<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/NCT01714908</url>
  </required_header>
  <id_info>
    <org_study_id>ML28545</org_study_id>
    <nct_id>NCT01714908</nct_id>
  </id_info>
  <brief_title>Phase II Study of Erlotinib With Concurrent Radiotherapy in Unresectable NSCLC With Activating Mutation of EGFR in Exon 19 or 21</brief_title>
  <acronym>RECEL</acronym>
  <official_title>A Multicenter, Randomized, Open-label, Phase II Study to Evaluate the Efficacy and Safety of Erlotinib Versus Etoposide Plus Cisplatin With Concurrent Radiotherapy in Unresectable Stage III Non-small Cell Lung Cancer (NSCLC) With Activating Mutation of Epidermal Growth Factor Receptor (EGFR) in Exon 19 or 21</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jinming Yu</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Roche Pharma AG</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Shandong Cancer Hospital and Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Erlotinib with concurrent radiotherapy has superior efficacy and comparable safety profile in&#xD;
      unresectable stage III non-small cell lung cancer (NSCLC) patients with activating mutation&#xD;
      of epidermal growth factor receptor (EGFR) in exon 19 or 21 versus etoposide plus cis-platin&#xD;
      with concurrent radiotherapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">December 14, 2012</start_date>
  <completion_date type="Anticipated">October 20, 2018</completion_date>
  <primary_completion_date type="Anticipated">August 20, 2018</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>Progress Free Survival (PFS)</measure>
    <time_frame>5 years</time_frame>
    <description>The time frame from the randomization to the first confirmed disease progression or any cause to death (dependent on which comes first)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Non-small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Erlotinib w Concurrent Radiotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>erlotinib 150mg oral daily up to 2 years concurrent radiotherapy total dose 60-66 Gray (Gy) in 2 Gray (Gy) fractions. One fraction per day, and 5 fractions per week.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>etoposide/cis-platin (EP) w Concurrent Radiotherapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>etoposide 50mg/m2 on D1-5 and D29-33 cis-platin 50mg/m2 on D1, D8, D29 and D36 concurrent radiotherapy total 60-66 Gray (Gy) in 2 Gray (Gy) fractions. One fraction per day, 5 fractions per week.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Erlotinib w Concurrent Radiotherapy</intervention_name>
    <arm_group_label>Erlotinib w Concurrent Radiotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>etoposide/cis-platin (EP) w Concurrent Radiotherapy</intervention_name>
    <description>Etoposide / Cis-platin w Concurrent Radiotherapy</description>
    <arm_group_label>etoposide/cis-platin (EP) w Concurrent Radiotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  NSCLC confirmed by histopathology or cytology;&#xD;
&#xD;
          -  Stage IIA or IIIB NSCLC according to Tumor Node Metastasis (TMN) staging of Lung&#xD;
             Staging Standard version 7 2009, and be unresectable;&#xD;
&#xD;
          -  Has active mutation of EGFR in exon 19 or 21;&#xD;
&#xD;
          -  Has measurable lesion [according to Response Evaluation Criteria in Solid Tumors&#xD;
             (RECIST) 1.1, must have at least one evaluable lesion with the longest dimension &gt;=&#xD;
             10mm; if the evaluable lesion is lymph node, the shortest dimension should be measured&#xD;
             and &gt;=15mm];&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1;&#xD;
&#xD;
          -  expectancy life &gt;= 12 weeks;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Had be treated by HER-targeting agents;&#xD;
&#xD;
          -  Had systemic anit-NSCLC treatments;&#xD;
&#xD;
          -  Had local radiotherapy for NSCLC;&#xD;
&#xD;
          -  Has upper gastrointestinal physiological disorders, or malabsorption syndrome, or&#xD;
             intolerance of oral medication, or active peptic ulcer;&#xD;
&#xD;
          -  Diagnosed other malignant tumor besides NSCLC within 5 years prior the study treatment&#xD;
             (except having simple surgical resection with 5-year disease free survival, cured in&#xD;
             situ of cervical carcinoma, cured basal cell carcinoma and bladder epithelial tumor);&#xD;
&#xD;
          -  Any evidence to indicate moderate or severe chronic obstructive pulmonary disease&#xD;
             (COPD);&#xD;
&#xD;
          -  Known hypersensitivity to platinum, etoposide, EGFR-Tyrosine Kinase Inhibitor (TKI)&#xD;
             agents or relevant components in the formulation;&#xD;
&#xD;
          -  Uncontrolled eye inflammation or infection, or any potential circumstances lead to eye&#xD;
             inflammation or infection;&#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>Jinming Yu, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Shandong Cancer Hospital and Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Shenglin Ma, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The First People's Hospital of Hangzhou</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Conghua Xie, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wuhan University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ming Chen, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Zhejiang Cancer Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Gang Wu, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tongji Medical College, Huazhong University of Science and Technology, Wuhan Union Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jianhua Wang, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Henan Cancer Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jiancheng Li, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fujian Province Cancer Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Zhengfei Zhu, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fudan University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>You Lu, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>West China Hospital, West China School of Medicine, Sichuan