<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/NCT03785288</url>
  </required_header>
  <id_info>
    <org_study_id>20163</org_study_id>
    <nct_id>NCT03785288</nct_id>
  </id_info>
  <brief_title>Vaginal Cuff Brachytherapy Fractionation Study</brief_title>
  <official_title>A Randomized Phase III Trial of Two Standard Dose Fractionation Regimes for Adjuvant Vaginal Brachytherapy in Early Stage Endometrial Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kara Romano, MD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Virginia</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>
      The purpose of this study is to see the effects of two different standard of care treatments&#xD;
      of endometrial cancer on sexual dysfunction. This study will compare two standard of care&#xD;
      treatments: HDR (high dose radiation) vaginal brachytherapy 3 fractions of 7 Gy to HDR&#xD;
      vaginal brachytherapy 6 fractions of 4Gy for early stage endometrial cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients are randomized to HDR vaginal brachytherapy 7 Gy in 3 fractions prescribed at 5mm.&#xD;
      Radiation delivered 4-12 weeks after surgery OR HDR vaginal brachytherapy 4Gy in 6 fractions&#xD;
      prescribed at the cylinder surface. Patients have the option to request to decline their&#xD;
      randomization and switch to the alternate treatment ARM if they prefer.&#xD;
&#xD;
      Radiation delivered 4-12 weeks after surgery. Participants in all Arms will receive standard&#xD;
      vaginal dilator for use after treatment (to promote healing). 3 month, 1 year and 2 year&#xD;
      follow up assessments are performed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 17, 2019</start_date>
  <completion_date type="Anticipated">January 1, 2026</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2025</primary_completion_date>
  <phase>Phase 3</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>
    <intervention_model_description>This study will compare two standard of care treatments: HDR vaginal brachytherapy 3 fractions of 7Gy to HDR vaginal brachytherapy 6 fractions of 4Gy for early stage endometrial cancer.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Female Sexual Function Index (FSFI)</measure>
    <time_frame>1 year</time_frame>
    <description>Using the FSFI, compare patient reported sexual dysfunction at 1 year after completion of treatment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Preference Option Randomized Design (PORD)</measure>
    <time_frame>1 year</time_frame>
    <description>Assessing the comparative effectiveness of receiving HDR vaginal brachytherapy on Arm B or Arm A for early stage endometrial cancer.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Vaginal Length Measurement</measure>
    <time_frame>1 year</time_frame>
    <description>Using vaginal dilator compare patient vaginal measurement 1 year after completion of treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vaginal Length Measurement</measure>
    <time_frame>2 years</time_frame>
    <description>Using vaginal dilator compare patient vaginal measurement 2 years after completion of treatment</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">258</enrollment>
  <condition>Endometrial Cancer</condition>
  <arm_group>
    <arm_group_label>ARM A: 3 treatments of 7Gy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Arm A: accepted randomization to HDR vaginal brachytherapy in 3 treatments (fractions) of 7Gy for a total dose of 21gy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ARM B: 6 treatment of 4Gy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Arm B: accepted randomization to HDR vaginal brachytherapy 6 treatments (fractions) of 4Gy for a total does of 24gy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ARM AB: 6 treatment of 4Gy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Arm AB: initially randomized to ARM A but wanted to switch to ARM B treatment of HDR vaginal brachytherapy 6 treatments (fractions) of 4Gy for a total does of 24gy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ARM BA: 3 treatments of 7Gy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>initially randomized to ARM B but wanted to switch to ARM A of HDR vaginal brachytherapy in 3 treatments (fractions) of 7Gy for a total dose of 21gy</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>HDR vaginal brachytherapy</intervention_name>
    <description>HDR vaginal brachytherapy 7 Gy in 3 fractions or HDR vaginal brachytherapy 4 Gy in 6 fractions</description>
    <arm_group_label>ARM A: 3 treatments of 7Gy</arm_group_label>
    <arm_group_label>ARM AB: 6 treatment of 4Gy</arm_group_label>
    <arm_group_label>ARM B: 6 treatment of 4Gy</arm_group_label>
    <arm_group_label>ARM BA: 3 treatments of 7Gy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Willingness and ability to provide written informed consent and to comply with the&#xD;
             study protocol as judged by the investigator.&#xD;
&#xD;
          -  Surgery consisted of Total Abdominal or Laparoscopic Hysterectomy and Bilateral&#xD;
             Salpingo Oophorectomy (TH-BSO) with or without lymph node dissection.&#xD;
&#xD;
          -  Subject must have FIGO Stage I-II (grade 1-3) pathologically proven (histologic)&#xD;
             endometrioid cancer, including all subtypes. Serous, clear cell, and carcinosarcoma&#xD;
             histologic pathologies are allowed.&#xD;
