<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/NCT01725165</url>
  </required_header>
  <id_info>
    <org_study_id>2012-0618</org_study_id>
    <secondary_id>NCI-2012-02874</secondary_id>
    <secondary_id>2012-0618</secondary_id>
    <secondary_id>P30CA016672</secondary_id>
    <nct_id>NCT01725165</nct_id>
  </id_info>
  <brief_title>Surgery and/or Radiation Therapy or Standard Therapy and/or Clinical Observation in Treating Patients With Previously Treated Stage IV Non-small Cell Lung Cancer</brief_title>
  <official_title>A Randomized Phase II Study Assessing the Efficacy of Local Consolidative Therapy for Non-Small Cell Lung Cancer Patients With Induced Oligometastatic Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>M.D. Anderson Cancer Center</source>
  <brief_summary>
    <textblock>
      This randomized phase II trial studies how well surgery and/or radiation therapy or standard&#xD;
      therapy and/or clinical observation works in treating patients with previously treated stage&#xD;
      IV non-small cell lung cancer. Radiation therapy uses high energy x-rays to kill tumor cells.&#xD;
      Giving surgery and/or radiation therapy may be more effective than standard therapy and/or&#xD;
      clinical observation in patients with previously treated non-small cell lung cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. Determine whether oligometastatic non-small cell lung cancer (NSCLC) patients with no&#xD;
      disease progression after first line therapy have prolonged progression free survival (PFS)&#xD;
      when treated with local consolidation therapy (LCT) of residual disease (radiation or&#xD;
      surgery) followed by maintenance or surveillance as per physician choice compared with no&#xD;
      LCT.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. Determine the overall survival. II. Safety/tolerability of LCT. III. Time to progression&#xD;
      of prior metastatic lesions. IV. Time to appearance of new metastases (central nervous system&#xD;
      [CNS] vs. extra-CNS, treated lesion vs. new site).&#xD;
&#xD;
      V. Quality of life (QOL).&#xD;
&#xD;
      OUTLINE: Patients are randomized to 1 of 2 treatment arms.&#xD;
&#xD;
      ARM I (IMMEDIATE LCT): Patients undergo ablation of all residual local and metastatic sites&#xD;
      of disease by surgery and/or external beam radiation therapy (EBRT). After completion of LCT,&#xD;
      patients undergo either surveillance or maintenance treatment at the discretion of the&#xD;
      treating physician.&#xD;
&#xD;
      ARM II (DELAYED/NO LCT): Patients undergo standard maintenance therapy or clinical&#xD;
      observation, based on physician choice. Patients may cross-over to Arm I due to Response&#xD;
      Evaluation Criteria in Solid Tumors (RECIST) progression or toxicity at the treating&#xD;
      physician's discretion.&#xD;
&#xD;
      After completion of study treatment, patients are followed up for 9 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 28, 2012</start_date>
  <completion_date type="Anticipated">September 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2024</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Progression-free survival (PFS)</measure>
    <time_frame>Time from randomization (immediate local consolidation therapy [LCT] vs delayed/no LCT) to disease progression or death, assessed up to 9 months</time_frame>
    <description>Kaplan-Meier estimate will be computed and the log-rank test will be performed to compare the difference of PFS between the two arms. Cox regression model will be applied to correlate PFS with potential covariates in both the univariate and multi-covariate analyses. To account for patients that crossover for reasons other than Response Evaluation Criteria in Solid Tumors (RECIST) progression of disease, censoring will occur at the time of crossover for primary analysis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of toxicities</measure>
    <time_frame>Up to at least 1 year (periodically thereafter)</time_frame>
    <description>Descriptive statistics will be provided to summarize the toxicities by the treatment arms (immediate LCT and delayed/no LCT groups).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>Up to 9 months</time_frame>
    <description>Kaplan-Meier estimate will be used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to progression of prior metastatic lesions</measure>
    <time_frame>Up to 9 months</time_frame>
