<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/NCT03756207</url>
  </required_header>
  <id_info>
    <org_study_id>M2018183</org_study_id>
    <nct_id>NCT03756207</nct_id>
  </id_info>
  <brief_title>Multidisciplinary Bladder-preservation Therapy for Bladder Cancer</brief_title>
  <official_title>Clinical Study on Efficacy and Safety of Multidisciplinary Bladder-preservation Therapy for Muscle-invasive Bladder Cancer in China</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University Third Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking University Third Hospital</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>
      A multidisciplinary approach has led to the development of bladder-preservation therapy using&#xD;
      maximal transurethral resection followed by radiotherapy with concomitant radio-sensitizing&#xD;
      chemotherapy for muscle-invasive bladder cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Multidisciplinary management improves complex treatment decision making in cancer care, but&#xD;
      its impact for bladder cancer has not been documented. Although radical cystectomy (RC) has&#xD;
      long been the standard of care for the management of muscle-invasive bladder cancer (MIBC), a&#xD;
      multidisciplinary approach has led to the development of bladder-preservation therapy using&#xD;
      maximal transurethral resection (TURBt) followed by radiotherapy with concomitant&#xD;
      radio-sensitizing chemotherapy for MIBC. There are no randomized-controlled data comparing&#xD;
      radical cystectomy with multidisciplinary bladder-preservation therapy (MBPT) available for&#xD;
      comparison. However, observational data continues to support the use of MBPT as an acceptable&#xD;
      alternative for patients with MIBC who wish to preserve their bladder or are not candidates&#xD;
      for cystectomy because it may result in equivalent disease outcomes in select patients and&#xD;
      offers the benefit of maintaining a functioning urinary system with subsequent improvements&#xD;
      in quality of life. But there are also lots of issues need to be studied, such as the patient&#xD;
      selection, approaches for completeness of TURBt, choices of radio-sensitizing chemotherapy,&#xD;
      accuracy of radiotherapy and so on. In this study, the investigators plan to prospectively&#xD;
      recruit 80 MIBC patients, who don't want to receive RC or are not candidates for RC, treated&#xD;
      with MBPT from Nov 2018 to Dec 2020 in Peking University Third Hospital. The investigators&#xD;
      will collect, compare and analyze their clinic-pathological data before and after MBPT, in&#xD;
      order to confirm the safety and efficacy of MBPT for MIBC in China. At the same time, the&#xD;
      investigators want to find out the patients who are not suitable for MBPT and the approach&#xD;
      which can improve the efficacy of MBPT, as a result, the investigators intend to make a&#xD;
      standard MBPT approach for Chinese MIBC patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 1, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>In this study, the investigators plan to prospectively recruit 80 muscle-invasive bladder cancer patients, who don't want to receive radical cystectomy or are not candidates for radical cystectomy, treated with multidisciplinary bladder-preservation therapy from Nov 2018 to Dec 2020 in Peking University Third Hospital.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Complete response rate</measure>
    <time_frame>6-8 weeks after chemoradiation</time_frame>
    <description>Response to MBPT depending on cystoscopy, TURBt, or urinary cytology</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Disease specific survival (DSS) time</measure>
    <time_frame>From date of treatment initiation until the date of death due to bladder cancer, assessed up to 60 months.</time_frame>
    <description>Events were defined as death attributable to bladder cancer. The time to DSS was the interval between treatment initiation and death due to bladder cancer, or the most recent follow-up if no event occurred.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall survival (OS) time</measure>
    <time_frame>From date of treatment initiation until the date of death due to any cause, assessed up to 60 months.</time_frame>
    <description>Events were defined as death due to any cause. The time to OS was the interval between treatment initiation and death, or the most recent follow-up if no event occurred.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life score 1</measure>
    <time_frame>6-8 weeks after chemoradiation</time_frame>
    <description>Assessed by EORTC Quality of life questionaire (QLQ)-30</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life score 2</measure>
    <time_frame>6-8 weeks after chemoradiation</time_frame>
    <description>Assessed by EORTC QLQ-Bladder Cancer 30</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Bladder Cancer</condition>
  <arm_group>
    <arm_group_label>Multidisciplinary Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Multidisciplinary bladder-preservation therapy: Maximal transurethral resection followed by radiotherapy with concomitant radio-sensitizing chemotherapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>multidisciplinary bladder-preservation therapy</intervention_name>
    <description>Maximal transurethral resection followed by radiotherapy with concomitant radio-sensitizing chemotherapy</description>
    <arm_group_label>Multidisciplinary Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Bladder urothelial carcinoma&#xD;
&#xD;
          2. Clinical stage: T2-T4, non-metastasis&#xD;
&#xD;
          3. Eastern Cooperative Oncology Group score (ECOG)≤ 1, Karnofsky performance score≥ 70&#xD;
&#xD;
          4. Patients don't want to receive RC or are not candidates for RC&#xD;
&#xD;
          5. Normal bladder function&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of abdominal and pelvic radiotherapy&#xD;
&#xD;
          2. History of other malignant tumor&#xD;
&#xD;
          3. Pregnant or lactating patients&#xD;
&#xD;
          4. Severe comorbidity: cardiac infarction, arrhythmia, heart failure, et al&#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_official>
    <last_name>Yi Huang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Urology, Peking University Third Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hai Bi, MD</last_name>
    <phone>+86-13488714943</phone>
    <email>pku-bihai@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Peking University Third Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100191</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hai Bi, MD</last_name>
      <phone>+86-13488714943</phone>
      <email>pku-bihai@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 15, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>November 26, 2018</last_update_submitted>
  <last_update_submitted_qc>November 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>multidisciplinary; bladder cancer; bladder-preservation</keyword>
  <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/NCT03756207
org study id: M2018183
nct id: NCT03756207
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
A multidisciplinary approach has led to the development of bladder-preservation therapy using
      maximal transurethral resection followed by radiotherapy with concomitant radio-sensitizing
      chemotherapy for muscle-invasive bladder cancer.
