<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/NCT03239613</url>
  </required_header>
  <id_info>
    <org_study_id>SMC 2017-03-091-003</org_study_id>
    <nct_id>NCT03239613</nct_id>
  </id_info>
  <brief_title>Postoperative Hypofractionated Intensity-modulated Radiation Therapy With Concurrent Chemotherapy in Cervical Cancer</brief_title>
  <official_title>Postoperative Hypofractionated Intensity-modulated Radiation Therapy With Concurrent Chemotherapy in Cervical Cancer: A Prospective Exploratory Trial (POHIM_CCRT Trial)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Samsung Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Samsung Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</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>
      To investigate the acute toxicities, late toxicities, and treatment results when the early&#xD;
      cervical cancer patients are treated by concurrent chemotherapy with hypofractionated&#xD;
      intensity-modulated radiotherapy (2.5 Gy X 16 fractions, once a day) after radical&#xD;
      hysterectomy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 31, 2017</start_date>
  <completion_date type="Anticipated">April 28, 2024</completion_date>
  <primary_completion_date type="Anticipated">April 28, 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Acute toxicities according to CTCAE v4.0</measure>
    <time_frame>3 months</time_frame>
    <description>evaluation of acute toxicities within 3months after radiotherapy according to CTCAE v4.0</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Late toxicities according to CTCAE v4.0</measure>
    <time_frame>5-years</time_frame>
    <description>evaluation of late toxicities every year after 3months after radiotherapy according to CTCAE v4.0</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression free survival rate</measure>
    <time_frame>5-years</time_frame>
    <description>progression free survival rate after the time of surgery</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">84</enrollment>
  <condition>Cervix Cancer</condition>
  <condition>Radiotherapy, Adjuvant</condition>
  <condition>Radiotherapy, Intensity-Modulated</condition>
  <condition>Hypofractionated Dose</condition>
  <condition>Chemotherapy, Concurrent</condition>
  <arm_group>
    <arm_group_label>POHIM-CCRT</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>postoperative adjuvant concurrent chemotherapy with hypofractionated IMRT (2.5 Gy/fraction, 16 fractions, once a day)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>POHIM-CCRT</intervention_name>
    <description>postoperative adjuvant concurrent chemotherapy with hypofractionated IMRT (2.5 Gy/fraction, 16 fractions, once a day)</description>
    <arm_group_label>POHIM-CCRT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  histologically confirmed cervical cancer&#xD;
&#xD;
          -  radical hysterectomy and pelvic lymph node dissection was done&#xD;
&#xD;
          -  histologically indicated adjuvant chemoradiotherapy (more than one as below)&#xD;
&#xD;
               -  positive pelvic lymph node metastasis&#xD;
&#xD;
               -  positive parametrial invasion&#xD;
&#xD;
               -  positive tumor involvement on surgical margin&#xD;
&#xD;
          -  ECOG performance status 0 or 1&#xD;
&#xD;
          -  Bone marrow function: granulocyte ≥1.0 x 1000/µl, platelet ≥30 x 1000/µl, hemoglobin&#xD;
             ≥10 g/dl&#xD;
&#xD;
          -  Kidney function: Creatinine &lt;2.0 mg/dL, Bilirubin 1.5 mg/dl&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  positive distant metastasis (including retroperitoneal lymph node metastasis)&#xD;
&#xD;
          -  previous history of pelvic radiotherapy&#xD;
&#xD;
          -  more than 3 months after radical surgery for cervical cancer&#xD;
&#xD;
          -  neoadjuvant chemotherapy was done&#xD;
&#xD;
          -  previous history of other carcinoma except for thyroid cancer, skin cancer, in situ&#xD;
             carcinoma on cervix&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Won Park, M.D.,Ph.D</last_name>
    <phone>+82-10-9933-2616</phone>
    <email>wonro.park@samsung.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>06351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Won Park, M.D.,Ph.D</last_name>
      <phone>+82-2-3410-2616</phone>
      <email>wonro.park@samsung.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>August 2, 2017</study_first_submitted>
  <study_first_submitted_qc>August 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2017</study_first_posted>
  <last_update_submitted>July 7, 2022</last_update_submitted>
  <last_update_submitted_qc>July 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Uterine Cervical Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03239613
org study id: SMC 2017-03-091-003
nct id: NCT03239613
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To investigate the acute toxicities, late toxicities, and treatment results when the early
      cervical cancer patients are treated by concurrent chemotherapy with hypofractionated
      intensity-modulated radiotherapy (2.5 Gy X 16 fractions, once a day) after radical
      hysterectomy.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Acute toxicities according to CTCAE v4.0
time frame: 3 months
description: evaluation of acute toxicities within 3months after radiotherapy according to CTCAE v4.0
measure: Late toxicities according to CTCAE v4.0
time frame: 5-years
description: evaluation of late toxicities every year after 3months after radiotherapy according to CTCAE v4.0
measure: Progression free survival rate
time frame: 5-years
description: progression free survival rate after the time of surgery
arm group label: POHIM-CCRT
arm group type: Other
description: postoperative adjuvant concurrent chemotherapy with hypofractionated IMRT (2.5 Gy/fraction, 16 fractions, once a day)
intervention type: Other
intervention name: POHIM-CCRT
description: postoperative adjuvant concurrent chemotherapy with hypofractionated IMRT (2.5 Gy/fraction, 16 fractions, once a day)
arm group label: POHIM-CCRT
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Won Park, M.D.,Ph.D
phone: +82-10-9933-2616
email: wonro.park@samsung.com
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Uterine Cervical Neoplasms
sharing ipd: No