<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/NCT01675219</url>
  </required_header>
  <id_info>
    <org_study_id>FinnBladder 9</org_study_id>
    <secondary_id>2012-000559-15</secondary_id>
    <nct_id>NCT01675219</nct_id>
  </id_info>
  <brief_title>Fluorescence Cystoscopy and Optimized MMC in Recurrent Bladder Cancer (FinnBladder 9)</brief_title>
  <official_title>Treatment of Ta Bladder Cancer in High Risk of Recurrence - Fluorescence Cystoscopy With Optimized Adjuvant Mitomycin-C (FinnBladder 9)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Turku University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Finnbladder</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Turku University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Bladder cancer (BC), the second most common urological malignancy, is an important public&#xD;
      health issue. One of the main challenges in the treatment of bladder cancer if the prevention&#xD;
      of recurrences of non-invasive tumors, which is also associated with significant costs.&#xD;
&#xD;
      The current study will investigate optimal treatment of patients with bladder cancer with&#xD;
      high risk of tumor recurrence but low risk of progression. The main interest is comparison of&#xD;
      photodynamic (PDD) bladder tumor resection (TUR-BR)to traditional TUR-BT. Also the efficacy&#xD;
      of adjuvant optimized mitomycin-C is compared to patients with no adjuvant treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Anticipated">August 2023</completion_date>
  <primary_completion_date type="Actual">December 2021</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>bladder cancer recurrence rate</measure>
    <time_frame>2 years</time_frame>
    <description>any bladder cancer recurrence at 2 years.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Bladder cancer progression</measure>
    <time_frame>2 years</time_frame>
    <description>bladder cancer progression to T2 or higher</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment failure</measure>
    <time_frame>2 years</time_frame>
    <description>progression, recurrence or side effects preventing completing the trial</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mortality</measure>
    <time_frame>2 years</time_frame>
    <description>death due bladder cancer or other reasons</description>
  </secondary_outcome>
  <other_outcome>
    <measure>costs</measure>
    <time_frame>2 years</time_frame>
    <description>For analysis of cost-effectiveness. All bladder cancer treatment and treatment complications related costs are included.</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Bladder Cancer</condition>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Blue light TUR-BT with no adjuvant instillations</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>White light TUR-BT with no adjuvant instillations</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>White light TUR-BT with six weekly optimized mitomycin-C instillations.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group D</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Blue light (PDD) TUR-BT with six weekly optimized mitomycin-C instillations.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>white light TUR-BT</intervention_name>
    <description>traditional transurethral bladder tumor resection</description>
    <arm_group_label>Group A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>blue light TUR-BT</intervention_name>
    <description>photodynamic transurethral bladder tumor resection</description>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_label>Group D</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>optimized MMC</intervention_name>
    <description>six weekly optimized mitomycin-C instillations</description>
    <arm_group_label>Group C</arm_group_label>
    <arm_group_label>Group D</arm_group_label>
    <other_name>optimized mitomycin-C</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>single immediate chemotherapy instillation</intervention_name>
    <description>single immediate post TUR-BT epirubicin (2mg/ml, total of 100 ml) instillation</description>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_label>Group C</arm_group_label>
    <arm_group_label>Group D</arm_group_label>
    <other_name>single instillation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Primary papillary bladder cancer at high risk for further recurrence as defined as&#xD;
        follows:&#xD;
&#xD;
        Number of primary tumors ≥2, OR Size of solitary primary tumor ≥ 3 cm, OR Recurrent&#xD;
        papillary tumors&#xD;
&#xD;
          -  Histologically proven Ta bladder cancer&#xD;
&#xD;
          -  Histological grade 1-2 (WHO 1973 grading system) or papillary urothelial neoplasm of&#xD;
             low malignant potential (PUNLMP) or low grade (WHO 2004 grading system) bladder cancer&#xD;
&#xD;
          -  Written informed consent is required from every eligible patient&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Grade 3 tumors (WHO 1973 grading system), or high grade tumors (WHO 2004 grading&#xD;
             system)&#xD;
&#xD;
          -  CIS (carcinoma in situ)&#xD;
&#xD;
          -  Suspicion or evidence of papillary tumors or CIS of the upper urinary tract&#xD;
&#xD;
          -  Non-TCC (transitional cell carcinoma, i.e. urothelial carcinoma) bladder cancer&#xD;
&#xD;
          -  Suspicion or previous history of the patient not tolerating intravesical instillations&#xD;
&#xD;
          -  Known allergy to MMC or hexaminolevulinate (HAL, Hexvix®)&#xD;
&#xD;
          -  Urethral stricture, stone disease, chronic urinary tract infection or any other&#xD;
             urological condition that may compromise study participation (as judged by treating&#xD;
             physician)&#xD;
&#xD;
          -  Pregnancy or lactating patient&#xD;
&#xD;
          -  Other non-cured malignancy (excepting skin basalioma or cancer in situ of the cervix&#xD;
             uteri or any other malignancy in remission ≥5 years)&#xD;
&#xD;
          -  Age &lt; 18 years&#xD;
&#xD;
          -  Expected survival time less than one year&#xD;
&#xD;
          -  Expected poor compliance (e.g. some severe psychiatric disorders, antisocial&#xD;
             behaviour, or dementia)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter J. Boström, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Turku University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Eero Kaasinen, Md, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Hyvinkää District Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>HYKS Peijas Hospital</name>
      <address>
        <city>Helsinki</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hyvinkää District Hospital</name>
      <address>
        <city>Hyvinkää</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kuopio University Hospital</name>
      <address>
        <city>Kuopio</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mikkeli Central Hospital</name>
      <address>
        <city>Mikkeli</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oulu University Hospital</name>
      <address>
        <city>Oulu</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Satakunnan keskussairaala</name>
      <address>
        <city>Pori</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seinäjoki Central Hospital</name>
      <address>
        <city>Seinäjoki</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hatanpään sairaala</name>
      <address>
        <city>Tampere</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tampere University Hospital</name>
      <address>
        <city>Tampere</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Turku University Hospital</name>
      <address>
        <city>Turku</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>August 25, 2012</study_first_submitted>
  <study_first_submitted_qc>August 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2012</study_first_posted>
  <last_update_submitted>April 11, 2023</last_update_submitted>
  <last_update_submitted_qc>April 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Turku University Hospital</investigator_affiliation>
    <investigator_full_name>Peter Boström</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>bladder cancer</keyword>
  <keyword>recurrence</keyword>
  <keyword>photodynamic diagnosis</keyword>
  <keyword>PDD</keyword>
  <keyword>cost analysis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Bladder Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mitomycins</mesh_term>
    <mesh_term>Mitomycin</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/NCT01675219
org study id: FinnBladder 9
secondary id: 2012-000559-15
nct id: NCT01675219
lead sponsor: 
collaborator: 
has dmc: Yes
Bladder cancer (BC), the second most common urological malignancy, is an important public
      health issue. One of the main challenges in the treatment of bladder cancer if the prevention
      of recurrences of non-invasive tumors, which is also associated with significant costs.

      The current study will investigate optimal treatment of patients with bladder cancer with
      high risk of tumor recurrence but low risk of progression. The main interest is comparison of
      photodynamic (PDD) bladder tumor resection (TUR-BR)to traditional TUR-BT. Also the efficacy
      of adjuvant optimized mitomycin-C is compared to patients with no adjuvant treatment.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: bladder cancer recurrence rate
time frame: 2 years
description: any bladder cancer recurrence at 2 years.
measure: Bladder cancer progression
time frame: 2 years
description: bladder cancer progression to T2 or higher
measure: Treatment failure
time frame: 2 years
description: progression, recurrence or side effects preventing completing the trial
measure: mortality
time frame: 2 years
description: death due bladder cancer or other reasons
measure: costs
time frame: 2 years
description: For analysis of cost-effectiveness. All bladder cancer treatment and treatment complications related costs are included.
arm group label: Group B
arm group type: Experimental
description: Blue light TUR-BT with no adjuvant instillations
arm group label: Group A
arm group type: Active Comparator
description: White light TUR-BT with no adjuvant instillations
arm group label: Group C
arm group type: Experimental
description: White light TUR-BT with six weekly optimized mitomycin-C instillations.
arm group label: Group D
arm group type: Experimental
description: Blue light (PDD) TUR-BT with six weekly optimized mitomycin-C instillations.
intervention type: Procedure
intervention name: white light TUR-BT
description: traditional transurethral bladder tumor resection
arm group label: Group A
intervention type: Procedure
intervention name: blue light TUR-BT
description: photodynamic transurethral bladder tumor resection
arm group label: Group B
arm group label: Group D
intervention type: Drug
intervention name: optimized MMC
description: six weekly optimized mitomycin-C instillations
arm group label: Group C
arm group label: Group D
other name: optimized mitomycin-C
intervention type: Drug
intervention name: single immediate chemotherapy instillation
description: single immediate post TUR-BT epirubicin (2mg/ml, total of 100 ml) instillation
arm group label: Group A
arm group label: Group B
arm group label: Group C
arm group label: Group D
other name: single instillation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Peter J. Boström, MD, PhD
role: Principal Investigator
affiliation: Turku University Hospital
last name: Eero Kaasinen, Md, PhD
role: Study Director
affiliation: Hyvinkää District Hospital
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Finland
responsible party type: Principal Investigator
investigator affiliation: Turku University Hospital
investigator full name: Peter Boström
investigator title: MD, PhD
mesh term: Urinary Bladder Neoplasms
mesh term: Mitomycins
mesh term: Mitomycin