xml: <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/NCT06032728</url>
    </required_header>
    <id_info>
      <org_study_id>FirstSunYatSen</org_study_id>
      <nct_id>NCT06032728</nct_id>
    </id_info>
    <brief_title>Multimodal Recurrence Scoring System for Stratifying Stage III Clear Cell Renal Cell Carcinoma of Receiving Adjuvant Treatment</brief_title>
    <official_title>A Multi-site, Open, Perspective Study of Prognostic Value and Benefit From Adjuvant Targeted Therapy of Stage III Clear Cell Renal Cell Carcinoma Based on Multimodal Recurrence Scoring System</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>First Affiliated Hospital, Sun Yat-Sen University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>First Affiliated Hospital, Sun Yat-Sen University</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>
        Whether patients with stage III clear cell renal cell carcinoma (ccRCC) should receive&#xD;
        adjuvant targeted therapy or not is still on debate. The investigators invented a multimodal&#xD;
        recurrence scoring system that was successfully categorise patients with stage III clear cell&#xD;
        renal cell carcinoma into high-risk and low-risk groups with Hazard Ratio (HR) of 6.21. Here&#xD;
        the investigators randomly assign assay-defined high risk patients of locally advanced ccRCC&#xD;
        into adjuvant targeted therapy group and observation group. Disease free survival and overall&#xD;
        survival are the end points of observation.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">October 1, 2033</completion_date>
    <primary_completion_date type="Anticipated">October 1, 2033</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Disease free survival</measure>
      <time_frame>From the date of registration to up to 10 years</time_frame>
      <description>Disease free survival (DFS) was defined as the time interval (in years) from the date of randomization to the first date of recurrence or occurrence of a secondary malignancy or death.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Overall survival</measure>
      <time_frame>From the date of registration to up to 10 years</time_frame>
      <description>Overall survival (OS) was defined as the time from the date of randomization to the date of death due to any cause.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">488</enrollment>
    <condition>Renal Cell Carcinoma</condition>
    <arm_group>
      <arm_group_label>A</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>sunitinib 50 mg PO on schedule 4/2: 4 weeks on, 2 weeks off for 1 year or until disease recurrence or occurrence of a secondary malignancy, significant toxicity, or withdrawal of consent.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>B</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Patients with radical nephrectomy are observed without intervention</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Sunitinib</intervention_name>
      <description>The investigators randomly assign multimodal recurrence scoring system defined high risk patients of stage III ccRCC into intervention group and observation group. The intervention group should receive adjuvant targeted therapy while the control group deserve observation</description>
      <arm_group_label>A</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  The informed consent has been obtained from the patient.&#xD;
  &#xD;
            -  With confirmed diagnosis of stage III clear cell renal cell carcinoma&#xD;
  &#xD;
            -  With moderate/good Eastern Cooperative Oncology Group (ECOG) health rating (PS): 0-1&#xD;
               score.&#xD;
  &#xD;
            -  The patient receive no anti-cancer treatment before primary surgery.&#xD;
  &#xD;
            -  The patient receive radical operation for renal cancer with negative margin.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who have previously received neoadjuvant therapy&#xD;
  &#xD;
            -  With severe comorbidities, such as cardiovascular disease, chronic obstructive&#xD;
               pulmonary disease, diabetes mellitus, and chronic renal dysfunction.&#xD;
  &#xD;
            -  With bad compliance or contraindication to enrollment.&#xD;
  &#xD;
            -  Pregnant woman or lactating woman.&#xD;
  &#xD;
            -  With contraindication to receive adjuvant targeted therapy.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Jin-huan Wei, MD</last_name>
      <phone>+8613580314021</phone>
      <email>342729243@qq.com</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 30, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>First Affiliated Hospital, Sun Yat-Sen University</investigator_affiliation>
      <investigator_full_name>Jun-Hang Luo</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>target therapy</keyword>
    <keyword>tyrosine kinase inhibitors (TKIs)</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>
      <mesh_term>Recurrence</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Sunitinib</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06032728
  org study id: FirstSunYatSen
  nct id: NCT06032728
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Whether patients with stage III clear cell renal cell carcinoma (ccRCC) should receive
        adjuvant targeted therapy or not is still on debate. The investigators invented a multimodal
        recurrence scoring system that was successfully categorise patients with stage III clear cell
        renal cell carcinoma into high-risk and low-risk groups with Hazard Ratio (HR) of 6.21. Here
        the investigators randomly assign assay-defined high risk patients of locally advanced ccRCC
        into adjuvant targeted therapy group and observation group. Disease free survival and overall
        survival are the end points of observation.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Disease free survival
  time frame: From the date of registration to up to 10 years
  description: Disease free survival (DFS) was defined as the time interval (in years) from the date of randomization to the first date of recurrence or occurrence of a secondary malignancy or death.
  measure: Overall survival
  time frame: From the date of registration to up to 10 years
  description: Overall survival (OS) was defined as the time from the date of randomization to the date of death due to any cause.
  arm group label: A
  arm group type: Experimental
  description: sunitinib 50 mg PO on schedule 4/2: 4 weeks on, 2 weeks off for 1 year or until disease recurrence or occurrence of a secondary malignancy, significant toxicity, or withdrawal of consent.
  arm group label: B
  arm group type: No Intervention
  description: Patients with radical nephrectomy are observed without intervention
  intervention type: Drug
  intervention name: Sunitinib
  description: The investigators randomly assign multimodal recurrence scoring system defined high risk patients of stage III ccRCC into intervention group and observation group. The intervention group should receive adjuvant targeted therapy while the control group deserve observation
  arm group label: A
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Jin-huan Wei, MD
  phone: +8613580314021
  email: 342729243@qq.com
  responsible party type: Principal Investigator
  investigator affiliation: First Affiliated Hospital, Sun Yat-Sen University
  investigator full name: Jun-Hang Luo
  investigator title: Professor
  mesh term: Carcinoma
  mesh term: Carcinoma, Renal Cell
  mesh term: Recurrence
  mesh term: Sunitinib
  sharing ipd: No