<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/NCT04499521</url>
  </required_header>
  <id_info>
    <org_study_id>HSR 200128</org_study_id>
    <nct_id>NCT04499521</nct_id>
  </id_info>
  <brief_title>A Randomized Study to Compare a Hydrogel Packing System to Standard Packing During HDR Brachytherapy for Cervical Cancer</brief_title>
  <official_title>A Randomized, Non-Inferiority Study of a Hydrogel Packing System Compared to Standard of Care Packing During Image-Guided High-Dose Rate Brachytherapy Boost for Cervical Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Virginia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>BrachyFoam, LLC</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </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>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study, a new, low cost packing system (&quot;BrachyGel VHPS&quot;) is being tested as a packing&#xD;
      option during brachytherapy along with standard options to make sure that it keeps the&#xD;
      unrelated organs away from radiation at least as well as the standard options, and to better&#xD;
      understand the safety and patient discomfort associated with BrachyGel VHPS and the standard&#xD;
      packing options.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      As part of vaginal brachytherapy, the organs that do not need to receive radiation (unrelated&#xD;
      organs) are moved out of the way of the radiation with a &quot;packing system&quot;. The usual low cost&#xD;
      and available standard of care packing systems to move these unrelated organs out of the way&#xD;
      can sometimes be uncomfortable for the patient, may not move all of the unrelated organs all&#xD;
      the way out of the radiation's path, and rely on the doctor to place them correctly.&#xD;
&#xD;
      If you participate, you will receive 5 fractions of brachytherapy according to standard&#xD;
      clinical care. For three of the fractions, a standard packing option will be used and for two&#xD;
      of them BrachyGel VHPS will be used. For the first fraction both groups will have the same&#xD;
      packing option but participants will be randomized to either have BrachyGel during fractions&#xD;
      2 and 4 or during fractions 3 and 5. You'll be asked to complete a questionnaire after&#xD;
      fractions 2-5 to get your feedback on any discomfort you have during or after brachytherapy&#xD;
      from the packing system.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">March 17, 2021</start_date>
  <completion_date type="Anticipated">June 1, 2024</completion_date>
  <primary_completion_date type="Actual">September 30, 2022</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>
    <intervention_model_description>Both groups will have two fractions of brachytherapy with a standard packing system and two fractions of brachytherapy with BrachyGel VHPS - only the timing will be different between the two groups.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Highest dose of radiation (in Gy) to the rectum and bladder for each patient</measure>
    <time_frame>Fractions 2 and 3: About 1-2 weeks after starting brachytherapy</time_frame>
    <description>This number (dose) is based on the radiation treatment plan</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>Fractions/Radiation treatments 2 - 5: About 1-4 weeks after starting brachytherapy</time_frame>
    <description>Frequency, intensity, and duration of adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Highest dose of radiation (in Gy) to the rectum and bladder for each patient at each treatment</measure>
    <time_frame>Fractions/Radiation treatments 2 - 5: About 1-4 weeks after starting brachytherapy</time_frame>
    <description>This number (dose) is based on the radiation treatment plan</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Cervical Cancer</condition>
  <arm_group>
    <arm_group_label>Arm A: BrachyGel in fractions 3 and 5</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BrachyGel VHPS in fractions 3 and 5 and standard packing in fractions 2 and 4</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B: BrachyGel in fractions 2 and 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BrachyGel VHPS in fractions 2 and 4 and standard packing in fractions 3 and 5</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>BrachyGel VHPS</intervention_name>
    <description>Packing system for administering brachytherapy in cervical cancer patients</description>
    <arm_group_label>Arm A: BrachyGel in fractions 3 and 5</arm_group_label>
    <arm_group_label>Arm B: BrachyGel in fractions 2 and 4</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Biopsy showing cancer of the cervix (squamous cell carcinoma, adenocarcinoma,&#xD;
             adenosquamous, neuroendocrine, etc)&#xD;
&#xD;
          2. FIGO IB1 - IVB Staging according to FIGO and TNM guidelines&#xD;
&#xD;
          3. Planning to receive brachytherapy as a part of the definitive treatment for cervical&#xD;
             cancer&#xD;
&#xD;
          4. Karnofsky performance status (KPS) ≥ 70 or ECOG status ≤1&#xD;
&#xD;
          5. Stated willingness to comply with all study procedures and availability for the&#xD;
             duration of the study&#xD;
&#xD;
          6. Age ≥ 18 years&#xD;
&#xD;
          7. Agreement to adhere to Lifestyle Considerations throughout study duration&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of pelvis or abdominal radiation therapy (RT) that is not a part of the&#xD;
             definitive treatment plan for the cancer of interest&quot;&#xD;
&#xD;
          2. History of total or partial hysterectomy&#xD;
&#xD;
          3. Plan to receive external beam RT (EBRT) alone as the definitive treatment plan for the&#xD;
             cancer of interest&#xD;
&#xD;
          4. Known pregnancy or lactation (no pregnancy test required prior to participation)&#xD;
&#xD;
          5. Known contraindications to brachytherapy&#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</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Virginia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Virginia</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>July 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>September 7, 2023</last_update_submitted>
  <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Virginia</investigator_affiliation>
    <investigator_full_name>Kara Romano, MD</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Brachytherapy</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/NCT04499521
org study id: HSR 200128
nct id: NCT04499521
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
In this study, a new, low cost packing system ("BrachyGel VHPS") is being tested as a packing
      option during brachytherapy along with standard options to make sure that it keeps the
      unrelated organs away from radiation at least as well as the standard options, and to better
      understand the safety and patient discomfort associated with BrachyGel VHPS and the standard
      packing options.
As part of vaginal brachytherapy, the organs that do not need to receive radiation (unrelated
      organs) are moved out of the way of the radiation with a "packing system". The usual low cost
      and available standard of care packing systems to move these unrelated organs out of the way
      can sometimes be uncomfortable for the patient, may not move all of the unrelated organs all
      the way out of the radiation's path, and rely on the doctor to place them correctly.

      If you participate, you will receive 5 fractions of brachytherapy according to standard
      clinical care. For three of the fractions, a standard packing option will be used and for two
      of them BrachyGel VHPS will be used. For the first fraction both groups will have the same
      packing option but participants will be randomized to either have BrachyGel during fractions
      2 and 4 or during fractions 3 and 5. You'll be asked to complete a questionnaire after
      fractions 2-5 to get your feedback on any discomfort you have during or after brachytherapy
      from the packing system.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Both groups will have two fractions of brachytherapy with a standard packing system and two fractions of brachytherapy with BrachyGel VHPS - only the timing will be different between the two groups.
primary purpose: Supportive Care
masking: None (Open Label)
measure: Highest dose of radiation (in Gy) to the rectum and bladder for each patient
time frame: Fractions 2 and 3: About 1-2 weeks after starting brachytherapy
description: This number (dose) is based on the radiation treatment plan
measure: Adverse Events
time frame: Fractions/Radiation treatments 2 - 5: About 1-4 weeks after starting brachytherapy
description: Frequency, intensity, and duration of adverse events
measure: Highest dose of radiation (in Gy) to the rectum and bladder for each patient at each treatment
time frame: Fractions/Radiation treatments 2 - 5: About 1-4 weeks after starting brachytherapy
description: This number (dose) is based on the radiation treatment plan
arm group label: Arm A: BrachyGel in fractions 3 and 5
arm group type: Experimental
description: BrachyGel VHPS in fractions 3 and 5 and standard packing in fractions 2 and 4
arm group label: Arm B: BrachyGel in fractions 2 and 4
arm group type: Experimental
description: BrachyGel VHPS in fractions 2 and 4 and standard packing in fractions 3 and 5
intervention type: Device
intervention name: BrachyGel VHPS
description: Packing system for administering brachytherapy in cervical cancer patients
arm group label: Arm A: BrachyGel in fractions 3 and 5
arm group label: Arm B: BrachyGel in fractions 2 and 4
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kara Romano
role: Principal Investigator
affiliation: University of Virginia
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Virginia
investigator full name: Kara Romano, MD
investigator title: Assistant Professor
mesh term: Uterine Cervical Neoplasms