<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/NCT01680523</url>
  </required_header>
  <id_info>
    <org_study_id>KGOG 1029</org_study_id>
    <nct_id>NCT01680523</nct_id>
  </id_info>
  <brief_title>Radical Hysterectomy Followed by Tailored Adjuvant Therapy Versus Primary Chemoradiation Therapy in Bulky Early-stage Cervical Cancer (KGOG 1029)</brief_title>
  <official_title>A Randomized Controlled Trial Comparing Radical Hysterectomy Plus Tailored Adjuvant Therapy Versus Primary Chemoradiation Therapy in Bulky Early-stage Cervical Cancer (KGOG 1029)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Asan Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Asan Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To compare 5-year overall survival between patients who undergo radical hysterectomy followed&#xD;
      by tailored adjuvant therapy and patients who receive primary chemoradiation therapy in FIGO&#xD;
      stage IB2 and IIA2 cervical cancer&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">July 2020</completion_date>
  <primary_completion_date type="Anticipated">July 2020</primary_completion_date>
  <phase>N/A</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>5-year overall survival</measure>
    <time_frame>5 year after treatment</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>5-year progression-free survival</measure>
    <time_frame>5 years after treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pattern of disease recurrence</measure>
    <time_frame>within 5 years afer treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment-related toxicity</measure>
    <time_frame>within 5 years after treatment</time_frame>
    <description>Treatment related toxicity will be evaluated using CTCAE v3.0.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>within 1 year after treatment</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">409</enrollment>
  <condition>Cervical Cancer</condition>
  <arm_group>
    <arm_group_label>RH group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Radical hysterectomy followed by tailored adjuvant therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CCRT group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Primary concurrent chemoradiation therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Radical hysterectomy</intervention_name>
    <description>Piver-Rutledge type III hysterectomy New classification type C2 hysterectomy Open, vaginal, laparoscopic assisted, laparoscopic, robotic radical hysterectomy are all allowed</description>
    <arm_group_label>RH group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Tailored adjuvant therapy</intervention_name>
    <description>After radical hysterectomy, intermediate risk group according to GOG protocol 92 criteria will receive adjuvant radiation therapy. High risk group will receive adjuvant chemoradiation therapy with weekly cisplatin (40mg/m2, IV for 6 cycles). Extended filed radiation therapy is allowed in case of common iliac lymph node or para-aortic lymph node metastasis. Intracavitary brachytherapy and nodal or parametrial boost is not allowed.</description>
    <arm_group_label>RH group</arm_group_label>
    <other_name>Adjuvant radiation therapy</other_name>
    <other_name>Adjuvant chemoradiation therapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Primary chemoradiation therapy</intervention_name>
    <description>Patient will receive primary radiation therapy including external pelvic irradiation, intracavitary brachytherapy, and parametrial or nodal boost. Extended filed radiation therapy is allowed in case of common iliac lymph node enlargement. Patients will receive concurrent weekly cisplatin (cisplatin 40mg/m2 for 6 cycles) during external radiation therapy.</description>
    <arm_group_label>CCRT group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Previously untreated, histologically confirmed cervical cancer&#xD;
&#xD;
          -  FIGO stage IB2 and IIA2 disease&#xD;
&#xD;
          -  One of following histologic types&#xD;
&#xD;
               1. Squamous cell carcinoma&#xD;
&#xD;
               2. Adenocarcinoma&#xD;
&#xD;
               3. Adenosquamous carcinoma&#xD;
&#xD;
          -  Gynecologic Oncology Group performance status: 0-2&#xD;
&#xD;
          -  Adequate organ function&#xD;
&#xD;
               1. Bone marrow: WBC &gt; 3000/mm3, ANC ≥ 1,000/mm3, Platelet ≥ 100*103/mm3, Hemoglobin&#xD;
                  ≥ 10g/dL&#xD;
&#xD;
               2. Kidney: Creatine &lt; 1.25 * upper normal limit&#xD;
&#xD;
               3. Liver: AST, ANT &lt; 3 * upper normal limit, Total bilirubin &lt; 1.5 mg/mm3&#xD;
&#xD;
          -  Patient who have Singed an approved informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with cervical cancer who have received any previous radiation or chemotherapy&#xD;
&#xD;
          -  Neuroendocrine carcinoma of uterine cervix&#xD;
&#xD;
          -  Occult cervical cancer which was found after simple hysterectomy&#xD;
&#xD;
          -  Para-aortic nodal involvement (&gt; 10 mm short axis diameter on pretreatment imaging&#xD;
