<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/NCT01697306</url>
  </required_header>
  <id_info>
    <org_study_id>CE 70/06</org_study_id>
    <nct_id>NCT01697306</nct_id>
  </id_info>
  <brief_title>The Impact of Intravesical Gemcitabine and 1/3 Dose Bacillus Calmette-Guerin on the Quality of Life in Superficial Bladder Cancer</brief_title>
  <official_title>The Impact of Intravesical Gemcitabine and 1/3 Dose Bacillus-Calmette Guerin (BCG) Instillation Therapy on the Quality of Life in Non-muscle-invasive Bladder Cancer (NMIBC) Patients: Results of a Prospective, Randomised Phase II Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Azienda Ospedaliera San Giovanni Battista</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Turin, Italy</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Universitätsklinikum Hamburg-Eppendorf</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Eastern Piedmont</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Azienda Ospedaliera San Giovanni Battista</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To our knowledge, there are no comparative studies on bacillus Calmette-Guerin (BCG) and&#xD;
      intravesical chemotherapy addressing quality of life (QoL) issues. The aim of this study was&#xD;
      to prospectively evaluate and compare the QoL of intermediate-risk non-muscle-invasive&#xD;
      (NMIBC) patients treated with BCG or gemcitabine.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Intravesical Bacillus Calmette-Guérin (BCG) is considered the most effective agent for&#xD;
      non-muscle-invasive bladder cancer (NMIBC), representing the first-line option in the&#xD;
      management of carcinoma in situ (CIS) and high-risk disease. In intermediate-risk NMIBC,&#xD;
      however, both BCG and intravesical chemotherapy are accepted alternative adjuvant options&#xD;
      since the superiority of BCG has been only established for disease recurrence but not&#xD;
      progression and it needs to be balanced against higher toxicity. According to current&#xD;
      evidence, BCG is considered less tolerable than intravesical chemotherapy such as mitomycin-C&#xD;
      or doxorubicin, based on reported side effects. Among chemotherapeutic agents, gemcitabine&#xD;
      has an excellent toxicity profile and promising efficacy in NMIBC patients, including those&#xD;
      at high-risk of disease recurrence, even if its role on the management of NMIBC has not been&#xD;
      well-defined yet. To our knowledge, there are no comparative studies on BCG and intravesical&#xD;
      chemotherapy addressing quality of life (QoL) issues. The aim of this study was to&#xD;
      prospectively evaluate and compare the QoL of intermediate-risk NMIBC patients treated with&#xD;
      BCG or gemcitabine.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2006</start_date>
  <completion_date type="Actual">May 2012</completion_date>
  <primary_completion_date type="Actual">March 2011</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>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>quality of life of intermediate-risk NMIBC patients treated with intravesical Gemcitabine chemotherapy or BCG</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>comparison of the short term efficacy of the two treatments in terms of recurrence</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>comparison of the short term efficacy of the two treatments in terms of progression</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Bladder Cancer</condition>
  <arm_group>
    <arm_group_label>Gemcitabine-arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>7-15 days after TUR patients received six weekly instillations of gemcitabine (Gemzar, Eli Lilly SpA), 2.000 mg diluted in 50 cc of saline. Maintenance consisted in monthly instillations up to 1 year</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BCG-arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>7-15 days after TUR patients received an induction cycle of six weekly instillations of Connaught strain Bacillus Calmette-Guerin (BCG Immucyst) 1/3 dose (27 mg) diluted in 50 cc of saline. Maintenance consisted of 3 weekly instillations at 3, 6 and 12 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gemcitabine 2 g</intervention_name>
