<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/NCT02197897</url>
  </required_header>
  <id_info>
    <org_study_id>H-25233</org_study_id>
    <secondary_id>K23CA160664</secondary_id>
    <nct_id>NCT02197897</nct_id>
  </id_info>
  <brief_title>Evaluation the Treatment of Tamoxifen of Low/Intermediate Risk Bladder Tumors</brief_title>
  <acronym>BCTamoxifen</acronym>
  <official_title>Phase II Trial of Estrogen Receptor Targeted Treatment of Non-Muscle Invasive Bladder Cancer With Tamoxifen.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Baylor College of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Baylor College of Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluate the treatment of tamoxifen of low/intermediate-risk bladder tumors&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with primary or recurrent low/intermediate-risk papillary urothelial carcinoma of&#xD;
      the bladder will undergo resection of all but one marker lesion, measuring at least 6mm but&#xD;
      no greater than 10mm, and biopsy of normal-appearing mucosa. Patients with a solitary tumor&#xD;
      will undergo only biopsy prior to treatment. A 2mm cold cup biopsy of the marker lesion will&#xD;
      always be performed to rule out a potential high-grade lesion and for assessment of&#xD;
      pretreatment immunohistochemistry expression levels of ERα, ERβ1, Ki-67 (proliferation&#xD;
      marker) and TUNEL (apoptosis marker). If there are multiple tumors, all lesions, except the&#xD;
      marker lesion will be resected and sent for analysis. These patients will not receive single&#xD;
      immediate post-operative intravesical instillation of mitomycin-C. They will then undergo a&#xD;
      12-week course of treatment with tamoxifen administered as a single daily oral dose of 20mg.&#xD;
      At the completion of therapy, patients will undergo resection of the marker lesion (or biopsy&#xD;
      of the tumor bed, if a complete response is observed) and biopsy of normal-appearing bladder&#xD;
      mucosa again. Toxicity evaluations will be performed at the beginning (day 3), midway (week&#xD;
      6), and at completion of treatment (week 12), prior to resection of the marker lesion. A&#xD;
      final assessment for toxicity will also be performed 30 days after completion of therapy as&#xD;
      well as a second definitive resection of the marker lesion. Urine samples will be obtained&#xD;
      with the index tumor in place (marker lesion), and after completion of treatment, at the time&#xD;
      of definitive transurethral resection of the index tumor, as part of the standard clinical&#xD;
      care of these patients, and at the discretion of the surgeon for assessment of urinary&#xD;
      cytology. The urine samples will not be utilized for the research study. All normal-appearing&#xD;
      bladder biopsies (pre and post-treatment), the additional tumors (in case of multiple&#xD;
      lesions), and the definitive resection of the marker lesion (in the absence of response to&#xD;
      therapy) will provide sufficient material for immunohistochemistry assessment of the&#xD;
      expression levels of ERα, ERβ-1, ERβ-2, ERβ-5, Ki-67, and TUNEL, and also for RT-qPCR for&#xD;
      mRNA analyses of ERα, ERβ-1, ERβ-2, and ERβ-5. The pretreatment biopsy of the marker lesion&#xD;
      will be performed with a smaller biopsy forceps and will provide limited material, sufficient&#xD;
      only for immunohistochemistry assessment of the expression levels of ERα, ERβ-1, Ki-67, and&#xD;
      TUNEL.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2015</start_date>
  <completion_date type="Actual">June 28, 2019</completion_date>
  <primary_completion_date type="Actual">September 12, 2017</primary_completion_date>
  <phase>Phase 2</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluate the Efficacy for Treatment of Low/Intermediate- Risk Bladder Tumors, Assessing for the Clinical Response of the Marker Lesion</measure>
    <time_frame>2.5 years</time_frame>
    <description>Evaluate the efficacy of tamoxifen for treatment of low/intermediate-risk bladder tumors, utilizing the RECIST criteria combined with the final biopsy of the marker lesion or the bed of the lesion in case of a complete response</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Bladder Cancer</condition>
  <arm_group>
    <arm_group_label>Tamoxifen</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>As a single-arm study (single group assignment), Tamoxifen citrate will be given to all patients at a 20mg/day dose for 12 weeks using a marker-lesion study design.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tamoxifen Citrate</intervention_name>
    <description>Single-center, two-stage phase-II clinical trial (Simon design)</description>
    <arm_group_label>Tamoxifen</arm_group_label>
    <other_name>Nolvadex</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Males and females age 21 or older. Histologic evidence of urothelial carcinoma of the&#xD;
        bladder. Low/Intermediate-risk papillary urothelial carcinoma of the bladder, at initial&#xD;
        occurrence or recurrent with &gt;6 months interval free of disease.&#xD;
&#xD;
        Patients with multifocal tumors must have resectable lesions. Patients may be&#xD;
        treatment-naïve or have failed 1 previous regimen of intravesical therapy.&#xD;
&#xD;
        At least one endoscopically measurable tumor 6 - 10mm in diameter. Adequate hepatic and&#xD;
        renal function. Patient or authorized proxy needs to have signed the informed consent form.&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients with sessile appearing tumors, which may be invasive or high-grade. Diagnosis of&#xD;
        urothelial carcinoma involving the prostatic urethra or upper urinary tract.&#xD;
&#xD;
        Plans for pelvic radiation while participating in the study. Concurrent use of warfarin,&#xD;