    <description>Kaplan-Meier estimate will be used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to appearance of new metastases (central nervous system [CNS] vs extra-CNS, treated lesion vs. new site)</measure>
    <time_frame>Up to 9 months</time_frame>
    <description>Kaplan-Meier estimate will be used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life (QOL) assessed using the Symptom Assessment (optional)</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>QOL will be analyzed by the repeated measures analysis of variance to count for the change before and after treatment and during the follow-up period. Proper transformation will be performed if necessary to transform data to be closer to the Gaussian distribution.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of crossover without RECIST progression</measure>
    <time_frame>Up to 9 months</time_frame>
    <description>A time varying covariate model will be used.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">94</enrollment>
  <condition>Recurrent Lung Non-Small Cell Carcinoma</condition>
  <condition>Stage IV Non-Small Cell Lung Cancer AJCC v7</condition>
  <arm_group>
    <arm_group_label>Arm I (immediate LCT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergo ablation of all residual local and metastatic sites of disease by surgery and/or EBRT. After completion of LCT, patients undergo either surveillance or maintenance treatment at the discretion of the treating physician.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm II (delayed/no LCT)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients undergo standard maintenance therapy or clinical observation, based on physician choice. Patients may cross-over to Arm I due to RECIST progression or toxicity at the treating physician's discretion.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Clinical Observation</intervention_name>
    <description>Undergo clinical observation</description>
    <arm_group_label>Arm II (delayed/no LCT)</arm_group_label>
    <other_name>observation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>External Beam Radiation Therapy</intervention_name>
    <description>Undergo EBRT</description>
    <arm_group_label>Arm I (immediate LCT)</arm_group_label>
    <other_name>Definitive Radiation Therapy</other_name>
    <other_name>EBRT</other_name>
    <other_name>External Beam Radiotherapy</other_name>
    <other_name>External Beam RT</other_name>
    <other_name>external radiation</other_name>
    <other_name>External Radiation Therapy</other_name>
    <other_name>external-beam radiation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Laboratory Biomarker Analysis</intervention_name>
    <description>Optional correlative studies</description>
    <arm_group_label>Arm I (immediate LCT)</arm_group_label>
    <arm_group_label>Arm II (delayed/no LCT)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Quality-of-Life Assessment</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Arm I (immediate LCT)</arm_group_label>
    <arm_group_label>Arm II (delayed/no LCT)</arm_group_label>
    <other_name>Quality of Life Assessment</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Standard Follow-Up Care</intervention_name>
    <description>Undergo standard maintenance therapy</description>
    <arm_group_label>Arm II (delayed/no LCT)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Therapeutic Conventional Surgery</intervention_name>
    <description>Undergo surgery</description>
    <arm_group_label>Arm I (immediate LCT)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  STEP 1 ENROLLMENT: the patient has a diagnosis of pathologically confirmed NSCLC by&#xD;
             tumor biopsy and/or fine-needle aspiration; mixed tumors will be categorized by the&#xD;
             predominant cell type&#xD;
&#xD;
          -  STEP 1 ENROLLMENT: the patient has a diagnosis of American Joint Committee on Cancer&#xD;
             (AJCC) 7th Edition stage IV NSCLC&#xD;
&#xD;
          -  STEP 1 ENROLLMENT: three or less metastatic lesions (not sites); each lesion&#xD;
             (including a satellite nodule) will individually be counted as one, and intrathoracic&#xD;
             lymph node involvement (defined here as hilar, mediastinal, or supraclavicular nodes,&#xD;
             N1-N3) will collectively be counted as one; in addition, patients can receive&#xD;
             treatment to CNS lesions or other symptomatic lesions requiring urgent local therapy&#xD;
             prior to randomization, but these lesions will be counted towards the total number&#xD;
