<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/NCT03040804</url>
  </required_header>
  <id_info>
    <org_study_id>2016-7228</org_study_id>
    <nct_id>NCT03040804</nct_id>
  </id_info>
  <brief_title>Low Dose Radiotherapy for Advanced Hidradenitis Suppurativa</brief_title>
  <acronym>RTHS</acronym>
  <official_title>A Phase I Study of Low Dose Radiotherapy for Advanced Hidradenitis Suppurativa</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Montefiore Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Montefiore Medical Center</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_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To establish the safety of radiotherapy in the treatment of advanced hidradenitis&#xD;
      suppurativa. Patients will receive radiotherapy treatment over one week and then they will be&#xD;
      followed for the next three months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a phase I clinical trial using a Simon-two stage design to establish the safety of&#xD;
      radiotherapy in the treatment of advanced hidradenitis suppurativa (HS). In the first six&#xD;
      months, 6 patients will be enrolled, if the patients in the study do not meet the termination&#xD;
      criteria, then the study will extend to a second stage. A maximum of 20 patients will be&#xD;
      enrolled. Patients will be treated with skin-directed radiotherapy, using a total&#xD;
      prescription dose of 7.5 Gy in five fractions of 1.5 Gy over one week. Patients will then be&#xD;
      seen in the HS specialty clinic at Montefiore Medial Center for at least three months.&#xD;
      Quality of life changes, immunohistochemical changes, and cutaneous discharge will also be&#xD;
      evaluated during the study period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Infeasibility to continue study.&#xD;
  </why_stopped>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Actual">December 21, 2020</completion_date>
  <primary_completion_date type="Actual">December 21, 2020</primary_completion_date>
  <phase>N/A</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>
    <intervention_model_description>Simon two-stage design. In the first stage, 6 patients will be enrolled. If the patients in the study do not meet the termination criteria then the study will extend to a second stage and a maximum of 20 patients will be enrolled.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With HS Who Experience Treatment-related Grade ≥3 Adverse Events During Radiotherapy or Within 3 Months of Radiotherapy Completion, Assessed Using CTCAE Version 4.0</measure>
    <time_frame>follow up for 3-6 months post treatment</time_frame>
    <description>Number of participants with HS who experience treatment-related CTCAE version 4.0 Grade ≥3 adverse events during radiotherapy or within 3 months of radiotherapy completion. Common Terminology Criteria for Adverse Events (CTCAE) is an internationally accepted standard for defining and categorizing adverse events based on severity of reported adverse events. The grading scheme is from 1 (least severe) to 5 (most severe). For radiotherapy associated adverse events, CTCAE version 4.0 will be applied to &quot;Rash: dermatitis associated with radiation&quot;.&#xD;
Grade 1. Mild: Faint erythema or dry desquamation. Grade 2. Moderate: Moderate to brisk erythema; patchy moist desquamation, mostly confined to skin folds and creases; moderate edema.&#xD;
Grade 3. Severe: Moist desquamation other than skin folds and creases; bleeding induced by minor trauma or abrasion.&#xD;
Grade 4. Life threatening: Skin necrosis or ulceration of full thickness dermis; spontaneous bleeding from involved site.&#xD;
Grade 5</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in NIH Patient-Reported Outcomes Measurement Information System (PROMIS).</measure>
    <time_frame>6 months - 1 year post treatment</time_frame>
    <description>Evaluation of the efficacy of radiotherapy in improvement of patient's quality of life using patient reported outcome measures, including pain interference and physical functioning at 3 months (and optionally at 6 months and 12 months) after treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of Radiotherapy Associated Hidradenitis Suppurativa Lesions.</measure>
    <time_frame>3-6 months post treatment</time_frame>
    <description>Hematoxylin and Eosin (H&amp;E) stain and immunohistochemistry stains will be performed on skin biopsy specimens to investigate histological changes following radiotherapy for advanced hidradenitis suppurativa lesions.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Hidradenitis Suppurativa</condition>
  <condition>Hidradenitis</condition>
  <arm_group>
    <arm_group_label>Low Dose Radiotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive skin-directed radiotherapy, using a total prescription dose of 7.5 gy in five fractions of 1.5 gy over one week</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Low dose Radiotherapy</intervention_name>
    <description>Subjects in this protocol will only receive radiotherapy directed at one region, typically the region that is most bothersome to the patient. Patients will receive a total radiotherapy dose 7.5 Gy in five daily fractions of 1.5 Gy.</description>
    <arm_group_label>Low Dose Radiotherapy</arm_group_label>
    <other_name>Brachytherapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of Hidradenitis Suppurativa made at the Montefiore Hidradenitis Suppurativa&#xD;
             Treatment Center, with Hurley Stage 2-3 (defined as recurrent abscesses or boils with&#xD;
             diffuse or broad involvement, multiple interconnected sinus tracts in the whole area)&#xD;
&#xD;
          -  Failed maximal medical therapy for Hidradenitis Suppurativa or ineligible for&#xD;