Multidisciplinary management improves complex treatment decision making in cancer care, but
      its impact for bladder cancer has not been documented. Although radical cystectomy (RC) has
      long been the standard of care for the management of muscle-invasive bladder cancer (MIBC), a
      multidisciplinary approach has led to the development of bladder-preservation therapy using
      maximal transurethral resection (TURBt) followed by radiotherapy with concomitant
      radio-sensitizing chemotherapy for MIBC. There are no randomized-controlled data comparing
      radical cystectomy with multidisciplinary bladder-preservation therapy (MBPT) available for
      comparison. However, observational data continues to support the use of MBPT as an acceptable
      alternative for patients with MIBC who wish to preserve their bladder or are not candidates
      for cystectomy because it may result in equivalent disease outcomes in select patients and
      offers the benefit of maintaining a functioning urinary system with subsequent improvements
      in quality of life. But there are also lots of issues need to be studied, such as the patient
      selection, approaches for completeness of TURBt, choices of radio-sensitizing chemotherapy,
      accuracy of radiotherapy and so on. In this study, the investigators plan to prospectively
      recruit 80 MIBC patients, who don't want to receive RC or are not candidates for RC, treated
      with MBPT from Nov 2018 to Dec 2020 in Peking University Third Hospital. The investigators
      will collect, compare and analyze their clinic-pathological data before and after MBPT, in
      order to confirm the safety and efficacy of MBPT for MIBC in China. At the same time, the
      investigators want to find out the patients who are not suitable for MBPT and the approach
      which can improve the efficacy of MBPT, as a result, the investigators intend to make a
      standard MBPT approach for Chinese MIBC patients.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: In this study, the investigators plan to prospectively recruit 80 muscle-invasive bladder cancer patients, who don't want to receive radical cystectomy or are not candidates for radical cystectomy, treated with multidisciplinary bladder-preservation therapy from Nov 2018 to Dec 2020 in Peking University Third Hospital.
primary purpose: Treatment
masking: None (Open Label)
measure: Complete response rate
time frame: 6-8 weeks after chemoradiation
description: Response to MBPT depending on cystoscopy, TURBt, or urinary cytology
measure: Disease specific survival (DSS) time
time frame: From date of treatment initiation until the date of death due to bladder cancer, assessed up to 60 months.
description: Events were defined as death attributable to bladder cancer. The time to DSS was the interval between treatment initiation and death due to bladder cancer, or the most recent follow-up if no event occurred.
measure: Overall survival (OS) time
time frame: From date of treatment initiation until the date of death due to any cause, assessed up to 60 months.
description: Events were defined as death due to any cause. The time to OS was the interval between treatment initiation and death, or the most recent follow-up if no event occurred.
measure: Quality of life score 1
time frame: 6-8 weeks after chemoradiation
description: Assessed by EORTC Quality of life questionaire (QLQ)-30
measure: Quality of life score 2
time frame: 6-8 weeks after chemoradiation
description: Assessed by EORTC QLQ-Bladder Cancer 30
arm group label: Multidisciplinary Therapy
arm group type: Experimental
description: Multidisciplinary bladder-preservation therapy: Maximal transurethral resection followed by radiotherapy with concomitant radio-sensitizing chemotherapy
intervention type: Procedure
intervention name: multidisciplinary bladder-preservation therapy
description: Maximal transurethral resection followed by radiotherapy with concomitant radio-sensitizing chemotherapy
arm group label: Multidisciplinary Therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Yi Huang, MD
role: Principal Investigator
affiliation: Department of Urology, Peking University Third Hospital
last name: Hai Bi, MD
phone: +86-13488714943
email: pku-bihai@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Urinary Bladder Neoplasms