<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/NCT01710956</url>
  </required_header>
  <id_info>
    <org_study_id>NCCCTS-11-531</org_study_id>
    <nct_id>NCT01710956</nct_id>
  </id_info>
  <brief_title>Once Daily Accelerated Fractionation With Concomitant Boost to the Gross Tumor Volume Compared With Twice Daily Hyperfractionation in Concurrent Chemoradiation in Patients With Limited Disease Small Cell Lung Cancer</brief_title>
  <official_title>Randomized Phase II Study of Once Daily Accelerated Fractionation With Concomitant Boost to the Gross Tumor Volume Compared With Twice Daily Hyperfractionation in Concurrent Chemoradiation in Patients With Limited Disease Small Cell Lung Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Cancer Center, Korea</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Cancer Center, Korea</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Non-small cell lung cancer&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>March 2011</start_date>
  <completion_date type="Anticipated">December 2014</completion_date>
  <primary_completion_date type="Anticipated">December 2014</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>progression free survival</measure>
    <time_frame>5years after chemoradiotherapy</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">84</enrollment>
  <condition>Limited Disease Small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Arm 1(with twice-daily TRT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 2 (with once-daily TRT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Arm 1: with twice-daily thoracic radiotherapy/ Arm 2: with once-daily thoracic radiotherapy</intervention_name>
    <description>Arm 1: with twice-daily thoracic radiotherapy daily 1.5gy/fr. bid, total 45gy(30fr during 3weeks) Arm 2: with once-daily thoracic radiotherapy daily 2.4gy/fr. qd, total 60gy(25fr during 5weeks)</description>
    <arm_group_label>Arm 1(with twice-daily TRT)</arm_group_label>
    <arm_group_label>Arm 2 (with once-daily TRT)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically or cytologically (if cannot be proven histologically, at least twice&#xD;
             positive findings on fine needle aspiration or sputum cytology) confirmed SCLC&#xD;
&#xD;
          -  Limited stage (Clinical stage I-IIIb, lesion limited to one side of thorax, e.g.&#xD;
             Excluding T4 disease with malignant pleural effusion or N3 disease with contralateral&#xD;
             hilum/supraclavicular lymph node invasion).&#xD;
&#xD;
          -  Measurable or assessable lesion&#xD;
&#xD;
          -  Age over 18 years old&#xD;
&#xD;
          -  Performance status (ECOG scale): 0~2&#xD;
&#xD;
          -  Adequate organ functions: ANC ≥ 1500/ul, PLT ≥ 100 x 103/u, Total Bilirubin ≤ 1.5&#xD;
             mg/dl, Creatinine ≤ 1.5 mg/dl&#xD;
&#xD;
          -  Inclusion of tumor within the limited radiation field without significant loss of&#xD;
             pulmonary function (confirmed by radiation oncologist)&#xD;
&#xD;
          -  Sexually active fertile men and women using a contraceptive method&#xD;
&#xD;
          -  Patients should sign a written informed consest before study entry&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  T4 disease with malignant pleural effusion; N3 disease with contralateral&#xD;
             hilum/supraclavicular lymph node invasion&#xD;
&#xD;
          -  Lesion with mixed small cell nonsmall cell feature (pathologically)&#xD;
&#xD;
          -  prior chemotherapy or radiation therapy.&#xD;
&#xD;
          -  Pericardial or pleural effusion on chest X-ray image regardless of cytological finding&#xD;
&#xD;
          -  T4 disease with tumor invasion to great vessels, heart, trachea, or esophagus;&#xD;
             Concerns about possible perforation by tumor necrosis&#xD;
&#xD;
          -  Severe comorbidities such as cardiac disease with symptom, myocardiac infarction&#xD;
             within 6 months, chronic obstructive pulmonary disease with FEV1 less than 1.0ℓ, or&#xD;
             uncontrolled bronchospasm of unaffected lung&#xD;
&#xD;
          -  With atelectasis that makes GTV unidentifiable&#xD;
&#xD;
          -  Other primary malignancy (except in situ carcinoma of the cervix or adequately treated&#xD;
             basal cell carcinoma of the skin or prior malignancy treated more than 3 years ago&#xD;
             without recurrence)&#xD;
&#xD;
          -  Uncontrolled psychiatric disorder, serious head injury, chronic alcoholism, drug&#xD;
             addiction and central nervous system 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>Kwan Ho Cho, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Cancer Center, Korea</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kwan Ho Cho, M.D.</last_name>
