<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/NCT03256994</url>
  </required_header>
  <id_info>
    <org_study_id>CIRT-FR</org_study_id>
    <nct_id>NCT03256994</nct_id>
  </id_info>
  <brief_title>CIRSE Registry for SIR-Spheres in France (CIRT-FR)</brief_title>
  <acronym>CIRT-FR</acronym>
  <official_title>CIRSE Registry for SIR-Spheres in France (CIRT-FR)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cardiovascular and Interventional Radiological Society of Europe</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cardiovascular and Interventional Radiological Society of Europe</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>
      Selective Internal Radiation Therapy (SIRT), also known as radioembolisation, is a minimal&#xD;
      invasive, endovascular treatment for primary and secondary liver tumours. In France,&#xD;
      SIR-Spheres are listed as reimbursable by the national health authorities (Haute Autorité de&#xD;
      Santé [HAS]). In order to evaluate the reimbursement after five years, all patients treated&#xD;
      with SIR-Spheres will be entered into a registry that collects data on the real-life clinical&#xD;
      application of SIRT and reports to the national authorities.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Selective internal radiation therapy (SIRT), also called radioembolisation (RE), with&#xD;
      SIR-Spheres microspheres is an endovascular procedure, included within the interventional&#xD;
      oncologic technologies to treat primary and secondary liver tumours. Using a microcatheter, a&#xD;
      precise dose of resin microspheres is released in the hepatic artery, where they are carried&#xD;
      into the arterioles and selectively lodge in the tumour microvasculature. The microspheres&#xD;
      are loaded with the radioactive yttrium-90, a high-energy beta-emitting isotope with a&#xD;
      half-life of 64.1 hours. Following administration, 94% of the radiation is delivered in 11&#xD;
      days.&#xD;
&#xD;
      In France, SIR-Spheres are listed as reimbursable by the national health authorities (Haute&#xD;
      Autorité de Santé [HAS]). In order to evaluate the reimbursement after five years, all&#xD;
      patients treated with SIR-Spheres will be entered into a registry that collects data on the&#xD;
      real-life clinical application of SIRT and reports to the national authorities.&#xD;
&#xD;
      The goal of the research project is to gain a better understanding of the real-life clinical&#xD;
      application of radioembolisation with SIR-Spheres and the impact of the treatment in clinical&#xD;
      practice. Secondary objectives will be to assess the observed treatment outcomes of SIRT with&#xD;
      SIR-Spheres Y-90 resin microspheres in terms of safety, effectiveness, quality of life,&#xD;
      technical considerations and diagnosis and treatment-related considerations.&#xD;
&#xD;
      To better understand the palliative aspect of the treatment, acquisition of the change in&#xD;
      quality of life is included by means of EORTC's validated quality of life questionnaire QLQ&#xD;
      C30 with accompanying HCC module to measure quality of life in patients with hepatocellular&#xD;
      carcinoma.&#xD;
&#xD;
      Besides data collection on the initial treatment, it will be advised to collect follow-up&#xD;
      data and quality of life data every three months for a minimum of 24 months after treatment.&#xD;
&#xD;
      CIRT-FR is a post-market, prospective, non-randomized, observational study. Patients are only&#xD;
      asked to be enrolled when they are treated with SIR-Spheres microspheres as part of their&#xD;
      treatment determined by the treating clinician. In no way will participation of the patient&#xD;
      in the registry impact their treatment plan, or influence the quality of the treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">July 31, 2022</completion_date>
  <primary_completion_date type="Actual">July 31, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>24 Months</target_duration>
  <primary_outcome>
    <measure>Description of the clinical context in which SIR-Spheres are applied</measure>
    <time_frame>Baseline, follow-up every 3 months until 24 months</time_frame>
    <description>Context of systemic therapy; intention of treatment; prior hepatic procedures; post hepatic procedures</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse events, treatment complications and laboratory assessments</measure>
    <time_frame>Follow-up every 3 months until 24 months</time_frame>
    <description>Adverse events measured according to CTCAE 4.03, treatment complications reported bz investigators and abnormal laboratory assessments according to CTCAE 4.03</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effectiveness</measure>
    <time_frame>Follow-up every 3 months until 24 months</time_frame>
    <description>Based on overall survival (OS), progression free survival (PFS), liver specific PFS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>QLQ-C30</measure>
    <time_frame>Every 3 months until 24 months</time_frame>
    <description>Quality of life using QLQ-C30 from baseline until 24 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Technical considerations</measure>
    <time_frame>Baseline</time_frame>
    <description>Assessed by patient related characteristics, treatment related characteristics, treatment administration and procedure-related outcomes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diagnosis- and treatment-related considerations</measure>
    <time_frame>Baseline</time_frame>
