<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/NCT03043950</url>
  </required_header>
  <id_info>
    <org_study_id>IOM-050341</org_study_id>
    <nct_id>NCT03043950</nct_id>
  </id_info>
  <brief_title>Validation of a New Prognostic Score for Adult Patients With RAS Wild-type mCRC Treated With Vectibix® and FOLFIRI or FOLFOX in First Line (VALIDATE)</brief_title>
  <acronym>VALIDATE</acronym>
  <official_title>A Non-interventional Study to Assess the Safety and Efficacy of First Line Therapy With Vectibix® in Combination With FOLFIRI or FOLFOX and to Validate a Prognostic Score in Adult Patients With RAS Wild-type Metastatic Colorectal Cancer in a Real World Setting (VALIDATE)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>iOMEDICO AG</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Amgen</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>iOMEDICO AG</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A safety and efficacy study of first line therapy with Vectibix® in combination with FOLFIRI&#xD;
      or FOLFOX to validate a prognostic score in adult patients with RAS wild-type metastatic&#xD;
      colorectal cancer in a real world setting (VALIDATE)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a non-interventional, prospective, open-label, single-arm, 3-cohort, multicenter&#xD;
      study in Germany and Austria. In total, 606 patients will be enrolled in approx. 120&#xD;
      oncological sites (office-based medical oncologists, oncology outpatient-centers, and&#xD;
      university hospitals) in a time period of 48 months. Of these, 202 patients with high risk,&#xD;
      202 patients with intermediate risk, and 202 patients with low risk, as a priori assessed by&#xD;
      the metastatic colorectal cancer prognostic score (mCCS), will be included. Overall survival&#xD;
      of the pre-defined prognostic groups will be analyzed as primary endpoint to validate the&#xD;
      mCCS.&#xD;
&#xD;
      Patients have been scheduled to receive first line combination therapy with panitumumab and&#xD;
      FOLFIRI or FOLFOX according to the current SmPC valid for Germany and Austria, respectively.&#xD;
      Data on efficacy in terms of tumor response evaluation / survival and safety (ADRs) will be&#xD;
      collected during first line therapy. A subset of patients participating in the 'VALIDATE-PRO'&#xD;
      project (n=303) will be assessed for general and health-related quality of life with patient&#xD;
      questionnaires. Biomarker status beyond RAS will be collected at baseline. The documentation&#xD;
      of defined patient data including survival will continue until the end of the individual&#xD;
      study participation which is latest 36 months after last patient in. The end of study will be&#xD;
      at latest at 36 months after last patient in (LPI).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 25, 2017</start_date>
  <completion_date type="Anticipated">March 2024</completion_date>
  <primary_completion_date type="Anticipated">March 2024</primary_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>Overall Survival (OS) of pre-defined risk groups low vs. high</measure>
    <time_frame>From date of start of first line therapy to date of death due to any cause (assessed up to 84 months)</time_frame>
    <description>OS is defined as time from start of first line therapy to the date of death. For patients without date of start of first line therapy, date of informed consent will be the relevant date.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS) of pre-defined risk groups low vs. intermediate</measure>
    <time_frame>From date of start of first line therapy to date of death due to any cause (assessed up to 84 months)</time_frame>
    <description>OS is defined as time from start of first line therapy to the date of death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS) of pre-defined risk groups intermediate vs. high</measure>
    <time_frame>From date of start of first line therapy to date of death due to any cause (assessed up to 84 months)</time_frame>
    <description>OS is defined as time from start of first line therapy to the date of death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>From date of start of first line therapy to date of death due to any cause (assessed up to 84 months)</time_frame>
    <description>OS is defined as time from start of first line therapy to the date of death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>2-years OS Rate (2-yrs OSR)</measure>
    <time_frame>at 24 months</time_frame>
    <description>2-yrs OSR is defined as percentage of patients who are alive at 2 years after start of first line therapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free Survival (PFS)</measure>
    <time_frame>From date of start of first line therapy to date of progression or death due to any cause (assessed up to 84 months)</time_frame>
    <description>PFS is defined as time from start of first line therapy to first documentation of tumor progression or death due to any cause, whichever occurs first.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>12-months PFS Rate (12-mos PFSR)</measure>
    <time_frame>at 12 months</time_frame>
    <description>2-yrs PFSR is defined as percentage of patients who are have not progressed or died due to any cause at 2 years after start of first line therapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Response Rate (ORR)</measure>
    <time_frame>From date of start of first line therapy to date of progression or death to any cause (assessed up to 84 months)</time_frame>
    <description>ORR is defined as percentage of patients who achieve a partial or complete response as best response during the treatment period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response (DoR)</measure>
