<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/NCT02984761</url>
  </required_header>
  <id_info>
    <org_study_id>2005</org_study_id>
    <nct_id>NCT02984761</nct_id>
  </id_info>
  <brief_title>Veterans Affairs Lung Cancer Surgery Or Stereotactic Radiotherapy</brief_title>
  <acronym>VALOR</acronym>
  <official_title>CSP #2005 - Veterans Affairs Lung Cancer Surgery Or Stereotactic Radiotherapy Trial (VALOR)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Office of Research and Development</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VA Office of Research and Development</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_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients with stage I non-small cell lung cancer have been historically treated with surgery&#xD;
      whenever they are fit for an operation. However, an alternative treatment known as&#xD;
      stereotactic radiotherapy now appears to offer an equally effective alternative. Doctors&#xD;
      believe both are good treatments and are therefore conducting this study to determine if one&#xD;
      may be possibly better than the other.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The standard of care for stage I non-small cell lung cancer has historically been surgical&#xD;
      resection in patients who are medically fit to tolerate an operation. Recent data now&#xD;
      suggests that stereotactic radiotherapy may be a suitable alternative. This includes the&#xD;
      results from a pooled analysis of two incomplete phase III studies that reported a 15%&#xD;
      overall survival advantage with stereotactic radiotherapy at 3 years. While these data are&#xD;
      promising, the median follow-up period was short, the results underpowered, and the findings&#xD;
      were in contradiction to multiple retrospective studies that demonstrate the outcomes with&#xD;
      surgery are likely equal or superior. Therefore, the herein trial aims to evaluate these two&#xD;
      treatments in a prospective randomized fashion with a goal to compare the overall survival&#xD;
      beyond 5 years. It has been designed to enroll patients who have a long life-expectancy, and&#xD;
      are fit enough to tolerate an anatomic pulmonary resection with intraoperative lymph node&#xD;
      sampling.&#xD;
&#xD;
      This study is designed to open at Veterans Affairs medical centers with expertise in both&#xD;
      treatments. The recruitment process includes shared decision making and multi-disciplinary&#xD;
      evaluations with lung cancer specialists. Mandatory evaluations before randomization include&#xD;
      tissue confirmation of NSCLC, staging with FDG-PET/CT, and biopsies of all hilar and/or&#xD;
      mediastinal lymph nodes &gt;10mm that have a SUV &gt;2.5. Pre-randomization elective lymph node&#xD;
      sampling is strongly encouraged, but not required. Following treatment, patients will be&#xD;
      followed for a minimum of 5 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 13, 2017</start_date>
  <completion_date type="Anticipated">September 30, 2027</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2026</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>From date of randomization through study completion, up to 10 years</time_frame>
    <description>Survival estimates will include death from any cause.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient reported health-related quality of life</measure>
    <time_frame>5 years</time_frame>
    <description>The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and Lung Cancer (LC 13) survey instruments will assess patients' general state of physical, social/family, emotional and functional well-being.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Respiratory Function</measure>
    <time_frame>5 years</time_frame>
    <description>The St George's Respiratory Questionnaire will evaluate respiratory symptoms, activity limitations from breathlessness, and impact of respiratory function on social and psychological functioning.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health State Utilities</measure>
    <time_frame>5 years</time_frame>
    <description>The EQ-5D-5L (EuroQOL-5D) survey will measure quality adjusted life years.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lung cancer mortality</measure>
    <time_frame>From date of randomization until date of death from any cause, assessed up to 10 years.</time_frame>
    <description>Cause of death will be determined by an independent adjudication committee.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tumor patterns of failure</measure>
    <time_frame>5 years</time_frame>
    <description>Post-treatment surveillance imaging will evaluate patients every 6 months for local, regional, and/or distant disease control.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Respiratory Function</measure>
    <time_frame>5 years</time_frame>
    <description>The Forced Expiratory Volume at 1 second (FEV1) will evaluate an objective measure of breathing function.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">670</enrollment>
  <condition>Lung Neoplasm</condition>
  <arm_group>
