<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/NCT02262325</url>
  </required_header>
  <id_info>
    <org_study_id>OSU-14091</org_study_id>
    <secondary_id>NCI-2014-01663</secondary_id>
    <nct_id>NCT02262325</nct_id>
  </id_info>
  <brief_title>Hypofractionated Boost Before Chemoradiation for Patients With Stage II-III Non-small Cell Lung Cancer Unsuitable for Surgery</brief_title>
  <official_title>A Phase II Trial Combining Hypofractionated Radiation Boost With Conventionally-Fractionated Chemoradiation in Locally Advanced Non-small Cell Lung Cancer Not Suitable for Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ohio State University Comprehensive Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ohio State University Comprehensive Cancer Center</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This phase II trial studies how well giving a hypofractionated boost to the primary tumor&#xD;
      before standard chemotherapy and radiation therapy works in treating patients with stage II&#xD;
      or III non-small cell lung cancer that cannot be removed by surgery. Advances in radiation&#xD;
      oncology have allowed better radiation targeting which may be able to send x-rays directly to&#xD;
      the tumor and cause less damage to normal tissue. Drugs used in chemotherapy, such as&#xD;
      cisplatin and etoposide, work in different ways to stop the growth of tumor cells, either by&#xD;
      killing the cells, by stopping them from dividing, or by stopping them from spreading.&#xD;
      Radiation therapy uses high energy x-rays to kill tumor cells. Giving more precise and&#xD;
      targeted radiation before standard chemotherapy and radiation therapy may kill more tumor&#xD;
      cells and prevent the cancer from coming back in the location in which it started.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To estimate the primary tumor control rate at 12 months.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To further establish safety and tolerability of this regimen. II. To estimate the rates of&#xD;
      regional, distant control as well as progression-free survival and overall survival.&#xD;
&#xD;
      III. To evaluate the objective response rate (ORR) to this regimen. IV. To evaluate the&#xD;
      response of tumors to stereotactic (high-dose) radiation using magnetic resonance tumor&#xD;
      perfusion imaging modalities (magnetic resonance [MR]-dynamic contrast-enhanced&#xD;
      [DCE]/perfusion weighted imaging [PWI], MR-diffusion, blood oxygenation level dependent&#xD;
      [BOLD] sequences).&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients will receive a hypofractionated boost to the primary tumor over 2 fractions (at&#xD;
      least 40 hours apart) during week 1. Beginning week 2, patients receive cisplatin&#xD;
      intravenously (IV) on days 8, 15, 36, and 43; and etoposide IV over 60 minutes on days 8-12&#xD;
      and 36-40. If carboplatin and paclitaxel is administered concurrently with radiotherapy, 2&#xD;
      cycles of carboplatin (AUC=6 mg/min/mL IV on day 1, 22) and paclitaxel (200 mg/m2 IV on day&#xD;
      1, 22) consolidation chemotherapy are required, to be administered starting 4-6 weeks after&#xD;
      concurrent chemoradiation has ended. Each cycle is 21 days long. If cisplatin and etoposide&#xD;
      is administered concurrently with radiotherapy, consolidation chemotherapy is not allowed.&#xD;
      Patients also undergo standard conformal radiation therapy once daily (QD) 5 days a week for&#xD;
      a total of 30 fractions. Treatment continues for 6 weeks in the absence of disease&#xD;
      progression or unacceptable toxicity.&#xD;
&#xD;
      After completion of study treatment, patients are followed up every 3 months for 2 years and&#xD;
      then every 6 months for 3 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 8, 2015</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <phase>Phase 2</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>Primary tumor control rate, as measured from the time of treatment completion until the first documented date of local failure</measure>
    <time_frame>At 12 months following chemo/RT</time_frame>
    <description>Primary tumor control rate at 12 months, as well its 95% confidence interval, will be reported for all eligible subjects received treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Frequency of all adverse events, with special attention to grade 3-5 esophagitis, pneumonitis, and cardiac adverse events as defined by the National Cancer Institution Common Terminology Criteria for Adverse Events CTCAE version 4.0</measure>
    <time_frame>Up to 30 days after completion of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tolerability measured by the number of patients who discontinue treatment</measure>
    <time_frame>Up to 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Regional control</measure>
    <time_frame>Up to 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distant control</measure>