&#xD;
          -  Subjects must have no measurable disease after surgery.&#xD;
&#xD;
          -  ECOG Performance Status of 0-2&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Subject must have a life expectancy ≥ 12 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Disease of more advanced stage (FIGO stage III-IV) or disease for which adjuvant&#xD;
             external beam radiation therapy or chemotherapy is indicated&#xD;
&#xD;
          -  Patients with a history of prior pelvic radiation therapy or if additional pelvic&#xD;
             radiation therapy is planned&#xD;
&#xD;
          -  Subjects who have not recovered from side effects of agents administered more than 4&#xD;
             weeks prior to the on-study date&#xD;
&#xD;
          -  Subjects that require &gt; 14 weeks between surgery and initiation of radiation therapy&#xD;
             on study unless the subject is receiving chemotherapy. Subjects receiving chemotherapy&#xD;
             may have radiation therapy initiated within 6 months after surgery.&#xD;
&#xD;
             * Subjects who do not meet this criteria may still be eligible. The UVA Coordinating&#xD;
             Center and Overall Study PI will review each case and inform the site of the approval&#xD;
             decision.&#xD;
&#xD;
          -  Subjects who are receiving any investigational agents or have had any investigational&#xD;
             agent within the 30 days prior to the on-study date&#xD;
&#xD;
          -  Subject is unable or unwilling to participate in a study-related procedure&#xD;
&#xD;
          -  Pregnant and breastfeeding women are excluded from this study&#xD;
&#xD;
          -  Subject is a prisoner&#xD;
&#xD;
          -  A serious uncontrolled medical disorder that in the opinion of the Investigator would&#xD;
             impair the ability of the subject to receive protocol therapy.&#xD;
&#xD;
          -  Subjects with a history of evidence upon physical examination of central nervous&#xD;
             system disease including primary brain tumor, seizures not controlled with standard&#xD;
             medical therapy, any brain metastases, or history of cerebrovascular accident&#xD;
             (stroke), transient ischemic attack, or subarachnoid hemorrhage within six months of&#xD;
             study entry&#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_official>
    <last_name>Kara Romano, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Virginia</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Songserea Wood, BS</last_name>
    <phone>434-243-0008</phone>
    <email>stw2g@hscmail.mcc.virginia.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Dena Synder</last_name>
    <email>DS6HE@hscmail.mcc.virginia.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Maryland Medical Center (UMMC)</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Caitlin Eggleston</last_name>
      <phone>410-328-7586</phone>
      <email>caitlineggleston@umm.edu</email>
    </contact>
    <investigator>
      <last_name>Sarah McAvoy, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Elizabeth Nichols, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jack J Hong, MD, FACRO</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sally Cheston, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>SUNY Upstate Medical University</name>
      <address>
        <city>Syracuse</city>
        <state>New York</state>
        <zip>13210</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Erin Bingham</last_name>
      <phone>315-464-3603</phone>
      <email>BinghamE@upstate.edu</email>
    </contact>
    <contact_backup>
      <last_name>Lindsay Noah-Vermillion</last_name>
      <email>noahverl@upstate.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Brittany Simone, DO</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Virginia</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22903</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kara Romano, MD</last_name>
      <email>KED7C@uvahealth.org</email>
    </contact>
    <contact_backup>
      <last_name>Song Wood</last_name>
      <email>STW2G@uvahealth.org</email>
    </contact_backup>
    <investigator>
      <last_name>Kara Romano, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Timothy Showalter, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Leigh Cantrell, MD, MSPH</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>November 15, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>January 19, 2023</last_update_submitted>
  <last_update_submitted_qc>January 19, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 20, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Virginia</investigator_affiliation>
    <investigator_full_name>Kara Romano, MD</investigator_full_name>
    <investigator_title>Principle Investigator-MD Radiation Oncology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Endometrial 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/NCT03785288
org study id: 20163
nct id: NCT03785288
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to see the effects of two different standard of care treatments
      of endometrial cancer on sexual dysfunction. This study will compare two standard of care
      treatments: HDR (high dose radiation) vaginal brachytherapy 3 fractions of 7 Gy to HDR
      vaginal brachytherapy 6 fractions of 4Gy for early stage endometrial cancer.