    <description>Assessed by type of liver cancer, intention of the treatment, prior hepatic procedures, associated systemic therapy and post-SIRT hepatic procedures</description>
  </secondary_outcome>
  <enrollment type="Actual">332</enrollment>
  <condition>Liver Cancer</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Yttrium-90 loaded SIR-Spheres microspheres</intervention_name>
    <description>Selective internal radiation therapy (SIRT), also called radioembolisation (RE), with SIR-Spheres microspheres is an endovascular procedure, included within the interventional oncologic technologies to treat primary and secondary liver tumours. Using a microcatheter, a precise dose of resin microspheres is released in the hepatic artery, where they are carried into the arterioles and selectively lodge in the tumour microvasculature. The microspheres are loaded with the radioactive yttrium-90, a high-energy beta-emitting isotope with a half-life of 64.1 hours. SIR-Spheres microspheres are manufactured by Sirtex Medical.</description>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>QLQ-C30 with HCC module</intervention_name>
    <description>In order to measure the palliative aspect of RE with SIR-Spheres microspheres, CIRT-FR will incorporate a quality-of-life questionnaire. CIRT-FR will be using EORTC's QLQ-C30 with HCC Module to measure changes in the quality of life of the patient. The quality-of-life questionnaire will be offered to the patient before the treatment, shortly after the treatment (as soon as possible) and at every follow-up. Filling out the quality-of-life questionnaire is entirely voluntary for the patient</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        In a general manner and according to the Intent-To-Treat principle, no subject will be&#xD;
        excluded from the analysis. The primary and secondary endpoint analysis will include all&#xD;
        enrolled subjects in CIRT-FR.&#xD;
&#xD;
        However, patients who are considered for SIR-Spheres treatment but for whom it was decided&#xD;
        that they would not be treated will not be included in the analysis.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years or older&#xD;
&#xD;
          -  Primary or secondary liver tumours&#xD;
&#xD;
          -  Treatment of liver tumours with SIR-Spheres&#xD;
&#xD;
          -  Signed informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Consent denied&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Valérie I Vilgrain, Prof</last_name>
    <role>Study Chair</role>
    <affiliation>Cardiovascular and Interventional Radiological Society of Europe</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Thomas I Helmberger, Prof</last_name>
    <role>Study Chair</role>
    <affiliation>Cardiovascular and Interventional Radiological Society of Europe</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU d'Angers</name>
      <address>
        <city>Angers</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Bordeaux</name>
      <address>
        <city>Bordeaux</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Beaujon</name>
      <address>
        <city>Clichy</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Henri Mondor</name>
      <address>
        <city>Créteil</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chu de Dijon</name>
      <address>
        <city>Dijon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Grenoble Alpes</name>
      <address>
        <city>Grenoble</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Léon Bérard</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Lyon</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Paoli-Calmettes</name>
      <address>
        <city>Marseille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Nimes</name>
      <address>
        <city>Nîmes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Gustave Roussy</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Poitiers</name>
      <address>
        <city>Poitiers</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU de Strasbourg</name>
      <address>
        <city>Strasbourg</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>August 17, 2017</study_first_submitted>
  <study_first_submitted_qc>August 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <last_update_submitted>August 12, 2022</last_update_submitted>
  <last_update_submitted_qc>August 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT03256994
org study id: CIRT-FR
nct id: NCT03256994
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Selective Internal Radiation Therapy (SIRT), also known as radioembolisation, is a minimal
      invasive, endovascular treatment for primary and secondary liver tumours. In France,
      SIR-Spheres are listed as reimbursable by the national health authorities (Haute Autorité de
      Santé [HAS]). In order to evaluate the reimbursement after five years, all patients treated
      with SIR-Spheres will be entered into a registry that collects data on the real-life clinical
      application of SIRT and reports to the national authorities.
Selective internal radiation therapy (SIRT), also called radioembolisation (RE), with
      SIR-Spheres microspheres is an endovascular procedure, included within the interventional
      oncologic technologies to treat primary and secondary liver tumours. Using a microcatheter, a
      precise dose of resin microspheres is released in the hepatic artery, where they are carried
      into the arterioles and selectively lodge in the tumour microvasculature. The microspheres
      are loaded with the radioactive yttrium-90, a high-energy beta-emitting isotope with a
      half-life of 64.1 hours. Following administration, 94% of the radiation is delivered in 11
      days.