    <time_frame>Up to 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival (PFS)</measure>
    <time_frame>From date of treatment initiation to progression, assessed up to 24 months</time_frame>
    <description>Kaplan-Meier (K-M) analysis will be used to estimate PFS.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>K-M analysis will be used to estimate OS.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective response rate as measured by Response Evaluation Criteria in Solid Tumors criteria</measure>
    <time_frame>Up to 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in tumor perfusion measured by MR-DCE/PWI</measure>
    <time_frame>Baseline to the end of week 1</time_frame>
    <description>Changes in perfusion will be tested by comparing mean values pre- and post-hypofractionated boost radiation using a paired t-test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in diffusion measured by MR-diffusion</measure>
    <time_frame>Baseline to the end of week 1</time_frame>
    <description>Changes in diffusion will be tested by comparing mean values pre- and post-hypofractionated boost radiation using a paired t-test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in hypoxia measured by BOLD sequences</measure>
    <time_frame>Baseline to the end of week 1</time_frame>
    <description>Changes in hypoxia will be tested by comparing mean values pre- and post-hypofractionated boost radiation using a paired t-test.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Recurrent Non-small Cell Lung Cancer</condition>
  <condition>Stage IIA Non-small Cell Lung Cancer</condition>
  <condition>Stage IIB Non-small Cell Lung Cancer</condition>
  <condition>Stage IIIA Non-small Cell Lung Cancer</condition>
  <condition>Stage IIIB Non-small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Treatment (hypofractionated radiation boost, chemoradiation)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergo hypofractionated radiation boost over 2 fractions (at least 40 hours apart) during week 1. Beginning week 2, patients receive cisplatin IV on days 8, 15, 36, and 43; and etoposide IV over 60 minutes on days 8-12 and 36-40. Patients also undergo standard 3-D conformal radiation therapy QD 5 days a week for a total of 30 fractions. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>hypofractionated radiation therapy</intervention_name>
    <description>Radiation boost in week 1 (days 1-5)</description>
    <arm_group_label>Treatment (hypofractionated radiation boost, chemoradiation)</arm_group_label>
    <other_name>SBRT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>cisplatin</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Treatment (hypofractionated radiation boost, chemoradiation)</arm_group_label>
    <other_name>CACP</other_name>
    <other_name>CDDP</other_name>
    <other_name>CPDD</other_name>
    <other_name>DDP</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>etoposide</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Treatment (hypofractionated radiation boost, chemoradiation)</arm_group_label>
    <other_name>EPEG</other_name>
    <other_name>VP-16</other_name>
    <other_name>VP-16-213</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>3-dimensional conformal radiation therapy</intervention_name>
    <description>Undergo 3-dimensional conformal radiation therapy</description>
    <arm_group_label>Treatment (hypofractionated radiation boost, chemoradiation)</arm_group_label>
    <other_name>3D conformal radiation therapy</other_name>
    <other_name>3D-CRT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>laboratory biomarker analysis</intervention_name>
    <description>Correlative studies</description>
    <arm_group_label>Treatment (hypofractionated radiation boost, chemoradiation)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All prior treatment-related toxicities must be Common Terminology Criteria for Adverse&#xD;
             Events (CTCAE) (version 4.0) =&lt; grade 1 (except alopecia) at the time of enrollment&#xD;
&#xD;
          -  Adequate baseline organ function obtained within 30 days of study registration&#xD;
&#xD;
          -  Absolute neutrophil count &gt;= 1.5 x 10^9/L&#xD;
&#xD;
          -  Hemoglobin &gt;= 9 g/dL&#xD;
&#xD;
          -  Platelets &gt;= 100 x 10^9/L&#xD;
&#xD;
          -  Total bilirubin =&lt; 1.5 x upper limit of normal (ULN)&#xD;
&#xD;
          -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =&lt; 2.5 x ULN&#xD;
&#xD;
          -  Creatinine =&lt; 1.5 ULN AND&#xD;
&#xD;
          -  Calculated creatinine &gt;= 50 mL/min (calculated by the Cockcroft-Gault formula) or&#xD;
&#xD;
          -  24-hour urine creatinine clearance &gt;= 50 mL/min&#xD;
&#xD;
          -  Non-small cell lung cancer (NSCLC), histologically and/or cytologically proven&#xD;
&#xD;
          -  Clinical American Joint Committee on Cancer (AJCC) stage (7th edition) IIA-IIIB NSCLC&#xD;
             (T1-4N1-3M0)&#xD;
&#xD;
          -  Patients must be considered unresectable or medically-inoperable&#xD;
&#xD;
