<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/NCT03263663</url>
  </required_header>
  <id_info>
    <org_study_id>RESIST</org_study_id>
    <nct_id>NCT03263663</nct_id>
  </id_info>
  <brief_title>Optimization of Individualized Therapy for CRCs With Secondary RESISTance Towards Anti-EGFR Targeted Therapy Using an Avatar Model</brief_title>
  <acronym>2016-003295-46</acronym>
  <official_title>Optimization of Individualized Therapy for CRCs With Secondary RESISTance Towards Anti-EGFR Targeted Therapy Using an Avatar Model (Colon-Resist-Net)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>PD Dr. med. Volker Heinemann</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>MGO Ruhr-University Bochum (RUB)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Ludwig-Maximilians - University of Munich</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this exploratory phase II trial, the possibility of a personalized treatment after&#xD;
      resistance to cetuximab will be evaluated. Therefore, tumor material of all patients shall be&#xD;
      obtained, transferred into avatars and treated the same way as in the patient until&#xD;
      resistance arises. These resistant tumor cells are subsequently treated by different targeted&#xD;
      treatment combinations in the mouse avatar model to find the most active drug or combination&#xD;
      of drugs. This drug or combination of drugs may then be offered to the patient after&#xD;
      cetuximab resistance has occurred. Multiple liquid biopsies shall be obtained in patients&#xD;
      during first-line treatment with cetuximab as well as during second line experimental&#xD;
      treatment to monitor mutations that may be associated with cetuximab resistance. Furthermore&#xD;
      at the time of resistance a biopsy should be taken and analyzed to ensure that the mechanism&#xD;
      of resistance seen in the avatar model matches with the mechanism of resistance in the&#xD;
      individual patient.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Anticipated">January 1, 2025</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2021</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>
  <primary_outcome>
    <measure>Progression-free-survival</measure>
    <time_frame>5-7 months</time_frame>
    <description>according to RECIST 1.1</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Colo-rectal Cancer</condition>
  <condition>RAS Wild-type</condition>
  <condition>UICC III</condition>
  <condition>UICC II + RF</condition>
  <condition>UICC IV Curative Intent</condition>
  <arm_group>
    <arm_group_label>Chemotherapy plus targeted treatment</arm_group_label>
    <description>Patients are treated in second-line with chemotherapy plus a targeted treatment according to the resistance mechanism to cetuximab pretreatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Chemotherapy according to physician choice standard</arm_group_label>
    <description>Patients are treated in second-line with chemotherapy according to physicians choice after cetuximab pretreatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>targeted substance according to the avatar model</intervention_name>
    <description>individualized second line treatment</description>
    <arm_group_label>Chemotherapy plus targeted treatment</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Primary tumormaterial&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        locally advanced colorectal cancer&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female patients age ≥ 18 years&#xD;
&#xD;
          -  Written declaration of consent&#xD;
&#xD;
          -  ECOG Performance Status 0-1&#xD;
&#xD;
          -  Life expectancy&gt; 3 months&#xD;
&#xD;
          -  Histologically confirmed adenocarcinoma of the colon or rectum at stage UICC III or&#xD;
             UICC IV&#xD;
&#xD;
          -  Histologically confirmed adenocarcinoma of the colon or rectum in stage UICC II with&#xD;
             one of the following risk factors: CEA&gt; 200; T4 tumor, emergency surgery, &lt;12 distant&#xD;
             lymph nodes, surgery due to intestinal obstruction (ileus)&#xD;
&#xD;
          -  Patient agrees to the preservation of tumor material for the purpose of molecular&#xD;
             analyzes including the determination of the genetic profile of the tumor&#xD;
             (participation in the project &quot;RESIST&quot;)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Preoperative Radiotherapy&#xD;
&#xD;
          -  Preoperative chemotherapy&#xD;
&#xD;
          -  Heart failure&gt; Grade II (functional NYHA classification)&#xD;
&#xD;
          -  Existing concomitant disease or condition that would make the patient unsuitable for a&#xD;
