<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/NCT03030157</url>
  </required_header>
  <id_info>
    <org_study_id>RenJiH-PDU Trial</org_study_id>
    <nct_id>NCT03030157</nct_id>
  </id_info>
  <brief_title>Single Versus Long-term Intravesical Instillation Chemotherapy for Recurrence After Nephroureterectomy for Upper Tract Urothelial Carcinoma</brief_title>
  <official_title>Prospective Randomized Phase II Trial: Single Instillation Versus Long-term Prophylactic Intravesical Instillation of Pirarubicin in the Prevention of Bladder Recurrence After Nephroureterectomy for Primary Upper Tract Urothelial Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>RenJi Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Shanghai Pudong Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shanghai Pudong New Area Gongli Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>RenJi Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Up to 30-40% of the patients may develop bladder recurrance after radical nephroureterectomy&#xD;
      for primary upper tract urothelial carcinoma. Bladder tumor needs transurethral resection,&#xD;
      which is associated with costs of treatment and potential poor prognosis. Although several&#xD;
      randomized controlled trial have shown that prophylactic intravesical chemotherapy could&#xD;
      prevent bladder tumor recurrence, the optimal schedule and duration of treatment are unkown.&#xD;
      The investigators want to determine the efficiacy of single instillation versus long-term&#xD;
      intravesical instillation of pirarubicin for bladder recurrence after radical&#xD;
      nephrouretectomy for primary upper tract urothelial carcinoma.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Anticipated">January 2020</completion_date>
  <primary_completion_date type="Anticipated">January 2020</primary_completion_date>
  <phase>Phase 2</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The incidence of bladder cancer in the first 12 month following nephroureterectomy</measure>
    <time_frame>12 month</time_frame>
    <description>Bladder recurrence is judged on visual appearance, and histopathologic proof of recurrence was required.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with treatment-related adverse events as assessed by CTCAE v4.0</measure>
    <time_frame>2 day, 1 month and 12 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>questionnaire for quality of life</measure>
    <time_frame>baseline, 1 month and 12 month</time_frame>
    <description>e.g QLQ C-30</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>progression-free survival</measure>
    <time_frame>12 month</time_frame>
    <description>progression-free survival</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cancer-specific survival</measure>
    <time_frame>12 month</time_frame>
    <description>cancer-specific survival</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>overall survival</measure>
    <time_frame>12 month</time_frame>
    <description>overall survival</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">220</enrollment>
  <condition>Intravesical Instillation</condition>
  <arm_group>
    <arm_group_label>Long-term Intravesical Instillation of pirarubicin(THP)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A single instillation of pirarubicin (THP) plus one year long-term intravesical instillation after nephroureterectomy was performed. The ﬁrst instillation was initiated within 72-168 hours after surgery, followed by four times weekly and 11 times monthly (16 times in total in one year time) . Every time, THP 30 mg in 30 mL of normal saline was delivered into the bladder through a catheter and was retained for 30 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Single Intravesical Instillation of pirarubicin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A single intravesical instillation of THP after nephroureterectomy was performed. This instillation was initiated within 72-168 hours after surgery . THP 30 mg in 30 mL of normal saline was delivered into the bladder through a catheter and was retained for 30 minutes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>pirarubicin(THP)</intervention_name>
    <arm_group_label>Long-term Intravesical Instillation of pirarubicin(THP)</arm_group_label>
    <arm_group_label>Single Intravesical Instillation of pirarubicin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  clinically diagnosed with upper tract urothelial carcinoma&#xD;
&#xD;
          -  have no distant metastasis&#xD;
&#xD;
          -  have an ECOG 0 to 2&#xD;
&#xD;
          -  expected to receive radical nephroureterectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  a prior history of bladder or synchronous bladder cancer&#xD;
&#xD;
          -  administration of neoadjuvant chemotherapy&#xD;
