<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/NCT02189967</url>
  </required_header>
  <id_info>
    <org_study_id>STR-PORTAF-2014</org_study_id>
    <nct_id>NCT02189967</nct_id>
  </id_info>
  <brief_title>Postoperative Radiotherapy of Non-small Cell Lung Cancer: Accelerated vs. Conventional Fractionation</brief_title>
  <official_title>Postoperative Radiotherapy of Non-small Cell Lung Cancer: Accelerated vs. Conventional Fractionation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Technische Universität Dresden</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>German Consortium for Translational Cancer Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Center for Radiation Research in Oncology Dresden/Heidelberg</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Radiation Oncology Working Group of the German Cancer Society</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Technische Universität Dresden</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this randomized multicentric phase II study it will be investigated whether an accelerated&#xD;
      postoperative radiotherapy with photons or protons (7 fractions per week, 2 Gy single dose)&#xD;
      may improve locoregional tumour control in non-small cell lung cancer (NSCLC) in comparison&#xD;
      to conventional fractionation (5 fractions per week, 2 Gy single dose).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a randomized multicentric trial. Within this study an accelerated irradiation&#xD;
      schedule (7 fractions per week, 2 Gy single dose) will be compared with the currently used&#xD;
      conventional fractionation schedule (5 fractions per week, 2 Gy single dose) for&#xD;
      postoperative radiotherapy with photons or protons in patients with NSCLC. The primary&#xD;
      endpoint is locoregional tumour control after 36 months. Secondary endpoints are overall&#xD;
      survival of patients, local recurrence-free and distant metastases-free survival after 36&#xD;
      months, acute and late toxicity as well as quality of life for both treatment methods.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2014</start_date>
  <completion_date type="Actual">July 2020</completion_date>
  <primary_completion_date type="Actual">August 2019</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>assessment of local tumor control</measure>
    <time_frame>36 months after therapy</time_frame>
    <description>Local tumor control will be assessed by appropriate non-invasive (CT or PET-CT) and if necessary invasive examination methods (bronchoscopy with biopsy).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>overall survival</measure>
    <time_frame>36 months after therapy</time_frame>
    <description>Follow-up visits should be continued in all patients until death. Otherwise patients will be censored with date of the last follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>local recurrence-free survival</measure>
    <time_frame>36 months after therapy</time_frame>
    <description>Local-recurrences will be assessed by appropriate non-invasive (CT or PET-CT) and if necessary invasive examination methods (bronchoscopy with biopsy).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>acute toxicity</measure>
    <time_frame>Comparison after 20, 50, 100 and 200 patients have been treated. This number of patients is expected to be included after 6, 12, 18 and 40 months.</time_frame>
    <description>The occurrence of acute side effects (up to 90 days after start of treatment) will be recorded and documented based on CTCAE 4.0.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>quality of life</measure>
    <time_frame>36 months after therapy</time_frame>
    <description>The assessment of quality of life is carried out using the established EORTC QLQ-C30 questionnaire and the additional lung module QLQ-LC13. Quality of life will be documented immediately before the start of therapy, after completion of postoperative radiotherapy and at every follow-up visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>distant metastases-free survival</measure>
    <time_frame>36 months after therapy</time_frame>
    <description>Distant metastases will be assessed by PET-CT or abdominal sonography and chest x-ray.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>late toxicity</measure>
    <time_frame>Comparison after 20, 50, 100 and 200 patients have been treated. This number of patients is expected to be included after 6, 12, 18 and 40 months.</time_frame>
    <description>The occurrence of late side effects will be recorded and documented based on CTCAE 4.0 after every follow-up visit.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>Non-Small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>conventional fractionation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>radiotherapy with conventional fractionation (5 x 2Gy per week)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>accelerated fraction</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>radiotherapy with accelerated fraction (7 x 2 Gy per week)</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>conventional fractionation</intervention_name>
    <description>In this treatment arm patients will receive radiotherapy with the currently used conventional fractionation schedule i.e. 5 fractions per week, 2 Gy single dose.</description>
    <arm_group_label>conventional fractionation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>accelerated fraction</intervention_name>
