<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/NCT04500145</url>
  </required_header>
  <id_info>
    <org_study_id>CH-L-072</org_study_id>
    <nct_id>NCT04500145</nct_id>
  </id_info>
  <brief_title>Simultaneous Integrated Boost vs. Routine IMRT in Limited-stage Small-cell Lung Cancer</brief_title>
  <official_title>A Randomized Phase III Study of Comparison Between Simultaneous Integrated Boost (SIB) Intensity-modulated Radiation Therapy (IMRT) Versus Routine IMRT/VMAT in LD-SCLC</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Thoracic radiotherapy concurrent with chemotherapy stands for the standard regime for limited&#xD;
      staged small cell lung cancer. Involved node radiation（INF） replaced elective node&#xD;
      irradiation（ENI） as the more popular since several trails compared the two regimes.&#xD;
      simultaneous integrated boost IMRT becomes mature with advancing in IMRT and VMAT. The&#xD;
      investigator hypothesis that SIB-IMRT can confine the dose for organs at risk to reduce the&#xD;
      toxicities compared with routine IMRT in limited disease small-cell lung cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All patients recruited divided into two arms：SIB-IMRT or routine IMRT，in the routine arm，the&#xD;
      prescription dose was 60Gy/2Gy/30f，and in the SIB arm ，60Gy was given to the field of the&#xD;
      tumor and metastatic lymph nodes，50Gy was given to CR lesion and high-risk prevention. The&#xD;
      physical advantages of SIB-IMRT are to reduce the radiation dose of organs that are at risk&#xD;
      in the lungs, esophagus, and heart ensuring the adequate dose for tumor area at the same&#xD;
      time. The investigators are carrying out this trial to compare the efficacy, safety, side&#xD;
      effects, and type of failure of the two radiotherapy techniques, which will provide a new&#xD;
      choice and reliable basis for the future dose-segmentation study of limited-stage small-cell&#xD;
      lung cancer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 20, 2017</start_date>
  <completion_date type="Anticipated">October 20, 2021</completion_date>
  <primary_completion_date type="Anticipated">July 20, 2021</primary_completion_date>
  <phase>Phase 3</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>progress-free survival</measure>
    <time_frame>2 year</time_frame>
    <description>the rate of patients survival from the treatment to death or progress</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>overall survival</measure>
    <time_frame>2 year</time_frame>
    <description>rate of patients survival in 2 years</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>local control rate</measure>
    <time_frame>2 year</time_frame>
    <description>recurrence rate of local field in 2 years</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>side-effects</measure>
    <time_frame>3-6months after radiation</time_frame>
    <description>the rate of radiation pneumatic、oesophagitis、haematological toxicity</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">350</enrollment>
  <condition>Small-cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>SIB-IMRT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>patients received radiotherapy using IMRT or VMAT，60Gy is given to the field of tumor and metastatic lymph nodes and 50Gy given to CR lesion and high-risk area.concurrent or sequential with 4-6 circles of chemotherapy of EP.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>routine</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>patients received IMRT or VMAT，with the prescription of 60Gy/2Gy/30F to the planning tumor volume ，concurrent or sequential with EP chemotherapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>SIB-IMRT</intervention_name>
    <description>60Gy given to the tumor area，50Gy to the CR lesion or high-risk field at the same time</description>
    <arm_group_label>SIB-IMRT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>routine IMRT</intervention_name>
    <description>patients received IMRT or VMAT，with the prescription of 60Gy/2Gy/30F to the planning tumor volume ，concurrent or sequential with EP chemotherapy</description>
    <arm_group_label>routine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-70 years old,KPS≥80&#xD;
&#xD;
          -  pathological small cell lung cancer&#xD;
&#xD;
          -  staged as limited disease SCLC（contralateral hilar invasion not included）&#xD;
&#xD;
          -  receive radiotherapy concurrent or sequential with chemotherapy，if induction&#xD;
             chemotherapy，got PR or SD&#xD;
&#xD;
          -  no other tumors&#xD;
&#xD;
          -  No serious medical diseases and dysfunction of major organs&#xD;
&#xD;
          -  understand this study，able to complete the treatment，accept the following up and sign&#xD;
             the informed consent&#xD;
&#xD;