    <time_frame>From date of start of first line therapy to date of progression or death to any cause (assessed up to 84 months)</time_frame>
    <description>DoR is defined as time from first documentation of any tumor response (≥ PR) until disease progression or death due to tumor progression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Primary and secondary resection of metastases</measure>
    <time_frame>From date of start of first line therapy to date of death due to any cause (assessed up to 84 months)</time_frame>
    <description>Data on primary and/or secondary resections of liver or lung metastases will be collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Antineoplastic treatment in later lines</measure>
    <time_frame>From date of start of first line therapy to date of death due to any cause (assessed up to 84 months)</time_frame>
    <description>Treatment sequences with duration will be documented.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Patient-reported general and health-related quality of life ('VALIDATE PRO')</measure>
    <time_frame>From date of start of first line therapy to date of progression or death due to any cause (assessed up to 84 months)</time_frame>
    <description>Quality of life will be assessed with the EORTC QLQ-C30 and the EORTC Colorectal Modul QLQ-CR29 patient questionnaires during first line treatment and correlated with outcome.</description>
  </other_outcome>
  <other_outcome>
    <measure>Adverse Drug Reactions</measure>
    <time_frame>From start of first line therapy until 30 days after the end of treatment with panitumumab (assessed up to 84 months)</time_frame>
    <description>Adverse Drug Reactions of Panitumumab</description>
  </other_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">647</enrollment>
  <condition>Metastatic Colorectal Cancer</condition>
  <condition>RAS Wild-type</condition>
  <arm_group>
    <arm_group_label>low risk</arm_group_label>
    <description>Low risk according to metastatic Colorectal Cancer Prognostic Score (mCCS)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>medium risk</arm_group_label>
    <description>Medium risk according to metastatic Colorectal Cancer Prognostic Score (mCCS)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>high risk</arm_group_label>
    <description>High risk according to metastatic Colorectal Cancer Prognostic Score (mCCS)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Panitumumab</intervention_name>
    <description>Patients will be scheduled to receive first line therapy with the combination of Panitumumab (6 mg / kg i.v, given once every two weeks) and FOLFIRI or FOLFOX, according to current SmPC.</description>
    <arm_group_label>high risk</arm_group_label>
    <arm_group_label>low risk</arm_group_label>
    <arm_group_label>medium risk</arm_group_label>
    <other_name>+ FOLFIRI or FOLFOX</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients with RAS-WT mCRC scheduled for the treatment with panitumumab and FOLFIRI or&#xD;
        FOLFOX who have not received any prior systemic antineoplastic therapy in the palliative&#xD;
        setting.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Eligibility according to current SmPC&#xD;
&#xD;
          -  Signed written informed consent&#xD;
&#xD;
          -  Diagnosis of RAS-WT mCRC&#xD;
&#xD;
          -  No prior systemic therapy in the palliative setting&#xD;
&#xD;
          -  Aged 18 years or older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any contraindication according to current SmPC&#xD;
&#xD;
          -  Participation in other clinical trials&#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>Norbert Marschner, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Forschungs GbR Drs. Marschner, Zaiss, Kirste, Semsek</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Praxis für interdisziplinäre Onkologie &amp; Hämatologie</name>
      <address>
        <city>Freiburg</city>
        <state>Baden-Württemberg</state>
        <zip>79110</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>February 2, 2017</study_first_submitted>
  <study_first_submitted_qc>February 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 6, 2017</study_first_posted>
  <last_update_submitted>August 10, 2023</last_update_submitted>
  <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>mCRC</keyword>
  <keyword>First line</keyword>
  <keyword>Panitumumab</keyword>
  <keyword>mCCS Prognostic Score</keyword>
  <keyword>Prognosis</keyword>
  <keyword>Ras wild type</keyword>
  <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>Panitumumab</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/NCT03043950
org study id: IOM-050341
nct id: NCT03043950
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
A safety and efficacy study of first line therapy with Vectibix® in combination with FOLFIRI
      or FOLFOX to validate a prognostic score in adult patients with RAS wild-type metastatic
      colorectal cancer in a real world setting (VALIDATE)
This is a non-interventional, prospective, open-label, single-arm, 3-cohort, multicenter
      study in Germany and Austria. In total, 606 patients will be enrolled in approx. 120
      oncological sites (office-based medical oncologists, oncology outpatient-centers, and
      university hospitals) in a time period of 48 months. Of these, 202 patients with high risk,
      202 patients with intermediate risk, and 202 patients with low risk, as a priori assessed by
      the metastatic colorectal cancer prognostic score (mCCS), will be included. Overall survival
      of the pre-defined prognostic groups will be analyzed as primary endpoint to validate the
      mCCS.

