<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/NCT02252796</url>
  </required_header>
  <id_info>
    <org_study_id>WVU020513</org_study_id>
    <nct_id>NCT02252796</nct_id>
  </id_info>
  <brief_title>Phase I Hypofractionated Stereotactic Boost (Radiotherapy) for Non-Small Cell Lung Cancer</brief_title>
  <acronym>HySBst</acronym>
  <official_title>Phase I Dose Escalation Study of a Hypofractionated Stereotactic Boost (HySBst) to the Primary Site in Patients With Stage II-III Non-small Cell Lung Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>West Virginia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>West Virginia University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will help researchers test the safety of hypofractionated dose of radiotherapy&#xD;
      (HySBst) at different dose levels before or after chemo-radiation for Non Small Cell Lung&#xD;
      Cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients are assigned to Sub-group 1 or 2 based on the primary lesion size and location. This&#xD;
      protocol will utilize a standard 3 + 3 phase I design with three patients enrolled per&#xD;
      cohort.&#xD;
&#xD;
      Patients will be offered the opportunity to participate in the blood specimen component of&#xD;
      the study.&#xD;
&#xD;
      Patients will be followed up to 2 years post radiation therapy.&#xD;
&#xD;
      Sub-group 1 will receive HySBst for 1 week. Weeks 2-7 will be standard chemo-radiation&#xD;
      therapy. Patients have the option of consolidative chemotherapy at week 12.&#xD;
&#xD;
      Sub-group 2 will receive standard chemo-radiation therapy for weeks 1-6 then receive HySBst&#xD;
      during week 7. Patients have the option of consolidative chemotherapy at week 12.&#xD;
&#xD;
      HySBst dose escalation for each sub-group is listed below:&#xD;
&#xD;
      Optional: 4 Gy x 4 daily fractions Level 1: 5 Gy x 4 daily fractions Level 2: 5.5 Gy x 4&#xD;
      daily fractions Level 3: 6 Gy x 4 daily fractions&#xD;
&#xD;
      DLTs will be based on events occurring during the course of HySBst.&#xD;
&#xD;
      Chemo-Radiation Therapy is defined as:&#xD;
&#xD;
      Standard Carboplatin &amp; Paclitaxel Doublelet Regimen with weekly Carboplatin AUC 2/week and&#xD;
      Paclitaxel 45 mg/ m2/ week during conventionally fractionated IMRT&#xD;
&#xD;
      Image-guided IMRT to 60 Gy, 5 x per week for 6 weeks&#xD;
&#xD;
      Consolidative chemotherapy is defined as Carboplatin AUC 6 and Paclitaxel 200 mg/m2 every 21&#xD;
      days x 2 cycles will be given after ALL radiotherapy is delivered.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Investigator left institution&#xD;
  </why_stopped>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">September 2017</completion_date>
  <primary_completion_date type="Actual">September 2017</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum Tolerated Dose of HySBst</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Dose Limiting Toxicity</measure>
    <time_frame>1 week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood Sample Collection</measure>
    <time_frame>2 years</time_frame>
    <description>Biomarker analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Local Control</measure>
    <time_frame>2 years</time_frame>
    <description>To determine the 2-year regional, and distant metastasis rates, progression-free survival (PFS), local progression free survival (L-PFS), overall survival (OS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life</measure>
    <time_frame>2 years</time_frame>
    <description>To determine the quality of life before and after treatment using the European Organisation of Research and Treatment of Cancer Quality of Life Questionnaire, Core 30 and Lung Cancer 13 (EORTC QLQ-C30, and the LC 13) scales</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>Non-small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Sub-group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>HySBst to be delivered during week 1 with Chemo-radiation to be delivered weeks 2-7</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sub-group 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Chemo-radiation to be delivered weeks 1-6 and HySBst to be delivered week 7</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Hypofractionated Stereotactic Boost</intervention_name>
    <description>An ablative dose of radiation is delivered to the primary tumor target over a week through Stereotactic Ablative Radiotherapy.</description>
    <arm_group_label>Sub-group 1</arm_group_label>
    <arm_group_label>Sub-group 2</arm_group_label>
    <other_name>HySBst</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Carboplatin</intervention_name>
    <description>Given during chemo-radiation phase and optional consolidative phase.</description>
    <arm_group_label>Sub-group 1</arm_group_label>
    <arm_group_label>Sub-group 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paclitaxel</intervention_name>
    <description>Given during chemo-radiation phase and optional consolidative phase.</description>
    <arm_group_label>Sub-group 1</arm_group_label>
    <arm_group_label>Sub-group 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Image-guided IMRT</intervention_name>
    <description>Given during chemo-radiation phase</description>
    <arm_group_label>Sub-group 1</arm_group_label>
    <arm_group_label>Sub-group 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Stage II - III Non Small Cell Lung Cancer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Primary tumor directly invading into any mediastinal structures, such as the heart,&#xD;
             major blood vessels, esophagus, trachea, and the proximal bronchial tree.&#xD;
&#xD;
          -  Prior chemotherapy for NSCLC&#xD;
&#xD;
          -  Prior radiotherapy to the region of the study cancer that would result in overlap of&#xD;
             radiation therapy fields.&#xD;
&#xD;
          -  Severe, active co-morbidity&#xD;
&#xD;
          -  Pregnancy or women of childbearing potential&#xD;
&#xD;
          -  Any history of allergic reaction to paclitaxel or other taxanes, or to carboplatin&#xD;
&#xD;
          -  Uncontrolled neuropathy ≥ grade 2.&#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>Malcolm Mattes, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>West Virginia University - Mary Babb Randolph Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>West Virginia University Hospitals Mary Babb Randolph Cancer Center</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>26506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>September 25, 2014</study_first_submitted>
  <study_first_submitted_qc>September 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 30, 2014</study_first_posted>
  <last_update_submitted>May 25, 2018</last_update_submitted>
  <last_update_submitted_qc>May 25, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 30, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Non-small Cell Lung Cancer</keyword>
  <keyword>Radiotherapy Therapy</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>Paclitaxel</mesh_term>
    <mesh_term>Carboplatin</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/NCT02252796
org study id: WVU020513
nct id: NCT02252796
lead sponsor: 
has dmc: Yes
This study will help researchers test the safety of hypofractionated dose of radiotherapy
      (HySBst) at different dose levels before or after chemo-radiation for Non Small Cell Lung
      Cancer.
Patients are assigned to Sub-group 1 or 2 based on the primary lesion size and location. This
      protocol will utilize a standard 3 + 3 phase I design with three patients enrolled per
      cohort.

