<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/NCT04491929</url>
  </required_header>
  <id_info>
    <org_study_id>1-10-72-111-20</org_study_id>
    <nct_id>NCT04491929</nct_id>
  </id_info>
  <brief_title>Selective Internal Radiation Therapy With 90Y Resin Micropheres for Refractory Colorectal Cancer Liver Metastases</brief_title>
  <acronym>SIRT</acronym>
  <official_title>Selective Internal Radiation Therapy With 90Y Resin Micropheres for Refractory Colorectal Cancer Liver Metastases - SIRT - A Translational Feasibility Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aarhus University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aarhus University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Observational, feasibility study investigating biological aspects in patients with liver&#xD;
      metastasis from colorectal cancer undergoing treatment with SIRT, by translational analysis&#xD;
      of biological samples.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this study, the investigators seek to investigate biological aspects in patients with&#xD;
      colorectal cancer liver metastasis undergoing treatment with Selective Internal Radiation&#xD;
      Therapy, by translational analysis of biological samples.&#xD;
&#xD;
      SIRT will be conducted as per standard procedure at Aarhus University Hospital. Translational&#xD;
      blood samples will be drawn pre-treatment and during follow up.&#xD;
&#xD;
      The total cell free DNA level will be quantified in all samples. The samples will be analysed&#xD;
      for tumour specific mutations such as the KRAS, BRAF and NRAS oncogenes.&#xD;
&#xD;
      The investigators expect to include up to 30 patients.&#xD;
&#xD;
      This is a purely observational translational study. Results will be analysed in relation to&#xD;
      outcome data.&#xD;
&#xD;
      The study is conducted in collaboration with:&#xD;
&#xD;
      Department of Gastroenterology and Hepatology, Aarhus University Hospital Department of&#xD;
      Radiology, Aarhus University Hospital Department of Nuclear Medicine, Aarhus University&#xD;
      Hospital&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 1, 2020</start_date>
  <completion_date type="Anticipated">September 30, 2028</completion_date>
  <primary_completion_date type="Anticipated">February 28, 2026</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility and translational analysis</measure>
    <time_frame>When 5 patients are included, the blood samples will be analysed for explorative analysis (expected after the first year). In all we expect to include 30 patients if positive results.</time_frame>
    <description>Investigating potential prognostic and predictive markers for efficacy by molecular characteristics and mutational analysis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Response Rate</measure>
    <time_frame>6 months</time_frame>
    <description>According to RECIST 1.1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Liver Metastasis Colon Cancer</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The study population consists of patients with metastatic colorectal cancer with&#xD;
        chemorefractory liver dominant disease. Patients are found not eligible for surgical&#xD;
        resection, RFA or SBRT by a multidisciplinary tumour board (MDT), and considered candidates&#xD;
        for SIRT treatment in order to obtain disease control or resectability.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of metastatic colorectal adenocarcinoma with liver dominant disease&#xD;
&#xD;
          -  Diagnosis of liver metastasis may be made by histo- or cyto-pathology, or by clinical&#xD;
             and imaging criteria.&#xD;
&#xD;
          -  The Liver metastasis are not eligible for resection, RFA or SBRT&#xD;
&#xD;
          -  All patients must be off all chemotherapeutic regimens for 14 days prior to SIRT&#xD;
             treatment&#xD;
&#xD;
          -  All patients must be off vascular endothelial growth factor inhibitors for 6 weeks&#xD;
             prior to SIRT treatment&#xD;
&#xD;
          -  Progressive disease, severe intolerance during or following all standard lines of&#xD;
             chemo-therapy&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-1&#xD;
&#xD;
          -  Age 18 years or older&#xD;
&#xD;
          -  Able to understand written information&#xD;
&#xD;
          -  Consent to samples for translational research&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pretherapeutic work-up procedure with Tc-99m macroaggregated albumin (MAA)&#xD;
             scintigraphy showing extrahepatic foci in GI-tract&#xD;
&#xD;
          -  Evidence of any detectable Tc-99m macroaggregated albumin deposition in the stomach or&#xD;
             duodenum, after application of established angiographic techniques to stop such&#xD;
             deposition&#xD;
&#xD;
          -  Previous radiation therapy to the lungs and/or to the upper abdomen overlapping with&#xD;
             dose to the liver at interventionist´s decision&#xD;
&#xD;
          -  Lung shunt greater than 20% or &gt; 30 Gray radiation absorbed dose to the lungs, at&#xD;
             estimated by Tc-99m-MAA&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Symptomatic lung disease precluding SIRT at interventionist´s decision&#xD;
&#xD;
          -  Active uncontrolled infection&#xD;
&#xD;
          -  Any pre-treatment laboratory findings within 30 days of treatment demonstrating:&#xD;
             alanine aminotransferase level greater than 5 times upper normal limit and/or serum&#xD;
             bilirubin greater than 2 mg/dl (&gt;34 umol/l)&#xD;
&#xD;
          -  Current or previously evidence of ascites on CT-scan or physical examination&#xD;
&#xD;
          -  Tumour volume greater than 50% of liver volume&#xD;
&#xD;
          -  Conditions precluding translational samples&#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>Louise B Callesen</last_name>
    <role>Principal Investigator</role>
    <affiliation>Experimental Clinical Oncology</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Louise B Callesen, MD</last_name>
    <phone>+4578462535</phone>
    <email>louicall@rm.dk</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Oncology, Aarhus University Hospital</name>
      <address>
        <city>Aarhus N</city>
        <state>Danmark</state>
        <zip>8200</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Louise B Callesen, MD</last_name>
      <phone>30482884</phone>
      <email>louicall@rm.dk</email>
    </contact>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>July 27, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>July 19, 2023</last_update_submitted>
  <last_update_submitted_qc>July 19, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aarhus University Hospital</investigator_affiliation>
    <investigator_full_name>Louise Bach Callesen</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Liver metastasis Colon Cancer</keyword>
  <keyword>Circulating Tumour DNA</keyword>
  <keyword>Selective Internal Radiation Therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasm Metastasis</mesh_term>
    <mesh_term>Colonic Neoplasms</mesh_term>
    <mesh_term>Liver Neoplasms</mesh_term>
  </condition_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/NCT04491929
org study id: 1-10-72-111-20
nct id: NCT04491929
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Observational, feasibility study investigating biological aspects in patients with liver
      metastasis from colorectal cancer undergoing treatment with SIRT, by translational analysis
      of biological samples.
In this study, the investigators seek to investigate biological aspects in patients with
      colorectal cancer liver metastasis undergoing treatment with Selective Internal Radiation
      Therapy, by translational analysis of biological samples.