        heparin, or chronic use of NSAIDs, including aspirin (other than cardioprotective doses of&#xD;
        80mg daily) within 30 days prior to registration or during the trial.&#xD;
&#xD;
        Concurrent use of selective serotonin reuptake inhibitors or aromatase inhibitors.&#xD;
&#xD;
        Chronic or acute renal or hepatic disorder or any other condition, medical or psychological&#xD;
        that, in the opinion of the investigator, could jeopardize the subject's safe&#xD;
        participation.&#xD;
&#xD;
        Any other investigational drug within 30 days prior to registration and during the study.&#xD;
&#xD;
        Women Exclusion Pregnant or lactating women. Personal history of endometrial cancer or any&#xD;
        abnormal uterine bleeding. Previous or concurrent treatment with SERM and/or hormonal&#xD;
        replacement therapy within 3 months of the study.&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Guilherme Godoy, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Baylor College of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Baylor College of Medicine</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Harris Health System</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>July 21, 2014</study_first_submitted>
  <study_first_submitted_qc>July 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 23, 2014</study_first_posted>
  <results_first_submitted>July 21, 2020</results_first_submitted>
  <results_first_submitted_qc>December 18, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">January 13, 2021</results_first_posted>
  <last_update_submitted>December 18, 2020</last_update_submitted>
  <last_update_submitted_qc>December 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Baylor College of Medicine</investigator_affiliation>
    <investigator_full_name>Guilherme Godoy</investigator_full_name>
    <investigator_title>Guilherme Godoy, M.D.</investigator_title>
  </responsible_party>
  <keyword>Tamoxifen citrate</keyword>
  <keyword>Bladder Cancer</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>Tamoxifen</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 16, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/97/NCT02197897/ICF_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 18, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/97/NCT02197897/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Subjects will be identified from the Scott Department of Urology (SDU) and Affiliated Institutions.Patients will be informed verbally and in writing about the study, procedures involved. They will be given adequate opportunity to read it and discuss with family before it is signed. Participation in this study will last about 4 months.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Tamoxifen</title>
          <description>As a single-arm study (single group assignment), Tamoxifen citrate will be given to all patients at a 20mg/day dose for 12 weeks using a marker-lesion study design.&#xD;
Tamoxifen Citrate: Single-center, two-stage phase-II clinical trial (Simon design)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>not eligible</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Tamoxifen</title>
          <description>As a single-arm study (single group assignment), Tamoxifen citrate will be given to all patients at a 20mg/day dose for 12 weeks using a marker-lesion study design.&#xD;
Tamoxifen Citrate: Single-center, two-stage phase-II clinical trial (Simon design)</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="13"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Race Ethinicity</title>
              <category_list>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Evaluate the Efficacy for Treatment of Low/Intermediate- Risk Bladder Tumors, Assessing for the Clinical Response of the Marker Lesion</title>
        <description>Evaluate the efficacy of tamoxifen for treatment of low/intermediate-risk bladder tumors, utilizing the RECIST criteria combined with the final biopsy of the marker lesion or the bed of the lesion in case of a complete response</description>
        <time_frame>2.5 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Tamoxifen</title>
            <description>As a single-arm study (single group assignment), Tamoxifen citrate will be given to all patients at a 20mg/day dose for 12 weeks using a marker-lesion study design.&#xD;
Tamoxifen Citrate: Single-center, two-stage phase-II clinical trial (Simon design)</description>
          </group>
        </group_list>
        <measure>
          <title>Evaluate the Efficacy for Treatment of Low/Intermediate- Risk Bladder Tumors, Assessing for the Clinical Response of the Marker Lesion</title>
          <description>Evaluate the efficacy of tamoxifen for treatment of low/intermediate-risk bladder tumors, utilizing the RECIST criteria combined with the final biopsy of the marker lesion or the bed of the lesion in case of a complete response</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Clinical toxicity evaluations (secondary aim 1d) were performed at the beginning (postoperative day 3), midway (postoperative week 6), and at completion of treatment (postoperative week 12), prior to the final resection of the marker lesion. A final assessment for toxicity was also performed 30 days after completion of therapy and definitive resection of the marker lesion.</time_frame>
      <desc>Toxicity events were recorded utilizing the Common Terminology Criteria for Adverse Events version 4.02 (CTCAE v4.02). Figure 1 illustrates the study linear chronogram schema.</desc>
      <group_list>
        <group group_id="E1">
          <title>Tamoxifen</title>
          <description>As a single-arm study (single group assignment), Tamoxifen citrate will be given to all patients at a 20mg/day dose for 12 weeks using a marker-lesion study design.&#xD;
