<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/NCT02261181</url>
  </required_header>
  <id_info>
    <org_study_id>INT 52/14</org_study_id>
    <nct_id>NCT02261181</nct_id>
  </id_info>
  <brief_title>Preemptive Treatment With XONRID to Reduce Radiation Induced Dermatitis in Head and Neck Cancer Patients</brief_title>
  <official_title>Preemptive Treatment With XONRID a Medical Device to Reduce Radiation Induced Dermatitis in Head and Neck Cancer Patients Receiving Curative Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondazione IRCCS Istituto Nazionale dei Tumori, Milano</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fondazione IRCCS Istituto Nazionale dei Tumori, Milano</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      There is a strong need to study products with a preemptive role in radiation dermatitis&#xD;
      development, with a trial design taking in account patient subjective evaluation and&#xD;
      compliance.&#xD;
&#xD;
      XONRID is a promising device for radiation high grade dermatitis prevention; it is a topical&#xD;
      gel that prevents and treats skin symptoms such as erythema, itching, burning sensation and&#xD;
      pruritus, induced by radiotherapy or other causes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The patients will be treated with XONRID + standard of care (SOC) preemptive treatment&#xD;
      adopted during radiation treatment for head and neck cancer patients in the Institution.&#xD;
&#xD;
      Patients will be planned to receive Intensity-Modulated Radiotherapy Techniques (IMRT or&#xD;
      volumetric modulated radiotherapy, VMAT) with conventional fractionation at total dose of&#xD;
      50-66 GY in postoperative setting and 66-70 Gy in radical setting. Radiotherapy will be&#xD;
      planned with simultaneous boost (SIB) approaches, using conventional fractionation (1.8-2.12&#xD;
      Gy/die). According to histology, stage and pathology reports, patients could receive&#xD;
      concomitant platinum based chemotherapy.&#xD;
&#xD;
      The patients will be evaluated at baseline, at weekly intervals during RT and six months&#xD;
      after treatment completion by 2 different treating physicians for each visit. The evaluation&#xD;
      will consist of a physician-assessed toxicity assessment using the Radiation Therapy Oncology&#xD;
      Group (RTOG), and patient-reported outcome measured using the Skindex-16 questionnaire.&#xD;
&#xD;
      In addition objective in vivo measurements of skin erythema and pigmentation based on&#xD;
      reflectance spectrometry (RS) will be performed.&#xD;
&#xD;
      Measurements will be performed before RT, every 5 RT fractions (once a week) up to the end of&#xD;
      RT and 6 months after RT completion (same timing as clinical evaluation). Instrumental RS&#xD;
      measurement will be performed at five different fixed regions within the area treated with&#xD;
      RT, in any cases only on flat skin regions of the neck in an area corresponding to the second&#xD;
      node level and in absence of hair or nevus.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2015</start_date>
  <completion_date type="Actual">January 2019</completion_date>
  <primary_completion_date type="Actual">July 2018</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Worst skin toxicity</measure>
    <time_frame>14 months</time_frame>
    <description>Worst skin toxicity during treatment and until 2 weeks after according to CTCAE , as assessed independently by 2 physicians</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>MeanPatient Reported Outcome (PRO)</measure>
    <time_frame>14 months</time_frame>
    <description>Mean and worst score (measured on a numeric 0-6 scale, where 0= absence of symptom and 6= worst intensity of symptom) of Patient Reported Outcome (PRO) with Skindex 16 questionnaire performed weekly until reaching a total dose of 50 Gy on neck</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median time to G2 radiation dermatitis development</measure>
    <time_frame>14 months</time_frame>
    <description>Median time to G2 radiation dermatitis development according to CTCAE</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compliance</measure>
    <time_frame>14 months</time_frame>
    <description>Compliance to experimental treatment assumption considering a complete cpmpliance from 0 to 2 applications skipped, a partial compiance from 3 to 10 applications skipped and an absent compliance from 11 to 14 applications skipped.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Grade of late toxicity</measure>
    <time_frame>14 months</time_frame>