      Patients will be offered the opportunity to participate in the blood specimen component of
      the study.

      Patients will be followed up to 2 years post radiation therapy.

      Sub-group 1 will receive HySBst for 1 week. Weeks 2-7 will be standard chemo-radiation
      therapy. Patients have the option of consolidative chemotherapy at week 12.

      Sub-group 2 will receive standard chemo-radiation therapy for weeks 1-6 then receive HySBst
      during week 7. Patients have the option of consolidative chemotherapy at week 12.

      HySBst dose escalation for each sub-group is listed below:

      Optional: 4 Gy x 4 daily fractions Level 1: 5 Gy x 4 daily fractions Level 2: 5.5 Gy x 4
      daily fractions Level 3: 6 Gy x 4 daily fractions

      DLTs will be based on events occurring during the course of HySBst.

      Chemo-Radiation Therapy is defined as:

      Standard Carboplatin & Paclitaxel Doublelet Regimen with weekly Carboplatin AUC 2/week and
      Paclitaxel 45 mg/ m2/ week during conventionally fractionated IMRT

      Image-guided IMRT to 60 Gy, 5 x per week for 6 weeks

      Consolidative chemotherapy is defined as Carboplatin AUC 6 and Paclitaxel 200 mg/m2 every 21
      days x 2 cycles will be given after ALL radiotherapy is delivered.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum Tolerated Dose of HySBst
time frame: 2 years
measure: Dose Limiting Toxicity
time frame: 1 week
measure: Blood Sample Collection
time frame: 2 years
description: Biomarker analysis
measure: Local Control
time frame: 2 years
description: To determine the 2-year regional, and distant metastasis rates, progression-free survival (PFS), local progression free survival (L-PFS), overall survival (OS)
measure: Quality of Life
time frame: 2 years
description: To determine the quality of life before and after treatment using the European Organisation of Research and Treatment of Cancer Quality of Life Questionnaire, Core 30 and Lung Cancer 13 (EORTC QLQ-C30, and the LC 13) scales
arm group label: Sub-group 1
arm group type: Experimental
description: HySBst to be delivered during week 1 with Chemo-radiation to be delivered weeks 2-7
arm group label: Sub-group 2
arm group type: Experimental
description: Chemo-radiation to be delivered weeks 1-6 and HySBst to be delivered week 7
intervention type: Radiation
intervention name: Hypofractionated Stereotactic Boost
description: An ablative dose of radiation is delivered to the primary tumor target over a week through Stereotactic Ablative Radiotherapy.
arm group label: Sub-group 1
arm group label: Sub-group 2
other name: HySBst
intervention type: Drug
intervention name: Carboplatin
description: Given during chemo-radiation phase and optional consolidative phase.
arm group label: Sub-group 1
arm group label: Sub-group 2
intervention type: Drug
intervention name: Paclitaxel
description: Given during chemo-radiation phase and optional consolidative phase.
arm group label: Sub-group 1
arm group label: Sub-group 2
intervention type: Radiation
intervention name: Image-guided IMRT
description: Given during chemo-radiation phase
arm group label: Sub-group 1
arm group label: Sub-group 2
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Malcolm Mattes, MD
role: Principal Investigator
affiliation: West Virginia University - Mary Babb Randolph Cancer Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Paclitaxel
mesh term: Carboplatin
sharing ipd: No