University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lvhua Wang, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Guangying Zhu, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking University Cancer Hospital &amp; Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tingyi Xia, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chinese PLA General Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Chun Han, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hebei Medical University Fourth Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Guang Li, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>First Hospital of China Medical University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Zhiyong Yuan, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tianjin Medical University Cancer Institute and Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Qin Lin, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The First Affiliated Hospital of Xiamen University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Qibin Song, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Renmin Hospital of Wuhan University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yaping Xu, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Zhejiang Cancer Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Bing Lu, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cancer Hospital of Guizhou Province</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Baolin Qu, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chinese PLA General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cancer Institute &amp; Hospital, Chinese Academy of Medical Sciences</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100021</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Cancer Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100142</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chinese PLA General Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100853</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The General Hospital of the People's Liberation Army</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100853</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fujian Province Cancer Hospital</name>
      <address>
        <city>Fuzhou</city>
        <state>Fujian</state>
        <zip>350008</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Xiamen University</name>
      <address>
        <city>Xiamen</city>
        <state>Fujian</state>
        <zip>361003</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guizhou Cancer Hospital</name>
      <address>
        <city>Guiyang</city>
        <state>Guizhou</state>
        <zip>550004</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hebei Medical University Fourth Hospital</name>
      <address>
        <city>Shijiazhuang</city>
        <state>Hebei</state>
        <zip>050011</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henan Cancer Hospital</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>450008</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430022</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zhongnan Hospital of Wuhan University</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430030</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Renmin Hospital of Wuhan University</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430060</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Hospital of China Medical University</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <zip>110001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shandong Cancer Hospital and Institute</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <zip>250117</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fudan University Shanghai Cancer Center</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West China Hospital, West China School of Medicine, Sichuan University</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610041</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tianjin Medical University Cancer Institute and Hospital</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300060</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First People's Hospital of Hangzhou</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310006</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zhejiang Cancer Hospital</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310022</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>October 23, 2012</study_first_submitted>
  <study_first_submitted_qc>October 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 26, 2012</study_first_posted>
  <last_update_submitted>February 4, 2017</last_update_submitted>
  <last_update_submitted_qc>February 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Shandong Cancer Hospital and Institute</investigator_affiliation>
    <investigator_full_name>Jinming Yu</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>NSCLC</keyword>
  <keyword>EGFR mutation</keyword>
  <keyword>unresectable</keyword>
  <keyword>erlotinib</keyword>
  <keyword>concurrent radiotherapy</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Etoposide</mesh_term>
    <mesh_term>Erlotinib Hydrochloride</mesh_term>
    <mesh_term>Cisplatin</mesh_term>
  </intervention_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/NCT01714908
org study id: ML28545
nct id: NCT01714908
lead sponsor: 
collaborator: 
has dmc: Yes
Erlotinib with concurrent radiotherapy has superior efficacy and comparable safety profile in
      unresectable stage III non-small cell lung cancer (NSCLC) patients with activating mutation
      of epidermal growth factor receptor (EGFR) in exon 19 or 21 versus etoposide plus cis-platin
      with concurrent radiotherapy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progress Free Survival (PFS)
time frame: 5 years
description: The time frame from the randomization to the first confirmed disease progression or any cause to death (dependent on which comes first)
arm group label: Erlotinib w Concurrent Radiotherapy
arm group type: Experimental
description: erlotinib 150mg oral daily up to 2 years concurrent radiotherapy total dose 60-66 Gray (Gy) in 2 Gray (Gy) fractions. One fraction per day, and 5 fractions per week.