    <arm_group_label>Stereotactic radiotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Stereotactic radiotherapy is an FDA approved treatment for lung cancer. However, for purposes of this study, it is being delivered to an operable population that is typically treated with surgical resection. Participants randomized to stereotactic radiotherapy will be treated according to the location of the tumor. Peripheral tumors will receive either 18 Gy x 3, 14 Gy x 4, or 11.5 Gy x 5 fractions, while central tumors will be treated with 10 Gy x 5. There will not be any elective coverage of local microscopic spread or regional lymph nodes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Surgery</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants randomized to surgery will undergo a standard lobectomy or limited anatomic pulmonary resection (segmentectomy) under general anesthesia. Non-anatomic (wedge) resections are not permitted. Pathological specimens must contain a separately divided pulmonary artery and bronchus, as well as sampled lymph nodes from mediastinal lymph node stations. Participants found to have incidental nodal involvement after surgery will be referred for adjuvant chemotherapy, with our without postoperative radiotherapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Stereotactic Radiotherapy</intervention_name>
    <description>Stereotactic radiotherapy uses high doses of ionizing energy to treat cancer cells with image guidance. The treatment is delivered in an outpatient setting, and for purposes of this trial is delivered in 3-5 fractions.</description>
    <arm_group_label>Stereotactic radiotherapy</arm_group_label>
    <other_name>Stereotactic Body Radiation Therapy (SBRT) or Stereotactic Ablative Radiotherapy (SAbR)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Anatomic Pulmonary Resection</intervention_name>
    <description>An anatomic pulmonary resection is an oncologic procedure that dissects out an anatomically defined segment of the lung to remove all of the lung tissue around a lung tumor. It requires an operation with general anesthesia, with a short hospital stay. The procedure entails removal of lymph nodes inside the chest that might not be easily accessible without an operation.</description>
    <arm_group_label>Surgery</arm_group_label>
    <other_name>Lobectomy or Anatomic Segmentectomy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Inclusion Criteria for Screening&#xD;
&#xD;
          -  Age 18 or older&#xD;
&#xD;
          -  Any patient with a preliminary diagnosis of stage I Non-Small Cell Lung Cancer&#xD;
             (NSCLC), whether pathologically proven by biopsy, or highly suspicious by radiographic&#xD;
             imaging. [Participants will ultimately need biopsy confirmation before enrolling]&#xD;
&#xD;
          -  Primary tumor size less than or equal to 5 cm by CT (may include CT images from&#xD;
             PET/CT)&#xD;
&#xD;
          -  Karnofsky performance status greater than or equal to 70&#xD;
&#xD;
          -  Participant has willingness and ability to provided informed consent for participation&#xD;
&#xD;
        Inclusion Criteria for Randomization&#xD;
&#xD;
          -  Biopsy proven non-small cell lung cancer&#xD;
&#xD;
          -  Participant's case reviewed at multidisciplinary conference&#xD;
&#xD;
          -  Tumor size less than or equal to 5cm (measured on the most recent CT images available,&#xD;
             and may include PET/CT images)&#xD;
&#xD;
          -  Tumor is equal to or greater than 1.0cm from the trachea, esophagus, brachial plexus,&#xD;
             1st bifurcation of the proximal bronchial tree, or spinal cord (measured on the most&#xD;
             recent CT images available, and may include PET/CT images).&#xD;
&#xD;
          -  Mandatory FDG-PET/CT within 60 days of the randomization date (note: FDG-PET/CT may&#xD;
             need to be repeated prior to treatment if outside of this requirement)&#xD;
&#xD;
          -  Mandatory pathological assessment of any lymph nodes &gt;10mm with a SUV &gt;2.5 seen on&#xD;
             FDG- PET/CT&#xD;
&#xD;
          -  Mandatory biopsy of any additional concerning lesions seen on FDG-PET/CT, to make&#xD;
             better determination that the patient is not harboring metastatic disease or a&#xD;
             secondary primary malignancy.&#xD;
&#xD;
          -  Pre-operative FEV1 greater than or equal to 40% of predicted value and pre-operative&#xD;
             DLCO greater than or equal to 40% of predicted value.&#xD;
&#xD;
          -  Formally evaluated and documented by a local thoracic surgeon to be medically fit to&#xD;
             undergo a complete anatomic pulmonary resection (wedge resection not allowed)&#xD;
&#xD;
          -  Formally evaluated and documented by a local radiation oncologist to be eligible to&#xD;
             receive protocol-defined stereotactic radiotherapy&#xD;
&#xD;
          -  Participant willingness to be randomized&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Exclusion Criteria for Screening&#xD;
&#xD;
          -  Previously evaluated by a local thoracic surgeon and determined to be medically&#xD;
             inoperable&#xD;
&#xD;
          -  Pathological confirmation of nodal or distant metastasis&#xD;
&#xD;
          -  Prior history of lung cancer, not including current lesion&#xD;
&#xD;
          -  Prior history of thoracic surgery or lung or esophageal cancer. [prior cardiac surgery&#xD;
             acceptable]&#xD;
&#xD;
          -  Prior history of radiotherapy to the thorax&#xD;
