<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/NCT03793205</url>
  </required_header>
  <id_info>
    <org_study_id>GO-GCSF</org_study_id>
    <nct_id>NCT03793205</nct_id>
  </id_info>
  <brief_title>G-CSF for the Prevention of Febrile Neutropenia in Gynecologic Cancer Patients</brief_title>
  <official_title>Long-acting Granulocyte Colony Stimulating Factor for the Prevention of Febrile Neutropenia in Gynecologic Cancer Patients: A Prospective Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lei Li</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking Union Medical College Hospital</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to analyze the effects of long-acting granulocyte colony stimulating factor&#xD;
      (G-CSF) on the prevention febrile neutropenia (FN) in gynecologic cancer patients. Patients&#xD;
      all accepted platinum-based chemotherapy 3-4 weeks once per course. The primary end is the&#xD;
      incidence of FN in every course of chemotherapy. After the chemotherapy, patients accepted&#xD;
      long-acting G-CSF and/or short-acting G-CSF. The secondary ends include: the incidences of&#xD;
      myelosuppression, doses of G-CSF and its expenses, visits to outpatient and emergency&#xD;
      clinics, adverse events related to G-CSF.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 3, 2019</start_date>
  <completion_date type="Anticipated">January 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2020</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>After the chemotherapy, patients accepted long-acting G-CSF and/or short-acting G-CSF.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of febrile neutropenia</measure>
    <time_frame>One year</time_frame>
    <description>Incidence of febrile neutropenia in each course</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidences of grade 3/4 myelosuppression</measure>
    <time_frame>One year</time_frame>
    <description>Incidences of grade 3/4 myelosuppression in each course</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Times of visits to outpatient and emergency clinics</measure>
    <time_frame>One year</time_frame>
    <description>Visits to outpatient and emergency clinics in each course</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Doses of G-CSF</measure>
    <time_frame>One year</time_frame>
    <description>Doses of G-CSF administrated in each course</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Gynecologic Cancer</condition>
  <condition>Myelosuppression Adult</condition>
  <condition>Febrile Neutropenia</condition>
  <condition>Chemotherapy-induced Neutropenia</condition>
  <arm_group>
    <arm_group_label>Long-acting G-CSF group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in long-acting G-CSF group accept long-acting with or without short-acting G-CSF.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Short-acting G-CSF group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in long-acting G-CSF group only accept short-acting G-CSF.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Long-acting G-CSF</intervention_name>
    <description>Long-acting G-CSF will be given 48 hours after the chemotherapy. A supplement of short-acting G-CSF will be given as required.</description>
    <arm_group_label>Long-acting G-CSF group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Short-acting G-CSF</intervention_name>
    <description>Short-acting G-CSF will be given as required 24 hours after the chemotherapy.</description>
    <arm_group_label>Short-acting G-CSF group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Confirmed primary gynecologic cancer&#xD;
&#xD;
          -  Good performance status&#xD;
&#xD;
          -  Aged 18 years or older&#xD;
&#xD;
          -  Signed an approved informed consents&#xD;
&#xD;
          -  No immunosuppressive disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not meeting all of the inclusion criteria&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Lei Li</last_name>
    <phone>+8613911988831</phone>
    <email>lileigh@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Lei Li</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lei Li, MD</last_name>
      <phone>008613911988831</phone>
      <email>lileigh@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 3, 2019</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <last_update_submitted>January 3, 2019</last_update_submitted>
  <last_update_submitted_qc>January 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Peking Union Medical College Hospital</investigator_affiliation>
    <investigator_full_name>Lei Li</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neutropenia</mesh_term>
    <mesh_term>Febrile Neutropenia</mesh_term>
    <mesh_term>Hyperthermia</mesh_term>
    <mesh_term>Fever</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lenograstim</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03793205
org study id: GO-GCSF
nct id: NCT03793205
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to analyze the effects of long-acting granulocyte colony stimulating factor
      (G-CSF) on the prevention febrile neutropenia (FN) in gynecologic cancer patients. Patients
      all accepted platinum-based chemotherapy 3-4 weeks once per course. The primary end is the
      incidence of FN in every course of chemotherapy. After the chemotherapy, patients accepted
      long-acting G-CSF and/or short-acting G-CSF. The secondary ends include: the incidences of
      myelosuppression, doses of G-CSF and its expenses, visits to outpatient and emergency
      clinics, adverse events related to G-CSF.
allocation: Non-Randomized
intervention model: Crossover Assignment
intervention model description: After the chemotherapy, patients accepted long-acting G-CSF and/or short-acting G-CSF.
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of febrile neutropenia
time frame: One year
description: Incidence of febrile neutropenia in each course
measure: Incidences of grade 3/4 myelosuppression
time frame: One year
description: Incidences of grade 3/4 myelosuppression in each course
measure: Times of visits to outpatient and emergency clinics
time frame: One year
description: Visits to outpatient and emergency clinics in each course
measure: Doses of G-CSF
time frame: One year
description: Doses of G-CSF administrated in each course
arm group label: Long-acting G-CSF group
arm group type: Experimental
description: Patients in long-acting G-CSF group accept long-acting with or without short-acting G-CSF.
arm group label: Short-acting G-CSF group
arm group type: Experimental
description: Patients in long-acting G-CSF group only accept short-acting G-CSF.
intervention type: Drug
intervention name: Long-acting G-CSF
description: Long-acting G-CSF will be given 48 hours after the chemotherapy. A supplement of short-acting G-CSF will be given as required.
arm group label: Long-acting G-CSF group
intervention type: Drug
intervention name: Short-acting G-CSF
description: Short-acting G-CSF will be given as required 24 hours after the chemotherapy.
arm group label: Short-acting G-CSF group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lei Li
phone: +8613911988831
email: lileigh@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Peking Union Medical College Hospital
investigator full name: Lei Li
investigator title: Professor
mesh term: Neutropenia
mesh term: Febrile Neutropenia
mesh term: Hyperthermia
mesh term: Fever
mesh term: Lenograstim
sharing ipd: Undecided