    <phone>+82 31 920 1720</phone>
    <email>kwancho@ncc.re.kr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sung Ho Moon, M.D.</last_name>
    <phone>+82 31 920 1726</phone>
    <email>shmoon@ncc.re.kr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>National Cancer Canter, Korea</name>
      <address>
        <city>Ilsan-ro 323, Ilsandoung-gu, Goyang-si</city>
        <state>Gyeonggi-do</state>
        <zip>410-769</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kwan Ho Cho, M.D.</last_name>
      <phone>+82 31 920 1720</phone>
      <email>ncckrog@ncc.re.kr</email>
    </contact>
    <contact_backup>
      <last_name>Sung Ho Moon, M.D.</last_name>
      <phone>+82 31 920 1726</phone>
      <email>ncckrog@ncc.re.kr</email>
    </contact_backup>
    <investigator>
      <last_name>Sung Ho Moon, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jin Soo Lee, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Heung Tae Kim, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ji Youn Han, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Tak Yun, M.D</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Young Joo Lee, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Geon Kook Lee, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Hyae Young Kim, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Byung Ho Nam, Statistician</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>National Cancer Canter, Korea</name>
      <address>
        <city>Ilsan-ro 323, Ilsandoung-gu, Goyang-si</city>
        <state>Gyeonggi-do</state>
        <zip>410-769</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kwan Ho Cho, M.D.</last_name>
      <phone>+82 31 920 1720</phone>
      <email>kwancho@ncc.re.kr</email>
    </contact>
    <contact_backup>
      <last_name>Sung Ho Moon, M.D.</last_name>
      <phone>+82 31 920 1726</phone>
      <email>shmoon@ncc.re.kr</email>
    </contact_backup>
    <investigator>
      <last_name>Sung Ho Moon, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jin Soo Lee, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Heung Tae Kim, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ji Youn Han, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Tak Yun, M.D</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Young Joo Lee, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 16, 2012</study_first_submitted>
  <study_first_submitted_qc>October 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 19, 2012</study_first_posted>
  <last_update_submitted>October 17, 2012</last_update_submitted>
  <last_update_submitted_qc>October 17, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 19, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Cancer Center, Korea</investigator_affiliation>
    <investigator_full_name>Kwan Ho Cho</investigator_full_name>
    <investigator_title>PI</investigator_title>
  </responsible_party>
  <keyword>concurrent chemoradiation in patients with limited disease small cell lung cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Small Cell Lung Carcinoma</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/NCT01710956
org study id: NCCCTS-11-531
nct id: NCT01710956
lead sponsor: 
has dmc: No
Non-small cell lung cancer
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: progression free survival
time frame: 5years after chemoradiotherapy
arm group label: Arm 1(with twice-daily TRT)
arm group type: Experimental
arm group label: Arm 2 (with once-daily TRT)
arm group type: Experimental
intervention type: Radiation
intervention name: Arm 1: with twice-daily thoracic radiotherapy/ Arm 2: with once-daily thoracic radiotherapy
description: Arm 1: with twice-daily thoracic radiotherapy daily 1.5gy/fr. bid, total 45gy(30fr during 3weeks) Arm 2: with once-daily thoracic radiotherapy daily 2.4gy/fr. qd, total 60gy(25fr during 5weeks)
arm group label: Arm 1(with twice-daily TRT)
arm group label: Arm 2 (with once-daily TRT)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kwan Ho Cho, M.D.
role: Principal Investigator
affiliation: National Cancer Center, Korea
last name: Kwan Ho Cho, M.D.
phone: +82 31 920 1720
email: kwancho@ncc.re.kr
last name: Sung Ho Moon, M.D.
phone: +82 31 920 1726
email: shmoon@ncc.re.kr
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
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investigator: 
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facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
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country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: National Cancer Center, Korea
investigator full name: Kwan Ho Cho
investigator title: PI
mesh term: Lung Neoplasms
mesh term: Small Cell Lung Carcinoma