<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/NCT03802058</url>
  </required_header>
  <id_info>
    <org_study_id>Nab-P RT</org_study_id>
    <nct_id>NCT03802058</nct_id>
  </id_info>
  <brief_title>Concurrent Nab-P/Carboplatin and Thoracic Radiotherapy in Squamous Cell Lung Cancer</brief_title>
  <official_title>Concurrent Nab--paclitaxel/Carboplatin and Thoracic Radiotherapy in Inoperable Stage III Squamous Cell Lung Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wuhan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>CSPC Ouyi Pharmaceutical Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Wuhan University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Nab-paclitaxel and carboplatin showed better treatment response compared with cremophor-based&#xD;
      paclitaxel and carboplatin as first-line therapy in advanced non-small cell lung cancer,&#xD;
      especially for squamous cell cancer. This study is conducted to evaluate the efficacy and&#xD;
      safety of nab-paclitaxel, carboplatin and concurrent radiotherapy in patients with local&#xD;
      advanced inoperable squamous cell lung cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study was conducted to explore the efficacy and safety of concurrent concurrent&#xD;
      nab-paclitaxel, carboplatin and thoracic radiotherapy in inoperable local advanced squamous&#xD;
      cell lung cancer. Patients will be given nab-paclitaxel weekly at a dose of 40mg/m2, in&#xD;
      combination with carboplatin (AUC 2) weekly during concurrent chemoradiotherapy. Thoracic&#xD;
      radiation was administered at a dose of 60-66 Gy/30-33 fractions, both 3 dimensional&#xD;
      conformal and intensity modulated radiation therapy are allowed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The study was halted because enrollment was too slow&#xD;
  </why_stopped>
  <start_date type="Actual">March 20, 2019</start_date>
  <completion_date type="Actual">December 12, 2021</completion_date>
  <primary_completion_date type="Actual">December 12, 2021</primary_completion_date>
  <phase>Phase 2</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>PFS (progression-free survival )</measure>
    <time_frame>5 years from patient enrollment</time_frame>
    <description>PFS is defined as time from the start of treatment to death, progression of disease, or the last follow-up data, whichever comes first. Progression is evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. PFS will be analyzed using the Kaplan-Meier method.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ORR (Overall Response Rate )</measure>
    <time_frame>one month after the end of all treatment</time_frame>
    <description>The number of participants that achieve either a complete response (CR) or a partial response (PR). Response is evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LCR (Local Control Rate)</measure>
    <time_frame>one month after the end of all treatment</time_frame>
    <description>The number of participants that achieve either a complete response (CR) , a partial response (PR) or stable disease(SD).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>OS (Overall survival)</measure>
    <time_frame>5 years from patient enrollment</time_frame>
    <description>Overall survival is defined as time from the start of treatment until death. Overall survival will be analyzed using the Kaplan-Meier method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with adverse events as assessed by CTCAE v4.0</measure>
    <time_frame>5 years from patient enrollment</time_frame>
    <description>The adverse events(AE) is evaluated by National Cancer Institute- Common Terminology Criteria for Adverse Events(NCI -CTCAE) 4.02.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient quality of life (QOL)</measure>
    <time_frame>5 years from patient enrollment</time_frame>
    <description>Measured by the Functional Assessment of Cancer Therapy - Lung (FACT-L).The total range of scores:0-144,and higher values represent a better outcome.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Carcinoma, Non-Small-Cell Lung</condition>
  <condition>Squamous Cell Carcinoma</condition>
  <arm_group>
    <arm_group_label>Nab-paclitaxel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nab-paclitaxel and carboplatin for Injection; thoracic radiation therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nab-paclitaxel</intervention_name>
    <description>Nab-paclitaxel 40mg/m2 for Injection weekly</description>
    <arm_group_label>Nab-paclitaxel</arm_group_label>
    <other_name>Nab-P</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Carboplatin</intervention_name>
    <description>Carboplatin AUC=2 for Injection weekly</description>
    <arm_group_label>Nab-paclitaxel</arm_group_label>
    <other_name>CBP</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Thoracic radiation therapy</intervention_name>
    <description>Thoracic radiation therapy 60-66Gy/30-33 fractions,both three-dimensional conformal and intensity modulated radiation therapy are allowed</description>
    <arm_group_label>Nab-paclitaxel</arm_group_label>
    <other_name>RT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: 18 Years to 70 Years&#xD;
&#xD;
          -  Performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) Scale.&#xD;
&#xD;
          -  Previously untreated, histological documented, inoperable stage III squamous cell&#xD;
             carcinoma of lung, excluding those with pericardial, pleural effusion, and those with&#xD;
             contralateral hilar or contralateral supraclavicular lymph nodes.&#xD;
&#xD;
          -  Patients must have measurable disease according to RECIST criteria, and all detectable&#xD;
             tumor can be encompassed by radiation therapy fields.&#xD;
&#xD;
          -  Patient must have adequate blood, liver, lungs and kidney function within the&#xD;
             requirements of this study.&#xD;
&#xD;
          -  Female patients of child-bearing potential must test negative for pregnancy at the&#xD;
             time of enrollment based on a serum pregnancy test. Male and female patients must&#xD;
             agree to use a reliable method of birth control during and for 3 months following the&#xD;
             last dose of study drug.&#xD;
&#xD;
          -  Patients must sign a study-specific informed consent form prior to study entry.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Complete tumor resection, recurrent disease, or those patients eligible for definitive&#xD;
             surgery.&#xD;
&#xD;
          -  Previous chemotherapy or previous biologic response modifiers for current lung cancer.&#xD;
&#xD;
          -  Patient has previously had thoracic radiation therapy.&#xD;
&#xD;
          -  Prior or concurrent malignancy except non-melanomatous skin cancer unless disease-free&#xD;
             for five years or more.&#xD;
&#xD;
          -  Serious concomitant disorders that would compromise the safety of the patient, or&#xD;
             compromise the patient's ability to complete the study, at the discretion of the&#xD;
             investigator.&#xD;
&#xD;
          -  History of significant neurological or mental disorder, including seizures or&#xD;
             dementia.&#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>Conghua Xie, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wuhan University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Zhongnan Hospital of Wuhan University</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430071</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>January 6, 2019</study_first_submitted>
  <study_first_submitted_qc>January 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>April 27, 2023</last_update_submitted>
  <last_update_submitted_qc>April 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Wuhan University</investigator_affiliation>
    <investigator_full_name>Conghua Xie,MD,PhD</investigator_full_name>
    <investigator_title>director of Department of Radiation and Medical Oncology, Zhongnan Hospital</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</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>Paclitaxel</mesh_term>
    <mesh_term>Carboplatin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>all IPD can be shared by all researchers who participate in this study by e-mail contact</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>2 years after the end of the study</ipd_time_frame>
    <ipd_access_criteria>Researchers who participate in this study</ipd_access_criteria>
  </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/NCT03802058
org study id: Nab-P RT
nct id: NCT03802058
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Nab-paclitaxel and carboplatin showed better treatment response compared with cremophor-based
      paclitaxel and carboplatin as first-line therapy in advanced non-small cell lung cancer,
      especially for squamous cell cancer. This study is conducted to evaluate the efficacy and
      safety of nab-paclitaxel, carboplatin and concurrent radiotherapy in patients with local
      advanced inoperable squamous cell lung cancer.
This study was conducted to explore the efficacy and safety of concurrent concurrent
      nab-paclitaxel, carboplatin and thoracic radiotherapy in inoperable local advanced squamous
      cell lung cancer. Patients will be given nab-paclitaxel weekly at a dose of 40mg/m2, in
      combination with carboplatin (AUC 2) weekly during concurrent chemoradiotherapy. Thoracic
      radiation was administered at a dose of 60-66 Gy/30-33 fractions, both 3 dimensional
      conformal and intensity modulated radiation therapy are allowed.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: PFS (progression-free survival )
time frame: 5 years from patient enrollment
description: PFS is defined as time from the start of treatment to death, progression of disease, or the last follow-up data, whichever comes first. Progression is evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. PFS will be analyzed using the Kaplan-Meier method.
measure: ORR (Overall Response Rate )
time frame: one month after the end of all treatment
description: The number of participants that achieve either a complete response (CR) or a partial response (PR). Response is evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
measure: LCR (Local Control Rate)
time frame: one month after the end of all treatment
description: The number of participants that achieve either a complete response (CR) , a partial response (PR) or stable disease(SD).
measure: OS (Overall survival)
time frame: 5 years from patient enrollment
description: Overall survival is defined as time from the start of treatment until death. Overall survival will be analyzed using the Kaplan-Meier method.
measure: Number of participants with adverse events as assessed by CTCAE v4.0
time frame: 5 years from patient enrollment
description: The adverse events(AE) is evaluated by National Cancer Institute- Common Terminology Criteria for Adverse Events(NCI -CTCAE) 4.02.
measure: Patient quality of life (QOL)
time frame: 5 years from patient enrollment
description: Measured by the Functional Assessment of Cancer Therapy - Lung (FACT-L).The total range of scores:0-144,and higher values represent a better outcome.
arm group label: Nab-paclitaxel
arm group type: Experimental
description: Nab-paclitaxel and carboplatin for Injection; thoracic radiation therapy
intervention type: Drug
intervention name: Nab-paclitaxel
description: Nab-paclitaxel 40mg/m2 for Injection weekly
arm group label: Nab-paclitaxel
other name: Nab-P
intervention type: Drug
intervention name: Carboplatin
description: Carboplatin AUC=2 for Injection weekly
arm group label: Nab-paclitaxel
other name: CBP
intervention type: Radiation
intervention name: Thoracic radiation therapy
description: Thoracic radiation therapy 60-66Gy/30-33 fractions,both three-dimensional conformal and intensity modulated radiation therapy are allowed
arm group label: Nab-paclitaxel
other name: RT
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Conghua Xie, Dr
role: Principal Investigator
affiliation: Wuhan University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Wuhan University
investigator full name: Conghua Xie,MD,PhD
investigator title: director of Department of Radiation and Medical Oncology, Zhongnan Hospital
mesh term: Carcinoma
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Paclitaxel
mesh term: Carboplatin
sharing ipd: Yes
ipd description: all IPD can be shared by all researchers who participate in this study by e-mail contact
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: 2 years after the end of the study
ipd access criteria: Researchers who participate in this study