<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/NCT01728948</url>
  </required_header>
  <id_info>
    <org_study_id>16399</org_study_id>
    <secondary_id>NX1212CN</secondary_id>
    <nct_id>NCT01728948</nct_id>
  </id_info>
  <brief_title>Sorafenib in Elderly mRCC</brief_title>
  <official_title>Non-interventional Study of Effectiveness of Elderly Metastatic Renal Cell Carcinoma (mRCC) Treated With Sorafenib</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bayer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bayer</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This prospective, single arm, multi-center pilot study includes 120 mRCC patients over 65&#xD;
      years, no prior systemic treatment, determined to be candidates for systemic therapy by the&#xD;
      investigator. The treatment with Sorafenib should comply with the recommendations written in&#xD;
      the local product information. The primary endpoint is overall survival. The secondary&#xD;
      endpoints including other effectiveness points, safety and patients characteristics. With 120&#xD;
      completed patients, if the observed survival rate at 12 months is 60%, the width of a 95%&#xD;
      confidence interval will be approximately 18%.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 6, 2013</start_date>
  <completion_date type="Actual">January 16, 2017</completion_date>
  <primary_completion_date type="Actual">January 4, 2016</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</measure>
    <time_frame>up to 2.5 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression free survival by the Response Evaluation Criteria in Solid Tumor (RECIST) Criteria</measure>
    <time_frame>up to 2.5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease control rate by the Response Evaluation Criteria in Solid Tumor (RECIST) Criteria</measure>
    <time_frame>up to 2.5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Survival rate by one year</measure>
    <time_frame>up to 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with adverse events (AE) and Serious adverse events (SAE) as a measure of safety and tolerability</measure>
    <time_frame>up to 3.5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient characteristics (birthdate (at least year), sex, weight, height, etc)</measure>
    <time_frame>up to 2.5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response rate (RR)</measure>
    <time_frame>up to 3.5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to first relief of clinical symptoms and physical signs</measure>
    <time_frame>up to 3.5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment pattern</measure>
    <time_frame>up to 3.5 years</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">60</enrollment>
  <condition>Carcinoma, Renal Cell</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sorafenib (Nexavar, BAY43-9006)</intervention_name>
    <description>treatment (including dose, duration, modification) decided by the investigator</description>
    <arm_group_label>Group 1</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        mRCC patients, &gt;= 65 years of age, No prior systemic treatment, need systemic therapy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with histologically/cytologically diagnosed metastasis RCC who are candidates&#xD;
             for systemic therapy and have decided to accept Sorafenib treatment.&#xD;
&#xD;
          -  &gt;=65 years of age&#xD;
&#xD;
          -  Patients who have signed the informed consent&#xD;
&#xD;
          -  Patients with a life expectancy of ≥12 weeks&#xD;
&#xD;
          -  No prior systemic treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The approved local product label must be followed for the exclusion criteria&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bayer Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Bayer</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Many Locations</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>November 14, 2012</study_first_submitted>
  <study_first_submitted_qc>November 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 20, 2012</study_first_posted>
  <last_update_submitted>November 8, 2017</last_update_submitted>
  <last_update_submitted_qc>November 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Sorafenib</keyword>
  <keyword>renal cell carcinoma(RCC)</keyword>
  <keyword>elderly</keyword>
  <keyword>effectiveness</keyword>
  <keyword>safety</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Renal Cell</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sorafenib</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01728948
org study id: 16399
secondary id: NX1212CN
nct id: NCT01728948
lead sponsor: 
has dmc: No
This prospective, single arm, multi-center pilot study includes 120 mRCC patients over 65
      years, no prior systemic treatment, determined to be candidates for systemic therapy by the
      investigator. The treatment with Sorafenib should comply with the recommendations written in
      the local product information. The primary endpoint is overall survival. The secondary
      endpoints including other effectiveness points, safety and patients characteristics. With 120
      completed patients, if the observed survival rate at 12 months is 60%, the width of a 95%
      confidence interval will be approximately 18%.
observational model: Cohort
time perspective: Prospective
measure: Overall survival
time frame: up to 2.5 years
measure: Progression free survival by the Response Evaluation Criteria in Solid Tumor (RECIST) Criteria
time frame: up to 2.5 years
measure: Disease control rate by the Response Evaluation Criteria in Solid Tumor (RECIST) Criteria
time frame: up to 2.5 years
measure: Survival rate by one year
time frame: up to 1 year
measure: Number of participants with adverse events (AE) and Serious adverse events (SAE) as a measure of safety and tolerability
time frame: up to 3.5 years
measure: Patient characteristics (birthdate (at least year), sex, weight, height, etc)
time frame: up to 2.5 years
measure: Response rate (RR)
time frame: up to 3.5 years
measure: Time to first relief of clinical symptoms and physical signs
time frame: up to 3.5 years
measure: Treatment pattern
time frame: up to 3.5 years
arm group label: Group 1
intervention type: Drug
intervention name: Sorafenib (Nexavar, BAY43-9006)
description: treatment (including dose, duration, modification) decided by the investigator
arm group label: Group 1
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Bayer Study Director
role: Study Director
affiliation: Bayer
facility: 
country: China
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Renal Cell
mesh term: Sorafenib