             after chemotherapy, and patients will only be eligible if there are remaining sites&#xD;
             amenable to local therapy after up-front systemic therapy&#xD;
&#xD;
          -  STEP 1 ENROLLMENT: standard induction chemotherapy planned defined as: at least 4&#xD;
             cycles of platinum doublet chemotherapy for metastatic disease (with or without&#xD;
             bevacizumab); if the patient is known to be EGFR mutation positive, erlotinib,&#xD;
             afatinib, or gefitinib for &gt;= 3 months, or for patients with known EML4-ALK fusions,&#xD;
             crizotinib for &gt;= 3 months&#xD;
&#xD;
          -  STEP 2 ENROLLMENT AND RANDOMIZATION: the patient has a diagnosis of pathologically&#xD;
             confirmed NSCLC by tumor biopsy and/or fine-needle aspiration; mixed tumors will be&#xD;
             categorized by the predominant cell type&#xD;
&#xD;
          -  STEP 2 ENROLLMENT AND RANDOMIZATION: the patient has a diagnosis of American Joint&#xD;
             Committee on Cancer (AJCC) 7th edition stage IV NSCLC&#xD;
&#xD;
          -  STEP 2 ENROLLMENT AND RANDOMIZATION: completion of standard induction chemotherapy&#xD;
             planned defined as: at least 4 cycles of platinum doublet chemotherapy for metastatic&#xD;
             disease (with or without bevacizumab); if the patient is known to be EGFR mutation&#xD;
             positive, erlotinib, afatinib, or gefitinib for &gt;= 3 months, or for patients with&#xD;
             known EML4-ALK fusions, crizotinib; note that it is not mandatory to check EGFR&#xD;
             mutation or EML4-ALK status prior to entry, but patients that receive options 2 or 3&#xD;
             should have had these molecular tests performed&#xD;
&#xD;
          -  STEP 2 ENROLLMENT AND RANDOMIZATION: less than or equal to three metastatic lesions&#xD;
             and no evidence of disease progression based on RECIST criteria; note that patients&#xD;
             that had &gt; 3 metastatic lesions in Step 1 may be eligible for enrollment in Step 2 if&#xD;
             the number of metastatic sites is reduced to three or less&#xD;
&#xD;
          -  STEP 2 ENROLLMENT AND RANDOMIZATION: the patient's Eastern Cooperative Oncology Group&#xD;
             (ECOG) performance status is =&lt; 2 at study entry&#xD;
&#xD;
          -  STEP 2 ENROLLMENT AND RANDOMIZATION: absolute neutrophil count (ANC) &gt;= 1,500/mm^3&#xD;
             within 3 weeks of study entry&#xD;
&#xD;
          -  STEP 2 ENROLLMENT AND RANDOMIZATION: platelet count &gt;= 100,000/mm^3 within 3 weeks of&#xD;
             study entry&#xD;
&#xD;
          -  STEP 2 ENROLLMENT AND RANDOMIZATION: white blood cells (WBC) &gt;= 3,000/mm^3 within 3&#xD;
             weeks of study entry&#xD;
&#xD;
          -  STEP 2 ENROLLMENT AND RANDOMIZATION: hemoglobin &gt;= 9 g/dL within 3 weeks of study&#xD;
             entry&#xD;
&#xD;
          -  STEP 2 ENROLLMENT AND RANDOMIZATION: the patient must be a suitable candidate for LCT&#xD;
             (radiotherapy and/or surgery) to every site of disease, as determined by the treating&#xD;
             physician(s); consultation with a multidisciplinary team, including a medical&#xD;
             oncologist, radiation oncologist, and thoracic surgeon, is encouraged but not required&#xD;
&#xD;
          -  STEP 2 ENROLLMENT AND RANDOMIZATION: concurrent chemoradiation is permitted as&#xD;
             consolidative therapy; the following concurrent therapies are permitted: tyrosine&#xD;
             kinase inhibitors (i.e. erlotinib) - can be delivered with both hypofractionated (&gt;= 3&#xD;
             Gray [Gy] per fraction) and standard fractionated radiation therapy (&lt; 3 Gy per&#xD;
             fraction); platinum-based chemotherapy - standard fractionated radiation therapy (&lt; 3&#xD;
             Gy per fraction)&#xD;
&#xD;
          -  STEP 2 ENROLLMENT AND RANDOMIZATION: bevacizumab will not be permitted within 2 weeks&#xD;
             of the initiation of the radiation therapy course&#xD;
&#xD;
          -  STEP 2 ENROLLMENT AND RANDOMIZATION: treatment to central nervous system lesions, such&#xD;
             as the brain or spine (prior to first line systemic therapy), or symptomatic lesions&#xD;
             requiring urgent palliative radiation, is permitted prior to randomization, in which&#xD;
             case the patient would be randomized to treatment of other metastatic sites or the&#xD;
             primary sites (based on the disease remaining after first-line treatment); these&#xD;