&#xD;
          -  Prior history of an invasive malignancy within the past 5 years, whether newly&#xD;
             diagnosed or recurrent, excluding low-risk prostate cancer, non-melanoma skin cancers,&#xD;
             and in-situ cancers&#xD;
&#xD;
          -  Ever diagnosed with stage IV metastatic cancer of any type&#xD;
&#xD;
          -  History of scleroderma&#xD;
&#xD;
          -  Positive Pregnancy test (for women &lt;61 years of age or without prior hysterectomy)&#xD;
&#xD;
        Exclusion Criteria for Randomization&#xD;
&#xD;
          -  Pathological confirmation of nodal or metastatic disease&#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>Drew Moghanaki, MD MPH</last_name>
    <role>Study Chair</role>
    <affiliation>VA Greater Los Angeles Healthcare System, West Los Angeles, CA</affiliation>
  </overall_official>
  <overall_official>
    <last_name>David H Harpole, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Durham VA Medical Center, Durham, NC</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Cheryl C Odle, MBA</last_name>
    <phone>(708) 202-8387</phone>
    <phone_ext>23117</phone_ext>
    <email>cheryl.odle@va.gov</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Matt Leiner, MS</last_name>
    <phone>(708) 202-5853</phone>
    <email>Matt.Leiner@va.gov</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>VA Long Beach Healthcare System, Long Beach, CA</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90822</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bahman Saatian, MD</last_name>
      <phone>562-826-5591</phone>
      <email>bahman.saatian@va.gov</email>
    </contact>
    <contact_backup>
      <last_name>Gelincik K Orakcilar, MS</last_name>
      <phone>5628268000</phone>
      <phone_ext>24172</phone_ext>
      <email>gelincik.orakcilar@va.gov</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>VA Greater Los Angeles Healthcare System, West Los Angeles, CA</name>
      <address>
        <city>West Los Angeles</city>
        <state>California</state>
        <zip>90073-1003</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Drew Moghanaki, MD MPH</last_name>
      <phone>804-306-9045</phone>
      <email>Drew.Moghanaki@va.gov</email>
    </contact>
    <contact_backup>
      <last_name>Vicki L Skinner, RN</last_name>
      <phone>(894) 675-5105</phone>
      <email>vicki.skinner@va.gov</email>
    </contact_backup>
    <investigator>
      <last_name>Drew Moghanaki, MD MPH</last_name>
      <role>Study Chair</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Bay Pines VA Healthcare System, Pay Pines, FL</name>
      <address>
        <city>Bay Pines</city>
        <state>Florida</state>
        <zip>33744</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Edward Hong, MD</last_name>
      <phone>727-398-6661</phone>
      <phone_ext>6661</phone_ext>
      <email>edward.hong@va.gov</email>
    </contact>
    <contact_backup>
      <last_name>Ryan J Burri, MD</last_name>
      <phone>7273986661</phone>
      <phone_ext>13912</phone_ext>
      <email>ryan.burri@va.gov</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Miami VA Healthcare System, Miami, FL</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33125</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gregory Holt, MD</last_name>
      <phone>305-575-7000</phone>
      <phone_ext>3227</phone_ext>
      <email>gregory.holt@va.gov</email>
    </contact>
    <contact_backup>
      <last_name>Jalima Quintero</last_name>
      <phone>3059928621</phone>
      <email>Jalima.Quintero@va.gov</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Edward Hines Jr. VA Hospital, Hines, IL</name>
      <address>
        <city>Hines</city>
        <state>Illinois</state>
        <zip>60141-5000</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cheryl Czerlanis, MD</last_name>
      <email>Cheryl.Czerlanis@va.gov</email>
    </contact>
    <contact_backup>
      <last_name>Eliza Kintanar, RN</last_name>
      <email>Eliza.kintanar@va.gov</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Richard L. Roudebush VA Medical Center, Indianapolis, IN</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202-2884</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Catherine Sears, MD</last_name>
      <email>Catherine.Sears@va.gov</email>
    </contact>
    <contact_backup>
      <last_name>Sharon Henson, RN</last_name>
      <email>Sharon.Henson@va.gov</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Janaki Deepak, MD</last_name>
      <phone>410-605-7000</phone>
      <email>Janaki.Deepak@va.gov</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02130</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ronald Goldstein, MD</last_name>
      <phone>857-203-6478</phone>
      <email>ronald.goldstein@va.gov</email>
    </contact>
    <contact_backup>
      <last_name>Kathleen Lacerda</last_name>
      <phone>8572036295</phone>
      <email>Kathleen.Lacerda@va.gov</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>VA Ann Arbor Healthcare System, Ann Arbor, MI</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48105</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jane Deng, MD</last_name>
      <phone>734-845-3039</phone>
      <email>Jane.deng@va.gov</email>
    </contact>
    <contact_backup>
      <last_name>David Elliott, MD</last_name>
      <phone>7348453914</phone>