    <description>In this treatment arm patients will receive radiotherapy with an accelerated fractionation schedule i.e. 7 fractions per week, 2 Gy single dose.</description>
    <arm_group_label>accelerated fraction</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  histologically confirmed non-small cell lung cancer&#xD;
&#xD;
          -  previous tumor resection with curative intention&#xD;
&#xD;
          -  postoperative indication for irradiation (&gt; pN1 and/ or R1)&#xD;
&#xD;
          -  R2-resection or recurrence postoperative/after adjuvant chemotherapy diagnosed by the&#xD;
             restaging-imaging&#xD;
&#xD;
          -  exclusion of distant metastases (M0)&#xD;
&#xD;
          -  age &gt; 18 years&#xD;
&#xD;
          -  good general condition (ECOG performance status 0 or 1)&#xD;
&#xD;
          -  written informed consent&#xD;
&#xD;
          -  appropriate compliance to ensure close follow-up&#xD;
&#xD;
          -  women of childbearing age: adequate contraception&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  histologically confirmed small cell lung cancer&#xD;
&#xD;
          -  distant metastases&#xD;
&#xD;
          -  no written informed consent or lack of cooperation relating to therapy or follow-up&#xD;
&#xD;
          -  previous (&lt; 5 years) or concomitant other malignant disease (exception: malignant&#xD;
             disease, which is very likely healed and not influenced therapy or follow up of the&#xD;
             non-small cell lung cancer, e.g. carcinoma in-situ, basaliomas, very early skin&#xD;
             cancers)&#xD;
&#xD;
          -  for proton therapy: heart pacemaker&#xD;
&#xD;
          -  previous radiotherapy of the thorax or lower neck region&#xD;
&#xD;
          -  pregnancy or lactation&#xD;
&#xD;
          -  participation in another intervention study or not completed follow-up of a&#xD;
             intervention study. Exceptions are psychological studies, supportive or observation&#xD;
             studies, the previous therapy of non-small cell lung cancer is in accordance with the&#xD;
             guideline and the participation in radiotherapy studies is not excluded in the trial&#xD;
             protocol of the previous study&#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>Rebecca Bütof, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dresden University of Technology, University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universitätsklinikum Dresden, Department of Radiation Therapy and Radiation Oncology</name>
      <address>
        <city>Dresden</city>
        <zip>01307</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Freiburg, Department of Radiation Therapy and Radiation Oncology</name>
      <address>
        <city>Freiburg</city>
        <zip>79106</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praxis für Strahlentherapie Hamburg-Harburg</name>
      <address>
        <city>Hamburg</city>
        <zip>21075</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum des Saarlandes, Department of Radiotherapy and Radiation Oncology</name>
      <address>
        <city>Homburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum der Universität München,Department of Radiation Therapy and Radiation Oncology</name>
      <address>
        <city>München</city>
        <zip>81377</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum rechts der Isar, Technische Universität München, Department of Radiation Therapy and Radiation Oncology</name>
      <address>
        <city>München</city>
        <zip>81675</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marienhospital Stuttgart, Department of Radiotherapy and Palliative Medicine</name>
      <address>
        <city>Stuttgart</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Tübingen, Department of Radiation Therapy and Radiation Oncology</name>
      <address>
        <city>Tübingen</city>
        <zip>72016</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SPZOZ MSW; Warmia &amp; Mazury Oncology Center; Warmia &amp; Mazury Medical University</name>
      <address>
        <city>Olsztyn</city>
        <zip>10-228</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
    <country>Poland</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>May 22, 2014</study_first_submitted>
  <study_first_submitted_qc>July 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <last_update_submitted>July 21, 2020</last_update_submitted>
  <last_update_submitted_qc>July 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Technische Universität Dresden</investigator_affiliation>
    <investigator_full_name>Dr. Rebecca Bütof</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>non-small cell lung cancer</keyword>
  <keyword>radiotherapy</keyword>
  <keyword>accelerated fractionation</keyword>
  <keyword>conventional fractionation</keyword>
  <keyword>postoperative</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>
  <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/NCT02189967
org study id: STR-PORTAF-2014
nct id: NCT02189967
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
In this randomized multicentric phase II study it will be investigated whether an accelerated
      postoperative radiotherapy with photons or protons (7 fractions per week, 2 Gy single dose)
      may improve locoregional tumour control in non-small cell lung cancer (NSCLC) in comparison
      to conventional fractionation (5 fractions per week, 2 Gy single dose).