    <description>Grade of late toxicity (skin fibrosis according to CTCAE) at 6 month follow up visit after treatment ending</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Head and Neck Cancer</condition>
  <arm_group>
    <arm_group_label>XONRID</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will be treated with XONRID + standard of care (SOC) preemptive treatment adopted during radiation treatment for head and neck cancer patients.&#xD;
Patients will be instructed to apply the study cream (XONRID) on the irradiated area two times daily, the first application 1-2 h after the morning radiotherapy session, the second in the evening, starting on the first day of irradiation and continuing until 2 weeks after the completion of the radiation treatments or the development of Grade 3 or 4 skin toxicity. When G3 toxicity will occur the patient will be discontinued from the study medication and the skin toxicity will be managed according to internal guidelines. The use of other topical medications for the treatment of dermatitis will be not permitted during the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>XONRID</intervention_name>
    <description>The patients will be treated with XONRID + standard of care (SOC) preemptive treatment adopted during radiation treatment for head and neck cancer patients. Patients will be instructed to apply the study cream (XONRID) on the irradiated area two times daily, the first application 1-2 h after the morning radiotherapy session, the second in the evening, starting on the first day of irradiation and continuing until 2 weeks after the completion of the radiation treatments or the development of Grade 3 or 4 skin toxicity. When G3 toxicity will occur the patient will be discontinued from the study medication and the skin toxicity will be managed according to internal guidelines.</description>
    <arm_group_label>XONRID</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  &gt; 18 years&#xD;
&#xD;
          -  Performance status &lt; 2&#xD;
&#xD;
          -  Epithelial carcinoma of oropharynx, nasopharynx, larynx, hypopharynx, paranasal sinus&#xD;
             and salivary glands&#xD;
&#xD;
          -  Planned to receive at least 50 Gy on one side of the neck with at least the 2nd level&#xD;
             of neck nodes irradiated&#xD;
&#xD;
          -  Postoperative or curative radiation treatment&#xD;
&#xD;
          -  Concurrent platinum based chemotherapy is accepted, but not mandatory&#xD;
&#xD;
          -  Conventional fractionation (1.8-2.12 GY per fraction, one daily fraction, 5 fractions&#xD;
             a week )&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
&#xD;
          -  Planned to receive concurrent cetuximab&#xD;
&#xD;
          -  Previous radiation therapy on the head and neck area&#xD;
&#xD;
          -  Cutaneous and connettive diseases (i.e. lupus erythematosus or scleroderma)&#xD;
&#xD;
          -  Systemic diseases known to delay the skin healing process such as diabetes mellitus or&#xD;
             severe renal failure.&#xD;
&#xD;
          -  Use of a tissue-equivalent bolus&#xD;
&#xD;
          -  Use of over-the-counter topical medications containing steroids&#xD;
&#xD;
          -  Presence of rashes or unhealed wounds in the radiation field&#xD;
&#xD;
          -  Recent sun exposure&#xD;
&#xD;
          -  Mental conditions that could adversely affect patients' adherence to the study&#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>Ester Orlandi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fondazione IRCCS Istituto Nazionale dei Tumori, Milano</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fondazione IRCCS Istituto Nazionale Tumori</name>
      <address>
        <city>Milan</city>
        <zip>20133</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>September 1, 2014</study_first_submitted>
  <study_first_submitted_qc>October 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2014</study_first_posted>
  <last_update_submitted>September 23, 2021</last_update_submitted>
  <last_update_submitted_qc>September 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>head neck cancer XONRID radiation induced dermatitis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Head and Neck Neoplasms</mesh_term>
    <mesh_term>Dermatitis</mesh_term>
    <mesh_term>Radiodermatitis</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/NCT02261181
org study id: INT 52/14
nct id: NCT02261181
lead sponsor: 
has dmc: No
There is a strong need to study products with a preemptive role in radiation dermatitis
      development, with a trial design taking in account patient subjective evaluation and
      compliance.