             study participation or interfere with the safety of the subject&#xD;
&#xD;
          -  Any psychological, familial, sociological or geographical event which does not allow&#xD;
             observance of the study protocol&#xD;
&#xD;
          -  Additional carcinoma therapy (chemotherapy, radiation, biological therapy,&#xD;
             immunotherapy or hormonal therapy) during the study&#xD;
&#xD;
          -  Known malignant second neoplasia within the last 5 years (except for a basal cell&#xD;
             carcinoma or a carcinoma in situ of the uterine cervix).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sebastian Stintzing, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Senior Physician</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sebastian Stintzing, Prof. Dr.</last_name>
    <phone>+49 89 4400 0</phone>
    <email>sebastian.stintzing@med.uni-muenchen.de</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Munich - Klinikum der Universitaet Muenchen</name>
      <address>
        <city>Munich</city>
        <state>Bavaria</state>
        <zip>81379</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sebastian Stintzing, Prof. Dr.</last_name>
      <phone>+49 89 4400 0</phone>
      <email>sebastian.stintzing@med.uni-muenchen.de</email>
    </contact>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 24, 2017</study_first_submitted>
  <study_first_submitted_qc>August 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 28, 2017</study_first_posted>
  <last_update_submitted>August 24, 2017</last_update_submitted>
  <last_update_submitted_qc>August 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Ludwig-Maximilians - University of Munich</investigator_affiliation>
    <investigator_full_name>PD Dr. med. Volker Heinemann</investigator_full_name>
    <investigator_title>Director of the CCC LMU</investigator_title>
  </responsible_party>
  <keyword>colorectal cancer</keyword>
  <keyword>adjuvant</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rectal Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</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/NCT03263663
org study id: RESIST
nct id: NCT03263663
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this exploratory phase II trial, the possibility of a personalized treatment after
      resistance to cetuximab will be evaluated. Therefore, tumor material of all patients shall be
      obtained, transferred into avatars and treated the same way as in the patient until
      resistance arises. These resistant tumor cells are subsequently treated by different targeted
      treatment combinations in the mouse avatar model to find the most active drug or combination
      of drugs. This drug or combination of drugs may then be offered to the patient after
      cetuximab resistance has occurred. Multiple liquid biopsies shall be obtained in patients
      during first-line treatment with cetuximab as well as during second line experimental
      treatment to monitor mutations that may be associated with cetuximab resistance. Furthermore
      at the time of resistance a biopsy should be taken and analyzed to ensure that the mechanism
      of resistance seen in the avatar model matches with the mechanism of resistance in the
      individual patient.
observational model: Case-Control
time perspective: Prospective
measure: Progression-free-survival
time frame: 5-7 months
description: according to RECIST 1.1
arm group label: Chemotherapy plus targeted treatment
description: Patients are treated in second-line with chemotherapy plus a targeted treatment according to the resistance mechanism to cetuximab pretreatment
arm group label: Chemotherapy according to physician choice standard
description: Patients are treated in second-line with chemotherapy according to physicians choice after cetuximab pretreatment
intervention type: Drug
intervention name: targeted substance according to the avatar model
description: individualized second line treatment
arm group label: Chemotherapy plus targeted treatment
Primary tumormaterial
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sebastian Stintzing, Prof. Dr.
role: Principal Investigator
affiliation: Senior Physician
last name: Sebastian Stintzing, Prof. Dr.
phone: +49 89 4400 0
email: sebastian.stintzing@med.uni-muenchen.de
facility: 
status: Recruiting
contact: 
country: Germany
responsible party type: Sponsor-Investigator
investigator affiliation: Ludwig-Maximilians - University of Munich
investigator full name: PD Dr. med. Volker Heinemann
investigator title: Director of the CCC LMU
mesh term: Rectal Neoplasms
sharing ipd: Yes