<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/NCT02264886</url>
  </required_header>
  <id_info>
    <org_study_id>201410002</org_study_id>
    <nct_id>NCT02264886</nct_id>
  </id_info>
  <brief_title>Adaptive MRI-Guided SBRT for Unresectable Primary or Oligometastatic Central Thorax and Abdominal Malignancies</brief_title>
  <official_title>Pilot Study of Online, Adaptive MRI-Guided SBRT for Unresectable Primary or Oligometastatic Central Thorax and Abdominal Malignancies</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research study is evaluate whether it's feasible to give radiation&#xD;
      therapy using an MRI-guided adaptive technique. MRI-guided adaptive radiation therapy&#xD;
      involves the adjustment or re-planning of treatment day by day while the participant is&#xD;
      receiving treatment. The adaptive technique has previously been used in a different fashion&#xD;
      to adjust the treatment plan after the fact, but using MRI scanning to re-plan treatment&#xD;
      while the participant is still on the table is a new way of using the adaptive technique.&#xD;
      This may allow doctors to use more radiation to treat the tumor while better protecting&#xD;
      normal tissues. A special radiation treatment machine incorporates both an MRI scanner and&#xD;
      radiation treatment devices so that the planning and treatment can be done using the same&#xD;
      machine.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this trial, the feasibility of delivering online, adaptive MRI-guided stereotactic body&#xD;
      radiation therapy for oligometastatic disease using a novel, integrated Co-60-MRI machine&#xD;
      will be evaluated. To best assess this technology, we will focus on three specific&#xD;
      oligometastatic disease sites that have historically highlighted the limitations of SBRT.&#xD;
      Specifically, we will enroll patients with oligometastatic disease of the central thorax,&#xD;
      liver, and non-liver abdomen to receive adaptive, MRI-guided SBRT with MRI simulation and MRI&#xD;
      treatment gating. Patients will be treated in five fractions over one to two weeks. By&#xD;
      adhering to strict normal tissue constraints, expected toxicity will be within the current&#xD;
      standard of care, but allow adaptation based on daily anatomic changes. The prescription dose&#xD;
      will be determined based on above hard normal tissue constraints, and capped at 15 Gy per&#xD;
      fraction. Although our long-term goal will be to achieve improved local control and&#xD;
      disease-free survival with reduced toxicity, the present study will be driven by short-term&#xD;
      goals of demonstrating feasibility of an on-table adaptive approach, which has never&#xD;
      previously been reported.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2015</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">June 2016</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>Feasibility of the online, adaptive, MRI-guided SBRT</measure>
    <time_frame>Average time of 2 weeks</time_frame>
    <description>Feasibility is determined that confirming that the treatment can be delivered with less than 80 minutes total treatment (on table) time, for more than 75% of cases where treatment adaptation is indicated.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tumor response rate</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Local, in-field control rate</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression free survival rate (PFS)</measure>
    <time_frame>6 months</time_frame>
    <description>PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease free survival rate</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival rate</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-reported quality of life</measure>
    <time_frame>6 months</time_frame>
    <description>Using the EORTC QLQ-C30</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Central Thorax Cancer</condition>
  <condition>Liver Cancer</condition>
  <condition>Non-Liver Abdominal Cancer</condition>
  <arm_group>
    <arm_group_label>Arm 1: Stereotactic body radiation therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Radiotherapy will consist of stereotactic body therapy, to be given over five fractions, delivered once daily or once every other day for a period of one to two weeks, for a total of five treatments.&#xD;
All patients will undergo MRI simulation in positioning appropriate for the specific treatment site. When medically feasible and applicable, patients will be simulated with IV and small bowel contrast (for non-thorax cases).</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>MRI-guided stereotactive body radiation therapy</intervention_name>
    <arm_group_label>Arm 1: Stereotactic body radiation therapy</arm_group_label>
    <other_name>SBRT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Oligometastatic or unresectable primary disease planned for SBRT with biopsy-proven&#xD;
             primary disease histology of solid tumor categorization with the exception of small&#xD;
             cell cancers.&#xD;
&#xD;
          -  Must be deemed medically fit for SBRT to the liver or lung by the treating physician.&#xD;
&#xD;
          -  At least 18 years of age.&#xD;
&#xD;
          -  Karnofsky performance status &gt; 60 (see Appendix A)&#xD;
&#xD;
          -  Must have completed any systemic therapy at least one week prior to planned start of&#xD;
             SBRT (two weeks preferred), and must have no plans to initiate systemic therapy for at&#xD;
             least one week following end of SBRT (two weeks preferred).&#xD;
&#xD;
          -  Able to understand and willing to sign an IRB approved written informed consent&#xD;