    <description>six weekly instillations of gemcitabine (Gemzar, Eli Lilly SpA), 2.000 mg diluted in 50 cc of saline</description>
    <arm_group_label>Gemcitabine-arm</arm_group_label>
    <other_name>Gemzar, Eli Lilly SpA</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BCG Vaccine</intervention_name>
    <description>six weekly instillations of Connaught strain BCG (Immucyst) 1/3 dose (27 mg) diluted in 50 cc of saline</description>
    <arm_group_label>BCG-arm</arm_group_label>
    <other_name>BCG Connaught 1/3 dose</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with clinical evidence of intermediate-risk non-muscle invasive bladder&#xD;
             cancer (namely Ta-1, G1-2, multifocal or unique and recurrent, &gt;3 cm in diameter)&#xD;
&#xD;
          -  WHO performance status ≤2&#xD;
&#xD;
          -  age ≤85years&#xD;
&#xD;
          -  BCG naive&#xD;
&#xD;
          -  patients not treated with intravesical chemotherapy in the last 3 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  presence of T1G3 or CIS&#xD;
&#xD;
          -  preoperative urinary cytology positive for high-grade atypia&#xD;
&#xD;
          -  inadequate bone marrow reserve (white blood cells &lt;3 x 109/l, platelets &lt;100 x 109/l)&#xD;
&#xD;
          -  history of genito-urinary tuberculosis&#xD;
&#xD;
          -  presence of uncontrolled urinary infections.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Paolo Gontero, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>A.O.U. San Giovanni Battista Molinette</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>A.O.U. San Giovanni Battista Molinette</name>
      <address>
        <city>Torino</city>
        <state>TO</state>
        <zip>10126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>Martinez-Pineiro JA, Martinez-Pineiro L, Solsona E, Rodriguez RH, Gomez JM, Martin MG, Molina JR, Collado AG, Flores N, Isorna S, Pertusa C, Rabadan M, Astobieta A, Camacho JE, Arribas S, Madero R; Club Urologico Espanol de Tratamiento Oncologico (CUETO). Has a 3-fold decreased dose of bacillus Calmette-Guerin the same efficacy against recurrences and progression of T1G3 and Tis bladder tumors than the standard dose? Results of a prospective randomized trial. J Urol. 2005 Oct;174(4 Pt 1):1242-7. doi: 10.1097/01.ju.0000173919.28835.aa.</citation>
    <PMID>16145378</PMID>
  </reference>
  <reference>
    <citation>Porena M, Del Zingaro M, Lazzeri M, Mearini L, Giannantoni A, Bini V, Costantini E. Bacillus Calmette-Guerin versus gemcitabine for intravesical therapy in high-risk superficial bladder cancer: a randomised prospective study. Urol Int. 2010;84(1):23-7. doi: 10.1159/000273461. Epub 2010 Feb 17.</citation>
    <PMID>20173364</PMID>
  </reference>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 21, 2012</study_first_submitted>
  <study_first_submitted_qc>September 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <last_update_submitted>September 27, 2012</last_update_submitted>
  <last_update_submitted_qc>September 27, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 2, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Azienda Ospedaliera San Giovanni Battista</investigator_affiliation>
    <investigator_full_name>Marco Oderda</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>non muscle invasive bladder cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Bladder Neoplasms</mesh_term>
    <mesh_term>Non-Muscle Invasive Bladder Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gemcitabine</mesh_term>
    <mesh_term>BCG Vaccine</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/NCT01697306
org study id: CE 70/06
nct id: NCT01697306
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
To our knowledge, there are no comparative studies on bacillus Calmette-Guerin (BCG) and
      intravesical chemotherapy addressing quality of life (QoL) issues. The aim of this study was
      to prospectively evaluate and compare the QoL of intermediate-risk non-muscle-invasive
      (NMIBC) patients treated with BCG or gemcitabine.
