<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/NCT03230201</url>
  </required_header>
  <id_info>
    <org_study_id>IUPU-16-UTUC-3</org_study_id>
    <nct_id>NCT03230201</nct_id>
  </id_info>
  <brief_title>Lymph Node Dissection in High-risk UTUC(Upper Tract Urothelial Carcinoma)</brief_title>
  <acronym>UTUC</acronym>
  <official_title>Impact of Lymph Node Dissection in the Management of High-risk Primary Upper Tract Urothelial Carcinoma Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University First Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking University First Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This clinical trial is designed to evaluate the role of lymph node dissection in the&#xD;
      prevention of recurrence and metastasis after radical nephroureterectomy for high-risk&#xD;
      primary upper tract urothelial carcinoma (UTUC) patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      INTRODUCTION Upper tract urothelial carcinomas (UTUC) are relatively uncommon compared to&#xD;
      bladder cancer and account for only 5-10% of urothelial carcinomas, with an estimated annual&#xD;
      incidence in Western countries of&#xD;
&#xD;
      ~2 cases per 100,000 inhabitants. The therapeutic role of regional lymph node dissection&#xD;
      (LND) for patients with UTUC remains undetermined. Most reports have supported its staging&#xD;
      benefit in which patients with no lymph node metastases (pN0) and those with pathological&#xD;
      node metastasis (pN+) are stratified from those without LND (pNx). However, the therapeutic&#xD;
      benefit of LND remains controversial. This discrepancy might be attributed to two factors.&#xD;
      First, there remains a lack of standardization in the extent of LND. Kondo T et al and Matin&#xD;
      SF et al previously reported the primary sites of lymphatic metastases from a mapping study,&#xD;
      and then determined the anatomical extent of regional lymph nodes. Second, all results&#xD;
      reported so far have been, to the best of our knowledge, derived from retrospective studies.&#xD;
      Thus, the current guideline recommends LND for invasive UTUC on the basis of insufficient&#xD;
      evidence. AIM OF THE WORK This clinical trial is designed to evaluate the role of lymph node&#xD;
      dissection in the prevention of recurrence and metastasis after radical nephroureterectomy&#xD;
      for high-risk primary upper tract urothelial carcinoma (UTUC) patients. PATIENTS AND METHODS&#xD;
      Patients Type of the study: A randomized controlled trial (RCT), phase II. Study locality:&#xD;
      Department of Urology, Peking University First Hospital. Institute of Urology, Peking&#xD;
      University. National Urological Cancer Center, Beijing, China. Study design: Patients who was&#xD;
      ready to receive nephroureterectomy for high-risk primary UTUC will be prospectively&#xD;
      randomized into two groups using excel software by random table function. I. Group 1: will&#xD;
      receive LND during radical nephroureterectomy. II. Group 2: do not receive LND during&#xD;
      surgery.&#xD;
&#xD;
      Inclusion Criteria:&#xD;
&#xD;
      I. Suspected high-risk UTUC patients without metastases in their preoperative radiological&#xD;
      imaging (cN0M0).II. Suspected high-risk UTUC patients without history of bladder tumor.&#xD;
&#xD;
      III. Suspected high-risk UTUC patients without synchronous bladder tumor. IV. Suspected&#xD;
      high-risk UTUC patients without contralateral UTUCs.&#xD;
&#xD;
      Exclusion criteria:&#xD;
&#xD;
      I. Patients with significant metastases in their preoperative radiological imaging.&#xD;
&#xD;
      II. Patients with history of bladder tumor. III. Patients with synchronous bladder tumor. IV.&#xD;
      Patients with contralateral UTUCs. V. Patients with advanced stage (T4). VI. Patients with&#xD;
      other malignant tumors. Methods Intervention Patients who sign an informed consent for&#xD;
      agreement to participate will be randomly allocated into one of the two groups using excel&#xD;
      software by random table function at the day of nephroureterectomy. In group 1, patients will&#xD;
      receive LND during radical nephroureterectomy. While for patients in group 2, no LND will be&#xD;
      received. All data will be prospectively maintained and include patients' demographics,&#xD;
      preoperative laboratory parameters, operative details and postoperative complications Follow&#xD;
      up The scheduled follow up will be according to the EAU guidelines (Rouprêt et al., 2015) by&#xD;
      scheduling a urine cytology and cystoscopy at 3 months then yearly while CT urography every&#xD;
      year for non-invasive tumors and every 6 months over 2 years and then yearly for invasive&#xD;
      tumors. All chemotherapy-related complications will be reported. Outcome and end-point The&#xD;
      primary outcome of the study is to determine the overall survival (OS). The secondary outcome&#xD;
      is to determine the adverse events postoperative morbidity, mortality and other survival&#xD;
      (RFS, CSS, EFS) of patients with high-risk UTUC.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Anticipated">January 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2021</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>overall survival</measure>
    <time_frame>three years after surgery</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>postoperative morbidity and mortality</measure>
    <time_frame>three years after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>recurrence-free survival</measure>
    <time_frame>three years after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cancer specific survival</measure>
    <time_frame>three years after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>event-free survival</measure>
    <time_frame>three years after surgery</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Recurrence</condition>
  <condition>Metastasis</condition>
  <condition>Upper Tract Urothelial Carcinoma</condition>
  <condition>Lymph Node Dissection</condition>
  <arm_group>
    <arm_group_label>Blank control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>do not receive Lymph node dissection during surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lymph node dissection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>will receive Lymph node dissection during radical nephroureterectomy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Lymph node dissection</intervention_name>
    <description>Lymph node dissection during radical nephroureterectomy</description>
    <arm_group_label>Lymph node dissection</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  I. Suspected high-risk UTUC patients without metastases in their preoperative&#xD;
             radiological imaging (cN0M0).II. Suspected high-risk UTUC patients without history of&#xD;
             bladder tumor.&#xD;
&#xD;
        III. Suspected high-risk UTUC patients without synchronous bladder tumor. IV. Suspected&#xD;
        high-risk UTUC patients without contralateral UTUCs&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  I. Patients with significant metastases in their preoperative radiological imaging.&#xD;
&#xD;
        II. Patients with history of bladder tumor. III. Patients with synchronous bladder tumor.&#xD;
        IV. Patients with contralateral UTUCs. V. Patients with advanced stage (T4). VI. Patients&#xD;
        with other malignant tumors&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Liqun Zhou, M.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Peking University First Hosipital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xuesong Li, M.D.</last_name>
    <phone>8601083572481</phone>
    <email>pineneedle@sina.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Peking University First Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100034</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gengyan XIONG, M.D.</last_name>
    </contact>
    <contact_backup>
      <last_name>Runqi GUO, M.D.</last_name>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 24, 2017</study_first_submitted>
  <study_first_submitted_qc>July 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 26, 2017</study_first_posted>
  <last_update_submitted>August 5, 2017</last_update_submitted>
  <last_update_submitted_qc>August 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking University First Hospital</investigator_affiliation>
    <investigator_full_name>Xuesong Li</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Transitional Cell</mesh_term>
    <mesh_term>Recurrence</mesh_term>
  </condition_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/NCT03230201
org study id: IUPU-16-UTUC-3
nct id: NCT03230201
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This clinical trial is designed to evaluate the role of lymph node dissection in the
      prevention of recurrence and metastasis after radical nephroureterectomy for high-risk
      primary upper tract urothelial carcinoma (UTUC) patients.
INTRODUCTION Upper tract urothelial carcinomas (UTUC) are relatively uncommon compared to
      bladder cancer and account for only 5-10% of urothelial carcinomas, with an estimated annual
      incidence in Western countries of