      Patients have been scheduled to receive first line combination therapy with panitumumab and
      FOLFIRI or FOLFOX according to the current SmPC valid for Germany and Austria, respectively.
      Data on efficacy in terms of tumor response evaluation / survival and safety (ADRs) will be
      collected during first line therapy. A subset of patients participating in the 'VALIDATE-PRO'
      project (n=303) will be assessed for general and health-related quality of life with patient
      questionnaires. Biomarker status beyond RAS will be collected at baseline. The documentation
      of defined patient data including survival will continue until the end of the individual
      study participation which is latest 36 months after last patient in. The end of study will be
      at latest at 36 months after last patient in (LPI).
observational model: Cohort
time perspective: Prospective
measure: Overall Survival (OS) of pre-defined risk groups low vs. high
time frame: From date of start of first line therapy to date of death due to any cause (assessed up to 84 months)
description: OS is defined as time from start of first line therapy to the date of death. For patients without date of start of first line therapy, date of informed consent will be the relevant date.
measure: Overall Survival (OS) of pre-defined risk groups low vs. intermediate
time frame: From date of start of first line therapy to date of death due to any cause (assessed up to 84 months)
description: OS is defined as time from start of first line therapy to the date of death.
measure: Overall Survival (OS) of pre-defined risk groups intermediate vs. high
time frame: From date of start of first line therapy to date of death due to any cause (assessed up to 84 months)
description: OS is defined as time from start of first line therapy to the date of death.
measure: Overall Survival (OS)
time frame: From date of start of first line therapy to date of death due to any cause (assessed up to 84 months)
description: OS is defined as time from start of first line therapy to the date of death.
measure: 2-years OS Rate (2-yrs OSR)
time frame: at 24 months
description: 2-yrs OSR is defined as percentage of patients who are alive at 2 years after start of first line therapy.
measure: Progression-free Survival (PFS)
time frame: From date of start of first line therapy to date of progression or death due to any cause (assessed up to 84 months)
description: PFS is defined as time from start of first line therapy to first documentation of tumor progression or death due to any cause, whichever occurs first.
measure: 12-months PFS Rate (12-mos PFSR)
time frame: at 12 months
description: 2-yrs PFSR is defined as percentage of patients who are have not progressed or died due to any cause at 2 years after start of first line therapy.
measure: Overall Response Rate (ORR)
time frame: From date of start of first line therapy to date of progression or death to any cause (assessed up to 84 months)
description: ORR is defined as percentage of patients who achieve a partial or complete response as best response during the treatment period.
measure: Duration of Response (DoR)
time frame: From date of start of first line therapy to date of progression or death to any cause (assessed up to 84 months)
description: DoR is defined as time from first documentation of any tumor response (≥ PR) until disease progression or death due to tumor progression.
measure: Primary and secondary resection of metastases
time frame: From date of start of first line therapy to date of death due to any cause (assessed up to 84 months)
description: Data on primary and/or secondary resections of liver or lung metastases will be collected.
measure: Antineoplastic treatment in later lines
time frame: From date of start of first line therapy to date of death due to any cause (assessed up to 84 months)
description: Treatment sequences with duration will be documented.
measure: Patient-reported general and health-related quality of life ('VALIDATE PRO')
time frame: From date of start of first line therapy to date of progression or death due to any cause (assessed up to 84 months)
description: Quality of life will be assessed with the EORTC QLQ-C30 and the EORTC Colorectal Modul QLQ-CR29 patient questionnaires during first line treatment and correlated with outcome.
measure: Adverse Drug Reactions
time frame: From start of first line therapy until 30 days after the end of treatment with panitumumab (assessed up to 84 months)
description: Adverse Drug Reactions of Panitumumab
arm group label: low risk
description: Low risk according to metastatic Colorectal Cancer Prognostic Score (mCCS)
arm group label: medium risk
description: Medium risk according to metastatic Colorectal Cancer Prognostic Score (mCCS)
arm group label: high risk
description: High risk according to metastatic Colorectal Cancer Prognostic Score (mCCS)
intervention type: Drug
intervention name: Panitumumab
description: Patients will be scheduled to receive first line therapy with the combination of Panitumumab (6 mg / kg i.v, given once every two weeks) and FOLFIRI or FOLFOX, according to current SmPC.
arm group label: high risk
arm group label: low risk
arm group label: medium risk
other name: + FOLFIRI or FOLFOX
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Norbert Marschner, Dr.
role: Principal Investigator
affiliation: Forschungs GbR Drs. Marschner, Zaiss, Kirste, Semsek
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Colorectal Neoplasms
mesh term: Panitumumab
sharing ipd: No