      XONRID is a promising device for radiation high grade dermatitis prevention; it is a topical
      gel that prevents and treats skin symptoms such as erythema, itching, burning sensation and
      pruritus, induced by radiotherapy or other causes.
The patients will be treated with XONRID + standard of care (SOC) preemptive treatment
      adopted during radiation treatment for head and neck cancer patients in the Institution.

      Patients will be planned to receive Intensity-Modulated Radiotherapy Techniques (IMRT or
      volumetric modulated radiotherapy, VMAT) with conventional fractionation at total dose of
      50-66 GY in postoperative setting and 66-70 Gy in radical setting. Radiotherapy will be
      planned with simultaneous boost (SIB) approaches, using conventional fractionation (1.8-2.12
      Gy/die). According to histology, stage and pathology reports, patients could receive
      concomitant platinum based chemotherapy.

      The patients will be evaluated at baseline, at weekly intervals during RT and six months
      after treatment completion by 2 different treating physicians for each visit. The evaluation
      will consist of a physician-assessed toxicity assessment using the Radiation Therapy Oncology
      Group (RTOG), and patient-reported outcome measured using the Skindex-16 questionnaire.

      In addition objective in vivo measurements of skin erythema and pigmentation based on
      reflectance spectrometry (RS) will be performed.

      Measurements will be performed before RT, every 5 RT fractions (once a week) up to the end of
      RT and 6 months after RT completion (same timing as clinical evaluation). Instrumental RS
      measurement will be performed at five different fixed regions within the area treated with
      RT, in any cases only on flat skin regions of the neck in an area corresponding to the second
      node level and in absence of hair or nevus.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Worst skin toxicity
time frame: 14 months
description: Worst skin toxicity during treatment and until 2 weeks after according to CTCAE , as assessed independently by 2 physicians
measure: MeanPatient Reported Outcome (PRO)
time frame: 14 months
description: Mean and worst score (measured on a numeric 0-6 scale, where 0= absence of symptom and 6= worst intensity of symptom) of Patient Reported Outcome (PRO) with Skindex 16 questionnaire performed weekly until reaching a total dose of 50 Gy on neck
measure: Median time to G2 radiation dermatitis development
time frame: 14 months
description: Median time to G2 radiation dermatitis development according to CTCAE
measure: Compliance
time frame: 14 months
description: Compliance to experimental treatment assumption considering a complete cpmpliance from 0 to 2 applications skipped, a partial compiance from 3 to 10 applications skipped and an absent compliance from 11 to 14 applications skipped.
measure: Grade of late toxicity
time frame: 14 months
description: Grade of late toxicity (skin fibrosis according to CTCAE) at 6 month follow up visit after treatment ending
arm group label: XONRID
arm group type: Experimental
description: Patients will be treated with XONRID + standard of care (SOC) preemptive treatment adopted during radiation treatment for head and neck cancer patients.
Patients will be instructed to apply the study cream (XONRID) on the irradiated area two times daily, the first application 1-2 h after the morning radiotherapy session, the second in the evening, starting on the first day of irradiation and continuing until 2 weeks after the completion of the radiation treatments or the development of Grade 3 or 4 skin toxicity. When G3 toxicity will occur the patient will be discontinued from the study medication and the skin toxicity will be managed according to internal guidelines. The use of other topical medications for the treatment of dermatitis will be not permitted during the study.
intervention type: Device
intervention name: XONRID
description: The patients will be treated with XONRID + standard of care (SOC) preemptive treatment adopted during radiation treatment for head and neck cancer patients. Patients will be instructed to apply the study cream (XONRID) on the irradiated area two times daily, the first application 1-2 h after the morning radiotherapy session, the second in the evening, starting on the first day of irradiation and continuing until 2 weeks after the completion of the radiation treatments or the development of Grade 3 or 4 skin toxicity. When G3 toxicity will occur the patient will be discontinued from the study medication and the skin toxicity will be managed according to internal guidelines.
arm group label: XONRID
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ester Orlandi, MD
role: Principal Investigator
affiliation: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
facility: 
country: Italy
responsible party type: Sponsor
mesh term: Head and Neck Neoplasms
mesh term: Dermatitis
mesh term: Radiodermatitis