<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/NCT02252393</url>
  </required_header>
  <id_info>
    <org_study_id>CASE7814</org_study_id>
    <secondary_id>NCI-2014-01530</secondary_id>
    <secondary_id>CASE 7814</secondary_id>
    <secondary_id>P30CA043703</secondary_id>
    <nct_id>NCT02252393</nct_id>
  </id_info>
  <brief_title>Urinary Diversion During Robotic Assisted Radical Cystectomy in Patients With Bladder Cancer</brief_title>
  <official_title>Prospective Randomized Comparison of Intracorporeal Versus Extracorporeal Urinary Diversion During Robotic Radical Cystectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Case Comprehensive Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Case Comprehensive Cancer Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This randomized clinical trial studies intracorporeal or extracorporeal urinary diversion&#xD;
      during robotic assisted radical cystectomy in reducing complications in patients with bladder&#xD;
      cancer. Radical cystectomy is surgery to remove the entire bladder as well as nearby tissues&#xD;
      and organs. After the bladder is removed, urinary diversion (a surgical procedure to make a&#xD;
      new way for urine to leave the body) is performed. It is not yet known whether intracorporeal&#xD;
      (within the body) or extracorporeal (outside of the body) urinary diversion is a better&#xD;
      method in patients with bladder cancer undergoing robotic assisted radical cystectomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To compare perioperative outcomes and complications after robotic assisted radical&#xD;
      cystectomy (RARC) with intracorporeal urinary diversion (IUD) and RARC with extracorporeal&#xD;
      urinary diversion (EUD) in a prospective randomized fashion.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. Time to passage of flatus. II. Analgesic requirement (narcotic use). III. Hospital length&#xD;
      of stay. IV. Total operating time. V. Estimated blood loss. VI. Readmission rate. VII.&#xD;
      Bladder Cancer Index Questionnaire. VIII. Ureteral strictures. IX. Stomal stenosis. X.&#xD;
      Disease recurrence. XI. Secondary procedures.&#xD;
&#xD;
      OUTLINE: Patients are randomized to 1 of 2 treatment arms.&#xD;
&#xD;
      ARM I: Patients undergo RARC with IUD.&#xD;
&#xD;
      ARM II: Patients undergo RARC with EUD.&#xD;
&#xD;
      After completion of study treatment, patients are followed up within 90 days and then for 2-5&#xD;
      years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    waiting on surgeon training&#xD;
  </why_stopped>
  <start_date>October 2015</start_date>
  <completion_date type="Actual">November 2016</completion_date>
  <primary_completion_date type="Actual">November 2016</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Complication rate</measure>
    <time_frame>90 days after surgery</time_frame>
    <description>Analyzed using multivariable logistical regression. Descriptions and grading scales found in the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for adverse event reporting.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to passage of flatus</measure>
    <time_frame>Up to 90 days</time_frame>
    <description>Analyzed using regression analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analgesic requirement (narcotic use)</measure>
    <time_frame>Up to 90 days</time_frame>
    <description>Analyzed using logistical regression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital length of stay</measure>
    <time_frame>Up to 90 days</time_frame>
    <description>Analyzed using regression analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total operating time</measure>
    <time_frame>Up to completion of surgery</time_frame>
    <description>Analyzed using regression analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Estimated blood loss</measure>
    <time_frame>Up to 90 days</time_frame>
    <description>Analyzed using regression analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Readmission rate</measure>
    <time_frame>Up to 90 days</time_frame>
    <description>Analyzed using regression analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life assessed using the Bladder Cancer Index Questionnaire</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>The Cox proportional hazards model will be used. The hazard ratio (HR) and 95% confidence interval (95% CI) associated with the use of RARC with IUD compared with the use of RARC with EUD will be calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ureteral strictures</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>The Cox proportional hazards model will be used. The HR and 95% CI associated with the use of RARC with IUD compared with the use of RARC with EUD will be calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stromal stenosis</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>The Cox proportional hazards model will be used. The HR and 95% CI associated with the use of RARC with IUD compared with the use of RARC with EUD will be calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease recurrence</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>The Cox proportional hazards model will be used. The HR and 95% CI associated with the use of RARC with IUD compared with the use of RARC with EUD will be calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary procedures</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>The Cox proportional hazards model will be used. The HR and 95% CI associated with the use of RARC with IUD compared with the use of RARC with EUD will be calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative complication incidence</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>Graphically described using the Kaplan-Meier method. Descriptions and grading scales found in the NCI CTCAE version 4.0 will be utilized for adverse event reporting.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Recurrent Bladder Cancer</condition>