Tamoxifen Citrate: Single-center, two-stage phase-II clinical trial (Simon design)</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Hematuria</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Platelet Count decreased</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Blood Bilirubin Increase</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>creatinine increase</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Lymphocyte Count decrease</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Hypocalcemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Hyperkalemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Hypoalbuminemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Hypomagnesemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Hyponatremia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Thromboembolic event</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Sinus Bradycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Sinus Tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Non Cardiac Chest Pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Eye Disorders</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Urinary Tract Pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Edema limbs</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Erectile Dysfunction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Dyspenia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pain in Extremity</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Flank Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Urinary Frequency</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash Maculo- Papular</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Guilherme Godoy</name_or_title>
      <organization>Baylor College of Medicine</organization>
      <phone>713-798-4001</phone>
      <email>godoy@bcm.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02197897
org study id: H-25233
secondary id: K23CA160664
nct id: NCT02197897
lead sponsor: 
collaborator: 
has dmc: Yes
Evaluate the treatment of tamoxifen of low/intermediate-risk bladder tumors
Patients with primary or recurrent low/intermediate-risk papillary urothelial carcinoma of
      the bladder will undergo resection of all but one marker lesion, measuring at least 6mm but
      no greater than 10mm, and biopsy of normal-appearing mucosa. Patients with a solitary tumor
      will undergo only biopsy prior to treatment. A 2mm cold cup biopsy of the marker lesion will
      always be performed to rule out a potential high-grade lesion and for assessment of
      pretreatment immunohistochemistry expression levels of ERα, ERβ1, Ki-67 (proliferation
      marker) and TUNEL (apoptosis marker). If there are multiple tumors, all lesions, except the
      marker lesion will be resected and sent for analysis. These patients will not receive single
      immediate post-operative intravesical instillation of mitomycin-C. They will then undergo a
      12-week course of treatment with tamoxifen administered as a single daily oral dose of 20mg.
      At the completion of therapy, patients will undergo resection of the marker lesion (or biopsy
      of the tumor bed, if a complete response is observed) and biopsy of normal-appearing bladder
      mucosa again. Toxicity evaluations will be performed at the beginning (day 3), midway (week
      6), and at completion of treatment (week 12), prior to resection of the marker lesion. A
      final assessment for toxicity will also be performed 30 days after completion of therapy as
      well as a second definitive resection of the marker lesion. Urine samples will be obtained
      with the index tumor in place (marker lesion), and after completion of treatment, at the time
      of definitive transurethral resection of the index tumor, as part of the standard clinical
      care of these patients, and at the discretion of the surgeon for assessment of urinary
      cytology. The urine samples will not be utilized for the research study. All normal-appearing
      bladder biopsies (pre and post-treatment), the additional tumors (in case of multiple
      lesions), and the definitive resection of the marker lesion (in the absence of response to
      therapy) will provide sufficient material for immunohistochemistry assessment of the
      expression levels of ERα, ERβ-1, ERβ-2, ERβ-5, Ki-67, and TUNEL, and also for RT-qPCR for
      mRNA analyses of ERα, ERβ-1, ERβ-2, and ERβ-5. The pretreatment biopsy of the marker lesion
      will be performed with a smaller biopsy forceps and will provide limited material, sufficient
      only for immunohistochemistry assessment of the expression levels of ERα, ERβ-1, Ki-67, and
      TUNEL.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Evaluate the Efficacy for Treatment of Low/Intermediate- Risk Bladder Tumors, Assessing for the Clinical Response of the Marker Lesion
time frame: 2.5 years
description: Evaluate the efficacy of tamoxifen for treatment of low/intermediate-risk bladder tumors, utilizing the RECIST criteria combined with the final biopsy of the marker lesion or the bed of the lesion in case of a complete response
arm group label: Tamoxifen
arm group type: Experimental
description: As a single-arm study (single group assignment), Tamoxifen citrate will be given to all patients at a 20mg/day dose for 12 weeks using a marker-lesion study design.
intervention type: Drug
intervention name: Tamoxifen Citrate
description: Single-center, two-stage phase-II clinical trial (Simon design)
arm group label: Tamoxifen
other name: Nolvadex
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Guilherme Godoy, M.D.
role: Principal Investigator
affiliation: Baylor College of Medicine
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Baylor College of Medicine
investigator full name: Guilherme Godoy
investigator title: Guilherme Godoy, M.D.
mesh term: Urinary Bladder Neoplasms
mesh term: Tamoxifen
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 