             study)&#xD;
&#xD;
          -  History of other invasive malignancies, with the exception of non-melanoma skin&#xD;
             cancer, in situ melanoma and thyroid cancer, who had (or have) no evidence of the&#xD;
             other cancer present within the last 5 years&#xD;
&#xD;
          -  Serious illness or medical condition that precludes the safe administration of the&#xD;
             trial treatment including, but not limited to, ongoing or active infection,&#xD;
             symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or&#xD;
             psychiatric illness/social situations that would limit compliance with study&#xD;
             requirements&#xD;
&#xD;
          -  Prior diagnosis of Crohn's disease or ulcerative colitis&#xD;
&#xD;
          -  Neurologic or psychiatric disease&#xD;
&#xD;
          -  Patients who are pregnant or lactating&#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_official>
    <last_name>Joo-Hyun Nam, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Asan Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Joo-Hyun Nam, M.D., Ph.D.</last_name>
    <phone>82-2-3010-3633</phone>
    <email>jhnam@amc.seoul.kr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>138-736</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Joo-Hyun Nam, M.D., Ph.D.</last_name>
      <phone>82-2-3010-3633</phone>
      <email>jhnam@amc.seoul.kr</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>September 4, 2012</study_first_submitted>
  <study_first_submitted_qc>September 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 7, 2012</study_first_posted>
  <last_update_submitted>May 27, 2017</last_update_submitted>
  <last_update_submitted_qc>May 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Asan Medical Center</investigator_affiliation>
    <investigator_full_name>Joo-Hyun Nam</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>cervical cancer</keyword>
  <keyword>bulky early-stage</keyword>
  <keyword>locally advanced</keyword>
  <keyword>radical hysterectomy</keyword>
  <keyword>concurrent chemoradiation therapy</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/NCT01680523
org study id: KGOG 1029
nct id: NCT01680523
lead sponsor: 
has dmc: Yes
To compare 5-year overall survival between patients who undergo radical hysterectomy followed
      by tailored adjuvant therapy and patients who receive primary chemoradiation therapy in FIGO
      stage IB2 and IIA2 cervical cancer
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: 5-year overall survival
time frame: 5 year after treatment
measure: 5-year progression-free survival
time frame: 5 years after treatment
measure: Pattern of disease recurrence
time frame: within 5 years afer treatment
measure: Treatment-related toxicity
time frame: within 5 years after treatment
description: Treatment related toxicity will be evaluated using CTCAE v3.0.
measure: Quality of life
time frame: within 1 year after treatment
arm group label: RH group
arm group type: Experimental
description: Radical hysterectomy followed by tailored adjuvant therapy
arm group label: CCRT group
arm group type: Active Comparator
description: Primary concurrent chemoradiation therapy
intervention type: Procedure
intervention name: Radical hysterectomy
description: Piver-Rutledge type III hysterectomy New classification type C2 hysterectomy Open, vaginal, laparoscopic assisted, laparoscopic, robotic radical hysterectomy are all allowed
arm group label: RH group
intervention type: Radiation
intervention name: Tailored adjuvant therapy
description: After radical hysterectomy, intermediate risk group according to GOG protocol 92 criteria will receive adjuvant radiation therapy. High risk group will receive adjuvant chemoradiation therapy with weekly cisplatin (40mg/m2, IV for 6 cycles). Extended filed radiation therapy is allowed in case of common iliac lymph node or para-aortic lymph node metastasis. Intracavitary brachytherapy and nodal or parametrial boost is not allowed.
arm group label: RH group
other name: Adjuvant radiation therapy
other name: Adjuvant chemoradiation therapy
intervention type: Radiation
intervention name: Primary chemoradiation therapy
description: Patient will receive primary radiation therapy including external pelvic irradiation, intracavitary brachytherapy, and parametrial or nodal boost. Extended filed radiation therapy is allowed in case of common iliac lymph node enlargement. Patients will receive concurrent weekly cisplatin (cisplatin 40mg/m2 for 6 cycles) during external radiation therapy.
arm group label: CCRT group
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 75 Years
healthy volunteers: No
last name: Joo-Hyun Nam, M.D., Ph.D.
role: Principal Investigator
affiliation: Asan Medical Center
last name: Joo-Hyun Nam, M.D., Ph.D.
phone: 82-2-3010-3633
email: jhnam@amc.seoul.kr
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Asan Medical Center
investigator full name: Joo-Hyun Nam
investigator title: Professor
mesh term: Uterine Cervical Neoplasms