<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/NCT02203253</url>
  </required_header>
  <id_info>
    <org_study_id>CLOG1302</org_study_id>
    <nct_id>NCT02203253</nct_id>
  </id_info>
  <brief_title>Efficacy of Thalidomide in Preventing Chemotherapy-induced Delayed Nausea and Vomiting</brief_title>
  <official_title>Efficacy of Thalidomide in Preventing Chemotherapy-induced Delayed Nausea and Vomiting From Highly Emetogenic Chemotherapy: a Randomized, Multicenter, Double-blind, Placebo-controlled Phase III Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>China Medical University, China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The First Hospital of Liaoning Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First Affiliated Hospital of Dalian Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Second Affiliated Hospital of Dalian Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Liaoning Tumor Hospital &amp; Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shengjing Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>General Hospital of Shenyang Military Region</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Liaoyang Central Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Third People's hospital Liaoyang</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Petrochemical General Hospital of Liaoyang city</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Anshan Tumor Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>China Medical University, China</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study was aimed to evaluate efficacy and tolerability of thalidomide in improving&#xD;
      prevention of chemotherapy-induced delayed nausea and vomiting in chemotherapy-naive patients&#xD;
      after highly emetogenic chemotherapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, randomized, multi-center, double-blind, placebo-controlled clinical&#xD;
      trial, aimed to evaluate efficacy and tolerability of thalidomide in improving prevention of&#xD;
      chemotherapy-induced delayed nausea and vomiting (CINV) in chemotherapy-naive patients after&#xD;
      highly emetogenic chemotherapy(HEC) (cisplatin-based regimen or cyclophosphamide combination&#xD;
      with doxorubicin/epirubicin). A total of 820 patients are planned to be enrolled into the&#xD;
      study. Patients treating with highly emetogenic chemotherapy will be randomized into two&#xD;
      groups, and be treated with Thalidomide+ Palonosetron+ Dexamethasone or Placebo +&#xD;
      Palonosetron+ Dexamethasone, respectively. The primary end point is complete response rate&#xD;
      (CRR) for delayed CINV, and the secondary end points include the safety and quality of life&#xD;
      (QOL).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">July 2016</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>Prevention</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>complete response rate (CRR) for delayed CINV</measure>
    <time_frame>120 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>Up to 3 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>quality of life</measure>
    <time_frame>up to 7 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">642</enrollment>
  <condition>Neoplasms</condition>
  <arm_group>
    <arm_group_label>Thalidomide Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Thalidomide 100 mg by mouth twice a day on days 1-5; Palonosetron 0.25 mg intravenously on day 1; Dexamethasone 12 mg by mouth or intravenously before chemotherapy on day 1 and 8 mg on days 2-4; cycle 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo (for Thalidomide) tablet 100 mg by mouth twice a day on days 1-5; Palonosetron 0.25 mg intravenously on day 1; Dexamethasone 12 mg by mouth or intravenously before chemotherapy on day 1 and 8 mg on days 2-4; cycle 1.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Thalidomide</intervention_name>
    <description>100 mg by mouth twice a day on days 1-5 after chemotherapy, cycle 1</description>
    <arm_group_label>Thalidomide Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo for thalidomide</intervention_name>
    <description>Placebo tablet manufactured to mimic Thalidomide 25 mg tablet 100 mg by mouth twice a day on days 1-5 after chemotherapy , cycle 1</description>
    <arm_group_label>Placebo Group</arm_group_label>
    <other_name>Placebo tablet for thalidomide</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Palonosetron and Dexamethasone</intervention_name>
    <description>Palonosetron 0.25 mg intravenously on day 1; Dexamethasone 12 mg by mouth or intravenously before chemotherapy on day 1 and 8 mg on days 2-4; cycle 1.</description>
    <arm_group_label>Placebo Group</arm_group_label>
    <arm_group_label>Thalidomide Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18y ≤Age≤70y&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2&#xD;
&#xD;
          -  Histologically confirmed solid neoplasm&#xD;
&#xD;
          -  No prior chemotherapy&#xD;
&#xD;
          -  Laboratory test must meet the following criteria: hemoglobin (HGB) ≥90g/L, neutrophil&#xD;
             count ≥1.5×109/L, platelet count ≥85×109/L, creatinine clearance rate (CCr) ≥60ml/min,&#xD;
             total bilirubin (TBil) ≤1.5 upper normal limitation (UNL), alanine aminotransferase&#xD;
             (ALT) and aspartate aminotransferase (AST) ≤2.5 UNL (For patients with liver&#xD;