             treated lesions should be counted towards the total number of metastases at the time&#xD;
             of enrollment&#xD;
&#xD;
          -  STEP 2 ENROLLMENT AND RANDOMIZATION: the patient has signed informed consent&#xD;
&#xD;
          -  STEP 2 ENROLLMENT AND RANDOMIZATION: women of childbearing potential must agree to use&#xD;
             adequate contraception (hormonal or barrier method of birth control; abstinence) for&#xD;
             the duration of study participation and for six (6) months after discontinuation of&#xD;
             the study drugs; childbearing potential will be defined as women who have had menses&#xD;
             within the past 12 months, who have not had tubal ligation, hysterectomy or bilateral&#xD;
             oophorectomy; should a woman become pregnant or suspect that she is pregnant while&#xD;
             participating in this study, she should inform her treating physician immediately; the&#xD;
             patient, if a man, agrees to use effective contraception or abstinence for the&#xD;
             duration of study participation and for six (6) months after discontinuation of the&#xD;
             study drugs&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  STEPS 1 AND 2 AND RANDOMIZATION&#xD;
&#xD;
          -  The patient has a history of uncontrolled angina, arrhythmias, or congestive heart&#xD;
             failure&#xD;
&#xD;
          -  Patients with a history of malignant pleural effusions are not eligible; pleural&#xD;
             effusions considered by the investigator too small for a diagnostic thoracentesis are&#xD;
             permissible&#xD;
&#xD;
          -  Patient is pregnant (confirmed by serum beta- b-human chorionic gonadotropin [HCG] if&#xD;
             applicable) or is breastfeeding&#xD;
&#xD;
          -  Presence of significant third space fluid which cannot be controlled by drainage&#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>Chad Tang</last_name>
    <role>Principal Investigator</role>
    <affiliation>M.D. Anderson Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Colorado</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80217-3364</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>M D Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>London Health Sciences Centre-South Street</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 4G5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mdanderson.org</url>
    <description>MD Anderson Cancer Center Website</description>
  </link>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>November 8, 2012</study_first_submitted>
  <study_first_submitted_qc>November 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 12, 2012</study_first_posted>
  <last_update_submitted>September 5, 2023</last_update_submitted>
  <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2023</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>Lung Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Non-Small-Cell Lung</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/NCT01725165
org study id: 2012-0618
secondary id: NCI-2012-02874
secondary id: 2012-0618
secondary id: P30CA016672
nct id: NCT01725165
lead sponsor: 
collaborator: 
This randomized phase II trial studies how well surgery and/or radiation therapy or standard
      therapy and/or clinical observation works in treating patients with previously treated stage
      IV non-small cell lung cancer. Radiation therapy uses high energy x-rays to kill tumor cells.
      Giving surgery and/or radiation therapy may be more effective than standard therapy and/or
      clinical observation in patients with previously treated non-small cell lung cancer.
PRIMARY OBJECTIVES:

      I. Determine whether oligometastatic non-small cell lung cancer (NSCLC) patients with no
      disease progression after first line therapy have prolonged progression free survival (PFS)
      when treated with local consolidation therapy (LCT) of residual disease (radiation or
      surgery) followed by maintenance or surveillance as per physician choice compared with no
      LCT.

      SECONDARY OBJECTIVES:

      I. Determine the overall survival. II. Safety/tolerability of LCT. III. Time to progression
      of prior metastatic lesions. IV. Time to appearance of new metastases (central nervous system
      [CNS] vs. extra-CNS, treated lesion vs. new site).

      V. Quality of life (QOL).

      OUTLINE: Patients are randomized to 1 of 2 treatment arms.

