<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/NCT03777384</url>
  </required_header>
  <id_info>
    <org_study_id>SH EVOLVE</org_study_id>
    <nct_id>NCT03777384</nct_id>
  </id_info>
  <brief_title>EValuating the Safety Of De-escaLated Head and Neck Irradiation in HPV positivE Oropharynx Cancer in Non-smokers/Minimal Smokers</brief_title>
  <official_title>EValuating the Safety Of De-escaLated Head and Neck Irradiation in HPV positivE Oropharynx Cancer in Non-smokers/Minimal Smokers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sanford Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sanford Health</source>
  <oversight_info>
    <has_dmc>No</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>
      A prospective, observational study evaluating the durability of local/regional control of&#xD;
      previously published de-escalated radiotherapy protocols for patients with P16 positive&#xD;
      oropharynx cancers who have minimal nicotine exposure who are not current uses (&lt; 10 pack&#xD;
      year smoking history; &lt; 10 year history of any nicotine product [electronic cigarette,&#xD;
      chewing tobacco]). Quality of Life measures will also be collected.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, single-site, observational study in head and neck cancer participants.&#xD;
      The purpose of this study is to provide a systematic platform to analyze, interpret, and&#xD;
      track radiation dose de-escalation therapy and associated participant outcomes from&#xD;
      treatments identified by these results.&#xD;
&#xD;
      Participants will be asked to complete quality of life questionnaires at regular time points&#xD;
      before, during, and after treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 12, 2018</start_date>
  <completion_date type="Anticipated">December 2025</completion_date>
  <primary_completion_date type="Anticipated">July 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The durability of local disease control of de-escalated radiotherapy protocols in the community cancer center setting.</measure>
    <time_frame>End of treatment to 5 years after end of treatment</time_frame>
    <description>Number of participants who remain disease free from the end of treatment to 5 years after treatment.</description>
  </primary_outcome>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Oropharyngeal Cancer</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with HPV positive oropharynx cancers who have minimal nicotine exposure who are&#xD;
        not current uses (&lt; 10 pack year smoking history; &lt; 10 year history of any nicotine product&#xD;
        [electronic cigarette, chewing tobacco]).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 18 years&#xD;
&#xD;
          -  Histologic confirmation of tumor of the oropharynx&#xD;
&#xD;
          -  Radiation therapy (de-escalated head and neck irradiation) decision has been made&#xD;
&#xD;
          -  Human Papilloma Virus (HPV) associated cancer as determined by positive p16&#xD;
             immunohistochemistry&#xD;
&#xD;
               -  HPV positivity is defined by p16 IHC staining of &gt; 70% of tumor cells (strong and&#xD;
                  diffuse nuclear and cytoplasmic staining)&#xD;
&#xD;
               -  For cases that are indeterminate or if p16 testing cannot be accurately&#xD;
                  performed, HPV positivity can be confirmed by high-risk HPV DNA Testing which&#xD;
                  covers the following HPV subtypes: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58,&#xD;
                  59, 66, 68&#xD;
&#xD;
          -  &lt; 10 pack year smoking history OR &lt; 10 year nicotine use history&#xD;
&#xD;
          -  No current tobacco/nicotine use (including electronic cigarettes and chewing tobacco)&#xD;
&#xD;
          -  T1-T3, N0-N2 (AJCC8) requiring definitive therapy greater than surgery alone&#xD;
&#xD;
          -  Ability to provide informed written consent&#xD;
&#xD;
          -  Willingness to return to Sanford Cancer Center for follow-up&#xD;
&#xD;
          -  Life expectancy &gt; 12 weeks&#xD;
&#xD;
          -  ECOG performance status &lt; 3 (Appendix B)&#xD;
&#xD;
          -  Adequate organ function for chemotherapy and radiotherapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any of the following because the inclusion criteria require delivery of radiotherapy&#xD;
             and chemotherapy which is known to be genotoxic, and is associated with mutagenic and&#xD;
             teratogenic effects: pregnant women, nursing women, men or women of childbearing&#xD;
             potential who are unwilling to employ adequate contraception.&#xD;
&#xD;
          -  Prior head and neck radiotherapy&#xD;
&#xD;
          -  Any factor precluding safe delivery of chemotherapy&#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>Miran Blanchard, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Sanford Health</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Christie Ellison, BSN</last_name>
    <phone>605-312-6030</phone>
    <email>christie.ellison@sanfordhealth.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Sanford Roger Maris Cancer Center</name>
      <address>
        <city>Fargo</city>
        <state>North Dakota</state>
        <zip>58102</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Brittany Bloch</last_name>
      <phone>701-234-7563</phone>
      <email>Brittany.Bloch@SanfordHealth.org</email>
    </contact>
    <investigator>
      <last_name>Miran Blanchard, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Sanford Edith Cancer Center</name>
      <address>
        <city>Sioux Falls</city>
        <state>South Dakota</state>
        <zip>57104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ryan Sprecher</last_name>
      <phone>605-312-3328</phone>
      <email>ryan.sprecher@sanfordhealth.org</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>October 12, 2018</study_first_submitted>
  <study_first_submitted_qc>December 13, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 17, 2018</study_first_posted>
  <last_update_submitted>August 17, 2023</last_update_submitted>
  <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>oropharynx</keyword>
  <keyword>head and neck cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Oropharyngeal 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/NCT03777384
org study id: SH EVOLVE
nct id: NCT03777384
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A prospective, observational study evaluating the durability of local/regional control of
      previously published de-escalated radiotherapy protocols for patients with P16 positive
      oropharynx cancers who have minimal nicotine exposure who are not current uses (< 10 pack
      year smoking history; < 10 year history of any nicotine product [electronic cigarette,
      chewing tobacco]). Quality of Life measures will also be collected.
This is a prospective, single-site, observational study in head and neck cancer participants.
      The purpose of this study is to provide a systematic platform to analyze, interpret, and
      track radiation dose de-escalation therapy and associated participant outcomes from
      treatments identified by these results.

      Participants will be asked to complete quality of life questionnaires at regular time points
      before, during, and after treatment.
observational model: Case-Only
time perspective: Prospective
measure: The durability of local disease control of de-escalated radiotherapy protocols in the community cancer center setting.
time frame: End of treatment to 5 years after end of treatment
description: Number of participants who remain disease free from the end of treatment to 5 years after treatment.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Miran Blanchard, MD
role: Study Chair
affiliation: Sanford Health
last name: Christie Ellison, BSN
phone: 605-312-6030
email: christie.ellison@sanfordhealth.org
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Oropharyngeal Neoplasms
sharing ipd: No