      <email>David.Elliott1@va.gov</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Minneapolis VA Health Care System, Minneapolis, MN</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55417</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Erin Wetherbee, MD</last_name>
      <email>Erin.Wetherbee.@va.gov</email>
    </contact>
    <contact_backup>
      <last_name>Taira Miller</last_name>
      <email>Taira.Miller1@va.gov</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Durham VA Medical Center, Durham, NC</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27705</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Scott Shofer, MD</last_name>
      <email>Scott.Shofer@va.gov</email>
    </contact>
    <contact_backup>
      <last_name>Melissa A Wagner, BS</last_name>
      <phone>9192860411</phone>
      <phone_ext>7599</phone_ext>
      <email>melissa.wagner2@va.gov</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Louis Stokes VA Medical Center, Cleveland, OH</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Charles Nock, MD</last_name>
      <phone>216-791-3800</phone>
      <phone_ext>64825</phone_ext>
      <email>charles.nock@va.gov</email>
    </contact>
    <contact_backup>
      <last_name>Lisa Tucker</last_name>
      <phone>2167913800</phone>
      <phone_ext>63595</phone_ext>
      <email>Lisa.Tucker@va.gov</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anil Vachani, MD</last_name>
      <phone>215-823-5800</phone>
      <email>Anil.vachani@va.gov</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15240</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Charles W Atwood, MD</last_name>
      <phone>412-360-6316</phone>
      <email>charles.atwood@va.gov</email>
    </contact>
    <contact_backup>
      <last_name>Gregory A Owens, BA</last_name>
      <phone>4123601517</phone>
      <email>gregory.owens@va.gov</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Michael E. DeBakey VA Medical Center, Houston, TX</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lorraine Cornwell, MD</last_name>
      <email>Lorraine.Cornwell@va.gov</email>
    </contact>
    <contact_backup>
      <last_name>Adriana M Rueda, MS</last_name>
      <phone>7137947459</phone>
      <email>Adriana.Rueda@va.gov</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Hunter Holmes McGuire VA Medical Center, Richmond, VA</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23249</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Clement J. Zablocki VA Medical Center, Milwaukee, WI</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53295-1000</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andreea Anton, MD</last_name>
      <phone>414-384-2000</phone>
      <phone_ext>42895</phone_ext>
      <email>Andreea.Anton@va.gov</email>
    </contact>
    <contact_backup>
      <last_name>Angela Ogle</last_name>
      <email>Angela.Ogle@va.gov</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>November 30, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>February 10, 2023</last_update_submitted>
  <last_update_submitted_qc>February 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Carcinoma, Non-Small Cell Lung</keyword>
  <keyword>Respiratory Tract Neoplasms</keyword>
  <keyword>Thoracic Neoplasms</keyword>
  <keyword>Neoplasms by Site</keyword>
  <keyword>Neoplasms</keyword>
  <keyword>Lung Diseases</keyword>
  <keyword>Respiratory Tract Diseases</keyword>
  <keyword>Carcinoma, Bronchogenic</keyword>
  <keyword>Bronchial Neoplasms</keyword>
  <keyword>Radiosurgery</keyword>
  <keyword>Radiotherapy</keyword>
  <keyword>Radiotherapy, Image-Guided</keyword>
  <keyword>Lung Neoplasms</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Lung 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/NCT02984761
org study id: 2005
nct id: NCT02984761
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
Patients with stage I non-small cell lung cancer have been historically treated with surgery
      whenever they are fit for an operation. However, an alternative treatment known as
      stereotactic radiotherapy now appears to offer an equally effective alternative. Doctors
      believe both are good treatments and are therefore conducting this study to determine if one
      may be possibly better than the other.
The standard of care for stage I non-small cell lung cancer has historically been surgical
      resection in patients who are medically fit to tolerate an operation. Recent data now
      suggests that stereotactic radiotherapy may be a suitable alternative. This includes the
      results from a pooled analysis of two incomplete phase III studies that reported a 15%
      overall survival advantage with stereotactic radiotherapy at 3 years. While these data are
      promising, the median follow-up period was short, the results underpowered, and the findings
      were in contradiction to multiple retrospective studies that demonstrate the outcomes with
      surgery are likely equal or superior. Therefore, the herein trial aims to evaluate these two
      treatments in a prospective randomized fashion with a goal to compare the overall survival
      beyond 5 years. It has been designed to enroll patients who have a long life-expectancy, and
      are fit enough to tolerate an anatomic pulmonary resection with intraoperative lymph node
      sampling.