             document (or that of legally authorized representative, if applicable).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Primary disease of hematologic origin, lymphoma, or small cell cancer.&#xD;
&#xD;
          -  Past history of radiotherapy within the projected treatment field of any of the&#xD;
             disease sites to be treated by MRI-guided, online adaptive SBRT.&#xD;
&#xD;
          -  Widespread progressive disease, i.e., more than 3 sites of progressive disease (more&#xD;
             than 3 sites of disease are permitted provided there are no more than 3 sites of&#xD;
             progressive disease).&#xD;
&#xD;
          -  Currently receiving any other investigational agents.&#xD;
&#xD;
          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active&#xD;
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac&#xD;
             arrhythmia, or psychiatric illness/social situations that would limit compliance with&#xD;
             study requirements.&#xD;
&#xD;
          -  Pregnant and/or breastfeeding. Patient must have a negative pregnancy test within 14&#xD;
             days of study entry.&#xD;
&#xD;
          -  Medical contraindication to undergoing MR imaging.&#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 J 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://www.siteman.wustl.edu</url>
    <description>Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine</description>
  </link>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>October 8, 2014</study_first_submitted>
  <study_first_submitted_qc>October 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2014</study_first_posted>
  <last_update_submitted>December 7, 2016</last_update_submitted>
  <last_update_submitted_qc>December 7, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 9, 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>Liver 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/NCT02264886
org study id: 201410002
nct id: NCT02264886
lead sponsor: 
has dmc: Yes
The purpose of this research study is evaluate whether it's feasible to give radiation
      therapy using an MRI-guided adaptive technique. MRI-guided adaptive radiation therapy
      involves the adjustment or re-planning of treatment day by day while the participant is
      receiving treatment. The adaptive technique has previously been used in a different fashion
      to adjust the treatment plan after the fact, but using MRI scanning to re-plan treatment
      while the participant is still on the table is a new way of using the adaptive technique.
      This may allow doctors to use more radiation to treat the tumor while better protecting
      normal tissues. A special radiation treatment machine incorporates both an MRI scanner and
      radiation treatment devices so that the planning and treatment can be done using the same
      machine.
In this trial, the feasibility of delivering online, adaptive MRI-guided stereotactic body
      radiation therapy for oligometastatic disease using a novel, integrated Co-60-MRI machine
      will be evaluated. To best assess this technology, we will focus on three specific
      oligometastatic disease sites that have historically highlighted the limitations of SBRT.
      Specifically, we will enroll patients with oligometastatic disease of the central thorax,
      liver, and non-liver abdomen to receive adaptive, MRI-guided SBRT with MRI simulation and MRI
      treatment gating. Patients will be treated in five fractions over one to two weeks. By
      adhering to strict normal tissue constraints, expected toxicity will be within the current
      standard of care, but allow adaptation based on daily anatomic changes. The prescription dose
      will be determined based on above hard normal tissue constraints, and capped at 15 Gy per
      fraction. Although our long-term goal will be to achieve improved local control and
      disease-free survival with reduced toxicity, the present study will be driven by short-term
      goals of demonstrating feasibility of an on-table adaptive approach, which has never
      previously been reported.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Feasibility of the online, adaptive, MRI-guided SBRT
time frame: Average time of 2 weeks
description: Feasibility is determined that confirming that the treatment can be delivered with less than 80 minutes total treatment (on table) time, for more than 75% of cases where treatment adaptation is indicated.
measure: Tumor response rate
time frame: 3 months
measure: Local, in-field control rate
time frame: 6 months
measure: Progression free survival rate (PFS)
time frame: 6 months
description: PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.
measure: Disease free survival rate
time frame: 6 months
measure: Overall survival rate
time frame: 6 months
measure: Patient-reported quality of life
time frame: 6 months
description: Using the EORTC QLQ-C30
arm group label: Arm 1: Stereotactic body radiation therapy
arm group type: Experimental
description: Radiotherapy will consist of stereotactic body therapy, to be given over five fractions, delivered once daily or once every other day for a period of one to two weeks, for a total of five treatments.
All patients will undergo MRI simulation in positioning appropriate for the specific treatment site. When medically feasible and applicable, patients will be simulated with IV and small bowel contrast (for non-thorax cases).
intervention type: Radiation
intervention name: MRI-guided stereotactive body radiation therapy
arm group label: Arm 1: Stereotactic body radiation therapy
other name: SBRT
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Parag J Parikh, M.D.
role: Principal Investigator
affiliation: Washington University School of Medicine
facility: 
country: United States
url: http://www.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: Liver Neoplasms
sharing ipd: No