arm group label: etoposide/cis-platin (EP) w Concurrent Radiotherapy
arm group type: Active Comparator
description: etoposide 50mg/m2 on D1-5 and D29-33 cis-platin 50mg/m2 on D1, D8, D29 and D36 concurrent radiotherapy total 60-66 Gray (Gy) in 2 Gray (Gy) fractions. One fraction per day, 5 fractions per week.
intervention type: Other
intervention name: Erlotinib w Concurrent Radiotherapy
arm group label: Erlotinib w Concurrent Radiotherapy
intervention type: Other
intervention name: etoposide/cis-platin (EP) w Concurrent Radiotherapy
description: Etoposide / Cis-platin w Concurrent Radiotherapy
arm group label: etoposide/cis-platin (EP) w Concurrent Radiotherapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Jinming Yu, PhD
role: Study Chair
affiliation: Shandong Cancer Hospital and Institute
last name: Shenglin Ma, PhD
role: Principal Investigator
affiliation: The First People's Hospital of Hangzhou
last name: Conghua Xie, PhD
role: Principal Investigator
affiliation: Wuhan University
last name: Ming Chen, PhD
role: Principal Investigator
affiliation: Zhejiang Cancer Hospital
last name: Gang Wu, PhD
role: Principal Investigator
affiliation: Tongji Medical College, Huazhong University of Science and Technology, Wuhan Union Hospital
last name: Jianhua Wang, PhD
role: Principal Investigator
affiliation: Henan Cancer Hospital
last name: Jiancheng Li, PhD
role: Principal Investigator
affiliation: Fujian Province Cancer Hospital
last name: Zhengfei Zhu, PhD
role: Principal Investigator
affiliation: Fudan University
last name: You Lu, PhD
role: Principal Investigator
affiliation: West China Hospital, West China School of Medicine, Sichuan University
last name: Lvhua Wang, PhD
role: Principal Investigator
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
last name: Guangying Zhu, PhD
role: Principal Investigator
affiliation: Peking University Cancer Hospital & Institute
last name: Tingyi Xia, PhD
role: Principal Investigator
affiliation: Chinese PLA General Hospital
last name: Chun Han, PhD
role: Principal Investigator
affiliation: Hebei Medical University Fourth Hospital
last name: Guang Li, PhD
role: Principal Investigator
affiliation: First Hospital of China Medical University
last name: Zhiyong Yuan, PhD
role: Principal Investigator
affiliation: Tianjin Medical University Cancer Institute and Hospital
last name: Qin Lin, PhD
role: Principal Investigator
affiliation: The First Affiliated Hospital of Xiamen University
last name: Qibin Song, PhD
role: Principal Investigator
affiliation: Renmin Hospital of Wuhan University
last name: Yaping Xu, PhD
role: Principal Investigator
affiliation: Zhejiang Cancer Hospital
last name: Bing Lu, PhD
role: Principal Investigator
affiliation: Cancer Hospital of Guizhou Province
last name: Baolin Qu, PhD
role: Principal Investigator
affiliation: Chinese PLA General Hospital
facility: 
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country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Shandong Cancer Hospital and Institute
investigator full name: Jinming Yu
investigator title: Professor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Etoposide
mesh term: Erlotinib Hydrochloride
mesh term: Cisplatin