<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/NCT01731548</url>
  </required_header>
  <id_info>
    <org_study_id>2012-10-25</org_study_id>
    <nct_id>NCT01731548</nct_id>
  </id_info>
  <brief_title>A Prospective Randomized Study Comparing the Target Volume for Limited-stage Small Cell Lung Cancer</brief_title>
  <official_title>Omitting Elective Nodal Irradiation and Irradiating Post-induction Versus Pre-induction Chemotherapy Tumor Extent for Limited-stage Small Cell Lung Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zhejiang Cancer Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sun Yat-sen University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Zhejiang Cancer Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      We hypothesized that the local control for both arms were not statistically significant, when&#xD;
      irradiation to the post-induction chemotherapy tumor volume is compared with irradiation to&#xD;
      the pre-induction chemotherapy tumor volume.While elective nodal irradiation will be omitted&#xD;
      for both arms.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2002</start_date>
  <completion_date type="Anticipated">December 2016</completion_date>
  <primary_completion_date type="Anticipated">December 2014</primary_completion_date>
  <phase>Phase 2/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>local-regional progression</measure>
    <time_frame>at least 6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>overall survival</measure>
    <time_frame>at least 1 year</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Carcinoma of Lung</condition>
  <condition>Small Cell</condition>
  <condition>Limited Stage</condition>
  <arm_group>
    <arm_group_label>study arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>For patients who are randomized to study arm, (i.e. to irradiate the post-chemotherapy tumor extent) the clinical target volume-tumor (CTV-T) includes the post-chemotherapy gross tumor volume-tumor (GTV-T) with a margin of 0.8 cm.&#xD;
Chemotherapy includes etoposide 100mg/m2 d1-d3 combine with cisplatin 80mg/m2 d1 at 21-day interval for 4 cycles.&#xD;
Radiotherapy will be administered with cycle 3 chemotherapy（1.5 Gy twice daily to 45 Gy in 30 fractions over 3 weeks）</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>For patients who are randomized to control arm, (i.e. to irradiate the pre-chemotherapy tumor extent) the clinical target volume-tumor (CTV-T) includes the pre-chemotherapy gross tumor volume-tumor (GTV-T) with a margin of 0.8 cm.&#xD;
Chemotherapy includes etoposide 100mg/m2 d1-d3 combine with cisplatin 80mg/m2 d1 at 21-day interval for 4 cycles.&#xD;
Radiotherapy will be administered with cycle 3 chemotherapy (1.5 Gy twice daily to 45 Gy in 30 fractions over 3 weeks).</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>hyperfractionated radiation therapy for both arms</intervention_name>
    <description>1.5 Gy twice daily to 45 Gy in 30 fractions over 3 weeks for both arms</description>
    <arm_group_label>control arm</arm_group_label>
    <arm_group_label>study arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients were eligible if they had histologic or cytologic verification of small cell&#xD;
             lung cancer (SCLC) and were radiographically confirmed limited-stage&#xD;
&#xD;
          -  Patients with contralateral mediastinal and ipsilateral supraclavicular&#xD;
             lymphadenopathy were also included.&#xD;
&#xD;
          -  The patients should be between 18 and 75 years old without previous thoracic&#xD;
             radiotherapy, chemotherapy or biotherapy.&#xD;
&#xD;
          -  Karnofsky performance status was ≥ 80.&#xD;
&#xD;
          -  Forced expiratory volume at 1 second (FEV1) ≥ 1 L.&#xD;
&#xD;
          -  Had measurable or assessable disease.&#xD;
&#xD;
          -  Neutrophilic granulocyte ≥ 1.5×109/L, haemoglobin ≥ 100 g/L, platelet count ≥&#xD;
             100×109/L.&#xD;
&#xD;
          -  Serum creatine and bilirubin &lt; 1.5 × the upper normal limit (UNL), aminotransferase &lt;&#xD;
             2 × UNL.&#xD;
&#xD;
          -  Weight loss was less than 10% within 6 months before diagnosis.&#xD;
&#xD;
          -  Written informed consent was required from all patients.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients were ineligible if they had a history of other malignant diseases except for&#xD;
             non-melanomatous skin cancer and carcinoma in situ of the cervix, or any&#xD;
             contraindications for chemoradiotherapy, malignant pleural and/or pericardial&#xD;
             effusion.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ming Chen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Zhejiang Cancer Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ming Chen, MD</last_name>
    <phone>+86 18758875572</phone>
    <email>gzcm@263.net</email>
  </overall_contact>
  <location>
    <facility>
      <name>Sun Yat-Sen University, Cancer Center</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510060</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hui Liu, MD. PHD</last_name>
      <phone>086-020-87343033</phone>
      <email>liuhui@sysucc.org.cn</email>
    </contact>
    <contact_backup>
      <last_name>Yong Bao, MD</last_name>
      <phone>086-020-87343504</phone>
      <email>baoyong@sysucc.org.cn</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2013</verification_date>
  <study_first_submitted>November 14, 2012</study_first_submitted>
  <study_first_submitted_qc>November 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <last_update_submitted>January 21, 2013</last_update_submitted>
  <last_update_submitted_qc>January 21, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 23, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Small Cell Lung Carcinoma</mesh_term>
    <mesh_term>Lung Neoplasms</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/NCT01731548
org study id: 2012-10-25
nct id: NCT01731548
lead sponsor: 
collaborator: 
has dmc: Yes
We hypothesized that the local control for both arms were not statistically significant, when
      irradiation to the post-induction chemotherapy tumor volume is compared with irradiation to
      the pre-induction chemotherapy tumor volume.While elective nodal irradiation will be omitted
      for both arms.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: local-regional progression
time frame: at least 6 months
measure: overall survival
time frame: at least 1 year
arm group label: study arm
arm group type: Experimental
description: For patients who are randomized to study arm, (i.e. to irradiate the post-chemotherapy tumor extent) the clinical target volume-tumor (CTV-T) includes the post-chemotherapy gross tumor volume-tumor (GTV-T) with a margin of 0.8 cm.
Chemotherapy includes etoposide 100mg/m2 d1-d3 combine with cisplatin 80mg/m2 d1 at 21-day interval for 4 cycles.
Radiotherapy will be administered with cycle 3 chemotherapy（1.5 Gy twice daily to 45 Gy in 30 fractions over 3 weeks）
arm group label: control arm
arm group type: Active Comparator
description: For patients who are randomized to control arm, (i.e. to irradiate the pre-chemotherapy tumor extent) the clinical target volume-tumor (CTV-T) includes the pre-chemotherapy gross tumor volume-tumor (GTV-T) with a margin of 0.8 cm.
Chemotherapy includes etoposide 100mg/m2 d1-d3 combine with cisplatin 80mg/m2 d1 at 21-day interval for 4 cycles.
Radiotherapy will be administered with cycle 3 chemotherapy (1.5 Gy twice daily to 45 Gy in 30 fractions over 3 weeks).
intervention type: Radiation
intervention name: hyperfractionated radiation therapy for both arms
description: 1.5 Gy twice daily to 45 Gy in 30 fractions over 3 weeks for both arms
arm group label: control arm
arm group label: study arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Ming Chen, MD
role: Principal Investigator
affiliation: Zhejiang Cancer Hospital
last name: Ming Chen, MD
phone: +86 18758875572
email: gzcm@263.net
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Sponsor
mesh term: Small Cell Lung Carcinoma
mesh term: Lung Neoplasms