<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/NCT02975609</url>
  </required_header>
  <id_info>
    <org_study_id>SCHLC008</org_study_id>
    <nct_id>NCT02975609</nct_id>
  </id_info>
  <brief_title>Phase II Trial of SBRT Compared With Conventional Radiotherapy for Oligometastatic Non-Small Cell Lung Cancer</brief_title>
  <official_title>Phase II Trial of Stereotactic Body Radiation Therapy Compared With Conventional Fractionated Radiotherapy for Oligometastatic Non-Small Cell Lung Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Chest Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Chest Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This protocol is a phase II randomized controlled trial (RCT) evaluating the efficacy of SBRT&#xD;
      compared with conventional fractionated radiotherapy for oligometastatic Non-Small Cell Lung&#xD;
      Cancer&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Non small-cell lung cancer (NSCLC) is the leading cause of cancer-related death worldwide.&#xD;
      Approximately half of all patients with NSCLC present with metastatic disease at the time of&#xD;
      diagnosis, and the predominant pattern of failure in patients with localized NSCLC is distant&#xD;
      metastatic spread. The standard treatment in metastatic disease is cytotoxic chemotherapy&#xD;
      with a mean overall survival between 8-11 months.&#xD;
&#xD;
      Various studies suggest that patients who clinically present with a limited number of&#xD;
      metastases, a term defined as oligometastatic disease, could have a better prognosis of&#xD;
      survival with a radical treatment, than for their counterparts with a greater number of&#xD;
      metastasis. Much of the current clinical outcomes in oligometastatic disease is based on a&#xD;
      series of the retrospective studies.&#xD;
&#xD;
      This is a randomised prospective phase II study based on patients with stage IV&#xD;
      oligometastatic NSCLC according to UICC stage system(version 7,2009) or oligometastatic&#xD;
      disease after radical operation for stage I-III NSCLC. The purpose of this study is to add&#xD;
      more information to the current medical literature about the efficacy and safety of&#xD;
      Stereotactic Body Radiation Therapy (SBRT) compared with conventional fractionated&#xD;
      radiotherapy for oligometastatic non-small cell lung cancer (equal to or less than 5 sites&#xD;
      and equal to or less than 5cm in maximum diameter).&#xD;
&#xD;
      The patients enrolled receive firstly 4-6 cycles chemotherapy (platinum-based doublet&#xD;
      chemotherapy), and achieve response(stable disease or partial response or complete response).&#xD;
      Patients will be randomized into two groups. The control group will undergo the conventional&#xD;
      fractionated radiotherapy to all metastatic sites and the primary tumor. The experimental&#xD;
      group will receive SBRT to primary lesions or metastatic lesions.&#xD;
&#xD;
      The investigators will compare progress free survival(PFS) ,overall survival, incidence of&#xD;
      treatment-related adverse events of the two groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2019</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</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of treatment-related adverse events</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>NSCLC</condition>
  <arm_group>
    <arm_group_label>Conventional Fractionated Radiotherapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The patients enrolled receive firstly 4-6 cycles chemotherapy (platinum-based doublet chemotherapy), and achieve response(stable disease or partial response or complete response). Patients will be randomized into the control group undergoing the conventional fractionated radiotherapy to all metastatic sites and the primary tumor.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stereotactic Body Radiation Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patients enrolled receive firstly 4-6 cycles chemotherapy (platinum-based doublet chemotherapy), and achieve response(stable disease or partial response or complete response). Patients will be randomized into the experimental group undergoing SBRT to all metastatic sites and the primary tumor.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Conventional Fractionated Radiotherapy</intervention_name>