      ~2 cases per 100,000 inhabitants. The therapeutic role of regional lymph node dissection
      (LND) for patients with UTUC remains undetermined. Most reports have supported its staging
      benefit in which patients with no lymph node metastases (pN0) and those with pathological
      node metastasis (pN+) are stratified from those without LND (pNx). However, the therapeutic
      benefit of LND remains controversial. This discrepancy might be attributed to two factors.
      First, there remains a lack of standardization in the extent of LND. Kondo T et al and Matin
      SF et al previously reported the primary sites of lymphatic metastases from a mapping study,
      and then determined the anatomical extent of regional lymph nodes. Second, all results
      reported so far have been, to the best of our knowledge, derived from retrospective studies.
      Thus, the current guideline recommends LND for invasive UTUC on the basis of insufficient
      evidence. AIM OF THE WORK This clinical trial is designed to evaluate the role of lymph node
      dissection in the prevention of recurrence and metastasis after radical nephroureterectomy
      for high-risk primary upper tract urothelial carcinoma (UTUC) patients. PATIENTS AND METHODS
      Patients Type of the study: A randomized controlled trial (RCT), phase II. Study locality:
      Department of Urology, Peking University First Hospital. Institute of Urology, Peking
      University. National Urological Cancer Center, Beijing, China. Study design: Patients who was
      ready to receive nephroureterectomy for high-risk primary UTUC will be prospectively
      randomized into two groups using excel software by random table function. I. Group 1: will
      receive LND during radical nephroureterectomy. II. Group 2: do not receive LND during
      surgery.

