<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/NCT01668134</url>
  </required_header>
  <id_info>
    <org_study_id>09-1345 / 201107319</org_study_id>
    <nct_id>NCT01668134</nct_id>
  </id_info>
  <brief_title>Stereotactic Body Radiotherapy for Hepatocellular Carcinoma, and Intrahepatic Cholangiocarcinoma</brief_title>
  <official_title>Feasibility Study of Stereotactic Body Radiotherapy for Hepatocellular Carcinoma, and Intrahepatic Cholangiocarcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Washington University School of Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is being done to determine if targeted radiation therapy (stereotactic) can be&#xD;
      given to treat liver cancer, for patient who are unable to undergo surgery, over a short&#xD;
      period of time with a small amount of side effects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 16, 2009</start_date>
  <completion_date type="Actual">December 22, 2015</completion_date>
  <primary_completion_date type="Actual">August 30, 2014</primary_completion_date>
  <phase>Phase 1</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>Stereotactic radiation therapy (either photon or proton) can be delivered to the liver with a less than 10% 3-month incidence of Grade 4 study related toxicity.</measure>
    <time_frame>Up to 90 days after end of radiation therapy</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measure the late toxicity associated with using stereotactic radiation therapy in patients with unresectable HCC and IHC.</measure>
    <time_frame>Up to 60 days after end of radiation therapy</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measure the local recurrence rates associated with using SBRT in patients with unresectable HCC and IHC.</measure>
    <time_frame>Time of treatment until recurrance or progressive disease as measured by CT/MR from baseline to recurrance or progressive disease</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measure the overall survival rates associated with using SBRT in patients with unresectable HCC and IHC.</measure>
    <time_frame>Baseline to time of death</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measure the response rates associated with using SBRT in patients with resectable HCC and IHC</measure>
    <time_frame>Baseline to the first date of recurrance or progressive disease</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Carcinoma, Hepatocellular</condition>
  <condition>Intrahepatic Cholangiocarcinoma</condition>
  <arm_group>
    <arm_group_label>Stereotactic radiation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Stereotactic radiation</intervention_name>
    <arm_group_label>Stereotactic radiation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18&#xD;
&#xD;
          -  Karnofsky Performance Status of ≥ 60&#xD;
&#xD;
          -  Pathologically confirmed IHC or HCC. (Pathology not required for HCC if the lesion&#xD;
             enhances typically on MRI and the patient is evaluated by liver transplant surgery&#xD;
             team and thought to have HCC.)&#xD;
&#xD;
          -  4 or less separate intrahepatic lesions, with at least one lesion that is able to be&#xD;
             followed by EASL Criteria.&#xD;
&#xD;
          -  Local surgical resection is not possible due to tumor or patient factors&#xD;
&#xD;
          -  Limited metastatic disease is allowed if the volume of metastatic disease does not&#xD;
             exceed the volume of primary disease.&#xD;
&#xD;
          -  Prior TACE allowed if stopped/completed at least 2 weeks prior to enrollment&#xD;
&#xD;
          -  Prior chemotherapy except Sorafenib allowed if stopped/completed at least 2 weeks&#xD;
             prior to enrollment&#xD;
&#xD;
          -  Prior Sorafenib allowed if stopped/completed at least seven days prior to enrollment.&#xD;
&#xD;
          -  Able to provide signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Childs-Pugh score 9 or more&#xD;
&#xD;
          -  ALT or AST ≥ 6 x upper limit of normal&#xD;
&#xD;
          -  Prior history of abdominal irradiation&#xD;
&#xD;
          -  Women who are pregnant or nursing&#xD;
&#xD;
          -  Scheduled to undergo chemotherapy except Sorafenib at the time when radiation therapy&#xD;
             will be given, or for up to 4 weeks after completion of radiation therapy.&#xD;
&#xD;
          -  Scheduled to undergo Sorafenib within seven days of when radiation therapy will be&#xD;
             delivered, or for up to 2 weeks after completion of radiation therapy.&#xD;
&#xD;
          -  Undergone prior radiation therapy to the abdomen.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Parag Parikh, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Washington University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>St. Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://siteman.wustl.edu</url>
    <description>Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine</description>
  </link>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>August 8, 2012</study_first_submitted>
  <study_first_submitted_qc>August 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 17, 2012</study_first_posted>
  <last_update_submitted>February 16, 2017</last_update_submitted>
  <last_update_submitted_qc>February 16, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">February 20, 2017</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>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Hepatocellular</mesh_term>
    <mesh_term>Cholangiocarcinoma</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/NCT01668134
org study id: 09-1345 / 201107319
nct id: NCT01668134
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
This study is being done to determine if targeted radiation therapy (stereotactic) can be
      given to treat liver cancer, for patient who are unable to undergo surgery, over a short
      period of time with a small amount of side effects.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Stereotactic radiation therapy (either photon or proton) can be delivered to the liver with a less than 10% 3-month incidence of Grade 4 study related toxicity.
time frame: Up to 90 days after end of radiation therapy
measure: Measure the late toxicity associated with using stereotactic radiation therapy in patients with unresectable HCC and IHC.
time frame: Up to 60 days after end of radiation therapy
measure: Measure the local recurrence rates associated with using SBRT in patients with unresectable HCC and IHC.
time frame: Time of treatment until recurrance or progressive disease as measured by CT/MR from baseline to recurrance or progressive disease
measure: Measure the overall survival rates associated with using SBRT in patients with unresectable HCC and IHC.
time frame: Baseline to time of death
measure: Measure the response rates associated with using SBRT in patients with resectable HCC and IHC
time frame: Baseline to the first date of recurrance or progressive disease
arm group label: Stereotactic radiation
arm group type: Experimental
intervention type: Radiation
intervention name: Stereotactic radiation
arm group label: Stereotactic radiation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Parag Parikh, M.D.
role: Principal Investigator
affiliation: Washington University School of Medicine
facility: 
country: United States
url: http://siteman.wustl.edu
description: Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Hepatocellular
mesh term: Cholangiocarcinoma
sharing ipd: No