          -  Patients must have primary tumor =&lt; 6 cm as defined by CT largest axial dimension&#xD;
&#xD;
          -  Within 60 days of registration: patients must have fludeoxyglucose F 18 (FDG)-positron&#xD;
             emission tomography (PET)-CT scan (or CT chest/abdomen/pelvis with IV contrast), and&#xD;
             magnetic resonance imaging (MRI) brain with IV contrast (or CT scan of the brain with&#xD;
             contrast); a non-contrast MRI scans of the chest/abdomen/pelvis or brain are permitted&#xD;
             for workup if patient has allergy to CT contrast or renal insufficiency&#xD;
&#xD;
          -  Within 30 days of registration: patients must have vital signs, history/physical&#xD;
             examination, laboratory studies (complete blood count panel [CBCP] with differential,&#xD;
             chemistries including liver function tests, creatinine clearance [CrCl] assessment,&#xD;
             pregnancy test if needed within 14 days of registration)&#xD;
&#xD;
          -  If a pleural effusion is present and visible on both CT scan AND chest x-ray, the&#xD;
             investigator should exclude malignant disease by pleurocentesis to confirm&#xD;
             cytologically-negative pleural fluid; if fluid is exudative or cytologically positive&#xD;
             for tumor cells, patient is excluded&#xD;
&#xD;
          -  Patients with effusions that are minimal (i.e. not visible on chest x-ray) and that&#xD;
             are too small to safely tap are eligible.&#xD;
&#xD;
          -  Life expectancy of at least 12 weeks in the opinion of investigator&#xD;
&#xD;
          -  Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1&#xD;
             within 30 days of registration&#xD;
&#xD;
          -  Patients must have measurable primary tumor (undetectable NSCLC primary tumor is&#xD;
             ineligible)&#xD;
&#xD;
          -  Patients must be a minimum of 3 weeks from thoracotomy (if performed) and well-healed&#xD;
             before starting treatment&#xD;
&#xD;
          -  Ability to provide written informed consent obtained prior to participation in the&#xD;
             study and any related procedures being performed&#xD;
&#xD;
          -  Women of child-bearing potential (WOCBP) must have a negative pregnancy test within 14&#xD;
             days of registration; urine human gonadotropin (HCG) is an acceptable pregnancy&#xD;
             assessment&#xD;
&#xD;
          -  Nursing women may participate only if nursing is discontinued&#xD;
&#xD;
          -  Women/men of reproductive potential must be counseled on contraception/abstinence&#xD;
             while receiving the study treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with contralateral hilar involvement (greater than 1.5 cm on short axis or&#xD;
             positive on PET scan, or biopsy-proven)&#xD;
&#xD;
          -  Documented or pathologically-proven metastatic disease&#xD;
&#xD;
          -  Presence of nodules considered neoplastic in the same lobe or other ipsilateral lobe&#xD;
             as the primary tumor (stage T3-4), unless the nodule can be encompassed in the&#xD;
             stereotactic boost (gross tumor volume [GTV]boost) without exceeding a total GTVboost&#xD;
             size of 6 cm as defined by CT largest axial dimension&#xD;
&#xD;
          -  Presence of nodules considered neoplastic in contralateral lobes (M1a)&#xD;
&#xD;
          -  Patients with history of pneumonectomy&#xD;
&#xD;
          -  Prior cytotoxic chemotherapy or molecularly-targeted agents (e.g. erlotinib,&#xD;
             crizotinib), unless &gt; 2 years prior&#xD;
&#xD;
          -  Any concurrent malignancy other than non-melanoma skin cancer, non-invasive bladder&#xD;
             cancer, or carcinoma in situ of the cervix; patients with a previous malignancy&#xD;
             without evidence of disease for &gt;= 3 years will be allowed to enter the trial&#xD;
&#xD;
          -  History of active connective tissue disease (scleroderma) or idiopathic pulmonary&#xD;
             fibrosis&#xD;
&#xD;
          -  History of previous radiation therapy which would result in overlapping radiation&#xD;
             fields&#xD;
&#xD;
          -  Uncontrolled neuropathy grade 2 or greater, regardless of cause&#xD;
&#xD;
          -  Subjects who are breast-feeding and plan to continue breast-feeding during therapy, or&#xD;
             have a positive pregnancy test will be excluded from the study; should a woman become&#xD;
             pregnant or suspect she is pregnant while participating in this study, she should&#xD;
             inform her treating physician immediately&#xD;
&#xD;
          -  Medical contraindication to MR imaging (e.g. pacemakers, metallic implants, aneurysm&#xD;
             clips, known contrast allergy to Gadolinium contrast, pregnancy, nursing mothers,&#xD;
             weight greater than 350 pounds) [first 10 patients]&#xD;
&#xD;
          -  Any serious and/or unstable pre-existing medical disorder (aside from malignancy&#xD;
             exception above), psychiatric disorder, or other conditions that could interfere with&#xD;
             subject's safety, obtaining informed consent or compliance to the study procedures, in&#xD;
             the opinion of the Investigator; this could include severe, active co-morbidities such&#xD;
             as:&#xD;
&#xD;
               -  Unstable angina and/or congestive heart failure requiring hospitalization within&#xD;
                  the last months&#xD;
&#xD;
               -  Transmural myocardial infarction within the last 6 months&#xD;
&#xD;
               -  Acquired immune deficiency syndrome (AIDS) based upon the current CDC definition;&#xD;
                  note, however, that HIV testing is not required for entry to protocol. The need&#xD;
                  to exclude patients with AIDS from this protocol is necessary because the&#xD;
                  treatments involved may be significantly immunosuppressive&#xD;
&#xD;
               -  Chronic obstructive pulmonary disease exacerbation or other respiratory illness&#xD;
                  requiring hospitalization or precluding study therapy within 30 days of&#xD;
                  registration&#xD;
&#xD;
               -  Hepatic insufficiency resulting in jaundice and/or coagulation defects&#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>Eric Miller, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ohio State University Comprehensive Cancer Center</affiliation>
  </overall_official>
  <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_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://cancer.osu.edu</url>
    <description>The Jamesline</description>
  </link>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>October 7, 2014</study_first_submitted>
  <study_first_submitted_qc>October 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <last_update_submitted>March 21, 2023</last_update_submitted>
  <last_update_submitted_qc>March 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 23, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ohio State University Comprehensive Cancer Center</investigator_affiliation>
    <investigator_full_name>Eric Miller</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Non-small cell</keyword>
  <keyword>Lung Cancer</keyword>
  <keyword>Chemoradiation</keyword>
  <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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Etoposide</mesh_term>
    <mesh_term>Etoposide phosphate</mesh_term>
  </intervention_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/NCT02262325
org study id: OSU-14091
secondary id: NCI-2014-01663
nct id: NCT02262325
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
This phase II trial studies how well giving a hypofractionated boost to the primary tumor
      before standard chemotherapy and radiation therapy works in treating patients with stage II
      or III non-small cell lung cancer that cannot be removed by surgery. Advances in radiation
      oncology have allowed better radiation targeting which may be able to send x-rays directly to
      the tumor and cause less damage to normal tissue. Drugs used in chemotherapy, such as
      cisplatin and etoposide, work in different ways to stop the growth of tumor cells, either by
      killing the cells, by stopping them from dividing, or by stopping them from spreading.
      Radiation therapy uses high energy x-rays to kill tumor cells. Giving more precise and
      targeted radiation before standard chemotherapy and radiation therapy may kill more tumor
      cells and prevent the cancer from coming back in the location in which it started.
PRIMARY OBJECTIVES:

      I. To estimate the primary tumor control rate at 12 months.

      SECONDARY OBJECTIVES:

      I. To further establish safety and tolerability of this regimen. II. To estimate the rates of
      regional, distant control as well as progression-free survival and overall survival.

      III. To evaluate the objective response rate (ORR) to this regimen. IV. To evaluate the
      response of tumors to stereotactic (high-dose) radiation using magnetic resonance tumor
      perfusion imaging modalities (magnetic resonance [MR]-dynamic contrast-enhanced
      [DCE]/perfusion weighted imaging [PWI], MR-diffusion, blood oxygenation level dependent
      [BOLD] sequences).

      OUTLINE:

      Patients will receive a hypofractionated boost to the primary tumor over 2 fractions (at
      least 40 hours apart) during week 1. Beginning week 2, patients receive cisplatin
      intravenously (IV) on days 8, 15, 36, and 43; and etoposide IV over 60 minutes on days 8-12
      and 36-40. If carboplatin and paclitaxel is administered concurrently with radiotherapy, 2
      cycles of carboplatin (AUC=6 mg/min/mL IV on day 1, 22) and paclitaxel (200 mg/m2 IV on day
      1, 22) consolidation chemotherapy are required, to be administered starting 4-6 weeks after
      concurrent chemoradiation has ended. Each cycle is 21 days long. If cisplatin and etoposide
      is administered concurrently with radiotherapy, consolidation chemotherapy is not allowed.