             metastasis, the AST/ALT must be ≤5.0 UNL), blood glucose ≤11.1 mmol/L&#xD;
&#xD;
          -  Life expectancy of at least 12 weeks&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
          -  For women with child bearing potential, a negative serum or urine pregnancy test&#xD;
             result should be obtained before enrollment&#xD;
&#xD;
          -  Cancer patients scheduled to receive HEC regimen. The HEC regimen was defined as&#xD;
             chemotherapy containing a 50 mg/m2 or higher dose of cisplatin, or cyclophosphamide&#xD;
             combination with doxorubicin/epirubicin&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diabetic patients&#xD;
&#xD;
          -  Pregnant or lactated women&#xD;
&#xD;
          -  Patient with history of thrombosis&#xD;
&#xD;
          -  Concomitant radiotherapy&#xD;
&#xD;
          -  Known hypersensitivity to thalidomide, palonosetron, or dexamethasone.&#xD;
&#xD;
          -  Concurrent administration of any other drug which affect antiemetic effect evaluation&#xD;
             such as proton pump inhibitor, H2 blocker, amifostine, sedative drugs&#xD;
&#xD;
          -  CHOP regiment or taxanes-based regiment&#xD;
&#xD;
          -  Existing emesis within 24 hours before chemotherapy administration&#xD;
&#xD;
          -  Symptomatic brain metastasis or suspected clinical brain metastasis&#xD;
&#xD;
          -  Serious uncontrolled systemic illness or medical condition: congestive heart failure,&#xD;
             unstable angina, history of documented myocardial infarction within 6 months,&#xD;
             uncontrolled hypertension and high risk uncontrollable arrhythmias; Obvious&#xD;
             neurological or mental abnormalities including mental disorder, epileptic dementia,&#xD;
             which affect compliance; Uncontrolled acute infections; Uncontrolled peptic ulcer or&#xD;
             other contraindication for corticosteroid therapy.&#xD;
&#xD;
          -  Inability to take or absorb oral medicine&#xD;
&#xD;
          -  Concurrent administration of any other investigational drug, or have been enrolled in&#xD;
             other clinical trial with investigational drug treatment within the 30 days of start&#xD;
             of study treatment&#xD;
&#xD;
          -  Unsuitable for the study or other chemotherapy determined by 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>Yunpeng Liu, MD., PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>China Medical University, China</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Anshan Tumor Hospital</name>
      <address>
        <city>Anshan</city>
        <state>Liaoning</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Second Affiliated Hospital of Dalian Medical University</name>
      <address>
        <city>Dalian</city>
        <state>Liaoning</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Dalian Medical University</name>
      <address>
        <city>Dalian</city>
        <state>Liaoning</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Hospital of Liaoning Medical University</name>
      <address>
        <city>Jinzhou</city>
        <state>Liaoning</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Liaoyang Central Hospital</name>
      <address>
        <city>Liaoyang</city>
        <state>Liaoning</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Petrochemical General Hospital of Liaoyang city</name>
      <address>
        <city>Liaoyang</city>
        <state>Liaoning</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Third People's hospital Liaoyang</name>
      <address>
        <city>Liaoyang</city>
        <state>Liaoning</state>
        <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>Shengjing Hospital of China Medical University</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <zip>110004</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital of Shenyang Military Region</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Liaoning Tumor Hospital &amp; Institute</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>July 23, 2014</study_first_submitted>
  <study_first_submitted_qc>July 27, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 29, 2014</study_first_posted>
  <last_update_submitted>August 23, 2016</last_update_submitted>
  <last_update_submitted_qc>August 23, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 24, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>China Medical University, China</investigator_affiliation>
    <investigator_full_name>Yunpeng Liu</investigator_full_name>
    <investigator_title>M.D.,PhD</investigator_title>
  </responsible_party>
  <keyword>solid tumor</keyword>
  <keyword>chemotherapy-induced delayed nausea and vomiting</keyword>
  <keyword>thalidomide</keyword>
  <keyword>prevention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nausea</mesh_term>
    <mesh_term>Vomiting</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thalidomide</mesh_term>
    <mesh_term>Dexamethasone</mesh_term>
    <mesh_term>Palonosetron</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/NCT02203253
org study id: CLOG1302
nct id: NCT02203253
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
This study was aimed to evaluate efficacy and tolerability of thalidomide in improving
      prevention of chemotherapy-induced delayed nausea and vomiting in chemotherapy-naive patients
      after highly emetogenic chemotherapy.
