<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/NCT01704027</url>
  </required_header>
  <id_info>
    <org_study_id>2012-A00694-39</org_study_id>
    <nct_id>NCT01704027</nct_id>
  </id_info>
  <brief_title>Safety Study of Pelvic and Prostatic SIB-IMRT With Long-term Androgen Deprivation for High Risk Localized Prostate Cancer</brief_title>
  <official_title>Prospective Phase II Study Evaluating the Feasibility of a Conformational Pelvic and Prostatic Radiotherapy With Simultaneous Integrated Boost Modulated-intensity Arctherapy (SIB-IMAT) in Combination With Long Term Androgen Deprivation for High Risk Localized Prostate Cancer.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Georges Francois Leclerc</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Georges Francois Leclerc</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the incidence of urinary and rectal acute side&#xD;
      effects of a pelvic and prostatic intensity-modulated arctherapy with simultaneous integrated&#xD;
      boost (SIB-IMRT)combined with long-term androgen deprivation for patients with high risk&#xD;
      localized prostate cancer&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    termination of the trial after interim analysis. the main criterion could not be reached&#xD;
  </why_stopped>
  <start_date>October 2012</start_date>
  <primary_completion_date type="Actual">March 2014</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>Number of Participants with Acute urinary and rectal toxicities as a Measure of treatment specific Safety and Tolerability</measure>
    <time_frame>From start of radiotherapy to six months after the end of radiotherapy</time_frame>
    <description>Acute urinary and rectal toxicities will be assessed according to the NCI CTCAE v4.0 quotation each week during radiotherapy treatment period up to six months after the end of the radiotherapy treatment period.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To evaluate the late urinary and rectal toxicities</measure>
    <time_frame>for each patient every 6 months after the end of radiotherapy up to 5 years.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the 5-year biochemical-free survival</measure>
    <time_frame>for each patient from zero day up to 7 day after the end of radiotherapy, 6 weeks, 3 months, and every 6 months after the end of radiotherapy up to 5 years.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the metastase-free survival</measure>
    <time_frame>for each patient from zero day up to 7 day after the end of radiotherapy, 6 weeks, 3 months, and every 6 months after the end of radiotherapy up to 5 years.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To evaluate the specific survival</measure>
    <time_frame>for each patient from inclusion up to 5 years after the end of radiotherapy.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To evaluate the overall survival</measure>
    <time_frame>for each patient from inclusion up to 5 years after the end of radiotherapy.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To evaluate the quality of life</measure>
    <time_frame>inclusion day, from zero day up to 7 day after the end of radiotherapy, 6 weeks after the end of the radiotherapy, 3 months after the end of the radiotherapy, every 6 months after the end of radiotherapy up to 5 years.</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Radiotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient will receive a pelvic and prostatic simultaneous integrated boost intensity-modulated arctherapy (SIB-IMAT) in combination with three years of androgen deprivation</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Simultaneous integrated boost intensity-modulated arctherapy</intervention_name>
    <description>Three dose levels will be delivered at each fraction, 5 days a week, 30 fractions :&#xD;
Pelvis : 55,5 Gy (1,85 Gy/fr)&#xD;
Seminal vesicles : 66 Gy (2,2 Gy/fr)&#xD;
Prostate : 72 Gy (2,4 Gy/fr)</description>
    <arm_group_label>Radiotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Androgen deprivation</intervention_name>
    <description>Patients will received androgen deprivation for a maximum of three years. This treatment can start six months before radiotherapy and at least the day one of radiotherapy.</description>
    <arm_group_label>Radiotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Histologically confirmed adenocarcinoma of the prostate&#xD;
&#xD;
          2. High risk localized adenocarcinoma defined by at least one of the following criteria:&#xD;
&#xD;
               -  Clinical stage T2c, T3 or T4&#xD;
&#xD;
               -  Gleason score ≥ 8&#xD;
&#xD;
               -  Prostate-specific antigen (PSA)≥ 20 ng/ml and ≤ 100 ng/ml&#xD;
&#xD;
          3. Patient cN0, pN0 or Nx (negative lymphadenectomy or no lymphadenectomy)&#xD;
&#xD;
          4. No pelvic adenopathy ≥ 15 mm on CT or MRI,&#xD;
&#xD;
          5. Absence of bone and/or visceral metastasis&#xD;
&#xD;
          6. Androgen deprivation beginning no later than the day of radiotherapy and up to six&#xD;
             months before irradiation&#xD;
&#xD;
          7. Absence of prior pelvic radiotherapy,&#xD;
&#xD;
          8. Absence of surgical treatment of prostate cancer except transurethral resection&#xD;
             performed within 4 months minimum before radiotherapy,&#xD;