      SIRT will be conducted as per standard procedure at Aarhus University Hospital. Translational
      blood samples will be drawn pre-treatment and during follow up.

      The total cell free DNA level will be quantified in all samples. The samples will be analysed
      for tumour specific mutations such as the KRAS, BRAF and NRAS oncogenes.

      The investigators expect to include up to 30 patients.

      This is a purely observational translational study. Results will be analysed in relation to
      outcome data.

      The study is conducted in collaboration with:

      Department of Gastroenterology and Hepatology, Aarhus University Hospital Department of
      Radiology, Aarhus University Hospital Department of Nuclear Medicine, Aarhus University
      Hospital
observational model: Case-Only
time perspective: Prospective
measure: Feasibility and translational analysis
time frame: When 5 patients are included, the blood samples will be analysed for explorative analysis (expected after the first year). In all we expect to include 30 patients if positive results.
description: Investigating potential prognostic and predictive markers for efficacy by molecular characteristics and mutational analysis
measure: Response Rate
time frame: 6 months
description: According to RECIST 1.1
measure: Progression Free Survival
time frame: 3 years
measure: Overall Survival
time frame: 3 years
Blood
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Louise B Callesen
role: Principal Investigator
affiliation: Experimental Clinical Oncology
last name: Louise B Callesen, MD
phone: +4578462535
email: louicall@rm.dk
facility: 
status: Recruiting
contact: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Aarhus University Hospital
investigator full name: Louise Bach Callesen
investigator title: Principal Investigator
mesh term: Neoplasm Metastasis
mesh term: Colonic Neoplasms
mesh term: Liver Neoplasms
sharing ipd: No