<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/NCT02978313</url>
  </required_header>
  <id_info>
    <org_study_id>RJH-Cet-Maintenance</org_study_id>
    <nct_id>NCT02978313</nct_id>
  </id_info>
  <brief_title>Cetuximab Monotherapy Maintenance Treatment in mCRC</brief_title>
  <official_title>Biomarker-Panel Enriched Maintenance Treatment With Cetuximab Monotherapy Versus Continuation After Induction Treatment With Chemotherapy + Cetuximab in Metastatic Colorectal Cancer (mCRC)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ruijin Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Jiangsu Cancer Institute &amp; Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Henan Cancer Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Second Affiliated Hospital, School of Medicine, Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Ruijin Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Investigating the efficacy of Cetuximab Monotherapy versus Continuation after induction&#xD;
      treatment with chemotherapy + Cetuximab in inoperable or irresectable and non-progressive&#xD;
      metastatic colorectal cancer after first line induction treatment for 24 weeks with&#xD;
      mFOLFOX6/FOLFIRI and Cetuximab treatment. Reinduction treatment will be done in case of&#xD;
      progression.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Investigating the efficacy of Cetuximab Monotherapy versus Continuation after induction&#xD;
      treatment with chemotherapy + Cetuximab in inoperable or irresectable and non-progressive&#xD;
      metastatic colorectal cancer after first line induction treatment for 24 weeks with&#xD;
      mFOLFOX6/FOLFIRI and Cetuximab treatment. Reinduction treatment will be done in case of&#xD;
      progression. This treatment is continued until progression or severe toxicity.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">November 2019</completion_date>
  <primary_completion_date type="Anticipated">November 2019</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>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>PFS</measure>
    <time_frame>4-6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>OS</measure>
    <time_frame>22 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>QoL</measure>
    <time_frame>22 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>Cet maintenance</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cetuximab maintenance treatment following induction treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cet+chemo continuation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Cetuximab plus continuation mFOLFOX6/FOLFIRI regimens</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cetuximab</intervention_name>
    <description>anti-EGFR monoclonal antibody</description>
    <arm_group_label>Cet maintenance</arm_group_label>
    <arm_group_label>Cet+chemo continuation</arm_group_label>
    <other_name>erbitux</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>mFOLFOX6</intervention_name>
    <description>Oxaliplatin+LV5FU2</description>
    <arm_group_label>Cet+chemo continuation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>FOLFIRI</intervention_name>
    <description>Irinotecan+LV5FU2</description>
    <arm_group_label>Cet+chemo continuation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histological proof of colorectal cancer (in case of a single metastasis, histological&#xD;
             or cytological proof of this lesion should be obtained);&#xD;
&#xD;
          -  Distant metastases (patients with only local recurrence are not eligible);&#xD;
&#xD;
          -  Unidimensionally measurable disease (&gt; 1 cm on spiral CT scan or &gt; 2 cm on chest&#xD;
             X-ray; liver ultrasound is not allowed). Serum CEA may not be used as a parameter for&#xD;
             disease evaluation;&#xD;
&#xD;
          -  In case of previous radiotherapy, at least one measurable lesion should be located&#xD;
             outside the irradiated field;&#xD;
&#xD;
          -  Ongoing or planned first line treatment with 6 cycles of mFOLFOX6/FOLFIRI plus&#xD;
             Cetuximab.&#xD;
&#xD;
        At randomisation:&#xD;
&#xD;
          -  WHO performance status 0-1 (Karnofsky PS &gt; 70%);&#xD;
&#xD;
          -  Laboratory values obtained ≤ 2 weeks prior to randomisation:&#xD;
&#xD;
               -  adequate bone marrow function (Hb &gt; 6.0 mmol/L, absolute neutrophil count &gt; 1.5 x&#xD;
                  109/L, platelets &gt; 100 x 109/L),&#xD;
&#xD;
               -  renal function (serum creatinine ≤ 1.5x ULN and creatinine clearance, Cockroft&#xD;
                  formula, &gt; 30 ml/min),&#xD;
&#xD;
               -  liver function (serum bilirubin ≤ 2 x ULN, serum transaminases ≤ 3 x ULN without&#xD;
                  presence of liver metastases or ≤ 5x ULN with presence of liver metastases);&#xD;
&#xD;
          -  Negative pregnancy test in women with childbearing potential;&#xD;
&#xD;
          -  Expected adequacy of follow-up;&#xD;
&#xD;
          -  Institutional Review Board approval;&#xD;
&#xD;
          -  Written informed consent Exclusion criteria;&#xD;
&#xD;
          -  History or clinical signs/symptoms of CNS metastases;&#xD;
&#xD;
          -  History of a second malignancy ≤ 5 years with the exception of adequately treated&#xD;
             carcinoma of cervix or basal/squamous cell carcinoma of skin.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior adjuvant treatment for stage II/III colorectal cancer ending within 6 months&#xD;