      Patients also undergo standard conformal radiation therapy once daily (QD) 5 days a week for
      a total of 30 fractions. Treatment continues for 6 weeks in the absence of disease
      progression or unacceptable toxicity.

      After completion of study treatment, patients are followed up every 3 months for 2 years and
      then every 6 months for 3 years.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Primary tumor control rate, as measured from the time of treatment completion until the first documented date of local failure
time frame: At 12 months following chemo/RT
description: Primary tumor control rate at 12 months, as well its 95% confidence interval, will be reported for all eligible subjects received treatment.
measure: Frequency of all adverse events, with special attention to grade 3-5 esophagitis, pneumonitis, and cardiac adverse events as defined by the National Cancer Institution Common Terminology Criteria for Adverse Events CTCAE version 4.0
time frame: Up to 30 days after completion of treatment
measure: Tolerability measured by the number of patients who discontinue treatment
time frame: Up to 5 years
measure: Regional control
time frame: Up to 24 months
measure: Distant control
time frame: Up to 24 months
measure: Progression-free survival (PFS)
time frame: From date of treatment initiation to progression, assessed up to 24 months
description: Kaplan-Meier (K-M) analysis will be used to estimate PFS.
measure: Overall survival (OS)
time frame: Up to 24 months
description: K-M analysis will be used to estimate OS.
measure: Objective response rate as measured by Response Evaluation Criteria in Solid Tumors criteria
time frame: Up to 5 years
measure: Changes in tumor perfusion measured by MR-DCE/PWI
time frame: Baseline to the end of week 1
description: Changes in perfusion will be tested by comparing mean values pre- and post-hypofractionated boost radiation using a paired t-test.
measure: Changes in diffusion measured by MR-diffusion
time frame: Baseline to the end of week 1
description: Changes in diffusion will be tested by comparing mean values pre- and post-hypofractionated boost radiation using a paired t-test.
measure: Changes in hypoxia measured by BOLD sequences
time frame: Baseline to the end of week 1
description: Changes in hypoxia will be tested by comparing mean values pre- and post-hypofractionated boost radiation using a paired t-test.
arm group label: Treatment (hypofractionated radiation boost, chemoradiation)
arm group type: Experimental
description: Patients undergo hypofractionated radiation boost over 2 fractions (at least 40 hours apart) during week 1. Beginning week 2, patients receive cisplatin IV on days 8, 15, 36, and 43; and etoposide IV over 60 minutes on days 8-12 and 36-40. Patients also undergo standard 3-D conformal radiation therapy QD 5 days a week for a total of 30 fractions. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
intervention type: Radiation
intervention name: hypofractionated radiation therapy
description: Radiation boost in week 1 (days 1-5)
arm group label: Treatment (hypofractionated radiation boost, chemoradiation)
other name: SBRT
intervention type: Drug
intervention name: cisplatin
description: Given IV
arm group label: Treatment (hypofractionated radiation boost, chemoradiation)
other name: CACP
other name: CDDP
other name: CPDD
other name: DDP
intervention type: Drug
intervention name: etoposide
description: Given IV
arm group label: Treatment (hypofractionated radiation boost, chemoradiation)
other name: EPEG
other name: VP-16
other name: VP-16-213
intervention type: Radiation
intervention name: 3-dimensional conformal radiation therapy
description: Undergo 3-dimensional conformal radiation therapy
arm group label: Treatment (hypofractionated radiation boost, chemoradiation)
other name: 3D conformal radiation therapy
other name: 3D-CRT
intervention type: Other
intervention name: laboratory biomarker analysis
description: Correlative studies
arm group label: Treatment (hypofractionated radiation boost, chemoradiation)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Eric Miller, MD
role: Principal Investigator
affiliation: Ohio State University Comprehensive Cancer Center
facility: 
country: United States
url: http://cancer.osu.edu
description: The Jamesline
responsible party type: Principal Investigator
investigator affiliation: Ohio State University Comprehensive Cancer Center
investigator full name: Eric Miller
investigator title: Principal Investigator
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Etoposide
mesh term: Etoposide phosphate
sharing ipd: No