&#xD;
          -  the presence of severe complications&#xD;
&#xD;
          -  deny to receive cytoscopy&#xD;
&#xD;
          -  patients with advanced stage (T4)&#xD;
&#xD;
          -  patients with contralateral UTUCs&#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_contact>
    <last_name>jiwei huang</last_name>
    <phone>8613651682825</phone>
    <email>jiweihuang@outlook.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Renji Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200127</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>jiwei huang, M.D</last_name>
      <phone>8613651682825</phone>
      <email>jiweihuang@outlook.com</email>
    </contact>
    <contact_backup>
      <last_name>jin zhang</last_name>
      <phone>86-21-68383776</phone>
      <email>zhangjin@renji.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>January 17, 2017</study_first_submitted>
  <study_first_submitted_qc>January 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 24, 2017</study_first_posted>
  <last_update_submitted>October 7, 2019</last_update_submitted>
  <last_update_submitted_qc>October 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>RenJi Hospital</investigator_affiliation>
    <investigator_full_name>Yiran Huang</investigator_full_name>
    <investigator_title>Director of Urology department in Renji Hospital</investigator_title>
  </responsible_party>
  <keyword>urothelial cancer</keyword>
  <keyword>bladder cancer</keyword>
  <keyword>nephroureterectomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma, Transitional 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>Pirarubicin</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/NCT03030157
org study id: RenJiH-PDU Trial
nct id: NCT03030157
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Up to 30-40% of the patients may develop bladder recurrance after radical nephroureterectomy
      for primary upper tract urothelial carcinoma. Bladder tumor needs transurethral resection,
      which is associated with costs of treatment and potential poor prognosis. Although several
      randomized controlled trial have shown that prophylactic intravesical chemotherapy could
      prevent bladder tumor recurrence, the optimal schedule and duration of treatment are unkown.
      The investigators want to determine the efficiacy of single instillation versus long-term
      intravesical instillation of pirarubicin for bladder recurrence after radical
      nephrouretectomy for primary upper tract urothelial carcinoma.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: The incidence of bladder cancer in the first 12 month following nephroureterectomy
time frame: 12 month
description: Bladder recurrence is judged on visual appearance, and histopathologic proof of recurrence was required.
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
time frame: 2 day, 1 month and 12 month
measure: questionnaire for quality of life
time frame: baseline, 1 month and 12 month
description: e.g QLQ C-30
measure: progression-free survival
time frame: 12 month
description: progression-free survival
measure: cancer-specific survival
time frame: 12 month
description: cancer-specific survival
measure: overall survival
time frame: 12 month
description: overall survival
arm group label: Long-term Intravesical Instillation of pirarubicin(THP)
arm group type: Experimental
description: A single instillation of pirarubicin (THP) plus one year long-term intravesical instillation after nephroureterectomy was performed. The ﬁrst instillation was initiated within 72-168 hours after surgery, followed by four times weekly and 11 times monthly (16 times in total in one year time) . Every time, THP 30 mg in 30 mL of normal saline was delivered into the bladder through a catheter and was retained for 30 minutes.
arm group label: Single Intravesical Instillation of pirarubicin
arm group type: Active Comparator
description: A single intravesical instillation of THP after nephroureterectomy was performed. This instillation was initiated within 72-168 hours after surgery . THP 30 mg in 30 mL of normal saline was delivered into the bladder through a catheter and was retained for 30 minutes.
intervention type: Drug
intervention name: pirarubicin(THP)
arm group label: Long-term Intravesical Instillation of pirarubicin(THP)
arm group label: Single Intravesical Instillation of pirarubicin
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: jiwei huang
phone: 8613651682825
email: jiweihuang@outlook.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Principal Investigator
investigator affiliation: RenJi Hospital
investigator full name: Yiran Huang
investigator title: Director of Urology department in Renji Hospital
mesh term: Carcinoma, Transitional Cell
mesh term: Recurrence
mesh term: Pirarubicin