<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/NCT02206334</url>
  </required_header>
  <id_info>
    <org_study_id>NRG-BR001</org_study_id>
    <secondary_id>NCI-2014-00702</secondary_id>
    <secondary_id>NRG-BR001</secondary_id>
    <secondary_id>NRG-BR001</secondary_id>
    <secondary_id>U10CA180868</secondary_id>
    <secondary_id>U10CA021661</secondary_id>
    <nct_id>NCT02206334</nct_id>
  </id_info>
  <brief_title>Stereotactic Body Radiation Therapy in Treating Patients With Metastatic Breast Cancer, Non-small Cell Lung Cancer, or Prostate Cancer</brief_title>
  <official_title>A Phase 1 Study of Stereotactic Body Radiotherapy (SBRT) for the Treatment of Multiple Metastases</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NRG Oncology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>NRG Oncology</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This phase I trial studies the side effects and the best dose of stereotactic body radiation&#xD;
      therapy in treating patients with breast cancer, non-small cell lung cancer, or prostate&#xD;
      cancer that has spread to other parts of the body. Stereotactic body radiation therapy&#xD;
      delivers fewer, tightly-focused, high doses of radiation therapy to all known sites of cancer&#xD;
      in the body while minimizing radiation exposure of surrounding normal tissue.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To determine the recommended stereotactic body radiation therapy (SBRT) dose for each of&#xD;
      the metastatic locations being treated given the individual and overlapping fields when&#xD;
      multiple metastases are treated with SBRT in a national clinical trials network setting.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To estimate rates of &gt;= grade 3 Common Terminology Criteria for Adverse Events (CTCAE),&#xD;
      version (v.) 4.0 adverse events other than a dose-limiting toxicity (DLT) which is possibly,&#xD;
      probably, or definitely related to treatment and which occurs within 6 months from the start&#xD;
      of SBRT to multiple metastases.&#xD;
&#xD;
      II. To estimate the rates of long-term adverse events occurring up to 2 years from the end of&#xD;
      SBRT.&#xD;
&#xD;
      III. To explore the most appropriate and clinically relevant technological parameters to&#xD;
      ensure quality and effectiveness throughout radiation therapy processes, including imaging,&#xD;
      simulation, patient immobilization, target and critical structure definition, treatment&#xD;
      planning, image guidance and delivery.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients undergo 3-5 fractions of image-guided stereotactic body radiation therapy to all&#xD;
      existing metastases over 1-3 weeks with at least 40 hours between treatments for an&#xD;
      individual metastasis.&#xD;
&#xD;
      After completion of study treatment, patients are followed up at 35-45 days and then every 3&#xD;
      months for 2 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2014</start_date>
  <completion_date type="Actual">May 20, 2022</completion_date>
  <primary_completion_date type="Actual">June 2018</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>Dose-limiting toxicity (DLT) scored according to the National Cancer Institute (NCI) CTCAE version 4.0 for each of 7 metastatic locations when multiple metastases are treated with SBRT</measure>
    <time_frame>Within 6 months from the start of treatment; for each of the 7 metastatic locations, analysis occurs after 6 evaluable patients have been followed for a minimum of 6 months from the start of treatment</time_frame>
    <description>Adverse events outlined by metastatic location (full detail in protocol) reported as being probably or definitely related to protocol treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of long-term adverse events, scored according to the NCI CTCAE v. 4.0</measure>
    <time_frame>Up to 2 years from end of treatment; analysis occurs after all patients have been potentially followed for 2 years from registration</time_frame>
    <description>Adverse events reported as being possibly, probably, or definitely related to protocol treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of &gt;= grade 3 adverse events, scored according to NCI CTCAE v. 4.0</measure>
    <time_frame>Within 6 months from the start of treatment; analysis occurs after all patients have been followed for a minimum of 6 months from the start of treatment</time_frame>
    <description>Adverse events (other than DLTs) reported as being possibly, probably, or definitely related to protocol treatment.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Male Breast Carcinoma</condition>
  <condition>Prostate Adenocarcinoma</condition>
  <condition>Recurrent Breast Carcinoma</condition>
  <condition>Recurrent Non-Small Cell Lung Carcinoma</condition>
  <condition>Recurrent Prostate Carcinoma</condition>
  <condition>Stage IV Breast Cancer</condition>
  <condition>Stage IV Non-Small Cell Lung Cancer</condition>
  <condition>Stage IV Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Stereotactic Body Radiation Therapy (SBRT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergo 3-5 fractions of image-guided stereotactic body radiation therapy to all existing metastases over 1-3 weeks with at least 40 hours between treatments for an individual metastasis.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Stereotactic Body Radiation Therapy (SBRT)</intervention_name>
    <description>Undergo SBRT</description>
    <arm_group_label>Stereotactic Body Radiation Therapy (SBRT)</arm_group_label>
    <other_name>Stereotactic External Beam Irradiation</other_name>
    <other_name>stereotactic external-beam radiation therapy</other_name>
    <other_name>Stereotactic Radiation Therapy</other_name>
    <other_name>stereotactic radiosurgery</other_name>
    <other_name>Stereotactic Radiotherapy</other_name>
    <other_name>stereotaxic radiation therapy</other_name>
    <other_name>stereotaxic radiosurgery</other_name>
    <other_name>SBRT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Metastatic breast cancer (MBC) OR metastatic non-small cell lung cancer (NSCLC) OR&#xD;