&#xD;
          9. Age ≥ 18 years and ≤ 85 years&#xD;
&#xD;
         10. ECOG performance status ≤ 1,&#xD;
&#xD;
         11. Estimated life expectancy &gt; 5 years&#xD;
&#xD;
         12. Membership of a social security system,&#xD;
&#xD;
         13. Signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Prostate cancer histology other than adenocarcinoma,&#xD;
&#xD;
          2. pN1 patients (lymph node dissection after histologically proven)&#xD;
&#xD;
          3. PSA &gt; 100 ng/ml&#xD;
&#xD;
          4. History of cancer within 5 years prior to trial entry (with the exception of basal&#xD;
             cell carcinoma skin)&#xD;
&#xD;
          5. Patient with severe hypertension uncontrolled by appropriate treatment (≥ 160 mm Hg&#xD;
             systolic and / or ≥ 90 mm Hg diastolic)&#xD;
&#xD;
          6. Contra-indication for pelvic irradiation (eg scleroderma, chronic inflammatory disease&#xD;
             of the digestive tract, etc ...)&#xD;
&#xD;
          7. Contra-indication to agonists or antagonists of LH-RH&#xD;
&#xD;
          8. Bilateral hip prosthesis,&#xD;
&#xD;
          9. Patients already included in another clinical trial with an experimental molecule,&#xD;
&#xD;
         10. Persons deprived of liberty or under guardianship&#xD;
&#xD;
         11. Unable to undergo medical test for geographical, social or psychological.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Etienne MARTIN, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Georges François Leclerc</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre Georges-François Leclerc</name>
      <address>
        <city>Dijon</city>
        <state>Burgundy</state>
        <zip>21079</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>October 2, 2012</study_first_submitted>
  <study_first_submitted_qc>October 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 11, 2012</study_first_posted>
  <last_update_submitted>September 17, 2014</last_update_submitted>
  <last_update_submitted_qc>September 17, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 18, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Localized</keyword>
  <keyword>High risk</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Androgens</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/NCT01704027
org study id: 2012-A00694-39
nct id: NCT01704027
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the incidence of urinary and rectal acute side
      effects of a pelvic and prostatic intensity-modulated arctherapy with simultaneous integrated
      boost (SIB-IMRT)combined with long-term androgen deprivation for patients with high risk
      localized prostate cancer
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants with Acute urinary and rectal toxicities as a Measure of treatment specific Safety and Tolerability
time frame: From start of radiotherapy to six months after the end of radiotherapy
description: Acute urinary and rectal toxicities will be assessed according to the NCI CTCAE v4.0 quotation each week during radiotherapy treatment period up to six months after the end of the radiotherapy treatment period.
measure: To evaluate the late urinary and rectal toxicities
time frame: for each patient every 6 months after the end of radiotherapy up to 5 years.
measure: Evaluate the 5-year biochemical-free survival
time frame: for each patient from zero day up to 7 day after the end of radiotherapy, 6 weeks, 3 months, and every 6 months after the end of radiotherapy up to 5 years.
measure: Evaluate the metastase-free survival
time frame: for each patient from zero day up to 7 day after the end of radiotherapy, 6 weeks, 3 months, and every 6 months after the end of radiotherapy up to 5 years.
measure: To evaluate the specific survival
time frame: for each patient from inclusion up to 5 years after the end of radiotherapy.
measure: To evaluate the overall survival
time frame: for each patient from inclusion up to 5 years after the end of radiotherapy.
measure: To evaluate the quality of life
time frame: inclusion day, from zero day up to 7 day after the end of radiotherapy, 6 weeks after the end of the radiotherapy, 3 months after the end of the radiotherapy, every 6 months after the end of radiotherapy up to 5 years.
arm group label: Radiotherapy
arm group type: Experimental
description: Patient will receive a pelvic and prostatic simultaneous integrated boost intensity-modulated arctherapy (SIB-IMAT) in combination with three years of androgen deprivation
intervention type: Radiation
intervention name: Simultaneous integrated boost intensity-modulated arctherapy
description: Three dose levels will be delivered at each fraction, 5 days a week, 30 fractions :
Pelvis : 55,5 Gy (1,85 Gy/fr)
Seminal vesicles : 66 Gy (2,2 Gy/fr)
Prostate : 72 Gy (2,4 Gy/fr)
arm group label: Radiotherapy
intervention type: Drug
intervention name: Androgen deprivation
description: Patients will received androgen deprivation for a maximum of three years. This treatment can start six months before radiotherapy and at least the day one of radiotherapy.
arm group label: Radiotherapy
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Etienne MARTIN, MD
role: Principal Investigator
affiliation: Centre Georges François Leclerc
facility: 
country: France
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
mesh term: Androgens