<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/NCT01734798</url>
  </required_header>
  <id_info>
    <org_study_id>Bladder-02</org_study_id>
    <nct_id>NCT01734798</nct_id>
  </id_info>
  <brief_title>Adjuvant Post-radical Cystectomy Treatment for Bladder Cancer</brief_title>
  <official_title>Adjuvant Post-radical Cystectomy Treatment for Bladder Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Radical Cystectomy is still the standard treatment in muscle-invasive Bladder cancer. Local&#xD;
      recurrence is still the major cause of failure together with distant metastasis.&#xD;
      postoperative radiotherapy succeeded to decrease the local recurrence and hence improved the&#xD;
      overall survival. Adjuvant chemotherapy has also improved the survival in different studies.&#xD;
      This study is performed to test the efficacy and toxicity of adding the two modalities&#xD;
      together compared to each modality alone.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2002</start_date>
  <completion_date type="Actual">November 2012</completion_date>
  <primary_completion_date type="Actual">January 2008</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison of the disease-free survival and overall survival of post-operative radiotherapy , adjuvant chemotherapy and the combined modalities [radiotherapy and chemotherapy] after radical cystectomy</measure>
    <time_frame>Five-year overall and disease-free survival.</time_frame>
    <description>Regular follow up is performed every 2 months in the first 2 years postcystectomy and every 6 months thereafter. Periodical CT pelvis is performed every 6 months in the first 2 years and yearly thereafter. The other appropriate radiological studies are performed in response to patients' symptoms and signs. Treatment side effects (immediate and late) are reported in each follow up visit.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>comparison of the Local recurrence rate in the three Arms</measure>
    <time_frame>Five year local pelvic control rate</time_frame>
    <description>Periodical CT pelvis is performed every 6 months in the first 2 years and yearly thereafter. The other appropriate radiological studies are performed in response to patients' symptoms and signs. Treatment side effects (immediate and late) are reported in each follow up visit.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">198</enrollment>
  <condition>Locally Advanced Bladder Cancer</condition>
  <arm_group>
    <arm_group_label>Arm 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>post-operative radiotherapy will be done in locally advanced bladder cancer patients (P3b, P4a, G3 and / or LN positive patients) after radical cystectomy Dose of Radiotherapy: 45 Gray Gy/30 fractions/3 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>adjuvant chemotherapy (gemcitabine and cisplatin) in addition to post operative radiotherapy in locally advanced bladder cancer patients (P3b, P4a, G3 and / or LN positive patients) after radical cystectomy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Adjuvant chemotherapy alone in locally advanced bladder cancer patients (P3b, P4a, G3 and / or LN positive patients) after radical cystectomy</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Radiation</intervention_name>
    <arm_group_label>Arm 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>gemcitabine and cisplatin</intervention_name>
    <arm_group_label>Arm 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Radiotherapy and Drug</intervention_name>
    <arm_group_label>Arm 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients not more than 70 years old.&#xD;
&#xD;
          -  Radical cystectomy performed within 42 days with no microscopic or macroscopic&#xD;
             residual after surgery (negative surgical safety margins)&#xD;
&#xD;
          -  Having one or more of the risk factors ( P3b,P4a,G3 and /or positive LN)&#xD;
&#xD;
          -  ECOG Performance Scale (0-2).&#xD;
&#xD;
          -  Adequate liver functions.&#xD;
&#xD;
          -  Adequate renal function serum (creatinine &lt; 1.5 mg).&#xD;
&#xD;
          -  No evidence of distant metastasis or other malignancy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients who received radiotherapy or chemotherapy prior to radical cystectomy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>National cancer Institute-Cairo University</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 19, 2012</study_first_submitted>
  <study_first_submitted_qc>November 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2012</study_first_posted>
  <last_update_submitted>November 22, 2012</last_update_submitted>
  <last_update_submitted_qc>November 22, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 28, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Mohamed s. Zaghloul</investigator_full_name>
    <investigator_title>Professor of Radiation Oncology</investigator_title>
  </responsible_party>
  <keyword>locally advanced bladder cancer</keyword>
  <keyword>Postoperative radiotherapy</keyword>
  <keyword>Adjuvant chemotherapy</keyword>
  <keyword>Radical Cystectomy</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>Gemcitabine</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/NCT01734798
org study id: Bladder-02
nct id: NCT01734798
lead sponsor: 
has dmc: Yes
Radical Cystectomy is still the standard treatment in muscle-invasive Bladder cancer. Local
      recurrence is still the major cause of failure together with distant metastasis.
      postoperative radiotherapy succeeded to decrease the local recurrence and hence improved the
      overall survival. Adjuvant chemotherapy has also improved the survival in different studies.
      This study is performed to test the efficacy and toxicity of adding the two modalities
      together compared to each modality alone.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Comparison of the disease-free survival and overall survival of post-operative radiotherapy , adjuvant chemotherapy and the combined modalities [radiotherapy and chemotherapy] after radical cystectomy
time frame: Five-year overall and disease-free survival.
description: Regular follow up is performed every 2 months in the first 2 years postcystectomy and every 6 months thereafter. Periodical CT pelvis is performed every 6 months in the first 2 years and yearly thereafter. The other appropriate radiological studies are performed in response to patients' symptoms and signs. Treatment side effects (immediate and late) are reported in each follow up visit.
measure: comparison of the Local recurrence rate in the three Arms
time frame: Five year local pelvic control rate
description: Periodical CT pelvis is performed every 6 months in the first 2 years and yearly thereafter. The other appropriate radiological studies are performed in response to patients' symptoms and signs. Treatment side effects (immediate and late) are reported in each follow up visit.
arm group label: Arm 1
arm group type: Experimental
description: post-operative radiotherapy will be done in locally advanced bladder cancer patients (P3b, P4a, G3 and / or LN positive patients) after radical cystectomy Dose of Radiotherapy: 45 Gray Gy/30 fractions/3 weeks
arm group label: Arm 2
arm group type: Experimental
description: adjuvant chemotherapy (gemcitabine and cisplatin) in addition to post operative radiotherapy in locally advanced bladder cancer patients (P3b, P4a, G3 and / or LN positive patients) after radical cystectomy
arm group label: Arm 3
arm group type: Experimental
description: Adjuvant chemotherapy alone in locally advanced bladder cancer patients (P3b, P4a, G3 and / or LN positive patients) after radical cystectomy
intervention type: Radiation
intervention name: Radiation
arm group label: Arm 1
intervention type: Drug
intervention name: gemcitabine and cisplatin
arm group label: Arm 3
intervention type: Other
intervention name: Radiotherapy and Drug
arm group label: Arm 2
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Mohamed s. Zaghloul
investigator title: Professor of Radiation Oncology
mesh term: Urinary Bladder Neoplasms
mesh term: Gemcitabine