    <description>5Fx/W,3Gy/Fx,Dt:PTV-G:30Gy/10F/2W for metastatic sites, Dt:60Gy/30F for primary tumor and metastatic lymph node.</description>
    <arm_group_label>Conventional Fractionated Radiotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Stereotactic Body Radiation Therapy</intervention_name>
    <description>30Gy/3-5F for the primary and the metastases.</description>
    <arm_group_label>Stereotactic Body Radiation Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically proven non-small-cell lung cancer.&#xD;
&#xD;
          -  Stage IV oligometastatic NSCLC according to UICC stage system(version 7,2009) or&#xD;
             oligometastatic disease after radical operation for stage I-III NSCLC.&#xD;
&#xD;
          -  The patients receive firstly 4-6 cycles chemotherapy (platinum-based doublet&#xD;
             chemotherapy), and achieve response(stable disease or partial response or complete&#xD;
             response).&#xD;
&#xD;
          -  Staging with chest CT scan, abdominal ultrasonography , MRI brain, Bone scan and/or&#xD;
             FDG PET-CT whole body scan.&#xD;
&#xD;
          -  Number of metastatic lesions equal to or less than 5.&#xD;
&#xD;
          -  Maximum diameter of metastatic tumors equal to or less than 5cm.&#xD;
&#xD;
          -  ECOG performance status 0-2 at time of registration.&#xD;
&#xD;
          -  EGFR testing is mandatory.&#xD;
&#xD;
          -  No brain metastasis in MRI.&#xD;
&#xD;
          -  No liver metastasis in abdominal CT or MRI.&#xD;
&#xD;
          -  No malignant pleural effusion or pericardial effusion or peritoneal effusion.&#xD;
&#xD;
          -  Acceptable lung function for radical lung radiotherapy.&#xD;
&#xD;
          -  Stable lab values: Hematological:&#xD;
&#xD;
        Absolute neutrophil count (ANC) ≥1.5×109/L, Platelets ≥100×109/L, Hemoglobin≥9 g/dL Renal:&#xD;
        Creatinine OR Measured or calculated creatinine clearance (CrCl)(glomerular filtration rate&#xD;
        [GFR] can also be used in place of creatinine or CrCl) ≤1.5×the upper limit of normal (ULN)&#xD;
        OR ≥60 mL/min for patient with creatinine levels&gt;1.5× institutional ULN Hepatic: Total&#xD;
        bilirubin ≤1.5×ULN OR Direct bilirubin ≤ULN for patients with total bilirubin levels&#xD;
        &gt;1.5×ULN, Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)&#xD;
        ≤2.5×ULN,globulin≥20 g/L, albumin≥30 g/L.&#xD;
&#xD;
          -  No relevant co-morbidities, including pulmonary fibrosis and connective tissue&#xD;
             disorders&#xD;
&#xD;
          -  Able to understand and give written informed consent and comply with study procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient has had palliative radiotherapy to any tumour site prior to registration&#xD;
             and/or requires palliative radiotherapy prior to randomisation.&#xD;
&#xD;
          -  Patient has received any molecular targeted therapeutic drugs for NSCLC malignancy.&#xD;
&#xD;
          -  The patients receive firstly 4-6 cycles chemotherapy (platinum-based doublet&#xD;
             chemotherapy), and achieve progressive disease.&#xD;
&#xD;
          -  Any unstable systemic disease, including active infection, uncontrolled high blood&#xD;
             pressure, unstable angina, newly observed angina pectoris within the past 3 months,&#xD;
             congestive heart failure (New York heart association (NYHA) class II or higher),&#xD;
             myocardial infarction onset six months before included into the group, and severe&#xD;
             arrhythmia, liver, kidney, or metabolic disease in need of drug therapy.&#xD;
&#xD;
          -  Previously diagnosed with immunodeficiency disease.&#xD;
&#xD;
          -  Human immunodeficiency virus (HIV) infection.&#xD;
&#xD;
          -  Women in pregnancy or lactation.&#xD;
&#xD;
          -  Patients with mental illness, considered as &quot;can't fully understand the issues of this&#xD;
             research&quot;.&#xD;
&#xD;
          -  other Cancer history.&#xD;
&#xD;
          -  Histologically confirmed small cell carcinoma or other non NSCLC compositions in the&#xD;
             cancer tissue.&#xD;
&#xD;
          -  Brain metastasis or liver metastasis or malignant pleural effusion or pericardial&#xD;
             effusion or peritoneal effusion.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xiaolong Fu</last_name>
    <role>Study Director</role>
    <affiliation>Shanghai Chest Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xiaolong Fu, doctor</last_name>
    <phone>+862122200000</phone>
    <phone_ext>3602</phone_ext>
    <email>xlfu1964@126.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Shanghai Chest Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Salama JK, Schild SE. Radiation therapy for oligometastatic non-small cell lung cancer. Cancer Metastasis Rev. 2015 Jun;34(2):183-93. doi: 10.1007/s10555-015-9559-z.</citation>
    <PMID>25948377</PMID>
  </reference>
  <reference>
    <citation>Hanna GG, Landau D. Stereotactic body radiotherapy for oligometastatic disease. Clin Oncol (R Coll Radiol). 2015 May;27(5):290-7. doi: 10.1016/j.clon.2015.02.003. Epub 2015 Mar 12.</citation>
    <PMID>25770653</PMID>
  </reference>
  <reference>
    <citation>Tree AC, Khoo VS, Eeles RA, Ahmed M, Dearnaley DP, Hawkins MA, Huddart RA, Nutting CM, Ostler PJ, van As NJ. Stereotactic body radiotherapy for oligometastases. Lancet Oncol. 2013 Jan;14(1):e28-37. doi: 10.1016/S1470-2045(12)70510-7.</citation>
    <PMID>23276369</PMID>
  </reference>
  <reference>
    <citation>Ashworth A, Rodrigues G, Boldt G, Palma D. Is there an oligometastatic state in non-small cell lung cancer? A systematic review of the literature. Lung Cancer. 2013 Nov;82(2):197-203. doi: 10.1016/j.lungcan.2013.07.026. Epub 2013 Aug 20.</citation>
    <PMID>24051084</PMID>
  </reference>
  <reference>
    <citation>Ashworth AB, Senan S, Palma DA, Riquet M, Ahn YC, Ricardi U, Congedo MT, Gomez DR, Wright GM, Melloni G, Milano MT, Sole CV, De Pas TM, Carter DL, Warner AJ, Rodrigues GB. An individual patient data metaanalysis of outcomes and prognostic factors after treatment of oligometastatic non-small-cell lung cancer. Clin Lung Cancer. 2014 Sep;15(5):346-55. doi: 10.1016/j.cllc.2014.04.003. Epub 2014 May 15.</citation>
    <PMID>24894943</PMID>
  </reference>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 24, 2016</study_first_submitted>
  <study_first_submitted_qc>November 24, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>November 24, 2016</last_update_submitted>
  <last_update_submitted_qc>November 24, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 29, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai Chest Hospital</investigator_affiliation>
    <investigator_full_name>Xiaolong Fu</investigator_full_name>
    <investigator_title>Director, Department of Radiation Oncology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma, Non-Small-Cell Lung</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/NCT02975609
org study id: SCHLC008
nct id: NCT02975609
lead sponsor: 
has dmc: Yes
This protocol is a phase II randomized controlled trial (RCT) evaluating the efficacy of SBRT
      compared with conventional fractionated radiotherapy for oligometastatic Non-Small Cell Lung
      Cancer
Non small-cell lung cancer (NSCLC) is the leading cause of cancer-related death worldwide.
      Approximately half of all patients with NSCLC present with metastatic disease at the time of
      diagnosis, and the predominant pattern of failure in patients with localized NSCLC is distant
      metastatic spread. The standard treatment in metastatic disease is cytotoxic chemotherapy
      with a mean overall survival between 8-11 months.

      Various studies suggest that patients who clinically present with a limited number of
      metastases, a term defined as oligometastatic disease, could have a better prognosis of
      survival with a radical treatment, than for their counterparts with a greater number of
      metastasis. Much of the current clinical outcomes in oligometastatic disease is based on a
      series of the retrospective studies.

      This is a randomised prospective phase II study based on patients with stage IV
      oligometastatic NSCLC according to UICC stage system(version 7,2009) or oligometastatic
      disease after radical operation for stage I-III NSCLC. The purpose of this study is to add
      more information to the current medical literature about the efficacy and safety of
      Stereotactic Body Radiation Therapy (SBRT) compared with conventional fractionated
      radiotherapy for oligometastatic non-small cell lung cancer (equal to or less than 5 sites
      and equal to or less than 5cm in maximum diameter).

      The patients enrolled receive firstly 4-6 cycles chemotherapy (platinum-based doublet
      chemotherapy), and achieve response(stable disease or partial response or complete response).
      Patients will be randomized into two groups. The control group will undergo the conventional
      fractionated radiotherapy to all metastatic sites and the primary tumor. The experimental
      group will receive SBRT to primary lesions or metastatic lesions.

      The investigators will compare progress free survival(PFS) ,overall survival, incidence of
      treatment-related adverse events of the two groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progress Free Survival
time frame: 2 years
measure: Overall Survival
time frame: 2 years
measure: Incidence of treatment-related adverse events
time frame: 2 years
arm group label: Conventional Fractionated Radiotherapy
arm group type: Active Comparator
description: The patients enrolled receive firstly 4-6 cycles chemotherapy (platinum-based doublet chemotherapy), and achieve response(stable disease or partial response or complete response). Patients will be randomized into the control group undergoing the conventional fractionated radiotherapy to all metastatic sites and the primary tumor.
arm group label: Stereotactic Body Radiation Therapy
arm group type: Experimental
description: The patients enrolled receive firstly 4-6 cycles chemotherapy (platinum-based doublet chemotherapy), and achieve response(stable disease or partial response or complete response). Patients will be randomized into the experimental group undergoing SBRT to all metastatic sites and the primary tumor.
intervention type: Radiation
intervention name: Conventional Fractionated Radiotherapy
description: 5Fx/W,3Gy/Fx,Dt:PTV-G:30Gy/10F/2W for metastatic sites, Dt:60Gy/30F for primary tumor and metastatic lymph node.
arm group label: Conventional Fractionated Radiotherapy
intervention type: Radiation
intervention name: Stereotactic Body Radiation Therapy
description: 30Gy/3-5F for the primary and the metastases.
arm group label: Stereotactic Body Radiation Therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Xiaolong Fu
role: Study Director
affiliation: Shanghai Chest Hospital
last name: Xiaolong Fu, doctor
phone: +862122200000
phone ext: 3602
email: xlfu1964@126.com
facility: 
country: China
citation: Salama JK, Schild SE. Radiation therapy for oligometastatic non-small cell lung cancer. Cancer Metastasis Rev. 2015 Jun;34(2):183-93. doi: 10.1007/s10555-015-9559-z.
PMID: 25948377
citation: Hanna GG, Landau D. Stereotactic body radiotherapy for oligometastatic disease. Clin Oncol (R Coll Radiol). 2015 May;27(5):290-7. doi: 10.1016/j.clon.2015.02.003. Epub 2015 Mar 12.
PMID: 25770653
citation: Tree AC, Khoo VS, Eeles RA, Ahmed M, Dearnaley DP, Hawkins MA, Huddart RA, Nutting CM, Ostler PJ, van As NJ. Stereotactic body radiotherapy for oligometastases. Lancet Oncol. 2013 Jan;14(1):e28-37. doi: 10.1016/S1470-2045(12)70510-7.
PMID: 23276369
citation: Ashworth A, Rodrigues G, Boldt G, Palma D. Is there an oligometastatic state in non-small cell lung cancer? A systematic review of the literature. Lung Cancer. 2013 Nov;82(2):197-203. doi: 10.1016/j.lungcan.2013.07.026. Epub 2013 Aug 20.
PMID: 24051084
citation: Ashworth AB, Senan S, Palma DA, Riquet M, Ahn YC, Ricardi U, Congedo MT, Gomez DR, Wright GM, Melloni G, Milano MT, Sole CV, De Pas TM, Carter DL, Warner AJ, Rodrigues GB. An individual patient data metaanalysis of outcomes and prognostic factors after treatment of oligometastatic non-small-cell lung cancer. Clin Lung Cancer. 2014 Sep;15(5):346-55. doi: 10.1016/j.cllc.2014.04.003. Epub 2014 May 15.
PMID: 24894943
responsible party type: Principal Investigator
investigator affiliation: Shanghai Chest Hospital
investigator full name: Xiaolong Fu
investigator title: Director, Department of Radiation Oncology
mesh term: Carcinoma, Non-Small-Cell Lung
sharing ipd: No