<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/NCT02990780</url>
  </required_header>
  <id_info>
    <org_study_id>SCHLC010</org_study_id>
    <nct_id>NCT02990780</nct_id>
  </id_info>
  <brief_title>Accelerated Hypofractionated vs. Conventionally Fractionated Concurrent CRT for LS-SCLC</brief_title>
  <official_title>Phase III Randomized Study of Induction Chemotherapy Followed By Accelerated Hypofractionated vs. Conventionally Fractionated Concurrent Chemo-radiotherapy for Limited Stage 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 III randomized controlled trial (RCT) evaluating the efficacy of&#xD;
      induction chemotherapy followed by accelerated hypofractionated vs. conventionally&#xD;
      fractionated concurrent chemo-radiotherapy for limited-stage small cell lung cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Small-cell lung cancer accounts for approximately 13% of all lung cancers, and one-third of&#xD;
      these patients present with limited stage SCLC at diagnosis. Currently the standard of care&#xD;
      for LS-SCLC is concurrent chemotherapy and thoracic radiation therapy, with prophylactic&#xD;
      cranial irradiation for those who achieve a good response after combined chemoradiotherapy,&#xD;
      which has yielded a median survival of 15 to 23 months and 5-year survival rate up to 26%.&#xD;
&#xD;
      The optimal dose/fraction for LS-SCLC remains debatable. For SCLC with the characteristic of&#xD;
      rapid doubling time and high growth fraction, there is also evidence suggesting that&#xD;
      prolonged or interrupted overall radiation time contributes to treatment failure and poor&#xD;
      outcome because of accelerated repopulation.In our previous study we also found that overall&#xD;
      radiation time might play an important role in the treatment of LS-SCLC and that patients&#xD;
      treated with a high biologically effective dose (BED, including time factor) of &gt;57 Gy have&#xD;
      favorable local control and survival.&#xD;
&#xD;
      This is a randomised prospective phase III study based on patients with limited stage SCLC,&#xD;
      defined as disease confined to one hemithorax and hilar,mediastinal, or supraclavicular nodes&#xD;
      without pleural effusion, which can be safely encompassed within a tolerable radiation field.&#xD;
      The purpose of this study is to add more information to the current medical literature about&#xD;
      the efficacy and safety of accelerated hypofractionated vs. conventionally fractionated&#xD;
      concurrent chemo-radiotherapy for limited-stage SCLC.&#xD;
&#xD;
      Patients will be randomized into two groups. The control group will undergo the induction&#xD;
      chemotherapy followed by conventionally fractionated concurrent chemo-radiotherapy.The&#xD;
      experimental group will receive induction chemotherapy followed by accelerated&#xD;
      hypofractionated concurrent chemo-radiotherapy.The investigators compare overall survival&#xD;
      (OS) of the two groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 2015</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</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>Overall Survival</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progress Free Survival</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment-related adverse event</measure>
    <time_frame>1 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Locoregional recurrence-free survival</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">266</enrollment>
  <condition>SCLC</condition>
  <arm_group>
    <arm_group_label>Conventionally fractionated CRT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Induction chemotherapy followed by conventionally fractionated concurrent chemo-radiotherapy,with prophylactic cranial irradiation for those who achieve a good response after combined chemoradiotherapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Accelerated hypofractionated CRT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Induction chemotherapy followed by accelerated hypofractionated concurrent chemo-radiotherapy,with prophylactic cranial irradiation for those who achieve a good response after combined chemoradiotherapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Conventionally fractionated concurrent chemo-radiotherapy</intervention_name>
    <description>5Fx/W,2Gy/Fx,Dt:PTV-G:60Gy/30F/6W.</description>
    <arm_group_label>Conventionally fractionated CRT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Accelerated hypofractionated concurrent chemo-radiotherapy</intervention_name>
    <description>5Fx/W,2.5Gy/Fx,Dt:PTV-G:55Gy/22F/4.4W.</description>
    <arm_group_label>Accelerated hypofractionated CRT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically or cytologically confirmed SCLC.&#xD;
&#xD;
          -  Male or female, aged 18-70 years.&#xD;
&#xD;
          -  ECOG performance status 0 to 2.&#xD;
&#xD;
          -  Limited-stage SCLC was defined as disease confined to one hemithorax and&#xD;
             hilar,mediastinal, or supraclavicular nodes without pleural effusion, which can be&#xD;
             safely encompassed within a tolerable radiation field.&#xD;
&#xD;
          -  No prior thoracic RT.&#xD;
&#xD;
          -  Weight loss in six months less than or equal to five percent.&#xD;
&#xD;
          -  FEV1 greater than 0.75L.&#xD;
&#xD;
          -  No severe internal diseases and no organ dysfunction.&#xD;
&#xD;
          -  No prior history of any tumor.&#xD;
&#xD;
          -  Skin test of CT contrast agents was negative.&#xD;
&#xD;
          -  Had received 1-6 cycles of VP16 plus DDP/carboplatin.&#xD;
&#xD;
          -  Voluntarily participated in this study and signed the informed consent form by himself&#xD;
             or his agent. Had good compliance with the study procedures, and can cooperate with&#xD;
             the relevant examination, treatment and follow-up.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other tumor history(Except skin cancer/breast cancer/oral cancer/cervical cancer with&#xD;
             expected lifespan more than or equal to 3 months).&#xD;
&#xD;
          -  Multiple primary lung cancer.&#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. Human&#xD;
             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;
          -  Had received other chemotherapy regimens,any radiotherapy or TKI.&#xD;
&#xD;
          -  Refuse to write informed consent.&#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_contact>
    <last_name>Xiaolong Fu, PhD</last_name>
    <phone>862122200000</phone>
    <phone_ext>3609</phone_ext>
    <email>xlfu1964@126.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yiting Wang</last_name>
    <phone>862122200000</phone>
    <phone_ext>3609</phone_ext>
    <email>yitingwang_1111@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Shanghai Chest Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiaolong Fu, PhD</last_name>
      <phone>+862122200000</phone>
      <phone_ext>3602</phone_ext>
      <email>xlfu1964@126.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Govindan R, Page N, Morgensztern D, Read W, Tierney R, Vlahiotis A, Spitznagel EL, Piccirillo J. Changing epidemiology of small-cell lung cancer in the United States over the last 30 years: analysis of the surveillance, epidemiologic, and end results database. J Clin Oncol. 2006 Oct 1;24(28):4539-44. doi: 10.1200/JCO.2005.04.4859.</citation>
    <PMID>17008692</PMID>
  </reference>
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    <citation>Bayman NA, Sheikh H, Kularatne B, Lorigan P, Blackhall F, Thatcher N, Faivre-Finn C. Radiotherapy for small-cell lung cancer-Where are we heading? Lung Cancer. 2009 Mar;63(3):307-14. doi: 10.1016/j.lungcan.2008.06.013. Epub 2008 Aug 3.</citation>
    <PMID>18676057</PMID>
  </reference>
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    <citation>Stinchcombe TE, Gore EM. Limited-stage small cell lung cancer: current chemoradiotherapy treatment paradigms. Oncologist. 2010;15(2):187-95. doi: 10.1634/theoncologist.2009-0298. Epub 2010 Feb 9.</citation>
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    <PMID>26629422</PMID>
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    <citation>Semenova EA, Nagel R, Berns A. Origins, genetic landscape, and emerging therapies of small cell lung cancer. Genes Dev. 2015 Jul 15;29(14):1447-62. doi: 10.1101/gad.263145.115.</citation>
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    <citation>Pietanza MC, Byers LA, Minna JD, Rudin CM. Small cell lung cancer: will recent progress lead to improved outcomes? Clin Cancer Res. 2015 May 15;21(10):2244-55. doi: 10.1158/1078-0432.CCR-14-2958.</citation>
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    <citation>Kalemkerian GP. Advances in pharmacotherapy of small cell lung cancer. Expert Opin Pharmacother. 2014 Nov;15(16):2385-96. doi: 10.1517/14656566.2014.957180. Epub 2014 Sep 26.</citation>
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    <citation>Pignon JP, Arriagada R, Ihde DC, Johnson DH, Perry MC, Souhami RL, Brodin O, Joss RA, Kies MS, Lebeau B, et al. A meta-analysis of thoracic radiotherapy for small-cell lung cancer. N Engl J Med. 1992 Dec 3;327(23):1618-24. doi: 10.1056/NEJM199212033272302.</citation>
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    <citation>Warde P, Payne D. Does thoracic irradiation improve survival and local control in limited-stage small-cell carcinoma of the lung? A meta-analysis. J Clin Oncol. 1992 Jun;10(6):890-5. doi: 10.1200/JCO.1992.10.6.890.</citation>
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  <verification_date>April 2021</verification_date>
  <study_first_submitted>December 9, 2016</study_first_submitted>
  <study_first_submitted_qc>December 9, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>April 26, 2021</last_update_submitted>
  <last_update_submitted_qc>April 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 28, 2021</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>
  <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/NCT02990780
org study id: SCHLC010
nct id: NCT02990780
lead sponsor: 
has dmc: Yes
This protocol is a phase III randomized controlled trial (RCT) evaluating the efficacy of
      induction chemotherapy followed by accelerated hypofractionated vs. conventionally
      fractionated concurrent chemo-radiotherapy for limited-stage small cell lung cancer.
Small-cell lung cancer accounts for approximately 13% of all lung cancers, and one-third of
      these patients present with limited stage SCLC at diagnosis. Currently the standard of care
      for LS-SCLC is concurrent chemotherapy and thoracic radiation therapy, with prophylactic
      cranial irradiation for those who achieve a good response after combined chemoradiotherapy,
      which has yielded a median survival of 15 to 23 months and 5-year survival rate up to 26%.

      The optimal dose/fraction for LS-SCLC remains debatable. For SCLC with the characteristic of
      rapid doubling time and high growth fraction, there is also evidence suggesting that
      prolonged or interrupted overall radiation time contributes to treatment failure and poor
      outcome because of accelerated repopulation.In our previous study we also found that overall
      radiation time might play an important role in the treatment of LS-SCLC and that patients
      treated with a high biologically effective dose (BED, including time factor) of >57 Gy have
      favorable local control and survival.

      This is a randomised prospective phase III study based on patients with limited stage SCLC,
      defined as disease confined to one hemithorax and hilar,mediastinal, or supraclavicular nodes
      without pleural effusion, which can be safely encompassed within a tolerable radiation field.
      The purpose of this study is to add more information to the current medical literature about
      the efficacy and safety of accelerated hypofractionated vs. conventionally fractionated
      concurrent chemo-radiotherapy for limited-stage SCLC.

      Patients will be randomized into two groups. The control group will undergo the induction
      chemotherapy followed by conventionally fractionated concurrent chemo-radiotherapy.The
      experimental group will receive induction chemotherapy followed by accelerated
      hypofractionated concurrent chemo-radiotherapy.The investigators compare overall survival
      (OS) of the two groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall Survival
time frame: 2 years
measure: Progress Free Survival
time frame: 2 years
measure: Treatment-related adverse event
time frame: 1 years
measure: Locoregional recurrence-free survival
time frame: 2 years
arm group label: Conventionally fractionated CRT
arm group type: Active Comparator
description: Induction chemotherapy followed by conventionally fractionated concurrent chemo-radiotherapy,with prophylactic cranial irradiation for those who achieve a good response after combined chemoradiotherapy.
arm group label: Accelerated hypofractionated CRT
arm group type: Experimental
description: Induction chemotherapy followed by accelerated hypofractionated concurrent chemo-radiotherapy,with prophylactic cranial irradiation for those who achieve a good response after combined chemoradiotherapy.
intervention type: Radiation
intervention name: Conventionally fractionated concurrent chemo-radiotherapy
description: 5Fx/W,2Gy/Fx,Dt:PTV-G:60Gy/30F/6W.
arm group label: Conventionally fractionated CRT
intervention type: Radiation
intervention name: Accelerated hypofractionated concurrent chemo-radiotherapy
description: 5Fx/W,2.5Gy/Fx,Dt:PTV-G:55Gy/22F/4.4W.
arm group label: Accelerated hypofractionated CRT
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Xiaolong Fu, PhD
phone: 862122200000
phone ext: 3609
email: xlfu1964@126.com
last name: Yiting Wang
phone: 862122200000
phone ext: 3609
email: yitingwang_1111@163.com
facility: 
status: Recruiting
contact: 
country: China
citation: Govindan R, Page N, Morgensztern D, Read W, Tierney R, Vlahiotis A, Spitznagel EL, Piccirillo J. Changing epidemiology of small-cell lung cancer in the United States over the last 30 years: analysis of the surveillance, epidemiologic, and end results database. J Clin Oncol. 2006 Oct 1;24(28):4539-44. doi: 10.1200/JCO.2005.04.4859.
PMID: 17008692
citation: Bayman NA, Sheikh H, Kularatne B, Lorigan P, Blackhall F, Thatcher N, Faivre-Finn C. Radiotherapy for small-cell lung cancer-Where are we heading? Lung Cancer. 2009 Mar;63(3):307-14. doi: 10.1016/j.lungcan.2008.06.013. Epub 2008 Aug 3.
PMID: 18676057
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responsible party type: Principal Investigator
investigator affiliation: Shanghai Chest Hospital
investigator full name: Xiaolong Fu
investigator title: Director, Department of Radiation Oncology
sharing ipd: No