<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/NCT02974231</url>
  </required_header>
  <id_info>
    <org_study_id>ICL_2014_0002</org_study_id>
    <nct_id>NCT02974231</nct_id>
  </id_info>
  <brief_title>Intensity-modulated Radiation Therapy From 70Gy to 80Gy in Localized Prostate Cancer</brief_title>
  <official_title>Intensity-modulated Radiation Therapy From 70Gy to 80Gy in Localized Prostate Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut de Cancérologie de Lorraine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut de Cancérologie de Lorraine</source>
  <brief_summary>
    <textblock>
      The objective is to report outcomes,including grade ≥2 overall late rectal and urinary&#xD;
      toxicity and biochemical control rates in patients treated with IMRT (70 gy, 74 Gy and 80 Gy)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2014</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>grade≥ 2 overall late rectal 5 years after the end of radiotherapy</measure>
    <time_frame>60 months</time_frame>
  </primary_outcome>
  <enrollment type="Actual">240</enrollment>
  <condition>Prostate Cancer</condition>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Intensity-modulated radiation therapy</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients records would be extracted from the electronic health record system of Institut de&#xD;
        Cancérologie de Lorraine&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Consecutive patients from June 2000 to December 2010 with&#xD;
&#xD;
          -  untreated histologically confirmed adenocarcinoma of the prostate&#xD;
&#xD;
          -  stage T1c-T4 N0 M0 according to the 1992 American Joint Committee on Cancer staging&#xD;
             system&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with positive pelvic lymphadenectomy or radiological positives nodes&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>October 10, 2016</study_first_submitted>
  <study_first_submitted_qc>November 25, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2016</study_first_posted>
  <last_update_submitted>November 25, 2016</last_update_submitted>
  <last_update_submitted_qc>November 25, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 28, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic 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/NCT02974231
org study id: ICL_2014_0002
nct id: NCT02974231
lead sponsor: 
The objective is to report outcomes,including grade ≥2 overall late rectal and urinary
      toxicity and biochemical control rates in patients treated with IMRT (70 gy, 74 Gy and 80 Gy)
observational model: Case-Only
time perspective: Retrospective
measure: grade≥ 2 overall late rectal 5 years after the end of radiotherapy
time frame: 60 months
intervention type: Radiation
intervention name: Intensity-modulated radiation therapy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
mesh term: Prostatic Neoplasms