxaliplatin</mesh_term>
  </intervention_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/NCT03031444
org study id: PX2016002
nct id: NCT03031444
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
This study was designed to analyze the prognosis and recurrence predictive factors of high
      risk patients (Clinical Risk Score≥3) of resectable colorectal liver metastasis.

      The efficacy of perioperative chemotherapy plus cetuximab and chemotherapy alone was compared
      for these patients.
Resection could prolong the survival of colorectal liver metastasis patients, however,the
      curative resection rate was still low and more than 2/3 of the patients would experience
      tumor recurrence.This study was designed to formulate a more accurate and individual
      evaluation system via the multivariate analysis.

      Up to now, there was no data to demonstrate the addition of cetuximab to perioperative
      chemotherapy could decrease recurrence and prolong survival for RAS wild-type, high
      risk(Clinical Risk Score≥3) resectable colorectal liver metastasis patients. This study was
      also designed to elucidate this question and to observe the objective response rate(ORR) and
      the safety data of the regime.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: disease free survival
time frame: From date of hepatectomy until the date of first documented recurrence or metastasis or date of death from any cause, whichever came first, assessed up to 60 months
description: months the patient lived from the date of liver resection to the date of disease recurrence or metastasis
measure: overall survival
time frame: From date of hepatectomy until the date of first documented death from any cause or the last follow-up if no death happened, assessed up to 60 months
description: months the patient lived from the date of liver resection to the date of patient death
measure: objective response rate
time frame: from the date of the first chemotherapy until the date two weeks after the completion of the last preoperative chemotherapy, assessed up to 6 weeks
description: percent of the number of patients who showed partial response(PR) or complete response(CR) who received preoperative chemotherapy to the number of all the patients enrolled.
arm group label: chemotherapy plus cetuximab
arm group type: Active Comparator
description: Cetuximab plus FOLFIRI/FOLFOX:FOLFIRI plus cetuximab [Irinotecan 180 mg/m2 IV over 30-90 minutes, day 1;Leucovorin 400 mg/m2 IV infusion to match duration of irinotecan infusion, day 1;5-fluoruracil(5-FU) 400 mg/m2 IV bolus day 1, then 1200 mg/m2/day x 2 days (total 2400 mg/m2 over 46-48 hours) IV continuous infusion.Repeat every 2 weeks.Cetuximab 500 mg/m2 IV over 2 hours, day 1, every 2 weeks] or FOLFOX plus Cetuximab [Oxaliplatin 85 mg/m2 IV over 2 hours, day 1 Leucovorin 400 mg/m2 IV over 2 hours, day 1 5-FU 400 mg/m2 IV bolus on day 1, then 1200 mg/m2/day x 2 days (total 2400 mg/m2 over 46-48 hours) IV continuous infusion Repeat every 2 weeks;Cetuximab 500 mg/m2 IV over 2 hours, day 1, every 2 weeks]
arm group label: perioperative chemotherapy alone
arm group type: Active Comparator
description: FOLFIRI/FOLFOX/CapeOX:routine perioperative chemotherapy including FOLFIRI[Irinotecan 180 mg/m2 IV over 30-90 minutes, day 1 Leucovorin 400 mg/m2 IV infusion to match duration of irinotecan infusion, day 1 5-FU 400 mg/m2 IV bolus day 1, then 1200 mg/m2/day x 2 days (total 2400 mg/m2 over 46-48 hours) continuous infusion Repeat every 2 weeks] or FOLFOX[Oxaliplatin 85 mg/m2 IV over 2 hours, day 1;Leucovorin 400 mg/m2 IV over 2 hours, day 1 5-FU 400 mg/m2 IV bolus on day 1, then 1200 mg/m2/day x 2 days (total 2400 mg/m2 over 46-48 hours) IV continuous infusion Repeat every 2 weeks] or CapeOX[Oxaliplatin 130 mg/m2 IV over 2 hours, day 1 Capecitabine 850-1000mg/m2 twice daily PO for 14 days Repeat every 3 weeks] was adopted in this control arm.
intervention type: Drug
intervention name: Cetuximab plus FOLFIRI/FOLFOX
description: cetuximab was added into the routine perioperative chemotherapy(FOLFIRI/FOLFOX) to evaluate its safety and efficacy
arm group label: chemotherapy plus cetuximab
other name: Erbitux
other name: C225
intervention type: Drug
intervention name: FOLFIRI/FOLFOX/CapeOX
description: to evaluate its safety and efficacy of routine perioperative chemotherapy(FOLFIRI/FOLFOX/CapeOX)
arm group label: perioperative chemotherapy alone
other name: XELOX
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Baocai Xing, MD
role: Study Director
affiliation: Beijing Cancer Hospital,Peking University
facility: 
facility: 
facility: 
facility: 
country: China
url: http://ncbi.nlm.nih.gov
description: test link
citation: Primrose J, Falk S, Finch-Jones M, Valle J, O'Reilly D, Siriwardena A, Hornbuckle J, Peterson M, Rees M, Iveson T, Hickish T, Butler R, Stanton L, Dixon E, Little L, Bowers M, Pugh S, Garden OJ, Cunningham D, Maughan T, Bridgewater J. Systemic chemotherapy with or without cetuximab in patients with resectable colorectal liver metastasis: the New EPOC randomised controlled trial. Lancet Oncol. 2014 May;15(6):601-11. doi: 10.1016/S1470-2045(14)70105-6. Epub 2014 Apr 7. Erratum In: Lancet Oncol. 2014 Jun;15(7):e253.
PMID: 24717919
citation: Fong Y, Fortner J, Sun RL, Brennan MF, Blumgart LH. Clinical score for predicting recurrence after hepatic resection for metastatic colorectal cancer: analysis of 1001 consecutive cases. Ann Surg. 1999 Sep;230(3):309-18; discussion 318-21. doi: 10.1097/00000658-199909000-00004.
PMID: 10493478
responsible party type: Principal Investigator
investigator affiliation: Peking University Cancer Hospital & Institute
investigator full name: Wang Kun
investigator title: associate director
mesh term: Neoplasm Metastasis
mesh term: Leucovorin
mesh term: Cetuximab
mesh term: Fluorouracil
mesh term: Oxaliplatin
sharing ipd: No