<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/NCT03243825</url>
  </required_header>
  <id_info>
    <org_study_id>LC2012B38</org_study_id>
    <nct_id>NCT03243825</nct_id>
  </id_info>
  <brief_title>Comparative Study of Different Neoadjuvant Therapies Before Radical Hysterectomy in Stage Ib2-IIa2 Cervical Cancer</brief_title>
  <official_title>Comparative Study of Neoadjuvant Chemo/Brachytherapy and Chemotherapy Alone Before Radical Hysterectomy in Stage Ib2-IIa2 Cervical Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      For stage Ib2-IIa2 cervical cancer patients, neoadjuvant therapy followed by radical&#xD;
      hysterectomy and pelvic lymphadenectomy is one of the managements. Post-operative concurrent&#xD;
      chemo-radiotherapy is necessary if the patients have high-risk factors, including positive&#xD;
      surgical margin, parametrium and pelvic nodes. Our previous retrospective study showed that&#xD;
      combination of neoadjuvant chemotherapy and brachytherapy reduced the proportion of&#xD;
      post-operative concurrent chemo-radiotherapy compared to neoadjuvant chemotherapy alone.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the present study, the patients with stage Ib2-IIa2 cervical cancer will receive either&#xD;
      neoadjuvant chemo/brachytherapy or neoadjuvant chemotherapy before radical hysterectomy and&#xD;
      pelvic+/- para-aortic lymph node dissection. According to the surgical findings,&#xD;
      post-operative chemo-radiotherapy will be performed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>proportion of post-operative chemo-radiotherapy</measure>
    <time_frame>2 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>3-year disease-free survival</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Cervical Cancer</condition>
  <arm_group>
    <arm_group_label>chemo/brachytherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in this arm will receive neoadjuvant chemotherapy (paclitaxel/cisplatinum) and brachytherapy before radical hysterectomy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>chemotherapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in this arm will receive neoadjuvant chemotherapy (paclitaxel/cisplatinum) before radical hysterectomy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>combination group</intervention_name>
    <description>chemotherapy (paclitaxel/cisplatinum) and brachytherapy</description>
    <arm_group_label>chemo/brachytherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>chemotherapy group</intervention_name>
    <description>chemotherapy: (paclitaxel/cisplatinum)</description>
    <arm_group_label>chemotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histology confirmed cervical cancer&#xD;
&#xD;
          -  Clinical stage Ib2 or IIa2 (FIGO 2009)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who not suitable for surgery&#xD;
&#xD;
          -  Personal history of pelvic radiotherapy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ning Li, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cancer Hospital, Chinese Acadamy of Medical Sceinces</name>
      <address>
        <city>Beijing</city>
        <zip>100021</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 27, 2014</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 9, 2017</study_first_posted>
  <last_update_submitted>August 8, 2017</last_update_submitted>
  <last_update_submitted_qc>August 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Ning Li</investigator_full_name>
    <investigator_title>Doctor</investigator_title>
  </responsible_party>
  <keyword>neoadjuvant chemotherapy</keyword>
  <keyword>brachytherapy</keyword>
  <keyword>radiotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Uterine Cervical Neoplasms</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/NCT03243825
org study id: LC2012B38
nct id: NCT03243825
lead sponsor: 
has dmc: Yes
For stage Ib2-IIa2 cervical cancer patients, neoadjuvant therapy followed by radical
      hysterectomy and pelvic lymphadenectomy is one of the managements. Post-operative concurrent
      chemo-radiotherapy is necessary if the patients have high-risk factors, including positive
      surgical margin, parametrium and pelvic nodes. Our previous retrospective study showed that
      combination of neoadjuvant chemotherapy and brachytherapy reduced the proportion of
      post-operative concurrent chemo-radiotherapy compared to neoadjuvant chemotherapy alone.
In the present study, the patients with stage Ib2-IIa2 cervical cancer will receive either
      neoadjuvant chemo/brachytherapy or neoadjuvant chemotherapy before radical hysterectomy and
      pelvic+/- para-aortic lymph node dissection. According to the surgical findings,
      post-operative chemo-radiotherapy will be performed.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: proportion of post-operative chemo-radiotherapy
time frame: 2 months
measure: 3-year disease-free survival
time frame: 3 years
arm group label: chemo/brachytherapy
arm group type: Experimental
description: Patients in this arm will receive neoadjuvant chemotherapy (paclitaxel/cisplatinum) and brachytherapy before radical hysterectomy.
arm group label: chemotherapy
arm group type: Active Comparator
description: Patients in this arm will receive neoadjuvant chemotherapy (paclitaxel/cisplatinum) before radical hysterectomy.
intervention type: Radiation
intervention name: combination group
description: chemotherapy (paclitaxel/cisplatinum) and brachytherapy
arm group label: chemo/brachytherapy
intervention type: Drug
intervention name: chemotherapy group
description: chemotherapy: (paclitaxel/cisplatinum)
arm group label: chemotherapy
criteria: 
gender: Female
minimum age: 25 Years
maximum age: 70 Years
healthy volunteers: No
last name: Ning Li, MD
role: Principal Investigator
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
investigator full name: Ning Li
investigator title: Doctor
mesh term: Uterine Cervical Neoplasms