             &quot;standard&quot; medical therapy or surgery&#xD;
&#xD;
          -  Age &gt; 20 years&#xD;
&#xD;
          -  Women of childbearing age: must have a negative pregnancy test within 72 hours prior&#xD;
             to the start of study therapy and agree to an adequate method of contraception&#xD;
             throughout treatment and for at least 4 weeks after study contraception.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Individuals &lt; 20 years old&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Steven R Cohen, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Montefiore Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Montefiore Medical Center</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10467</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.montefiore.org/hidradenitis-suppurativa</url>
    <description>Montefiore Hidradenitis Suppurativa Multispecialty clinic</description>
  </link>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>January 30, 2017</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <results_first_submitted>August 26, 2021</results_first_submitted>
  <results_first_submitted_qc>September 22, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">October 20, 2021</results_first_posted>
  <last_update_submitted>October 20, 2021</last_update_submitted>
  <last_update_submitted_qc>October 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Montefiore Medical Center</investigator_affiliation>
    <investigator_full_name>Steven R Cohen</investigator_full_name>
    <investigator_title>Chief of Dermatology at Montefiore</investigator_title>
  </responsible_party>
  <keyword>hidradenitis suppurativa</keyword>
  <keyword>HS</keyword>
  <keyword>radiotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hidradenitis Suppurativa</mesh_term>
    <mesh_term>Hidradenitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 5, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/04/NCT03040804/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 13, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/04/NCT03040804/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Low Dose Radiotherapy</title>
          <description>Patients will receive skin-directed radiotherapy, using a total prescription dose of 7.5 gy in five fractions of 1.5 gy over one week&#xD;
Low dose Radiotherapy: Subjects in this protocol will only receive radiotherapy directed at one region, typically the region that is most bothersome to the patient. Patients will receive a total radiotherapy dose 7.5 Gy in five daily fractions of 1.5 Gy.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Low Dose Radiotherapy</title>
          <description>Patients will receive skin-directed radiotherapy, using a total prescription dose of 7.5 gy in five fractions of 1.5 gy over one week&#xD;
Low dose Radiotherapy: Subjects in this protocol will only receive radiotherapy directed at one region, typically the region that is most bothersome to the patient. Patients will receive a total radiotherapy dose 7.5 Gy in five daily fractions of 1.5 Gy.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="2"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="70" lower_limit="67" upper_limit="73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Caucasian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Improvement in hidradenitis suppurativa lesion size</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With HS Who Experience Treatment-related Grade ≥3 Adverse Events During Radiotherapy or Within 3 Months of Radiotherapy Completion, Assessed Using CTCAE Version 4.0</title>
        <description>Number of participants with HS who experience treatment-related CTCAE version 4.0 Grade ≥3 adverse events during radiotherapy or within 3 months of radiotherapy completion. Common Terminology Criteria for Adverse Events (CTCAE) is an internationally accepted standard for defining and categorizing adverse events based on severity of reported adverse events. The grading scheme is from 1 (least severe) to 5 (most severe). For radiotherapy associated adverse events, CTCAE version 4.0 will be applied to &quot;Rash: dermatitis associated with radiation&quot;.&#xD;
Grade 1. Mild: Faint erythema or dry desquamation. Grade 2. Moderate: Moderate to brisk erythema; patchy moist desquamation, mostly confined to skin folds and creases; moderate edema.&#xD;
Grade 3. Severe: Moist desquamation other than skin folds and creases; bleeding induced by minor trauma or abrasion.&#xD;
Grade 4. Life threatening: Skin necrosis or ulceration of full thickness dermis; spontaneous bleeding from involved site.&#xD;
Grade 5</description>
        <time_frame>follow up for 3-6 months post treatment</time_frame>
        <population>Patients with Hidradenitis Suppurativa (HS) Hurley Stage 2-3.</population>
        <group_list>
          <group group_id="O1">
            <title>Low Dose Radiotherapy</title>
            <description>Patients will receive skin-directed radiotherapy, using a total prescription dose of 7.5 gy in five fractions of 1.5 gy over one week&#xD;
Low dose Radiotherapy: Subjects in this protocol will only receive radiotherapy directed at one region, typically the region that is most bothersome to the patient. Patients will receive a total radiotherapy dose 7.5 Gy in five daily fractions of 1.5 Gy.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With HS Who Experience Treatment-related Grade ≥3 Adverse Events During Radiotherapy or Within 3 Months of Radiotherapy Completion, Assessed Using CTCAE Version 4.0</title>