             metastatic adenocarcinoma of the prostate; the sites of allowed metastases are:&#xD;
             peripheral lung, central lung, mediastinal/cervical lymph node, liver,&#xD;
             spinal/paraspinal, osseous, and abdominal-pelvic&#xD;
&#xD;
               -  NOTE: after the required number of evaluable patients have been accrued for a&#xD;
                  given dose level, the accrual for that metastatic location will be temporarily&#xD;
                  suspended while the safety of that dose level is assessed; a patient can only be&#xD;
                  entered onto the trial if all of their metastatic locations are open to accrual&#xD;
                  (e.g. if central lung is temporarily suspended for safety assessment and the&#xD;
                  patient has a central lung metastases, regardless of other metastases, they&#xD;
                  cannot enroll until the safety of dose to central lung is determined)&#xD;
&#xD;
          -  Primary tumor site without progression at registration&#xD;
&#xD;
          -  All metastases not resected must be amenable to SBRT&#xD;
&#xD;
          -  The patient must meet ONE of the three following criteria:&#xD;
&#xD;
               -  3-4 radiographically distinct metastases of any distribution in the allowed&#xD;
                  anatomical sites OR&#xD;
&#xD;
               -  2 radiographically distinct metastases that must be anatomically close (i.e.,&#xD;
                  with less than or equal to 5 cm of normal tissue between them) OR&#xD;
&#xD;
               -  3 or 4 distinct metastasis, 2 or 3 to be treated with SBRT and the other (s)&#xD;
                  having been surgically removed&#xD;
&#xD;
          -  Evaluation by a radiation oncologist within 45 days prior to study registration&#xD;
&#xD;
          -  Evaluation by a medical oncologist within 45 days prior to study registration&#xD;
&#xD;
          -  The following imaging workup to document metastases within 45 days prior to study&#xD;
             registration:&#xD;
&#xD;
               -  Computed tomography (CT) scans of the chest, abdomen and pelvis with radionuclide&#xD;
                  bone scan OR whole body positron emission tomography (PET)/CT&#xD;
&#xD;
          -  History/physical examination within 45 days prior to study registration&#xD;
&#xD;
          -  Zubrod performance status =&lt; 2 within 45 days prior to study registration&#xD;
&#xD;
          -  Age &gt;= 18 years&#xD;
&#xD;
          -  Absolute neutrophil count (ANC) &gt;= 500 cells/mm^3&#xD;
&#xD;
          -  Platelets &gt;= 50,000 /mm^3&#xD;
&#xD;
          -  Hemoglobin &gt;= 8.0 g/dl (Note: the use of transfusion or other intervention to achieve&#xD;
             hemoglobin [Hgb] &gt;= 8.0 g/dl is acceptable)&#xD;
&#xD;
          -  If liver metastases present, aspartate aminotransferase (AST) and alanine&#xD;
             aminotransferase (ALT) must be &lt; 3 x upper limit of normal (ULN)&#xD;
&#xD;
          -  Patient must provide study specific informed consent prior to study entry&#xD;
&#xD;
          -  For females of child-bearing potential, negative serum/urine pregnancy test within 14&#xD;
             days prior to study registration&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Progression of primary tumor site (breast, prostate, or lung) at time of registration&#xD;
&#xD;
          -  Metastases with indistinct borders making targeting not feasible&#xD;
&#xD;
          -  Known brain metastases&#xD;
&#xD;
          -  Prior palliative radiotherapy to metastases&#xD;
&#xD;
          -  Metastases located within 3 cm of the previously irradiated structures:&#xD;
&#xD;
               -  Spinal cord previously irradiated to &gt; 40 Gy (delivered in =&lt; 3 Gy/fraction)&#xD;
&#xD;
               -  Brachial plexus previously irradiated to &gt; 50 Gy (delivered in =&lt; 3 Gy/fraction)&#xD;
&#xD;
               -  Small intestine, large intestine, or stomach previously irradiated to &gt; 45 Gy&#xD;
                  (delivered in =&lt; 3 Gy/fraction)&#xD;
&#xD;
               -  Brain stem previously irradiated to &gt; 50 Gy (delivered in =&lt; 3 Gy/fraction)&#xD;
&#xD;
               -  Whole lung previously irradiated with prior volume 20 Gy (V20Gy) &gt; 30% (delivered&#xD;
                  in =&lt; 3 Gy/fraction)&#xD;
&#xD;
               -  Primary tumor irradiated with SBRT&#xD;
&#xD;
               -  Metastasis irradiated with SBRT&#xD;
&#xD;
          -  Severe, active co-morbidity, defined as follows:&#xD;
&#xD;
               -  Unstable angina and/or congestive heart failure requiring hospitalization within&#xD;
                  the last 6 months prior to registration&#xD;
&#xD;
               -  Transmural myocardial infarction within the last 6 months prior to registration&#xD;
&#xD;
               -  Acute bacterial or fungal infection requiring intravenous antibiotics at the time&#xD;
                  of registration&#xD;
&#xD;
               -  Chronic obstructive pulmonary disease exacerbation or other respiratory illness&#xD;
                  requiring hospitalization or precluding study therapy within 30 days prior to&#xD;
                  registration&#xD;
&#xD;
               -  Severe hepatic disease, defined as a diagnosis of Child-Pugh class B or C hepatic&#xD;
                  disease&#xD;
&#xD;
               -  Human immunodeficiency virus (HIV) positive with cluster of differentiation (CD)&#xD;
                  4 count &lt; 200 cells/microliter; note that patients who are HIV positive are&#xD;
                  eligible, provided they are under treatment with highly active antiretroviral&#xD;
                  therapy (HAART) and have a CD4 count &gt;= 200 cells/microliter within 30 days prior&#xD;
                  to registration; note also that HIV testing is not required for eligibility for&#xD;
                  this protocol&#xD;
&#xD;
               -  End-stage renal disease (i.e., on dialysis or dialysis has been recommended)&#xD;
&#xD;
          -  Pregnancy or women of childbearing potential not willing/able to use medically&#xD;