This study is a randomized multicentric trial. Within this study an accelerated irradiation
      schedule (7 fractions per week, 2 Gy single dose) will be compared with the currently used
      conventional fractionation schedule (5 fractions per week, 2 Gy single dose) for
      postoperative radiotherapy with photons or protons in patients with NSCLC. The primary
      endpoint is locoregional tumour control after 36 months. Secondary endpoints are overall
      survival of patients, local recurrence-free and distant metastases-free survival after 36
      months, acute and late toxicity as well as quality of life for both treatment methods.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: assessment of local tumor control
time frame: 36 months after therapy
description: Local tumor control will be assessed by appropriate non-invasive (CT or PET-CT) and if necessary invasive examination methods (bronchoscopy with biopsy).
measure: overall survival
time frame: 36 months after therapy
description: Follow-up visits should be continued in all patients until death. Otherwise patients will be censored with date of the last follow-up.
measure: local recurrence-free survival
time frame: 36 months after therapy
description: Local-recurrences will be assessed by appropriate non-invasive (CT or PET-CT) and if necessary invasive examination methods (bronchoscopy with biopsy).
measure: acute toxicity
time frame: Comparison after 20, 50, 100 and 200 patients have been treated. This number of patients is expected to be included after 6, 12, 18 and 40 months.
description: The occurrence of acute side effects (up to 90 days after start of treatment) will be recorded and documented based on CTCAE 4.0.
measure: quality of life
time frame: 36 months after therapy
description: The assessment of quality of life is carried out using the established EORTC QLQ-C30 questionnaire and the additional lung module QLQ-LC13. Quality of life will be documented immediately before the start of therapy, after completion of postoperative radiotherapy and at every follow-up visit.
measure: distant metastases-free survival
time frame: 36 months after therapy
description: Distant metastases will be assessed by PET-CT or abdominal sonography and chest x-ray.
measure: late toxicity
time frame: Comparison after 20, 50, 100 and 200 patients have been treated. This number of patients is expected to be included after 6, 12, 18 and 40 months.
description: The occurrence of late side effects will be recorded and documented based on CTCAE 4.0 after every follow-up visit.
arm group label: conventional fractionation
arm group type: Active Comparator
description: radiotherapy with conventional fractionation (5 x 2Gy per week)
arm group label: accelerated fraction
arm group type: Active Comparator
description: radiotherapy with accelerated fraction (7 x 2 Gy per week)
intervention type: Radiation
intervention name: conventional fractionation
description: In this treatment arm patients will receive radiotherapy with the currently used conventional fractionation schedule i.e. 5 fractions per week, 2 Gy single dose.
arm group label: conventional fractionation
intervention type: Radiation
intervention name: accelerated fraction
description: In this treatment arm patients will receive radiotherapy with an accelerated fractionation schedule i.e. 7 fractions per week, 2 Gy single dose.
arm group label: accelerated fraction
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Rebecca Bütof, Dr.
role: Principal Investigator
affiliation: Dresden University of Technology, University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Germany
country: Poland
responsible party type: Principal Investigator
investigator affiliation: Technische Universität Dresden
investigator full name: Dr. Rebecca Bütof
investigator title: Principal Investigator
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
sharing ipd: No