      Inclusion Criteria:

      I. Suspected high-risk UTUC patients without metastases in their preoperative radiological
      imaging (cN0M0).II. Suspected high-risk UTUC patients without history of bladder tumor.

      III. Suspected high-risk UTUC patients without synchronous bladder tumor. IV. Suspected
      high-risk UTUC patients without contralateral UTUCs.

      Exclusion criteria:

      I. Patients with significant metastases in their preoperative radiological imaging.

      II. Patients with history of bladder tumor. III. Patients with synchronous bladder tumor. IV.
      Patients with contralateral UTUCs. V. Patients with advanced stage (T4). VI. Patients with
      other malignant tumors. Methods Intervention Patients who sign an informed consent for
      agreement to participate will be randomly allocated into one of the two groups using excel
      software by random table function at the day of nephroureterectomy. In group 1, patients will
      receive LND during radical nephroureterectomy. While for patients in group 2, no LND will be
      received. All data will be prospectively maintained and include patients' demographics,
      preoperative laboratory parameters, operative details and postoperative complications Follow
      up The scheduled follow up will be according to the EAU guidelines (Rouprêt et al., 2015) by
      scheduling a urine cytology and cystoscopy at 3 months then yearly while CT urography every
      year for non-invasive tumors and every 6 months over 2 years and then yearly for invasive
      tumors. All chemotherapy-related complications will be reported. Outcome and end-point The
      primary outcome of the study is to determine the overall survival (OS). The secondary outcome
      is to determine the adverse events postoperative morbidity, mortality and other survival
      (RFS, CSS, EFS) of patients with high-risk UTUC.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: overall survival
time frame: three years after surgery
measure: postoperative morbidity and mortality
time frame: three years after surgery
measure: recurrence-free survival
time frame: three years after surgery
measure: cancer specific survival
time frame: three years after surgery
measure: event-free survival
time frame: three years after surgery
arm group label: Blank control
arm group type: No Intervention
description: do not receive Lymph node dissection during surgery.
arm group label: Lymph node dissection
arm group type: Experimental
description: will receive Lymph node dissection during radical nephroureterectomy.
intervention type: Procedure
intervention name: Lymph node dissection
description: Lymph node dissection during radical nephroureterectomy
arm group label: Lymph node dissection
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Liqun Zhou, M.D.
role: Study Chair
affiliation: Peking University First Hosipital
last name: Xuesong Li, M.D.
phone: 8601083572481
email: pineneedle@sina.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Peking University First Hospital
investigator full name: Xuesong Li
investigator title: Professor
mesh term: Carcinoma
mesh term: Carcinoma, Transitional Cell
mesh term: Recurrence