<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/NCT03018418</url>
  </required_header>
  <id_info>
    <org_study_id>UCCI-GI-16-01</org_study_id>
    <nct_id>NCT03018418</nct_id>
  </id_info>
  <brief_title>Proton Therapy in Reducing Toxicity in Anal Cancer</brief_title>
  <official_title>A Prospective Pilot Study to Evaluate the Feasibility of Intensity Modulated Proton Therapy in Reducing Toxicity in Anal Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jordan Kharofa</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Cincinnati</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research study is to determine whether the amount of radiation given to&#xD;
      the normal areas around the anal cancer can be reduced by using Proton Therapy while reducing&#xD;
      the side effects that are seen with standard therapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 4, 2017</start_date>
  <completion_date type="Anticipated">January 2024</completion_date>
  <primary_completion_date type="Actual">April 7, 2022</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>Rates of acute toxicity</measure>
    <time_frame>3 months</time_frame>
    <description>Grade 3 or greater hematologic, gastrointestinal, genitourinary, and dermatologic toxicity</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rates of late toxicity</measure>
    <time_frame>every 6 months up to 60 months</time_frame>
    <description>Grade 3 or greater hematologic, gastrointestinal, genitourinary, and dermatologic toxicity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complete response rate</measure>
    <time_frame>every 6 months up to 60 months</time_frame>
    <description>clinical complete response</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Local progression free survival</measure>
    <time_frame>every 6 months up to 60 months</time_frame>
    <description>time from the date of registration to the date of the first documented locoregional recurrence</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>every 6 months up to 60 months</time_frame>
    <description>time from the date of registration to the date of death due to all causes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distant metastases free survival</measure>
    <time_frame>every 6 months up to 60 months</time_frame>
    <description>time from the date of registration to the date of first documented distant recurrence</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life Changes</measure>
    <time_frame>before and after treatment up to 12 months</time_frame>
    <description>Utilization of the Patient Reported Outcomes- Common Toxicity Criteria for Adverse Events at pretreatment, 2 weeks, 4 weeks, 3, 6, and 12 months</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Anus Neoplasms</condition>
  <arm_group>
    <arm_group_label>Proton Therapy and Chemotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Standard chemoradiation using 5-FU, Mitomycin, with pencil beam proton radiotherapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Proton therapy</intervention_name>
    <description>Primary target volume 50.4-54 CGE in 28-30 fractions; Nodal volumes 42-54 CGE in 28-30 fractions</description>
    <arm_group_label>Proton Therapy and Chemotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chemotherapy</intervention_name>
    <description>5FU 1000 mg/m2/day as 96 hour infusion days 1-5 and 29-33; Mitomycin 10mg/m2 days 1 and 29</description>
    <arm_group_label>Proton Therapy and Chemotherapy</arm_group_label>
    <other_name>5FU</other_name>
    <other_name>Mitomycin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Karnofsky Performance Status &gt;70%&#xD;
&#xD;
          -  Histologically documented squamous or basaloid carcinoma of the anal canal&#xD;
&#xD;
          -  Stage T2-4 disease with any N category&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • Patients with a life expectancy of &lt; 3 months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jordan Kharofa, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Cincinnati</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UC Health</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45044</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 12, 2017</study_first_posted>
  <last_update_submitted>March 7, 2023</last_update_submitted>
  <last_update_submitted_qc>March 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Cincinnati</investigator_affiliation>
    <investigator_full_name>Jordan Kharofa</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Anal Cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anus Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mitomycins</mesh_term>
    <mesh_term>Mitomycin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>May 11, 2023</submitted>
    <returned>June 7, 2023</returned>
    <submitted>July 12, 2023</submitted>
    <returned>July 28, 2023</returned>
    <submitted>August 9, 2023</submitted>
    <returned>August 29, 2023</returned>
    <submitted>September 12, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03018418
org study id: UCCI-GI-16-01
nct id: NCT03018418
lead sponsor: 
has dmc: Yes
The purpose of this research study is to determine whether the amount of radiation given to
      the normal areas around the anal cancer can be reduced by using Proton Therapy while reducing
      the side effects that are seen with standard therapy.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Rates of acute toxicity
time frame: 3 months
description: Grade 3 or greater hematologic, gastrointestinal, genitourinary, and dermatologic toxicity
measure: Rates of late toxicity
time frame: every 6 months up to 60 months
description: Grade 3 or greater hematologic, gastrointestinal, genitourinary, and dermatologic toxicity
measure: Complete response rate
time frame: every 6 months up to 60 months
description: clinical complete response
measure: Local progression free survival
time frame: every 6 months up to 60 months
description: time from the date of registration to the date of the first documented locoregional recurrence
measure: Overall survival
time frame: every 6 months up to 60 months
description: time from the date of registration to the date of death due to all causes
measure: Distant metastases free survival
time frame: every 6 months up to 60 months
description: time from the date of registration to the date of first documented distant recurrence
measure: Quality of Life Changes
time frame: before and after treatment up to 12 months
description: Utilization of the Patient Reported Outcomes- Common Toxicity Criteria for Adverse Events at pretreatment, 2 weeks, 4 weeks, 3, 6, and 12 months
arm group label: Proton Therapy and Chemotherapy
arm group type: Experimental
description: Standard chemoradiation using 5-FU, Mitomycin, with pencil beam proton radiotherapy
intervention type: Radiation
intervention name: Proton therapy
description: Primary target volume 50.4-54 CGE in 28-30 fractions; Nodal volumes 42-54 CGE in 28-30 fractions
arm group label: Proton Therapy and Chemotherapy
intervention type: Drug
intervention name: Chemotherapy
description: 5FU 1000 mg/m2/day as 96 hour infusion days 1-5 and 29-33; Mitomycin 10mg/m2 days 1 and 29
arm group label: Proton Therapy and Chemotherapy
other name: 5FU
other name: Mitomycin
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jordan Kharofa, MD
role: Principal Investigator
affiliation: University of Cincinnati
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Cincinnati
investigator full name: Jordan Kharofa
investigator title: Assistant Professor
mesh term: Anus Neoplasms
mesh term: Mitomycins
mesh term: Mitomycin
sharing ipd: No
submitted: May 11, 2023
returned: June 7, 2023
submitted: July 12, 2023
returned: July 28, 2023
submitted: August 9, 2023
returned: August 29, 2023
submitted: September 12, 2023