             before the start of induction treatment;&#xD;
&#xD;
          -  Any prior adjuvant treatment after resection of distant metastases;&#xD;
&#xD;
          -  Previous systemic treatment for advanced disease.&#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_official>
    <last_name>Yifeng Wang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ruijin Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jun Zhang, PhD</last_name>
    <phone>+-86-18917762326</phone>
    <email>junzhang@188.com</email>
  </overall_contact>
  <reference>
    <citation>Tveit KM, Guren T, Glimelius B, Pfeiffer P, Sorbye H, Pyrhonen S, Sigurdsson F, Kure E, Ikdahl T, Skovlund E, Fokstuen T, Hansen F, Hofsli E, Birkemeyer E, Johnsson A, Starkhammar H, Yilmaz MK, Keldsen N, Erdal AB, Dajani O, Dahl O, Christoffersen T. Phase III trial of cetuximab with continuous or intermittent fluorouracil, leucovorin, and oxaliplatin (Nordic FLOX) versus FLOX alone in first-line treatment of metastatic colorectal cancer: the NORDIC-VII study. J Clin Oncol. 2012 May 20;30(15):1755-62. doi: 10.1200/JCO.2011.38.0915. Epub 2012 Apr 2.</citation>
    <PMID>22473155</PMID>
  </reference>
  <reference>
    <citation>Van Cutsem E, Kohne CH, Hitre E, Zaluski J, Chang Chien CR, Makhson A, D'Haens G, Pinter T, Lim R, Bodoky G, Roh JK, Folprecht G, Ruff P, Stroh C, Tejpar S, Schlichting M, Nippgen J, Rougier P. Cetuximab and chemotherapy as initial treatment for metastatic colorectal cancer. N Engl J Med. 2009 Apr 2;360(14):1408-17. doi: 10.1056/NEJMoa0805019.</citation>
    <PMID>19339720</PMID>
  </reference>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>September 8, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>November 29, 2016</last_update_submitted>
  <last_update_submitted_qc>November 29, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 30, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ruijin Hospital</investigator_affiliation>
    <investigator_full_name>Hao Li</investigator_full_name>
    <investigator_title>MD &amp;Ph.D</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cetuximab</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/NCT02978313
org study id: RJH-Cet-Maintenance
nct id: NCT02978313
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
Investigating the efficacy of Cetuximab Monotherapy versus Continuation after induction
      treatment with chemotherapy + Cetuximab in inoperable or irresectable and non-progressive
      metastatic colorectal cancer after first line induction treatment for 24 weeks with
      mFOLFOX6/FOLFIRI and Cetuximab treatment. Reinduction treatment will be done in case of
      progression.
Investigating the efficacy of Cetuximab Monotherapy versus Continuation after induction
      treatment with chemotherapy + Cetuximab in inoperable or irresectable and non-progressive
      metastatic colorectal cancer after first line induction treatment for 24 weeks with
      mFOLFOX6/FOLFIRI and Cetuximab treatment. Reinduction treatment will be done in case of
      progression. This treatment is continued until progression or severe toxicity.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: PFS
time frame: 4-6 months
measure: OS
time frame: 22 months
measure: QoL
time frame: 22 months
arm group label: Cet maintenance
arm group type: Experimental
description: Cetuximab maintenance treatment following induction treatment
arm group label: Cet+chemo continuation
arm group type: Active Comparator
description: Cetuximab plus continuation mFOLFOX6/FOLFIRI regimens
intervention type: Drug
intervention name: Cetuximab
description: anti-EGFR monoclonal antibody
arm group label: Cet maintenance
arm group label: Cet+chemo continuation
other name: erbitux
intervention type: Drug
intervention name: mFOLFOX6
description: Oxaliplatin+LV5FU2
arm group label: Cet+chemo continuation
intervention type: Drug
intervention name: FOLFIRI
description: Irinotecan+LV5FU2
arm group label: Cet+chemo continuation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Yifeng Wang, MD
role: Principal Investigator
affiliation: Ruijin Hospital
last name: Jun Zhang, PhD
phone: +-86-18917762326
email: junzhang@188.com
citation: Tveit KM, Guren T, Glimelius B, Pfeiffer P, Sorbye H, Pyrhonen S, Sigurdsson F, Kure E, Ikdahl T, Skovlund E, Fokstuen T, Hansen F, Hofsli E, Birkemeyer E, Johnsson A, Starkhammar H, Yilmaz MK, Keldsen N, Erdal AB, Dajani O, Dahl O, Christoffersen T. Phase III trial of cetuximab with continuous or intermittent fluorouracil, leucovorin, and oxaliplatin (Nordic FLOX) versus FLOX alone in first-line treatment of metastatic colorectal cancer: the NORDIC-VII study. J Clin Oncol. 2012 May 20;30(15):1755-62. doi: 10.1200/JCO.2011.38.0915. Epub 2012 Apr 2.
PMID: 22473155
citation: Van Cutsem E, Kohne CH, Hitre E, Zaluski J, Chang Chien CR, Makhson A, D'Haens G, Pinter T, Lim R, Bodoky G, Roh JK, Folprecht G, Ruff P, Stroh C, Tejpar S, Schlichting M, Nippgen J, Rougier P. Cetuximab and chemotherapy as initial treatment for metastatic colorectal cancer. N Engl J Med. 2009 Apr 2;360(14):1408-17. doi: 10.1056/NEJMoa0805019.
PMID: 19339720
responsible party type: Principal Investigator
investigator affiliation: Ruijin Hospital
investigator full name: Hao Li
investigator title: MD &Ph.D
mesh term: Colorectal Neoplasms
mesh term: Cetuximab
sharing ipd: No