             acceptable forms of contraception during protocol treatment or for at least 6 months&#xD;
             following treatment&#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>Steven Chmura</last_name>
    <role>Principal Investigator</role>
    <affiliation>NRG Oncology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alabama at Birmingham Cancer Center</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35233</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arizona Center for Cancer Care-Peoria</name>
      <address>
        <city>Peoria</city>
        <state>Arizona</state>
        <zip>85381</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Banner University Medical Center - Tucson</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85719</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City of Hope Comprehensive Cancer Center</name>
      <address>
        <city>Duarte</city>
        <state>California</state>
        <zip>91010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UC San Diego Moores Cancer Center</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>USC / Norris Comprehensive Cancer Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sutter Medical Center Sacramento</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95816</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California Davis Comprehensive Cancer Center</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado Hospital</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Poudre Valley Hospital</name>
      <address>
        <city>Fort Collins</city>
        <state>Colorado</state>
        <zip>80524</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Florida Health Science Center - Gainesville</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Florida Health Science Center - Jacksonville</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Miami Miller School of Medicine-Sylvester Cancer Center</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Grady Health System</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University Hospital Midtown</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University Hospital/Winship Cancer Institute</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwest Community Hospital</name>
      <address>
        <city>Arlington Heights</city>
        <state>Illinois</state>
        <zip>60005</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Chicago Comprehensive Cancer Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Decatur Memorial Hospital</name>
      <address>
        <city>Decatur</city>
        <state>Illinois</state>
        <zip>62526</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Loyola University Medical Center</name>
      <address>
        <city>Maywood</city>
        <state>Illinois</state>
        <zip>60153</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OSF Saint Francis Medical Center</name>
      <address>
        <city>Peoria</city>
        <state>Illinois</state>
        <zip>61637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Medical Center</name>
      <address>
        <city>Springfield</city>
        <state>Illinois</state>
        <zip>62781</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southwest Illinois Health Services LLP</name>
      <address>
        <city>Swansea</city>
        <state>Illinois</state>
        <zip>62226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Vincent Anderson Regional Hospital/Cancer Center</name>
      <address>
        <city>Anderson</city>
        <state>Indiana</state>
        <zip>46016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Parkview Hospital Randallia</name>
      <address>
        <city>Fort Wayne</city>
        <state>Indiana</state>
        <zip>46805</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IU Health Methodist Hospital</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Iowa Methodist Medical Center</name>
      <address>
        <city>Des Moines</city>
        <state>Iowa</state>
        <zip>50309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Iowa/Holden Comprehensive Cancer Center</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ascension Via Christi Hospitals Wichita</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67214</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Kentucky/Markey Cancer Center</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40536</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The James Graham Brown Cancer Center at University of Louisville</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Maryland/Greenebaum Cancer Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UM Upper Chesapeake Medical Center</name>
      <address>
        <city>Bel Air</city>
        <state>Maryland</state>
        <zip>21014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Walter Reed National Military Medical Center</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20889-5600</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boston Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Michigan Comprehensive Cancer Center</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GenesisCare USA - Clarkston</name>
      <address>
        <city>Clarkston</city>
        <state>Michigan</state>
        <zip>48346</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry Ford Hospital</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GenesisCare USA - Farmington Hills</name>
      <address>
        <city>Farmington Hills</city>
        <state>Michigan</state>
        <zip>48334</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McLaren Cancer Institute-Flint</name>
      <address>
        <city>Flint</city>
        <state>Michigan</state>
        <zip>48532</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McLaren Cancer Institute-Macomb</name>
      <address>
        <city>Mount Clemens</city>
        <state>Michigan</state>
        <zip>48043</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McLaren Cancer Institute-Northern Michigan</name>
      <address>
        <city>Petoskey</city>