Intravesical Bacillus Calmette-Guérin (BCG) is considered the most effective agent for
      non-muscle-invasive bladder cancer (NMIBC), representing the first-line option in the
      management of carcinoma in situ (CIS) and high-risk disease. In intermediate-risk NMIBC,
      however, both BCG and intravesical chemotherapy are accepted alternative adjuvant options
      since the superiority of BCG has been only established for disease recurrence but not
      progression and it needs to be balanced against higher toxicity. According to current
      evidence, BCG is considered less tolerable than intravesical chemotherapy such as mitomycin-C
      or doxorubicin, based on reported side effects. Among chemotherapeutic agents, gemcitabine
      has an excellent toxicity profile and promising efficacy in NMIBC patients, including those
      at high-risk of disease recurrence, even if its role on the management of NMIBC has not been
      well-defined yet. To our knowledge, there are no comparative studies on BCG and intravesical
      chemotherapy addressing quality of life (QoL) issues. The aim of this study was to
      prospectively evaluate and compare the QoL of intermediate-risk NMIBC patients treated with
      BCG or gemcitabine.
allocation: Randomized
intervention model: Parallel Assignment
masking: None (Open Label)
measure: quality of life of intermediate-risk NMIBC patients treated with intravesical Gemcitabine chemotherapy or BCG
time frame: 1 year
measure: comparison of the short term efficacy of the two treatments in terms of recurrence
time frame: 1 year
measure: comparison of the short term efficacy of the two treatments in terms of progression
time frame: 1 year
arm group label: Gemcitabine-arm
arm group type: Active Comparator
description: 7-15 days after TUR patients received six weekly instillations of gemcitabine (Gemzar, Eli Lilly SpA), 2.000 mg diluted in 50 cc of saline. Maintenance consisted in monthly instillations up to 1 year
arm group label: BCG-arm
arm group type: Active Comparator
description: 7-15 days after TUR patients received an induction cycle of six weekly instillations of Connaught strain Bacillus Calmette-Guerin (BCG Immucyst) 1/3 dose (27 mg) diluted in 50 cc of saline. Maintenance consisted of 3 weekly instillations at 3, 6 and 12 months
intervention type: Drug
intervention name: Gemcitabine 2 g
description: six weekly instillations of gemcitabine (Gemzar, Eli Lilly SpA), 2.000 mg diluted in 50 cc of saline
arm group label: Gemcitabine-arm
other name: Gemzar, Eli Lilly SpA
intervention type: Drug
intervention name: BCG Vaccine
description: six weekly instillations of Connaught strain BCG (Immucyst) 1/3 dose (27 mg) diluted in 50 cc of saline
arm group label: BCG-arm
other name: BCG Connaught 1/3 dose
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Paolo Gontero, Professor
role: Principal Investigator
affiliation: A.O.U. San Giovanni Battista Molinette
facility: 
country: Italy
citation: Martinez-Pineiro JA, Martinez-Pineiro L, Solsona E, Rodriguez RH, Gomez JM, Martin MG, Molina JR, Collado AG, Flores N, Isorna S, Pertusa C, Rabadan M, Astobieta A, Camacho JE, Arribas S, Madero R; Club Urologico Espanol de Tratamiento Oncologico (CUETO). Has a 3-fold decreased dose of bacillus Calmette-Guerin the same efficacy against recurrences and progression of T1G3 and Tis bladder tumors than the standard dose? Results of a prospective randomized trial. J Urol. 2005 Oct;174(4 Pt 1):1242-7. doi: 10.1097/01.ju.0000173919.28835.aa.
PMID: 16145378
citation: Porena M, Del Zingaro M, Lazzeri M, Mearini L, Giannantoni A, Bini V, Costantini E. Bacillus Calmette-Guerin versus gemcitabine for intravesical therapy in high-risk superficial bladder cancer: a randomised prospective study. Urol Int. 2010;84(1):23-7. doi: 10.1159/000273461. Epub 2010 Feb 17.
PMID: 20173364
responsible party type: Principal Investigator
investigator affiliation: Azienda Ospedaliera San Giovanni Battista
investigator full name: Marco Oderda
investigator title: MD
mesh term: Urinary Bladder Neoplasms
mesh term: Non-Muscle Invasive Bladder Neoplasms
mesh term: Gemcitabine
mesh term: BCG Vaccine