      This study is designed to open at Veterans Affairs medical centers with expertise in both
      treatments. The recruitment process includes shared decision making and multi-disciplinary
      evaluations with lung cancer specialists. Mandatory evaluations before randomization include
      tissue confirmation of NSCLC, staging with FDG-PET/CT, and biopsies of all hilar and/or
      mediastinal lymph nodes >10mm that have a SUV >2.5. Pre-randomization elective lymph node
      sampling is strongly encouraged, but not required. Following treatment, patients will be
      followed for a minimum of 5 years.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall Survival
time frame: From date of randomization through study completion, up to 10 years
description: Survival estimates will include death from any cause.
measure: Patient reported health-related quality of life
time frame: 5 years
description: The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and Lung Cancer (LC 13) survey instruments will assess patients' general state of physical, social/family, emotional and functional well-being.
measure: Respiratory Function
time frame: 5 years
description: The St George's Respiratory Questionnaire will evaluate respiratory symptoms, activity limitations from breathlessness, and impact of respiratory function on social and psychological functioning.
measure: Health State Utilities
time frame: 5 years
description: The EQ-5D-5L (EuroQOL-5D) survey will measure quality adjusted life years.
measure: Lung cancer mortality
time frame: From date of randomization until date of death from any cause, assessed up to 10 years.
description: Cause of death will be determined by an independent adjudication committee.
measure: Tumor patterns of failure
time frame: 5 years
description: Post-treatment surveillance imaging will evaluate patients every 6 months for local, regional, and/or distant disease control.
measure: Respiratory Function
time frame: 5 years
description: The Forced Expiratory Volume at 1 second (FEV1) will evaluate an objective measure of breathing function.
arm group label: Stereotactic radiotherapy
arm group type: Experimental
description: Stereotactic radiotherapy is an FDA approved treatment for lung cancer. However, for purposes of this study, it is being delivered to an operable population that is typically treated with surgical resection. Participants randomized to stereotactic radiotherapy will be treated according to the location of the tumor. Peripheral tumors will receive either 18 Gy x 3, 14 Gy x 4, or 11.5 Gy x 5 fractions, while central tumors will be treated with 10 Gy x 5. There will not be any elective coverage of local microscopic spread or regional lymph nodes.
arm group label: Surgery
arm group type: Active Comparator
description: Participants randomized to surgery will undergo a standard lobectomy or limited anatomic pulmonary resection (segmentectomy) under general anesthesia. Non-anatomic (wedge) resections are not permitted. Pathological specimens must contain a separately divided pulmonary artery and bronchus, as well as sampled lymph nodes from mediastinal lymph node stations. Participants found to have incidental nodal involvement after surgery will be referred for adjuvant chemotherapy, with our without postoperative radiotherapy.
intervention type: Radiation
intervention name: Stereotactic Radiotherapy
description: Stereotactic radiotherapy uses high doses of ionizing energy to treat cancer cells with image guidance. The treatment is delivered in an outpatient setting, and for purposes of this trial is delivered in 3-5 fractions.
arm group label: Stereotactic radiotherapy
other name: Stereotactic Body Radiation Therapy (SBRT) or Stereotactic Ablative Radiotherapy (SAbR)
intervention type: Procedure
intervention name: Anatomic Pulmonary Resection
description: An anatomic pulmonary resection is an oncologic procedure that dissects out an anatomically defined segment of the lung to remove all of the lung tissue around a lung tumor. It requires an operation with general anesthesia, with a short hospital stay. The procedure entails removal of lymph nodes inside the chest that might not be easily accessible without an operation.
arm group label: Surgery
other name: Lobectomy or Anatomic Segmentectomy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Drew Moghanaki, MD MPH
role: Study Chair
affiliation: VA Greater Los Angeles Healthcare System, West Los Angeles, CA
last name: David H Harpole, MD
role: Study Chair
affiliation: Durham VA Medical Center, Durham, NC
last name: Cheryl C Odle, MBA
phone: (708) 202-8387
phone ext: 23117
email: cheryl.odle@va.gov
last name: Matt Leiner, MS
phone: (708) 202-5853
email: Matt.Leiner@va.gov
facility: 
status: Recruiting
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status: Terminated
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country: United States
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Lung Neoplasms
sharing ipd: No