          <description>Number of participants with HS who experience treatment-related CTCAE version 4.0 Grade ≥3 adverse events during radiotherapy or within 3 months of radiotherapy completion. Common Terminology Criteria for Adverse Events (CTCAE) is an internationally accepted standard for defining and categorizing adverse events based on severity of reported adverse events. The grading scheme is from 1 (least severe) to 5 (most severe). For radiotherapy associated adverse events, CTCAE version 4.0 will be applied to &quot;Rash: dermatitis associated with radiation&quot;.&#xD;
Grade 1. Mild: Faint erythema or dry desquamation. Grade 2. Moderate: Moderate to brisk erythema; patchy moist desquamation, mostly confined to skin folds and creases; moderate edema.&#xD;
Grade 3. Severe: Moist desquamation other than skin folds and creases; bleeding induced by minor trauma or abrasion.&#xD;
Grade 4. Life threatening: Skin necrosis or ulceration of full thickness dermis; spontaneous bleeding from involved site.&#xD;
Grade 5</description>
          <population>Patients with Hidradenitis Suppurativa (HS) Hurley Stage 2-3.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in NIH Patient-Reported Outcomes Measurement Information System (PROMIS).</title>
        <description>Evaluation of the efficacy of radiotherapy in improvement of patient's quality of life using patient reported outcome measures, including pain interference and physical functioning at 3 months (and optionally at 6 months and 12 months) after treatment.</description>
        <time_frame>6 months - 1 year post treatment</time_frame>
        <population>Due to COVID-19 pandemic, patient safety was prioritized and the study was terminated early. Participant outcome measures were not performed.</population>
        <group_list>
          <group group_id="O1">
            <title>Low Dose Radiotherapy</title>
            <description>Patients will receive skin-directed radiotherapy, using a total prescription dose of 7.5 gy in five fractions of 1.5 gy over one week&#xD;
Low dose Radiotherapy: Subjects in this protocol will only receive radiotherapy directed at one region, typically the region that is most bothersome to the patient. Patients will receive a total radiotherapy dose 7.5 Gy in five daily fractions of 1.5 Gy.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in NIH Patient-Reported Outcomes Measurement Information System (PROMIS).</title>
          <description>Evaluation of the efficacy of radiotherapy in improvement of patient's quality of life using patient reported outcome measures, including pain interference and physical functioning at 3 months (and optionally at 6 months and 12 months) after treatment.</description>
          <population>Due to COVID-19 pandemic, patient safety was prioritized and the study was terminated early. Participant outcome measures were not performed.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Evaluation of Radiotherapy Associated Hidradenitis Suppurativa Lesions.</title>
        <description>Hematoxylin and Eosin (H&amp;E) stain and immunohistochemistry stains will be performed on skin biopsy specimens to investigate histological changes following radiotherapy for advanced hidradenitis suppurativa lesions.</description>
        <time_frame>3-6 months post treatment</time_frame>
        <population>Due to COVID-19 pandemic, patient safety was prioritized and the study was terminated early. Participant outcome measures were not completed.</population>
        <group_list>
          <group group_id="O1">
            <title>Low Dose Radiotherapy</title>
            <description>Patients will receive skin-directed radiotherapy, using a total prescription dose of 7.5 gy in five fractions of 1.5 gy over one week&#xD;
Low dose Radiotherapy: Subjects in this protocol will only receive radiotherapy directed at one region, typically the region that is most bothersome to the patient. Patients will receive a total radiotherapy dose 7.5 Gy in five daily fractions of 1.5 Gy.</description>
          </group>
        </group_list>
        <measure>
          <title>Evaluation of Radiotherapy Associated Hidradenitis Suppurativa Lesions.</title>
          <description>Hematoxylin and Eosin (H&amp;E) stain and immunohistochemistry stains will be performed on skin biopsy specimens to investigate histological changes following radiotherapy for advanced hidradenitis suppurativa lesions.</description>
          <population>Due to COVID-19 pandemic, patient safety was prioritized and the study was terminated early. Participant outcome measures were not completed.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Two participants were observed in relation to baseline radiotherapy treatment for an average of 6 months.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Low Dose Radiotherapy</title>
          <description>Patients will receive skin-directed radiotherapy, using a total prescription dose of 7.5 gy in five fractions of 1.5 gy over one week&#xD;
Low dose Radiotherapy: Subjects in this protocol will only receive radiotherapy directed at one region, typically the region that is most bothersome to the patient. Patients will receive a total radiotherapy dose 7.5 Gy in five daily fractions of 1.5 Gy.&#xD;
No adverse event reported to date.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Steven R. Cohen, MD, MPH</name_or_title>
      <organization>Montefiore Medical Center</organization>
      <phone>7189208352</phone>
      <email>srcohen@montefiore.org</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03040804
org study id: 2016-7228
nct id: NCT03040804
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
To establish the safety of radiotherapy in the treatment of advanced hidradenitis
      suppurativa. Patients will receive radiotherapy treatment over one week and then they will be
      followed for the next three months.
This is a phase I clinical trial using a Simon-two stage design to establish the safety of
      radiotherapy in the treatment of advanced hidradenitis suppurativa (HS). In the first six
      months, 6 patients will be enrolled, if the patients in the study do not meet the termination
      criteria, then the study will extend to a second stage. A maximum of 20 patients will be
      enrolled. Patients will be treated with skin-directed radiotherapy, using a total
      prescription dose of 7.5 Gy in five fractions of 1.5 Gy over one week. Patients will then be
      seen in the HS specialty clinic at Montefiore Medial Center for at least three months.
      Quality of life changes, immunohistochemical changes, and cutaneous discharge will also be
      evaluated during the study period.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Simon two-stage design. In the first stage, 6 patients will be enrolled. If the patients in the study do not meet the termination criteria then the study will extend to a second stage and a maximum of 20 patients will be enrolled.
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants With HS Who Experience Treatment-related Grade ≥3 Adverse Events During Radiotherapy or Within 3 Months of Radiotherapy Completion, Assessed Using CTCAE Version 4.0
time frame: follow up for 3-6 months post treatment
description: Number of participants with HS who experience treatment-related CTCAE version 4.0 Grade ≥3 adverse events during radiotherapy or within 3 months of radiotherapy completion. Common Terminology Criteria for Adverse Events (CTCAE) is an internationally accepted standard for defining and categorizing adverse events based on severity of reported adverse events. The grading scheme is from 1 (least severe) to 5 (most severe). For radiotherapy associated adverse events, CTCAE version 4.0 will be applied to "Rash: dermatitis associated with radiation".
Grade 1. Mild: Faint erythema or dry desquamation. Grade 2. Moderate: Moderate to brisk erythema; patchy moist desquamation, mostly confined to skin folds and creases; moderate edema.
Grade 3. Severe: Moist desquamation other than skin folds and creases; bleeding induced by minor trauma or abrasion.
Grade 4. Life threatening: Skin necrosis or ulceration of full thickness dermis; spontaneous bleeding from involved site.
Grade 5
measure: Changes in NIH Patient-Reported Outcomes Measurement Information System (PROMIS).
time frame: 6 months - 1 year post treatment
description: Evaluation of the efficacy of radiotherapy in improvement of patient's quality of life using patient reported outcome measures, including pain interference and physical functioning at 3 months (and optionally at 6 months and 12 months) after treatment.
measure: Evaluation of Radiotherapy Associated Hidradenitis Suppurativa Lesions.
time frame: 3-6 months post treatment
description: Hematoxylin and Eosin (H&E) stain and immunohistochemistry stains will be performed on skin biopsy specimens to investigate histological changes following radiotherapy for advanced hidradenitis suppurativa lesions.
arm group label: Low Dose Radiotherapy
arm group type: Experimental
description: Patients will receive skin-directed radiotherapy, using a total prescription dose of 7.5 gy in five fractions of 1.5 gy over one week
intervention type: Radiation
intervention name: Low dose Radiotherapy
description: Subjects in this protocol will only receive radiotherapy directed at one region, typically the region that is most bothersome to the patient. Patients will receive a total radiotherapy dose 7.5 Gy in five daily fractions of 1.5 Gy.
arm group label: Low Dose Radiotherapy
other name: Brachytherapy
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Steven R Cohen, MD, MPH
role: Principal Investigator
affiliation: Montefiore Medical Center
facility: 
country: United States
url: http://www.montefiore.org/hidradenitis-suppurativa
description: Montefiore Hidradenitis Suppurativa Multispecialty clinic
responsible party type: Principal Investigator
investigator affiliation: Montefiore Medical Center
investigator full name: Steven R Cohen
investigator title: Chief of Dermatology at Montefiore
mesh term: Hidradenitis Suppurativa
mesh term: Hidradenitis
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 