  <condition>Stage 0 Bladder Cancer</condition>
  <condition>Stage I Bladder Cancer</condition>
  <condition>Stage II Bladder Cancer</condition>
  <condition>Urinary Complications</condition>
  <arm_group>
    <arm_group_label>Arm I (RARC with IUD)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergo RARC with IUD.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm II (RARC with EUD)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergo RARC with EUD.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>robot-assisted laparoscopic surgery</intervention_name>
    <description>Undergo RARC with IUD</description>
    <arm_group_label>Arm I (RARC with IUD)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>robot-assisted laparoscopic surgery</intervention_name>
    <description>Undergo RARC with EUD</description>
    <arm_group_label>Arm II (RARC with EUD)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>intraoperative complication management/prevention</intervention_name>
    <description>Undergo RARC with IUD</description>
    <arm_group_label>Arm I (RARC with IUD)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>intraoperative complication management/prevention</intervention_name>
    <description>Undergo RARC with EUD</description>
    <arm_group_label>Arm II (RARC with EUD)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>quality-of-life assessment</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Arm I (RARC with IUD)</arm_group_label>
    <arm_group_label>Arm II (RARC with EUD)</arm_group_label>
    <other_name>quality of life assessment</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Grade G1 - G3 bladder cancer&#xD;
&#xD;
          -  T stage: cTis - T2&#xD;
&#xD;
          -  N0&#xD;
&#xD;
          -  M0&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) &lt; 4&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status 2 or better&#xD;
&#xD;
          -  Hemoglobin (Hgb) &gt; 8.0 g/dL&#xD;
&#xD;
          -  White blood cell (WBC) &gt; 2.0 k/uL&#xD;
&#xD;
          -  Platelets &gt; 50,000&#xD;
&#xD;
          -  Creatinine &lt; 3.0 x upper limit of normal (ULN)&#xD;
&#xD;
          -  Aspartate aminotransferase (AST) &lt; 5.0 x ULN&#xD;
&#xD;
          -  Alanine transaminase (ALT) &lt; 5.0 x ULN&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient unsuitable for or refusing radical cystectomy&#xD;
&#xD;
          -  T stage ≥ T3 (mass extending outside the bladder)&#xD;
&#xD;
          -  Gross nodal or metastatic disease at presentation (≥ N1, M1)&#xD;
&#xD;
          -  Prior pelvic radiation&#xD;
&#xD;
          -  Prior open or laparoscopic/robotic bladder or prostate surgery&#xD;
&#xD;
          -  Prior colorectal surgery or history of inflammatory bowel disease&#xD;
&#xD;
          -  Body mass index (BMI) ≥ 40&#xD;
&#xD;
          -  ECOG performance status 3 or worse&#xD;
&#xD;
          -  History of coagulopathy or bleeding disorders&#xD;
&#xD;
          -  Chronic steroid use&#xD;
&#xD;
          -  Patients with end stage renal disease (ESRD) and/or on dialysis&#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>Jihad Kaouk</last_name>
    <role>Principal Investigator</role>
    <affiliation>Case Comprehensive Cancer Center</affiliation>
  </overall_official>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>September 26, 2014</study_first_submitted>
  <study_first_submitted_qc>September 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 30, 2014</study_first_posted>
  <last_update_submitted>November 8, 2016</last_update_submitted>
  <last_update_submitted_qc>November 8, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 9, 2016</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>Urinary Bladder Neoplasms</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/NCT02252393
org study id: CASE7814
secondary id: NCI-2014-01530
secondary id: CASE 7814
secondary id: P30CA043703
nct id: NCT02252393
lead sponsor: 
collaborator: 
has dmc: No
This randomized clinical trial studies intracorporeal or extracorporeal urinary diversion
      during robotic assisted radical cystectomy in reducing complications in patients with bladder
      cancer. Radical cystectomy is surgery to remove the entire bladder as well as nearby tissues
      and organs. After the bladder is removed, urinary diversion (a surgical procedure to make a
      new way for urine to leave the body) is performed. It is not yet known whether intracorporeal
      (within the body) or extracorporeal (outside of the body) urinary diversion is a better
      method in patients with bladder cancer undergoing robotic assisted radical cystectomy.
PRIMARY OBJECTIVES:

      I. To compare perioperative outcomes and complications after robotic assisted radical
      cystectomy (RARC) with intracorporeal urinary diversion (IUD) and RARC with extracorporeal
      urinary diversion (EUD) in a prospective randomized fashion.

      SECONDARY OBJECTIVES:

      I. Time to passage of flatus. II. Analgesic requirement (narcotic use). III. Hospital length
      of stay. IV. Total operating time. V. Estimated blood loss. VI. Readmission rate. VII.
      Bladder Cancer Index Questionnaire. VIII. Ureteral strictures. IX. Stomal stenosis. X.
      Disease recurrence. XI. Secondary procedures.

      OUTLINE: Patients are randomized to 1 of 2 treatment arms.

      ARM I: Patients undergo RARC with IUD.

      ARM II: Patients undergo RARC with EUD.

      After completion of study treatment, patients are followed up within 90 days and then for 2-5
      years.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Complication rate
time frame: 90 days after surgery
description: Analyzed using multivariable logistical regression. Descriptions and grading scales found in the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for adverse event reporting.
measure: Time to passage of flatus
time frame: Up to 90 days
description: Analyzed using regression analysis.
measure: Analgesic requirement (narcotic use)
time frame: Up to 90 days
description: Analyzed using logistical regression.
measure: Hospital length of stay
time frame: Up to 90 days
description: Analyzed using regression analysis.
measure: Total operating time
time frame: Up to completion of surgery
description: Analyzed using regression analysis.
measure: Estimated blood loss
time frame: Up to 90 days
description: Analyzed using regression analysis.
measure: Readmission rate
time frame: Up to 90 days
description: Analyzed using regression analysis.
measure: Quality of life assessed using the Bladder Cancer Index Questionnaire
time frame: Up to 5 years
description: The Cox proportional hazards model will be used. The hazard ratio (HR) and 95% confidence interval (95% CI) associated with the use of RARC with IUD compared with the use of RARC with EUD will be calculated.
measure: Ureteral strictures
time frame: Up to 5 years
description: The Cox proportional hazards model will be used. The HR and 95% CI associated with the use of RARC with IUD compared with the use of RARC with EUD will be calculated.
measure: Stromal stenosis
time frame: Up to 5 years
description: The Cox proportional hazards model will be used. The HR and 95% CI associated with the use of RARC with IUD compared with the use of RARC with EUD will be calculated.
measure: Disease recurrence
time frame: Up to 5 years
description: The Cox proportional hazards model will be used. The HR and 95% CI associated with the use of RARC with IUD compared with the use of RARC with EUD will be calculated.
measure: Secondary procedures
time frame: Up to 5 years
description: The Cox proportional hazards model will be used. The HR and 95% CI associated with the use of RARC with IUD compared with the use of RARC with EUD will be calculated.
measure: Cumulative complication incidence
time frame: Up to 5 years
description: Graphically described using the Kaplan-Meier method. Descriptions and grading scales found in the NCI CTCAE version 4.0 will be utilized for adverse event reporting.
arm group label: Arm I (RARC with IUD)
arm group type: Experimental
description: Patients undergo RARC with IUD.
arm group label: Arm II (RARC with EUD)
arm group type: Experimental
description: Patients undergo RARC with EUD.
intervention type: Procedure
intervention name: robot-assisted laparoscopic surgery
description: Undergo RARC with IUD
arm group label: Arm I (RARC with IUD)
intervention type: Procedure
intervention name: robot-assisted laparoscopic surgery
description: Undergo RARC with EUD
arm group label: Arm II (RARC with EUD)
intervention type: Other
intervention name: intraoperative complication management/prevention
description: Undergo RARC with IUD
arm group label: Arm I (RARC with IUD)
intervention type: Other
intervention name: intraoperative complication management/prevention
description: Undergo RARC with EUD
arm group label: Arm II (RARC with EUD)
intervention type: Other
intervention name: quality-of-life assessment
description: Ancillary studies
arm group label: Arm I (RARC with IUD)
arm group label: Arm II (RARC with EUD)
other name: quality of life assessment
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Jihad Kaouk
role: Principal Investigator
affiliation: Case Comprehensive Cancer Center
country: United States
responsible party type: Sponsor
mesh term: Urinary Bladder Neoplasms