      In France, SIR-Spheres are listed as reimbursable by the national health authorities (Haute
      Autorité de Santé [HAS]). In order to evaluate the reimbursement after five years, all
      patients treated with SIR-Spheres will be entered into a registry that collects data on the
      real-life clinical application of SIRT and reports to the national authorities.

      The goal of the research project is to gain a better understanding of the real-life clinical
      application of radioembolisation with SIR-Spheres and the impact of the treatment in clinical
      practice. Secondary objectives will be to assess the observed treatment outcomes of SIRT with
      SIR-Spheres Y-90 resin microspheres in terms of safety, effectiveness, quality of life,
      technical considerations and diagnosis and treatment-related considerations.

      To better understand the palliative aspect of the treatment, acquisition of the change in
      quality of life is included by means of EORTC's validated quality of life questionnaire QLQ
      C30 with accompanying HCC module to measure quality of life in patients with hepatocellular
      carcinoma.

      Besides data collection on the initial treatment, it will be advised to collect follow-up
      data and quality of life data every three months for a minimum of 24 months after treatment.

      CIRT-FR is a post-market, prospective, non-randomized, observational study. Patients are only
      asked to be enrolled when they are treated with SIR-Spheres microspheres as part of their
      treatment determined by the treating clinician. In no way will participation of the patient
      in the registry impact their treatment plan, or influence the quality of the treatment.
observational model: Cohort
time perspective: Prospective
measure: Description of the clinical context in which SIR-Spheres are applied
time frame: Baseline, follow-up every 3 months until 24 months
description: Context of systemic therapy; intention of treatment; prior hepatic procedures; post hepatic procedures
measure: Adverse events, treatment complications and laboratory assessments
time frame: Follow-up every 3 months until 24 months
description: Adverse events measured according to CTCAE 4.03, treatment complications reported bz investigators and abnormal laboratory assessments according to CTCAE 4.03
measure: Effectiveness
time frame: Follow-up every 3 months until 24 months
description: Based on overall survival (OS), progression free survival (PFS), liver specific PFS
measure: QLQ-C30
time frame: Every 3 months until 24 months
description: Quality of life using QLQ-C30 from baseline until 24 months
measure: Technical considerations
time frame: Baseline
description: Assessed by patient related characteristics, treatment related characteristics, treatment administration and procedure-related outcomes
measure: Diagnosis- and treatment-related considerations
time frame: Baseline
description: Assessed by type of liver cancer, intention of the treatment, prior hepatic procedures, associated systemic therapy and post-SIRT hepatic procedures
intervention type: Device
intervention name: Yttrium-90 loaded SIR-Spheres microspheres
description: Selective internal radiation therapy (SIRT), also called radioembolisation (RE), with SIR-Spheres microspheres is an endovascular procedure, included within the interventional oncologic technologies to treat primary and secondary liver tumours. Using a microcatheter, a precise dose of resin microspheres is released in the hepatic artery, where they are carried into the arterioles and selectively lodge in the tumour microvasculature. The microspheres are loaded with the radioactive yttrium-90, a high-energy beta-emitting isotope with a half-life of 64.1 hours. SIR-Spheres microspheres are manufactured by Sirtex Medical.
intervention type: Behavioral
intervention name: QLQ-C30 with HCC module
description: In order to measure the palliative aspect of RE with SIR-Spheres microspheres, CIRT-FR will incorporate a quality-of-life questionnaire. CIRT-FR will be using EORTC's QLQ-C30 with HCC Module to measure changes in the quality of life of the patient. The quality-of-life questionnaire will be offered to the patient before the treatment, shortly after the treatment (as soon as possible) and at every follow-up. Filling out the quality-of-life questionnaire is entirely voluntary for the patient
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Valérie I Vilgrain, Prof
role: Study Chair
affiliation: Cardiovascular and Interventional Radiological Society of Europe
last name: Thomas I Helmberger, Prof
role: Study Chair
affiliation: Cardiovascular and Interventional Radiological Society of Europe
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Liver Neoplasms
sharing ipd: No