<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/NCT02225197</url>
  </required_header>
  <id_info>
    <org_study_id>CK Perioptic-01</org_study_id>
    <nct_id>NCT02225197</nct_id>
  </id_info>
  <brief_title>A Phase II Trial of CyberKnife Radiosurgery to Perioptic Tumors</brief_title>
  <official_title>A Phase II Study of Fractionated CyberKnife Stereotactic Radiosurgery to Perioptic Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Community Cancer Center, Normal, Illinois</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Community Cancer Center, Normal, Illinois</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to find out what effects (good and bad) CyberKnife stereotactic&#xD;
      radiosurgery has on tumors near the critical structures of the eye (optic apparatus).&#xD;
&#xD;
      The investigators hypothesize that hypofractionated stereotactic radiotherapy via the&#xD;
      CyberKnife ® can deliver tumor ablating doses of radiation to perioptic lesions safely and&#xD;
      effectively while sparing the adjacent optic apparatus and normal brain tissues from&#xD;
      receiving damaging doses of radiation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The CyberKnife system is a type of radiation machine that uses a special system to precisely&#xD;
      focus large doses of x-rays (radiation) on the tumor. The device is designed to concentrate&#xD;
      large doses of radiation onto the tumor so that injury from radiation to the nearby normal&#xD;
      tissue will be minimal.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2007</start_date>
  <completion_date type="Actual">October 2017</completion_date>
  <primary_completion_date type="Actual">October 2017</primary_completion_date>
  <phase>N/A</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>Tumor status</measure>
    <time_frame>5 years</time_frame>
    <description>To determine the local control rate of patients with perioptic lesions treated with stereotactic CyberKnife radiosurgery.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Tumor, Benign, Optic Nerve</condition>
  <arm_group>
    <arm_group_label>CyberKnife Radiosurgery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>CyberKnife Radiosurgery</intervention_name>
    <description>25 Gy delivered in 5 fractions of 5 Gy per fraction</description>
    <arm_group_label>CyberKnife Radiosurgery</arm_group_label>
    <other_name>CyberKnife</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Perioptic lesion within 2mm of the optic apparatus&#xD;
&#xD;
          -  Age &gt;= 21&#xD;
&#xD;
          -  KPS &gt;= 50&#xD;
&#xD;
          -  Planning Target Volume (PTV) &lt;= 6.0 cm in maximal diameter&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Malignant histology&#xD;
&#xD;
          -  Age &lt; 21&#xD;
&#xD;
          -  KPS &lt;= 40&#xD;
&#xD;
          -  Planning Target Volume (PTV) &gt; 6.0 cm in maximal diameter&#xD;
&#xD;
          -  Prior whole brain XRT&#xD;
&#xD;
          -  Gross total resection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shermian Woodhouse, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Community Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Community Cancer Center</name>
      <address>
        <city>Normal</city>
        <state>Illinois</state>
        <zip>61761</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>August 22, 2014</study_first_submitted>
  <study_first_submitted_qc>August 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 26, 2014</study_first_posted>
  <last_update_submitted>July 23, 2019</last_update_submitted>
  <last_update_submitted_qc>July 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Perioptic</keyword>
  <keyword>Stereotactic</keyword>
  <keyword>Radiation</keyword>
  <keyword>Benign brain tumor</keyword>
  <keyword>Optic apparatus</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Optic Nerve 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/NCT02225197
org study id: CK Perioptic-01
nct id: NCT02225197
lead sponsor: 
has dmc: No
The purpose of this study is to find out what effects (good and bad) CyberKnife stereotactic
      radiosurgery has on tumors near the critical structures of the eye (optic apparatus).

      The investigators hypothesize that hypofractionated stereotactic radiotherapy via the
      CyberKnife ® can deliver tumor ablating doses of radiation to perioptic lesions safely and
      effectively while sparing the adjacent optic apparatus and normal brain tissues from
      receiving damaging doses of radiation.
The CyberKnife system is a type of radiation machine that uses a special system to precisely
      focus large doses of x-rays (radiation) on the tumor. The device is designed to concentrate
      large doses of radiation onto the tumor so that injury from radiation to the nearby normal
      tissue will be minimal.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Tumor status
time frame: 5 years
description: To determine the local control rate of patients with perioptic lesions treated with stereotactic CyberKnife radiosurgery.
arm group label: CyberKnife Radiosurgery
arm group type: Experimental
intervention type: Radiation
intervention name: CyberKnife Radiosurgery
description: 25 Gy delivered in 5 fractions of 5 Gy per fraction
arm group label: CyberKnife Radiosurgery
other name: CyberKnife
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Shermian Woodhouse, MD
role: Principal Investigator
affiliation: Community Cancer Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Optic Nerve Neoplasms