      ARM I (IMMEDIATE LCT): Patients undergo ablation of all residual local and metastatic sites
      of disease by surgery and/or external beam radiation therapy (EBRT). After completion of LCT,
      patients undergo either surveillance or maintenance treatment at the discretion of the
      treating physician.

      ARM II (DELAYED/NO LCT): Patients undergo standard maintenance therapy or clinical
      observation, based on physician choice. Patients may cross-over to Arm I due to Response
      Evaluation Criteria in Solid Tumors (RECIST) progression or toxicity at the treating
      physician's discretion.

      After completion of study treatment, patients are followed up for 9 months.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression-free survival (PFS)
time frame: Time from randomization (immediate local consolidation therapy [LCT] vs delayed/no LCT) to disease progression or death, assessed up to 9 months
description: Kaplan-Meier estimate will be computed and the log-rank test will be performed to compare the difference of PFS between the two arms. Cox regression model will be applied to correlate PFS with potential covariates in both the univariate and multi-covariate analyses. To account for patients that crossover for reasons other than Response Evaluation Criteria in Solid Tumors (RECIST) progression of disease, censoring will occur at the time of crossover for primary analysis.
measure: Incidence of toxicities
time frame: Up to at least 1 year (periodically thereafter)
description: Descriptive statistics will be provided to summarize the toxicities by the treatment arms (immediate LCT and delayed/no LCT groups).
measure: Overall survival
time frame: Up to 9 months
description: Kaplan-Meier estimate will be used.
measure: Time to progression of prior metastatic lesions
time frame: Up to 9 months
description: Kaplan-Meier estimate will be used.
measure: Time to appearance of new metastases (central nervous system [CNS] vs extra-CNS, treated lesion vs. new site)
time frame: Up to 9 months
description: Kaplan-Meier estimate will be used.
measure: Quality of life (QOL) assessed using the Symptom Assessment (optional)
time frame: Up to 1 year
description: QOL will be analyzed by the repeated measures analysis of variance to count for the change before and after treatment and during the follow-up period. Proper transformation will be performed if necessary to transform data to be closer to the Gaussian distribution.
measure: Impact of crossover without RECIST progression
time frame: Up to 9 months
description: A time varying covariate model will be used.
arm group label: Arm I (immediate LCT)
arm group type: Experimental
description: Patients undergo ablation of all residual local and metastatic sites of disease by surgery and/or EBRT. After completion of LCT, patients undergo either surveillance or maintenance treatment at the discretion of the treating physician.
arm group label: Arm II (delayed/no LCT)
arm group type: Active Comparator
description: Patients undergo standard maintenance therapy or clinical observation, based on physician choice. Patients may cross-over to Arm I due to RECIST progression or toxicity at the treating physician's discretion.
intervention type: Other
intervention name: Clinical Observation
description: Undergo clinical observation
arm group label: Arm II (delayed/no LCT)
other name: observation
intervention type: Radiation
intervention name: External Beam Radiation Therapy
description: Undergo EBRT
arm group label: Arm I (immediate LCT)
other name: Definitive Radiation Therapy
other name: EBRT
other name: External Beam Radiotherapy
other name: External Beam RT
other name: external radiation
other name: External Radiation Therapy
other name: external-beam radiation
intervention type: Other
intervention name: Laboratory Biomarker Analysis
description: Optional correlative studies
arm group label: Arm I (immediate LCT)
arm group label: Arm II (delayed/no LCT)
intervention type: Other
intervention name: Quality-of-Life Assessment
description: Ancillary studies
arm group label: Arm I (immediate LCT)
arm group label: Arm II (delayed/no LCT)
other name: Quality of Life Assessment
intervention type: Procedure
intervention name: Standard Follow-Up Care
description: Undergo standard maintenance therapy
arm group label: Arm II (delayed/no LCT)
intervention type: Procedure
intervention name: Therapeutic Conventional Surgery
description: Undergo surgery
arm group label: Arm I (immediate LCT)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Chad Tang
role: Principal Investigator
affiliation: M.D. Anderson Cancer Center
facility: 
facility: 
facility: 
country: Canada
country: United States
url: http://www.mdanderson.org
description: MD Anderson Cancer Center Website
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung