<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/NCT02195453</url>
  </required_header>
  <id_info>
    <org_study_id>yl-yxb08-lcsyfa-201302</org_study_id>
    <nct_id>NCT02195453</nct_id>
  </id_info>
  <brief_title>Chemotherapy Combined With Yangzhengxiaoji Capsule in Patients With Advanced Non-Small Cell Lung Cancer</brief_title>
  <official_title>A Randomized,Double-blind,Placebo-Controlled,Multicenter Clinical Trail of Chemotherapy Combined With Yangzhengxiaoji Capsule in Patients With Advanced Non-Small Cell Lung Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shandong Cancer Hospital and Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Peking University Cancer Hospital &amp; Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Shandong Cancer Hospital and Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to observe quality of life and treatment side effects in&#xD;
      patients with advanced non small cell lung cancer (NSCLC) receive chemotherapy and&#xD;
      Yangzhengxiaoji capsule.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>August 2014</start_date>
  <completion_date type="Anticipated">December 2016</completion_date>
  <primary_completion_date type="Anticipated">September 2016</primary_completion_date>
  <phase>Phase 4</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Functional Assessment of Cancer Therapy-Lung scale</measure>
    <time_frame>84day</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Lung Cancer Symptom Scale</measure>
    <time_frame>84day</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anti-cancer drugs common grading evaluation of adverse reaction</measure>
    <time_frame>84day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Completion of chemotherapy</measure>
    <time_frame>84 day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective response rate</measure>
    <time_frame>84day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival</measure>
    <time_frame>84 day</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">520</enrollment>
  <condition>Non-Small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Yangzhengxiaoji Capsule</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Gemcitabine or Pemetrexed&#xD;
Cisplatin&#xD;
Yangzhengxiaoji Capsule four granules t.i.d po</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Capsule</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Gemcitabine or Pemetrexed&#xD;
Cisplatin&#xD;
Placebo Capsule four granules t.i.d po</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Yangzhengxiaoji Capsule</intervention_name>
    <description>Gemcitabine 1000mg/m² or Pemetrexed 500mg/m² IV drip on D1 and D8,21 days for a cycle.&#xD;
Cisplatin 75mg/m² IV drip for one day or two-three days total injection,21 days for a cycle.&#xD;
Yangzhengxiaoji Capsule four granules t.i.d po.</description>
    <arm_group_label>Yangzhengxiaoji Capsule</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Capsule</intervention_name>
    <description>Gemcitabine 1000mg/m² or Pemetrexed 500mg/m²IV drip on D1 and D8,21 days for a cycle.&#xD;
Cisplatin 75mg/m² IV drip for one day or two-three days total injection, 21 days for a cycle.&#xD;
Placebo Capsule four granules t.i.d po.</description>
    <arm_group_label>Placebo Capsule</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          1. Histology and/or cytology confirmed stage Ⅳ NSCLC patients;&#xD;
&#xD;
          2. With at least one measurable solid tumor (RECIST standard version 1.1): tumor &gt;=10 mm&#xD;
             in diameter on CT or MRI images, or lymph node &gt;=15 mm in diameter on CT or MRI&#xD;
             images;&#xD;
&#xD;
          3. Eastern Cooperative Oncology Group(ECOG) score 0-1, expectant survival &gt; 3 months;&#xD;
&#xD;
          4. Age: 18-70 years;&#xD;
&#xD;
          5. Normal organ function:&#xD;
&#xD;
             Bone marrow: neutrophils (ANC) count&gt;=1.5×10^9/L, Platelets count&gt;=100×10^9/L,&#xD;
             hemoglobin&gt;=90g/L；Renal function, serum creatinine&lt;=1.5 mg/dl, and/or creatinine&#xD;
             clearance or&gt;=60 ml/min; Liver function: total serum bilirubin levels &lt;= 1.5 times the&#xD;
             upper limit of normal (ULN), serum aspartate aminotransferase (AST) or serum alanine&#xD;
             aminotransferase (ALT)&lt;=2.5 times the ULN, if abnormal liver function caused by the&#xD;
             underlying malignancy, the AST and ALT &gt;=5 times ULN;&#xD;
&#xD;
          6. For patients with brain metastases, bone metastases or pleural effusion, systemic&#xD;
             chemotherapy is proposed after the effective local treatment to control symptoms;&#xD;
&#xD;
          7. Informed consent.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          1. Clinically significant hepatic dysfunction: AST or ALT &gt; 2.5 times the ULN, total&#xD;
             serum bilirubin levels &gt; 1.5 times the ULN; clinically significant renal&#xD;
             insufficiency: serum creatinine &gt; 1.5 times the ULN;&#xD;
&#xD;
          2. Severe heart disease: New York Heart Association class Ⅲ-IV class of heart failure,&#xD;
             unstable angina, myocardial infarction, coronary revascularization six months before&#xD;
             randomization;&#xD;
&#xD;
          3. Spleen resection or combined with other severe hematopoietic system diseases;&#xD;
&#xD;
          4. Uncontrolled diabetes, hypertension (above 180/120mmHg), infection or severe&#xD;
             gastrointestinal ulcers;&#xD;
&#xD;
          5. History or present with other cancer, except for non melanoma skin cancer, cervical&#xD;
             cancer in situ and other cured cancer for at least 5 years;&#xD;
&#xD;
          6. Mental illness, without legal capacity or limited capacity;&#xD;
&#xD;
          7. Pregnancy, lactation or patients with pregnancy plan;&#xD;
&#xD;
          8. Participated in other clinical trail in the past 1 months or participating in other&#xD;
             trail now;&#xD;
&#xD;
          9. Other unsuitable condition decided by the investigator.&#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>Jinming Yu, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Shandong Cancer Hospital and Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jie Wang, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Biejing Cancer Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ligang Xing, M.D.</last_name>
    <phone>18053100188</phone>
    <email>xinglg@gmail.com</email>
  </overall_contact>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 7, 2014</study_first_submitted>
  <study_first_submitted_qc>July 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 21, 2014</study_first_posted>
  <last_update_submitted>July 17, 2014</last_update_submitted>
  <last_update_submitted_qc>July 17, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 21, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shandong Cancer Hospital and Institute</investigator_affiliation>
    <investigator_full_name>Jinming Yu</investigator_full_name>
    <investigator_title>Shandong Cancer Hospital and Institute</investigator_title>
  </responsible_party>
  <keyword>Non-small cell lung cancer</keyword>
  <keyword>FACT-L scale</keyword>
  <keyword>Yangzhengxiaoji</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>
  <!-- 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/NCT02195453
org study id: yl-yxb08-lcsyfa-201302
nct id: NCT02195453
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to observe quality of life and treatment side effects in
      patients with advanced non small cell lung cancer (NSCLC) receive chemotherapy and
      Yangzhengxiaoji capsule.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Functional Assessment of Cancer Therapy-Lung scale
time frame: 84day
measure: Lung Cancer Symptom Scale
time frame: 84day
measure: Anti-cancer drugs common grading evaluation of adverse reaction
time frame: 84day
measure: Completion of chemotherapy
time frame: 84 day
measure: Objective response rate
time frame: 84day
measure: Progression-free survival
time frame: 84 day
arm group label: Yangzhengxiaoji Capsule
arm group type: Experimental
description: Gemcitabine or Pemetrexed
Cisplatin
Yangzhengxiaoji Capsule four granules t.i.d po
arm group label: Placebo Capsule
arm group type: Placebo Comparator
description: Gemcitabine or Pemetrexed
Cisplatin
Placebo Capsule four granules t.i.d po
intervention type: Drug
intervention name: Yangzhengxiaoji Capsule
description: Gemcitabine 1000mg/m² or Pemetrexed 500mg/m² IV drip on D1 and D8,21 days for a cycle.
Cisplatin 75mg/m² IV drip for one day or two-three days total injection,21 days for a cycle.
Yangzhengxiaoji Capsule four granules t.i.d po.
arm group label: Yangzhengxiaoji Capsule
intervention type: Drug
intervention name: Placebo Capsule
description: Gemcitabine 1000mg/m² or Pemetrexed 500mg/m²IV drip on D1 and D8,21 days for a cycle.
Cisplatin 75mg/m² IV drip for one day or two-three days total injection, 21 days for a cycle.
Placebo Capsule four granules t.i.d po.
arm group label: Placebo Capsule
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Jinming Yu, PhD
role: Study Chair
affiliation: Shandong Cancer Hospital and Institute
last name: Jie Wang, PhD
role: Study Chair
affiliation: Biejing Cancer Hospital
last name: Ligang Xing, M.D.
phone: 18053100188
email: xinglg@gmail.com
responsible party type: Principal Investigator
investigator affiliation: Shandong Cancer Hospital and Institute
investigator full name: Jinming Yu
investigator title: Shandong Cancer Hospital and Institute
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung