<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/NCT03833193</url>
  </required_header>
  <id_info>
    <org_study_id>NorthChinaPBGHA</org_study_id>
    <nct_id>NCT03833193</nct_id>
  </id_info>
  <brief_title>Moderate Hypofractionated Radiotherapy for Lung Cancer</brief_title>
  <official_title>Moderate Hypofractionated(3Gy/f) Radiotherapy for Advanced Lung Cancer: a Retrospective Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>North China Petroleum Bureau General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>North China Petroleum Bureau General Hospital</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>
      The purpose of this study is to evaluate the incidences of Grade III and above&#xD;
      radiation-reduced esophagitis and radiation-reduced pneumonia of patients with advanced lung&#xD;
      cancer treated with moderate hypofractionated (3Gy/f) radiotherapy, and their predictors.&#xD;
      Efficacies are also evaluated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Radiotherapy plays an irreplaceable role in lung cancer. However, due to the long duration of&#xD;
      conventional fractionation irradiation, tumor cells will accelerate repopulation after 3 to 4&#xD;
      weeks during radiotherapy, resulting in decreased efficacy. Hypofractionated radiation is&#xD;
      increasingly used in radiotherapy of lung cancer. It can shorten the overall treatment time,&#xD;
      and can potentially reduce the effect of tumor accelerated repopulation. Compared with&#xD;
      conventional radiotherapy, hypofractionated radiotherapy can theoretically obtain a higher&#xD;
      biological effective dose (BED). The application of Stereotactic Body Radiation Therapy&#xD;
      (SBRT) or Stereotactic Ablative Radiotherapy (SABR) in advanced or central lung cancer is&#xD;
      restricted when the tumors are adjacent to important organs. Moderate hypofractionated&#xD;
      radiotherapy can not only shorten the overall total treatment time, but also reduce the&#xD;
      severe toxicities. It is widely used in lung cancer nowadays. However, most data of the&#xD;
      tolerated doses for normal tissue and organs comes from conventional radiotherapy. Whether or&#xD;
      not it is suitable for hypofractionated radiotherapy has not been determined. In our study,&#xD;
      the incidences of Grade III and above radiation-reduced esophagitis and radiation-reduced&#xD;
      pneumonia, as well as their predictors, were obtained by retrospective analysis of patients&#xD;
      received moderate hypofractionated radiotherapy of 3Gy/f. At the same time, the efficacies of&#xD;
      this scheme are also evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 1, 2016</start_date>
  <completion_date type="Anticipated">March 1, 2025</completion_date>
  <primary_completion_date type="Anticipated">May 1, 2024</primary_completion_date>
  <phase>N/A</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>Incidence of grade III and above radiation-reduced esophagitis</measure>
    <time_frame>three years</time_frame>
    <description>Incidence of grade III and above radiation-reduced esophagitis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of grade III and above radiation-reduced pneumonitis</measure>
    <time_frame>three years</time_frame>
    <description>Incidence of grade III and above radiation-reduced pneumonitis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Objective Response Rate</measure>
    <time_frame>three years</time_frame>
    <description>ORR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Local Control Rate</measure>
    <time_frame>three years</time_frame>
    <description>LCR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival</measure>
    <time_frame>three years</time_frame>
    <description>PFS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median Survival Time</measure>
    <time_frame>three years</time_frame>
    <description>MST</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>three years</time_frame>
    <description>OS</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Hypofractionated radiotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patients received daily accelerated radiotherapy with a total dose of 60Gy, delivered at 3Gy per fraction, five fractions per week, completed within 4 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Hypofractionated radiotherapy</intervention_name>
    <description>Radiation: Hypofractionated radiotherapy at 3Gy/f</description>
    <arm_group_label>Hypofractionated radiotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with previously untreated advanced lung cancer were recruited, who were&#xD;
             confirmed pathologically or cytologically.&#xD;
&#xD;
          2. The Karnofsky performance status (KPS) score ≥60.&#xD;
&#xD;
          3. The expected survival time was≥3 months.&#xD;
&#xD;
          4. The laboratory examination results showed a neutrophil count ≥2.0 × 109, a hemoglobin&#xD;
             level ≥100 g/L, a platelet count ≥100 × 109, and enough liver and kidney functions.&#xD;
&#xD;
          5. The patients did not show abnormal electrocardiogram (ECG) results.&#xD;
&#xD;
          6. They did not have other combined diseases that required hospitalization.&#xD;
&#xD;
          7. Informed consent required before enrollment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients who were pregnant or breastfeeding.&#xD;
&#xD;