        <state>Michigan</state>
        <zip>49770</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Joseph Mercy Oakland</name>
      <address>
        <city>Pontiac</city>
        <state>Michigan</state>
        <zip>48341</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GenesisCare USA - Troy</name>
      <address>
        <city>Troy</city>
        <state>Michigan</state>
        <zip>48098</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry Ford West Bloomfield Hospital</name>
      <address>
        <city>West Bloomfield</city>
        <state>Michigan</state>
        <zip>48322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Hospital</name>
      <address>
        <city>Coon Rapids</city>
        <state>Minnesota</state>
        <zip>55433</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Nebraska Medical Center</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68198</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virtua Memorial</name>
      <address>
        <city>Mount Holly</city>
        <state>New Jersey</state>
        <zip>08060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cooper CyberKnife Center</name>
      <address>
        <city>Mount Laurel</city>
        <state>New Jersey</state>
        <zip>08054</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Community Medical Center</name>
      <address>
        <city>Toms River</city>
        <state>New Jersey</state>
        <zip>08755</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virtua Voorhees</name>
      <address>
        <city>Voorhees</city>
        <state>New Jersey</state>
        <zip>08043</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of New Mexico Cancer Center</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montefiore Medical Center - Moses Campus</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10467</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwell Health/Center for Advanced Medicine</name>
      <address>
        <city>Lake Success</city>
        <state>New York</state>
        <zip>11042</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Rochester</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Forest University Health Sciences</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Cincinnati Cancer Center-UC Medical Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ohio State University Comprehensive Cancer Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Cincinnati Cancer Center-West Chester</name>
      <address>
        <city>West Chester</city>
        <state>Ohio</state>
        <zip>45069</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Legacy Good Samaritan Hospital and Medical Center</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Delaware County Memorial Hospital</name>
      <address>
        <city>Drexel Hill</city>
        <state>Pennsylvania</state>
        <zip>19026</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Reading Hospital</name>
      <address>
        <city>West Reading</city>
        <state>Pennsylvania</state>
        <zip>19611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Self Regional Healthcare</name>
      <address>
        <city>Greenwood</city>
        <state>South Carolina</state>
        <zip>29646</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ogden Regional Medical Center</name>
      <address>
        <city>Ogden</city>
        <state>Utah</state>
        <zip>84405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Huntsman Cancer Institute/University of Utah</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gundersen Lutheran Medical Center</name>
      <address>
        <city>La Crosse</city>
        <state>Wisconsin</state>
        <zip>54601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical College of Wisconsin</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zablocki Veterans Administration Medical Center</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53295</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cross Cancer Institute</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 1Z2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHUM - Hopital Notre-Dame</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H2L 4M1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHUM - Centre Hospitalier de l'Universite de Montreal</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H2X 3E4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jewish General Hospital</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3T 1E2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kantonsspital Aarau</name>
      <address>
        <city>Aarau</city>
        <zip>5001</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>Switzerland</country>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>July 30, 2014</study_first_submitted>
  <study_first_submitted_qc>July 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 1, 2014</study_first_posted>
  <last_update_submitted>May 23, 2022</last_update_submitted>
  <last_update_submitted_qc>May 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 25, 2022</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>Breast Neoplasms</mesh_term>
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Prostatic Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
    <mesh_term>Breast Neoplasms, Male</mesh_term>
    <mesh_term>Recurrence</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/NCT02206334
org study id: NRG-BR001
secondary id: NCI-2014-00702
secondary id: NRG-BR001
secondary id: NRG-BR001
secondary id: U10CA180868
secondary id: U10CA021661
nct id: NCT02206334
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This phase I trial studies the side effects and the best dose of stereotactic body radiation
      therapy in treating patients with breast cancer, non-small cell lung cancer, or prostate
      cancer that has spread to other parts of the body. Stereotactic body radiation therapy
      delivers fewer, tightly-focused, high doses of radiation therapy to all known sites of cancer
      in the body while minimizing radiation exposure of surrounding normal tissue.
