<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/NCT02993653</url>
  </required_header>
  <id_info>
    <org_study_id>VINPI1501</org_study_id>
    <nct_id>NCT02993653</nct_id>
  </id_info>
  <brief_title>Intensity-modulated Radiotherapy Protocol in Cervix Cancer</brief_title>
  <official_title>Definitive Treatment Protocol for High-dose Intensity-modulated Radiotherapy (IMRT) With Intracavitary Radiotherapy in Locally Advanced Cervical Cancer: A Phase II Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul St. Mary's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul St. Mary's Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Definitive treatment protocol for high-dose intensity-modulated radiotherapy (IMRT) with&#xD;
      intracavitary radiotherapy in locally advanced cervical cancer: A phase II trial&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Radiotherapy&#xD;
&#xD;
        1. intensity-modulated radiotherapy of whole pelvis: 60 Gy in 30 fx Re-simulation with&#xD;
           pelvic Magnetic resonance imaging at 46 Gy in 23 fx and intensity-modulated radiotherapy&#xD;
           on the gross cervical and nodal tumor (initially Positron emission tomography-positive),&#xD;
           14 Gy in 7 fx&#xD;
&#xD;
        2. intensity-modulated radiotherapy boost of gross cervical tumor or Intra-cavitary&#xD;
           radiotherapy (ICR)&#xD;
&#xD;
             -  Re-staging pelvic Magnetic resonance imaging , if complete response occurs&#xD;
                Intra-cavitary radiotherapy to A point, 25 Gy in 5 fx for 2 weeks&#xD;
&#xD;
             -  Re-staging pelvic Magnetic resonance imaging I, partial response or stable disease&#xD;
                occurs intensity-modulated radiotherapy boost , 10 Gy in 4 fx to the gross cervical&#xD;
                tumor for 1 week&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2015</start_date>
  <completion_date type="Anticipated">June 2018</completion_date>
  <primary_completion_date type="Anticipated">June 2018</primary_completion_date>
  <phase>Phase 2</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>Progression-free survival</measure>
    <time_frame>30 months</time_frame>
    <description>Progression means locoregional recurrence, distant metastasis, and local tumor pregression</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>30 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment-related adverse events are assessed by CTCAE v4.0.</measure>
    <time_frame>acute within 3 months and chronic after 3 months after radiotherapy</time_frame>
    <description>Toxicity</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Radiation</condition>
  <arm_group>
    <arm_group_label>Intensity-modulated radiotheapy arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intensity-modulated radiotheapy with stereotactic boost or intracavitary radiotherapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>High-dose Intensity-modulated radiotherapy</intervention_name>
    <description>Pelvic High-dose Intensity-modulated radiotherapy with stereotactic radiotherapy or intracavitary radiotherapy</description>
    <arm_group_label>Intensity-modulated radiotheapy arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. FIGO II-IVA Patients with untreated and histologically confirmed carcinoma of the&#xD;
             uterine cervix&#xD;
&#xD;
          2. Patients with Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1&#xD;
&#xD;
          3. Patients with adequate bone marrow function: Absolute nutrophil count (ANC) greater&#xD;
             than or equal to 1,500/mcl, platelets greater than or equal to 100,000/mcl at the&#xD;
             beginning&#xD;
&#xD;
          4. Patients with adequate renal function: creatinine equal to or less than 2.0 mg/mL&#xD;
&#xD;
          5. Patients who have signed an approved informed consent and authorization&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with recurrent cervical cancer&#xD;
&#xD;
          2. Patients who have diagnosis of other malignance tumors except papillary or follicular&#xD;
             thyroid cancer or skin cancer&#xD;
&#xD;
          3. Patients with metastatic lymphadenopathies other than pelvis (e.g. inguinal,&#xD;
             paraaortic, supraclavicular, or mediastinal node)&#xD;
&#xD;
          4. Patients with distant organ metastasis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jong Hoon Lee, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Vincent's Hospital, South Korea</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jong Hoon Lee, MD</last_name>
    <phone>+82-010-8607-1269</phone>
    <email>koppul@catholic.ac.kr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Lee Jong Hoon</name>
      <address>
        <city>Suwon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jong Hoon Lee</last_name>
      <email>koppul@catholic.ac.kr</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 11, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <last_update_submitted>December 14, 2016</last_update_submitted>
  <last_update_submitted_qc>December 14, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 15, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul St. Mary's Hospital</investigator_affiliation>
    <investigator_full_name>Jong Hoon Lee</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <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/NCT02993653
org study id: VINPI1501
nct id: NCT02993653
lead sponsor: 
has dmc: Yes
Definitive treatment protocol for high-dose intensity-modulated radiotherapy (IMRT) with
      intracavitary radiotherapy in locally advanced cervical cancer: A phase II trial
Radiotherapy

        1. intensity-modulated radiotherapy of whole pelvis: 60 Gy in 30 fx Re-simulation with
           pelvic Magnetic resonance imaging at 46 Gy in 23 fx and intensity-modulated radiotherapy
           on the gross cervical and nodal tumor (initially Positron emission tomography-positive),
           14 Gy in 7 fx

        2. intensity-modulated radiotherapy boost of gross cervical tumor or Intra-cavitary
           radiotherapy (ICR)

             -  Re-staging pelvic Magnetic resonance imaging , if complete response occurs
                Intra-cavitary radiotherapy to A point, 25 Gy in 5 fx for 2 weeks

             -  Re-staging pelvic Magnetic resonance imaging I, partial response or stable disease
                occurs intensity-modulated radiotherapy boost , 10 Gy in 4 fx to the gross cervical
                tumor for 1 week
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression-free survival
time frame: 30 months
description: Progression means locoregional recurrence, distant metastasis, and local tumor pregression
measure: Overall survival
time frame: 30 months
measure: Treatment-related adverse events are assessed by CTCAE v4.0.
time frame: acute within 3 months and chronic after 3 months after radiotherapy
description: Toxicity
arm group label: Intensity-modulated radiotheapy arm
arm group type: Experimental
description: Intensity-modulated radiotheapy with stereotactic boost or intracavitary radiotherapy
intervention type: Radiation
intervention name: High-dose Intensity-modulated radiotherapy
description: Pelvic High-dose Intensity-modulated radiotherapy with stereotactic radiotherapy or intracavitary radiotherapy
arm group label: Intensity-modulated radiotheapy arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jong Hoon Lee, MD
role: Principal Investigator
affiliation: St. Vincent's Hospital, South Korea
last name: Jong Hoon Lee, MD
phone: +82-010-8607-1269
email: koppul@catholic.ac.kr
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul St. Mary's Hospital
investigator full name: Jong Hoon Lee
investigator title: Professor
sharing ipd: No