          2. Patients who had another malignant tumor history (with the exception of patients with&#xD;
             cervical carcinoma in situ and non-malignant melanoma skin cancer that had been&#xD;
             clinically cured for at least 5 years), could not receive concurrent chemotherapy due&#xD;
             to medical reasons.&#xD;
&#xD;
          3. Superior vena cava syndrome.&#xD;
&#xD;
          4. Syndrome and severe lung diseases that affected lung function were excluded.&#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>QIANG LIN, Dr</last_name>
    <role>Study Director</role>
    <affiliation>North China Petroleum Bureau General Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>QIANG LIN, Dr</last_name>
    <phone>+86-177-177-37955</phone>
    <phone_ext>+86-317-272195</phone_ext>
    <email>billhappy001@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>YAN-HUA BI, Master</last_name>
    <phone>+86-18931705808</phone>
    <phone_ext>+86-3172723053</phone_ext>
    <email>zyy_byh@petrochina.com.cn</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>North China Petroleum Bureau General Hospital</name>
      <address>
        <city>Cangzhou</city>
        <state>HE BEI</state>
        <zip>062552</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>QIANG LIN, Dr</last_name>
      <phone>+86-317-272-1951</phone>
      <email>billhappy001@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>February 3, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>March 22, 2023</last_update_submitted>
  <last_update_submitted_qc>March 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 23, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hypofractionated radiotherapy;</keyword>
  <keyword>Radiation-reduced esophagitis;</keyword>
  <keyword>Radiation-reduced pneumonitis;Predictor</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</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/NCT03833193
org study id: NorthChinaPBGHA
nct id: NCT03833193
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the incidences of Grade III and above
      radiation-reduced esophagitis and radiation-reduced pneumonia of patients with advanced lung
      cancer treated with moderate hypofractionated (3Gy/f) radiotherapy, and their predictors.
      Efficacies are also evaluated.
Radiotherapy plays an irreplaceable role in lung cancer. However, due to the long duration of
      conventional fractionation irradiation, tumor cells will accelerate repopulation after 3 to 4
      weeks during radiotherapy, resulting in decreased efficacy. Hypofractionated radiation is
      increasingly used in radiotherapy of lung cancer. It can shorten the overall treatment time,
      and can potentially reduce the effect of tumor accelerated repopulation. Compared with
      conventional radiotherapy, hypofractionated radiotherapy can theoretically obtain a higher
      biological effective dose (BED). The application of Stereotactic Body Radiation Therapy
      (SBRT) or Stereotactic Ablative Radiotherapy (SABR) in advanced or central lung cancer is
      restricted when the tumors are adjacent to important organs. Moderate hypofractionated
      radiotherapy can not only shorten the overall total treatment time, but also reduce the
      severe toxicities. It is widely used in lung cancer nowadays. However, most data of the
      tolerated doses for normal tissue and organs comes from conventional radiotherapy. Whether or
      not it is suitable for hypofractionated radiotherapy has not been determined. In our study,
      the incidences of Grade III and above radiation-reduced esophagitis and radiation-reduced
      pneumonia, as well as their predictors, were obtained by retrospective analysis of patients
      received moderate hypofractionated radiotherapy of 3Gy/f. At the same time, the efficacies of
      this scheme are also evaluated.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of grade III and above radiation-reduced esophagitis
time frame: three years
description: Incidence of grade III and above radiation-reduced esophagitis
measure: Incidence of grade III and above radiation-reduced pneumonitis
time frame: three years
description: Incidence of grade III and above radiation-reduced pneumonitis
measure: Objective Response Rate
time frame: three years
description: ORR
measure: Local Control Rate
time frame: three years
description: LCR
measure: Progression Free Survival
time frame: three years
description: PFS
measure: Median Survival Time
time frame: three years
description: MST
measure: Overall Survival
time frame: three years
description: OS
arm group label: Hypofractionated radiotherapy
arm group type: Experimental
description: The patients received daily accelerated radiotherapy with a total dose of 60Gy, delivered at 3Gy per fraction, five fractions per week, completed within 4 weeks.
intervention type: Radiation
intervention name: Hypofractionated radiotherapy
description: Radiation: Hypofractionated radiotherapy at 3Gy/f
arm group label: Hypofractionated radiotherapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: QIANG LIN, Dr
role: Study Director
affiliation: North China Petroleum Bureau General Hospital
last name: QIANG LIN, Dr
phone: +86-177-177-37955
phone ext: +86-317-272195
email: billhappy001@163.com
last name: YAN-HUA BI, Master
phone: +86-18931705808
phone ext: +86-3172723053
email: zyy_byh@petrochina.com.cn
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Lung Neoplasms
sharing ipd: No