xml: <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/NCT06007586</url>
    </required_header>
    <id_info>
      <org_study_id>CINV202306</org_study_id>
      <nct_id>NCT06007586</nct_id>
    </id_info>
    <brief_title>To Determine the Best Method to Prevent CINV Caused by TC Regimen in Patients With Gynecological Malignant Tumor.</brief_title>
    <official_title>To Determine the Best Method to Prevent CINV Caused by TC Regimen in Patients With Gynecological Malignant Tumor.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sichuan Cancer Hospital and Research Institute</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sichuan Cancer Hospital and Research Institute</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        To determine the best method to prevent CINV caused by TC regimen in patients with&#xD;
        gynecological malignant tumor.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The risk of vomiting caused by high-dose carboplatin is controversial, and there is currently&#xD;
        no prevention of TC in patients with gynecological malignant tumors High-level evidence-based&#xD;
        medical evidence for programme-induced CINV. Therefore, different guidelines recommend the&#xD;
        best antiemetic regimen as well It's different. This study is intended to conduct a&#xD;
        prospective, multicenter, randomized, double-blind, placebo-controlled, crossover study The&#xD;
        designed Phase III clinical study provides important data and basis for clinical practice and&#xD;
        guideline formulation.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 10, 2023</start_date>
    <completion_date type="Anticipated">September 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2024</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>Prevention</primary_purpose>
      <masking>Triple (Participant, Care Provider, Investigator)</masking>
      <masking_description>Patients, nurses, and investigators were blinded.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Complete response (CR) rate in the delayed period</measure>
      <time_frame>24 hours to 7days</time_frame>
      <description>CR is defined as a patient who does not need rescue antiemesis treatment, no vomiting or retching.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">138</enrollment>
    <condition>Gynecological Tumor</condition>
    <arm_group>
      <arm_group_label>Two antiemetic groups</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Placebo 130mg iv d1 30min d1 before chemotherapy (IV time &amp;gt; 2min);Ondansetron 8mg iv once d1 30min before chemotherapy; Dexamethasone 12mg iv once d1 before chemotherapy 30min, dexamethasone 8mg po qd d2 ~ 4.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Three antiemetic group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Aprepitant injection 130mg iv d1 30min d1 before chemotherapy (push-back time &amp;gt; 2min);Ondansetron 8mg iv once d1 30min before chemotherapy;Dexamethasone 12mg iv once d1 30min before chemotherapy, 8mg po qd d2-4.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Aprepitant Injection</intervention_name>
      <description>Two antiemetic groups use placebo,Dexamethasone and Ondansetron, Three antiemetic groups use Aprepitant,Dexamethasone and Ondansetron.</description>
      <arm_group_label>Three antiemetic group</arm_group_label>
      <arm_group_label>Two antiemetic groups</arm_group_label>
      <other_name>Oribe</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age 20-75 years old;&#xD;
  &#xD;
            2. ECOG PS：0～2;&#xD;
  &#xD;
            3. She was diagnosed as gynecological malignant tumor and was to receive TC chemotherapy;&#xD;
  &#xD;
            4. Carboplatin AUC 5～6mg/ml/min；&#xD;
  &#xD;
            5. Basically normal organ function (normal bilirubin level circumference, normal range of&#xD;
               creatinine, ALT&amp;lt; 2 times the upper limit of normal, AST&amp;lt; 2 times the upper&#xD;
               normal value)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients with previous history of chemotherapy, radiotherapy or targeted therapy;&#xD;
  &#xD;
            2. Malignant tumors with brain metastases;&#xD;
  &#xD;
            3. History of gastrointestinal malignancy;&#xD;
  &#xD;
            4. History of brain tumor;&#xD;
  &#xD;
            5. Previous gastrointestinal surgery history, such as segmental resection, (partial)&#xD;
               gastrectomy, except intestinal polyp resection and appendectomy;&#xD;
  &#xD;
            6. (incomplete) intestinal obstruction;&#xD;
  &#xD;
            7. Vestibular dysfunction;&#xD;
  &#xD;
            8. Massive abdominal accumulation liquid (except for those who have undergone puncture&#xD;
               drainage);&#xD;
  &#xD;
            9. Opioid concomitant drug users;&#xD;
  &#xD;
           10. Diabetic.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Dengfeng Wang</last_name>
      <phone>15982222707</phone>
      <email>wonderful_96@163.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Dengfeng Wang</name>
        <address>
          <city>Chengdu</city>
          <state>Sichua</state>
          <zip>610041</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Wang Dengfeng, Doctor</last_name>
        <phone>15982222707</phone>
        <email>wonderful_96@163.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Sichuan Cancer Hospital and Research Institute</investigator_affiliation>
      <investigator_full_name>Dengfeng Wang</investigator_full_name>
      <investigator_title>Deputy chief</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Neoplasms</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Aprepitant</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06007586
  org study id: CINV202306
  nct id: NCT06007586
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  To determine the best method to prevent CINV caused by TC regimen in patients with
        gynecological malignant tumor.
  The risk of vomiting caused by high-dose carboplatin is controversial, and there is currently
        no prevention of TC in patients with gynecological malignant tumors High-level evidence-based
        medical evidence for programme-induced CINV. Therefore, different guidelines recommend the
        best antiemetic regimen as well It's different. This study is intended to conduct a
        prospective, multicenter, randomized, double-blind, placebo-controlled, crossover study The
        designed Phase III clinical study provides important data and basis for clinical practice and
        guideline formulation.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Triple (Participant, Care Provider, Investigator)
  masking description: Patients, nurses, and investigators were blinded.
  measure: Complete response (CR) rate in the delayed period
  time frame: 24 hours to 7days
  description: CR is defined as a patient who does not need rescue antiemesis treatment, no vomiting or retching.
  arm group label: Two antiemetic groups
  arm group type: Placebo Comparator
  description: Placebo 130mg iv d1 30min d1 before chemotherapy (IV time &gt; 2min);Ondansetron 8mg iv once d1 30min before chemotherapy; Dexamethasone 12mg iv once d1 before chemotherapy 30min, dexamethasone 8mg po qd d2 ~ 4.
  arm group label: Three antiemetic group
  arm group type: Experimental
  description: Aprepitant injection 130mg iv d1 30min d1 before chemotherapy (push-back time &gt; 2min);Ondansetron 8mg iv once d1 30min before chemotherapy;Dexamethasone 12mg iv once d1 30min before chemotherapy, 8mg po qd d2-4.
  intervention type: Drug
  intervention name: Aprepitant Injection
  description: Two antiemetic groups use placebo,Dexamethasone and Ondansetron, Three antiemetic groups use Aprepitant,Dexamethasone and Ondansetron.
  arm group label: Three antiemetic group
  arm group label: Two antiemetic groups
  other name: Oribe
  criteria: 
  gender: Female
  minimum age: 20 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Dengfeng Wang
  phone: 15982222707
  email: wonderful_96@163.com
  facility: 
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Sichuan Cancer Hospital and Research Institute
  investigator full name: Dengfeng Wang
  investigator title: Deputy chief
  mesh term: Neoplasms
  mesh term: Aprepitant
  sharing ipd: No