<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/NCT02998619</url>
  </required_header>
  <id_info>
    <org_study_id>BASEC 2016-01325</org_study_id>
    <nct_id>NCT02998619</nct_id>
  </id_info>
  <brief_title>Radiotherapy of Pelvic Lymph Nodes in High Risk Prostate Cancer - A Retrospective Analysis</brief_title>
  <official_title>Retrospektive Analyse Der Radiotherapie Des Pelvinen Lymphabflusses Beim Lokalisierten Prostatakarzinom Vom Hochrisikotyp Anhand Der Klinikdatenbank 2010-2016</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kantonsspital Graubuenden</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kantonsspital Graubuenden</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Men with high risk prostate cancer who underwent radiotherapy of the prostate/seminal&#xD;
      vesicles or underwent postoperative radiotherapy including pelvic lymph nodes between 2010&#xD;
      and 2016 are analyzed retrospectively. The aims are to estimate progression-free survival as&#xD;
      well as toxicity according to CTCAE v4.03.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Collection of data and retrospective analysis of patients with high risk prostate cancer&#xD;
      treated with radiotherapy to pelvic lymph nodes.&#xD;
&#xD;
      What influence has irradiation of pelvic lymph nodes on patients with high risk prostate&#xD;
      cancer in terms of progression free survival and toxicity. How does this influence side&#xD;
      effects with respect to gastrointestinal (proctitis, abdominal pain, diarrhea) and&#xD;
      genitourinary (cystitis, urinary disorders) toxicities (CTCAE v4.03)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">June 19, 2018</completion_date>
  <primary_completion_date type="Actual">November 11, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Progression-free survival</measure>
    <time_frame>through study completion, an average of 2 years</time_frame>
    <description>PSA progession-free survival will be measured</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Toxicity (CTCAE v4.03)</measure>
    <time_frame>through study completion, an average of 2 years</time_frame>
    <description>GI, GU Toxicities as well as Erectile Dysfunction will be measured</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">52</enrollment>
  <condition>Prostatic Neoplasms Benign</condition>
  <condition>Radiotherapy Side Effect</condition>
  <condition>Lymph Node Disease</condition>
  <arm_group>
    <arm_group_label>Radiotherapy</arm_group_label>
    <description>Radiation to prostate/seminal vesicles including pelvic lymph nodes Postoperative radiation to prostate bed including pelvic lymph nodes</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Radiotherapy</intervention_name>
    <description>Radiation to prostate/seminal vesicles including pelvic lymph nodes Postoperative radiation to prostate bed including pelvic lymph nodes</description>
    <arm_group_label>Radiotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Retrospective analysis of men irradiated for high risk prostate cancer including pelvic&#xD;
        lymph nodes (L5/S1)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men with high risk prostate cancer treated with radiotherapy to prostate/seminal&#xD;
             vesicles or postoperative radiotherapy and pelvic lymph nodes at the Kantonssptial&#xD;
             Graubuenden, Department of Radiation Oncology between 2010 and 2016&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Men with prostate cancer other than high risk disease and no radiotherapy to pelvic&#xD;
             lymph nodes&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel R Zwahlen, MD, MBA</last_name>
    <role>Study Chair</role>
    <affiliation>Kantonsspital Graubuenden</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kantonsspital Graubuenden</name>
      <address>
        <city>Chur</city>
        <zip>7000</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>December 11, 2016</study_first_submitted>
  <study_first_submitted_qc>December 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <last_update_submitted>July 27, 2018</last_update_submitted>
  <last_update_submitted_qc>July 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 31, 2018</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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02998619
org study id: BASEC 2016-01325
nct id: NCT02998619
lead sponsor: 
has dmc: No
Men with high risk prostate cancer who underwent radiotherapy of the prostate/seminal
      vesicles or underwent postoperative radiotherapy including pelvic lymph nodes between 2010
      and 2016 are analyzed retrospectively. The aims are to estimate progression-free survival as
      well as toxicity according to CTCAE v4.03.
Collection of data and retrospective analysis of patients with high risk prostate cancer
      treated with radiotherapy to pelvic lymph nodes.

      What influence has irradiation of pelvic lymph nodes on patients with high risk prostate
      cancer in terms of progression free survival and toxicity. How does this influence side
      effects with respect to gastrointestinal (proctitis, abdominal pain, diarrhea) and
      genitourinary (cystitis, urinary disorders) toxicities (CTCAE v4.03)
observational model: Other
time perspective: Retrospective
measure: Progression-free survival
time frame: through study completion, an average of 2 years
description: PSA progession-free survival will be measured
measure: Toxicity (CTCAE v4.03)
time frame: through study completion, an average of 2 years
description: GI, GU Toxicities as well as Erectile Dysfunction will be measured
arm group label: Radiotherapy
description: Radiation to prostate/seminal vesicles including pelvic lymph nodes Postoperative radiation to prostate bed including pelvic lymph nodes
intervention type: Radiation
intervention name: Radiotherapy
description: Radiation to prostate/seminal vesicles including pelvic lymph nodes Postoperative radiation to prostate bed including pelvic lymph nodes
arm group label: Radiotherapy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Daniel R Zwahlen, MD, MBA
role: Study Chair
affiliation: Kantonsspital Graubuenden
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
sharing ipd: No