Patients are randomized to HDR vaginal brachytherapy 7 Gy in 3 fractions prescribed at 5mm.
      Radiation delivered 4-12 weeks after surgery OR HDR vaginal brachytherapy 4Gy in 6 fractions
      prescribed at the cylinder surface. Patients have the option to request to decline their
      randomization and switch to the alternate treatment ARM if they prefer.

      Radiation delivered 4-12 weeks after surgery. Participants in all Arms will receive standard
      vaginal dilator for use after treatment (to promote healing). 3 month, 1 year and 2 year
      follow up assessments are performed.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This study will compare two standard of care treatments: HDR vaginal brachytherapy 3 fractions of 7Gy to HDR vaginal brachytherapy 6 fractions of 4Gy for early stage endometrial cancer.
primary purpose: Treatment
masking: None (Open Label)
measure: Female Sexual Function Index (FSFI)
time frame: 1 year
description: Using the FSFI, compare patient reported sexual dysfunction at 1 year after completion of treatment
measure: Preference Option Randomized Design (PORD)
time frame: 1 year
description: Assessing the comparative effectiveness of receiving HDR vaginal brachytherapy on Arm B or Arm A for early stage endometrial cancer.
measure: Vaginal Length Measurement
time frame: 1 year
description: Using vaginal dilator compare patient vaginal measurement 1 year after completion of treatment
measure: Vaginal Length Measurement
time frame: 2 years
description: Using vaginal dilator compare patient vaginal measurement 2 years after completion of treatment
arm group label: ARM A: 3 treatments of 7Gy
arm group type: Active Comparator
description: Arm A: accepted randomization to HDR vaginal brachytherapy in 3 treatments (fractions) of 7Gy for a total dose of 21gy
arm group label: ARM B: 6 treatment of 4Gy
arm group type: Active Comparator
description: Arm B: accepted randomization to HDR vaginal brachytherapy 6 treatments (fractions) of 4Gy for a total does of 24gy
arm group label: ARM AB: 6 treatment of 4Gy
arm group type: Active Comparator
description: Arm AB: initially randomized to ARM A but wanted to switch to ARM B treatment of HDR vaginal brachytherapy 6 treatments (fractions) of 4Gy for a total does of 24gy
arm group label: ARM BA: 3 treatments of 7Gy
arm group type: Active Comparator
description: initially randomized to ARM B but wanted to switch to ARM A of HDR vaginal brachytherapy in 3 treatments (fractions) of 7Gy for a total dose of 21gy
intervention type: Radiation
intervention name: HDR vaginal brachytherapy
description: HDR vaginal brachytherapy 7 Gy in 3 fractions or HDR vaginal brachytherapy 4 Gy in 6 fractions
arm group label: ARM A: 3 treatments of 7Gy
arm group label: ARM AB: 6 treatment of 4Gy
arm group label: ARM B: 6 treatment of 4Gy
arm group label: ARM BA: 3 treatments of 7Gy
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kara Romano, MD
role: Principal Investigator
affiliation: University of Virginia
last name: Songserea Wood, BS
phone: 434-243-0008
email: stw2g@hscmail.mcc.virginia.edu
last name: Dena Synder
email: DS6HE@hscmail.mcc.virginia.edu
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Virginia
investigator full name: Kara Romano, MD
investigator title: Principle Investigator-MD Radiation Oncology
mesh term: Endometrial Neoplasms