          -  Contraception in women of childbearing age.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  other malignant tumor（historically or simultaneously）curable non-melanoma skin cancer&#xD;
             and cervical carcinoma in situ not included&#xD;
&#xD;
          -  Uncontrolled heart disease or myocardial infarction within 6 months&#xD;
&#xD;
          -  History of mental illness&#xD;
&#xD;
          -  Pregnancy or Lactation&#xD;
&#xD;
          -  uncontrolled diabetes、hypertension&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>zongmei zhou, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>national cancer hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>zongmei zhou, Professor</last_name>
    <phone>86 13801389769</phone>
    <email>zhouzongmei2013@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>lei deng, Dr</last_name>
    <phone>86 13683377570</phone>
    <email>dengleipumc@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100021</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>zongmei zhou, professor</last_name>
      <phone>86 13801389769</phone>
      <email>zhouzongmei2013@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>August 3, 2020</study_first_submitted>
  <study_first_submitted_qc>August 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>January 27, 2021</last_update_submitted>
  <last_update_submitted_qc>January 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Zongmei Zhou</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>Limited-stage small-cell lung cancer</keyword>
  <keyword>radiotherapy</keyword>
  <keyword>simultaneous integrated boost</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/NCT04500145
org study id: CH-L-072
nct id: NCT04500145
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Thoracic radiotherapy concurrent with chemotherapy stands for the standard regime for limited
      staged small cell lung cancer. Involved node radiation（INF） replaced elective node
      irradiation（ENI） as the more popular since several trails compared the two regimes.
      simultaneous integrated boost IMRT becomes mature with advancing in IMRT and VMAT. The
      investigator hypothesis that SIB-IMRT can confine the dose for organs at risk to reduce the
      toxicities compared with routine IMRT in limited disease small-cell lung cancer.
All patients recruited divided into two arms：SIB-IMRT or routine IMRT，in the routine arm，the
      prescription dose was 60Gy/2Gy/30f，and in the SIB arm ，60Gy was given to the field of the
      tumor and metastatic lymph nodes，50Gy was given to CR lesion and high-risk prevention. The
      physical advantages of SIB-IMRT are to reduce the radiation dose of organs that are at risk
      in the lungs, esophagus, and heart ensuring the adequate dose for tumor area at the same
      time. The investigators are carrying out this trial to compare the efficacy, safety, side
      effects, and type of failure of the two radiotherapy techniques, which will provide a new
      choice and reliable basis for the future dose-segmentation study of limited-stage small-cell
      lung cancer.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: progress-free survival
time frame: 2 year
description: the rate of patients survival from the treatment to death or progress
measure: overall survival
time frame: 2 year
description: rate of patients survival in 2 years
measure: local control rate
time frame: 2 year
description: recurrence rate of local field in 2 years
measure: side-effects
time frame: 3-6months after radiation
description: the rate of radiation pneumatic、oesophagitis、haematological toxicity
arm group label: SIB-IMRT
arm group type: Active Comparator
description: patients received radiotherapy using IMRT or VMAT，60Gy is given to the field of tumor and metastatic lymph nodes and 50Gy given to CR lesion and high-risk area.concurrent or sequential with 4-6 circles of chemotherapy of EP.
arm group label: routine
arm group type: Other
description: patients received IMRT or VMAT，with the prescription of 60Gy/2Gy/30F to the planning tumor volume ，concurrent or sequential with EP chemotherapy
intervention type: Radiation
intervention name: SIB-IMRT
description: 60Gy given to the tumor area，50Gy to the CR lesion or high-risk field at the same time
arm group label: SIB-IMRT
intervention type: Radiation
intervention name: routine IMRT
description: patients received IMRT or VMAT，with the prescription of 60Gy/2Gy/30F to the planning tumor volume ，concurrent or sequential with EP chemotherapy
arm group label: routine
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: zongmei zhou, PhD
role: Principal Investigator
affiliation: national cancer hospital
last name: zongmei zhou, Professor
phone: 86 13801389769
email: zhouzongmei2013@163.com
last name: lei deng, Dr
phone: 86 13683377570
email: dengleipumc@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
investigator full name: Zongmei Zhou
investigator title: Clinical Professor
mesh term: Lung Neoplasms
mesh term: Small Cell Lung Carcinoma