PRIMARY OBJECTIVES:

      I. To determine the recommended stereotactic body radiation therapy (SBRT) dose for each of
      the metastatic locations being treated given the individual and overlapping fields when
      multiple metastases are treated with SBRT in a national clinical trials network setting.

      SECONDARY OBJECTIVES:

      I. To estimate rates of >= grade 3 Common Terminology Criteria for Adverse Events (CTCAE),
      version (v.) 4.0 adverse events other than a dose-limiting toxicity (DLT) which is possibly,
      probably, or definitely related to treatment and which occurs within 6 months from the start
      of SBRT to multiple metastases.

      II. To estimate the rates of long-term adverse events occurring up to 2 years from the end of
      SBRT.

      III. To explore the most appropriate and clinically relevant technological parameters to
      ensure quality and effectiveness throughout radiation therapy processes, including imaging,
      simulation, patient immobilization, target and critical structure definition, treatment
      planning, image guidance and delivery.

      OUTLINE:

      Patients undergo 3-5 fractions of image-guided stereotactic body radiation therapy to all
      existing metastases over 1-3 weeks with at least 40 hours between treatments for an
      individual metastasis.

      After completion of study treatment, patients are followed up at 35-45 days and then every 3
      months for 2 years.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Dose-limiting toxicity (DLT) scored according to the National Cancer Institute (NCI) CTCAE version 4.0 for each of 7 metastatic locations when multiple metastases are treated with SBRT
time frame: Within 6 months from the start of treatment; for each of the 7 metastatic locations, analysis occurs after 6 evaluable patients have been followed for a minimum of 6 months from the start of treatment
description: Adverse events outlined by metastatic location (full detail in protocol) reported as being probably or definitely related to protocol treatment.
measure: Rate of long-term adverse events, scored according to the NCI CTCAE v. 4.0
time frame: Up to 2 years from end of treatment; analysis occurs after all patients have been potentially followed for 2 years from registration
description: Adverse events reported as being possibly, probably, or definitely related to protocol treatment.
measure: Rates of >= grade 3 adverse events, scored according to NCI CTCAE v. 4.0
time frame: Within 6 months from the start of treatment; analysis occurs after all patients have been followed for a minimum of 6 months from the start of treatment
description: Adverse events (other than DLTs) reported as being possibly, probably, or definitely related to protocol treatment.
arm group label: Stereotactic Body Radiation Therapy (SBRT)
arm group type: Experimental
description: Patients undergo 3-5 fractions of image-guided stereotactic body radiation therapy to all existing metastases over 1-3 weeks with at least 40 hours between treatments for an individual metastasis.
intervention type: Radiation
intervention name: Stereotactic Body Radiation Therapy (SBRT)
description: Undergo SBRT
arm group label: Stereotactic Body Radiation Therapy (SBRT)
other name: Stereotactic External Beam Irradiation
other name: stereotactic external-beam radiation therapy
other name: Stereotactic Radiation Therapy
other name: stereotactic radiosurgery
other name: Stereotactic Radiotherapy
other name: stereotaxic radiation therapy
other name: stereotaxic radiosurgery
other name: SBRT
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Steven Chmura
role: Principal Investigator
affiliation: NRG Oncology
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country: Canada
country: Switzerland
country: United States
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Breast Neoplasms
mesh term: Lung Neoplasms
mesh term: Prostatic Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Breast Neoplasms, Male
mesh term: Recurrence