<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/NCT03274284</url>
  </required_header>
  <id_info>
    <org_study_id>Bl Cancer</org_study_id>
    <nct_id>NCT03274284</nct_id>
  </id_info>
  <brief_title>Chemoradiotherapy for Recurrent T1G3 Bladder Cancer</brief_title>
  <official_title>Chemoradiotherapy for Recurrent T1G3 Bladder Cancer After BCG Failure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>No</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>
      To evaluate the short term results of chemoradiation in case of T1G3 BC after BCG failure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Non- muscle invasive bladder cancer (NMIBC) is a heterogeneous group of cancers. For most&#xD;
      urologists the treatment of T1G3 tumor poses a dilemma of management.The spectrum of clinical&#xD;
      behavior includes; T1 lesions that will not progress however T1G3 may be potentially lethal,&#xD;
      associated with metastatic disease at the time of presentation.&#xD;
&#xD;
      The major goal of treatment for T1G3 BC should be bladder preservation whenever possible.&#xD;
&#xD;
      Intravesical therapy with Bacille Calmette Guerin (BCG) may decrease the recurrence rate by&#xD;
      compared with transurethral resection of bladder tumor (TURBT) alone.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 2017</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">November 2019</primary_completion_date>
  <phase>Phase 4</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>Result of chemoradiation for recurrentT1G3 BC after BCG failure</measure>
    <time_frame>followup within two years</time_frame>
    <description>treatment of 20 patients with recurrent T1G3&#xD;
BC by chemoradiation to see efficacy and safety .and to reduce the number of recurrent cases and improve survival.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Bladder Cancer</condition>
  <arm_group>
    <arm_group_label>chemoradiotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Chemoradiation in the form of cisplatin plus conformal radiotherapy 55GY/20 fractions which is biologically effective to 64GY/32 fractions fr</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>chemoradiation</intervention_name>
    <description>chemoradiation in case of T1G3 BC after BCG failure.</description>
    <arm_group_label>chemoradiotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients with recurrent T1G3 bladder cancer after 6 doses of BCG consenting for&#xD;
             chemoradiation and refusing radical cystectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any patients with distant metastasis or positive LN on CT or MRI.&#xD;
&#xD;
          -  Patients unfit for chemoradiation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ahmed Moeen</last_name>
    <role>Study Director</role>
    <affiliation>Moeen3@yahoo.com</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>moktar dawood</last_name>
    <phone>+201009442860</phone>
    <email>mokhtardawood@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Diaa El Din Mohamed</last_name>
    <phone>+201001229936</phone>
    <email>Diaa-hameed@hotmail.com</email>
  </overall_contact_backup>
  <reference>
    <citation>Lambert EH, Pierorazio PM, Olsson CA, Benson MC, McKiernan JM, Poon S. The increasing use of intravesical therapies for stage T1 bladder cancer coincides with decreasing survival after cystectomy. BJU Int. 2007 Jul;100(1):33-6. doi: 10.1111/j.1464-410X.2007.06912.x.</citation>
    <PMID>17552951</PMID>
  </reference>
  <reference>
    <citation>Soloway MS, Sofer M, Vaidya A. Contemporary management of stage T1 transitional cell carcinoma of the bladder. J Urol. 2002 Apr;167(4):1573-83.</citation>
    <PMID>11912367</PMID>
  </reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>September 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>September 6, 2017</last_update_submitted>
  <last_update_submitted_qc>September 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>MokhtarDawood</investigator_full_name>
    <investigator_title>Assistant Lecturer of Urology</investigator_title>
  </responsible_party>
  <keyword>chemoradiation for</keyword>
  <keyword>T1G3 BC</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/NCT03274284
org study id: Bl Cancer
nct id: NCT03274284
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To evaluate the short term results of chemoradiation in case of T1G3 BC after BCG failure.
Non- muscle invasive bladder cancer (NMIBC) is a heterogeneous group of cancers. For most
      urologists the treatment of T1G3 tumor poses a dilemma of management.The spectrum of clinical
      behavior includes; T1 lesions that will not progress however T1G3 may be potentially lethal,
      associated with metastatic disease at the time of presentation.

      The major goal of treatment for T1G3 BC should be bladder preservation whenever possible.

      Intravesical therapy with Bacille Calmette Guerin (BCG) may decrease the recurrence rate by
      compared with transurethral resection of bladder tumor (TURBT) alone.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Result of chemoradiation for recurrentT1G3 BC after BCG failure
time frame: followup within two years
description: treatment of 20 patients with recurrent T1G3
BC by chemoradiation to see efficacy and safety .and to reduce the number of recurrent cases and improve survival.
arm group label: chemoradiotherapy
arm group type: Experimental
description: Chemoradiation in the form of cisplatin plus conformal radiotherapy 55GY/20 fractions which is biologically effective to 64GY/32 fractions fr
intervention type: Combination Product
intervention name: chemoradiation
description: chemoradiation in case of T1G3 BC after BCG failure.
arm group label: chemoradiotherapy
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Ahmed Moeen
role: Study Director
affiliation: Moeen3@yahoo.com
last name: moktar dawood
phone: +201009442860
email: mokhtardawood@yahoo.com
last name: Diaa El Din Mohamed
phone: +201001229936
email: Diaa-hameed@hotmail.com
citation: Lambert EH, Pierorazio PM, Olsson CA, Benson MC, McKiernan JM, Poon S. The increasing use of intravesical therapies for stage T1 bladder cancer coincides with decreasing survival after cystectomy. BJU Int. 2007 Jul;100(1):33-6. doi: 10.1111/j.1464-410X.2007.06912.x.
PMID: 17552951
citation: Soloway MS, Sofer M, Vaidya A. Contemporary management of stage T1 transitional cell carcinoma of the bladder. J Urol. 2002 Apr;167(4):1573-83.
PMID: 11912367
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: MokhtarDawood
investigator title: Assistant Lecturer of Urology
mesh term: Urinary Bladder Neoplasms