This is a prospective, randomized, multi-center, double-blind, placebo-controlled clinical
      trial, aimed to evaluate efficacy and tolerability of thalidomide in improving prevention of
      chemotherapy-induced delayed nausea and vomiting (CINV) in chemotherapy-naive patients after
      highly emetogenic chemotherapy(HEC) (cisplatin-based regimen or cyclophosphamide combination
      with doxorubicin/epirubicin). A total of 820 patients are planned to be enrolled into the
      study. Patients treating with highly emetogenic chemotherapy will be randomized into two
      groups, and be treated with Thalidomide+ Palonosetron+ Dexamethasone or Placebo +
      Palonosetron+ Dexamethasone, respectively. The primary end point is complete response rate
      (CRR) for delayed CINV, and the secondary end points include the safety and quality of life
      (QOL).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Investigator)
measure: complete response rate (CRR) for delayed CINV
time frame: 120 hours
measure: Adverse Events
time frame: Up to 3 weeks
measure: quality of life
time frame: up to 7 days
arm group label: Thalidomide Group
arm group type: Active Comparator
description: Thalidomide 100 mg by mouth twice a day on days 1-5; Palonosetron 0.25 mg intravenously on day 1; Dexamethasone 12 mg by mouth or intravenously before chemotherapy on day 1 and 8 mg on days 2-4; cycle 1.
arm group label: Placebo Group
arm group type: Placebo Comparator
description: Placebo (for Thalidomide) tablet 100 mg by mouth twice a day on days 1-5; Palonosetron 0.25 mg intravenously on day 1; Dexamethasone 12 mg by mouth or intravenously before chemotherapy on day 1 and 8 mg on days 2-4; cycle 1.
intervention type: Drug
intervention name: Thalidomide
description: 100 mg by mouth twice a day on days 1-5 after chemotherapy, cycle 1
arm group label: Thalidomide Group
intervention type: Drug
intervention name: Placebo for thalidomide
description: Placebo tablet manufactured to mimic Thalidomide 25 mg tablet 100 mg by mouth twice a day on days 1-5 after chemotherapy , cycle 1
arm group label: Placebo Group
other name: Placebo tablet for thalidomide
intervention type: Drug
intervention name: Palonosetron and Dexamethasone
description: Palonosetron 0.25 mg intravenously on day 1; Dexamethasone 12 mg by mouth or intravenously before chemotherapy on day 1 and 8 mg on days 2-4; cycle 1.
arm group label: Placebo Group
arm group label: Thalidomide Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Yunpeng Liu, MD., PhD
role: Principal Investigator
affiliation: China Medical University, China
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: China Medical University, China
investigator full name: Yunpeng Liu
investigator title: M.D.,PhD
mesh term: Nausea
mesh term: Vomiting
mesh term: Thalidomide
mesh term: Dexamethasone
mesh term: Palonosetron