<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/NCT03839940</url>
  </required_header>
  <id_info>
    <org_study_id>A221701</org_study_id>
    <secondary_id>NCI-2018-02648</secondary_id>
    <secondary_id>UG1CA189823</secondary_id>
    <nct_id>NCT03839940</nct_id>
  </id_info>
  <brief_title>Dexamethasone in Reducing Everolimus-Induced Oral Stomatitis in Patients With Cancer</brief_title>
  <acronym>MIST</acronym>
  <official_title>Phase III Placebo-Controlled Trial to Evaluate Dexamethasone Use for Everolimus-Induced Oral Stomatitis: Prevention Versus Early Treatment Approaches: MIST (My Individualized Stomatitis Treatment)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alliance for Clinical Trials in Oncology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Alliance for Clinical Trials in Oncology</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This phase III trial studies how well dexamethasone works in reducing everolimus-induced oral&#xD;
      stomatitis in patients with cancer. Dexamethasone may help to reduce the everolimus-induced&#xD;
      oral stomatitis so as to improve quality of life in cancer patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To determine if the initiation of dexamethasone at the start of everolimus treatment&#xD;
      prevents mTOR inhibitor-associated stomatitis (mIAS)-associated pain, compared to the&#xD;
      initiation of placebo.&#xD;
&#xD;
      II. To determine if the initiation of dexamethasone at the start of everolimus treatment will&#xD;
      be superior compared to the initiation of placebo in terms of the overall severity of&#xD;
      mIAS-associated pain.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To utilize the same measurement method that was reported in the SWISH trial: A combination&#xD;
      of a patient reported pain scale, data from a normalcy of diet questionnaire, and clinician&#xD;
      grading of stomatitis to determine the incidence of &gt; grade 2 mIAS.&#xD;
&#xD;
      II. To determine if the initiation of dexamethasone at the start of everolimus increases time&#xD;
      to development of mouth pain using daily numerical analog scale patient-reported data&#xD;
      collection.&#xD;
&#xD;
      III. To assess if quality of life is better when dexamethasone mouth rinse use starts at the&#xD;
      same time as everolimus use versus at the time when mouth pain begins.&#xD;
&#xD;
      IV. To investigate if starting dexamethasone mouth rinse concurrent with starting everolimus&#xD;
      improves patients' ability to adhere to everolimus therapy.&#xD;
&#xD;
      V. To compare dexamethasone prescription fill rates and timing between patients who received&#xD;
      placebo versus study drug at the initiation of everolimus.&#xD;
&#xD;
      Trial Design:&#xD;
&#xD;
      OUTLINE: Patients are randomized to 1 of 2 groups.&#xD;
&#xD;
      GROUP I: Patients receive everolimus orally (PO) once daily (QD) as standard of care and&#xD;
      dexamethasone as mouthwash over 2 minutes 4 times per day (QID) for 8 weeks.&#xD;
&#xD;
      GROUP II: Patients receive everolimus PO QD as standard of care and placebo as mouthwash over&#xD;
      2 minutes QID for 8 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Severe lack of accrual&#xD;
  </why_stopped>
  <start_date type="Actual">February 15, 2019</start_date>
  <completion_date type="Actual">December 17, 2020</completion_date>
  <primary_completion_date type="Actual">December 17, 2020</primary_completion_date>
  <phase>Phase 3</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>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence Rate of the mTOR Inhibitor-associated Stomatitis (mIAS)-Related Pain Based on Daily Self-reports Via the Numerical Analogue Scale</measure>
    <time_frame>Up to 8 weeks</time_frame>
    <description>The numerical analogue mouth pain score (NAMPS) is a single item measured on a 0 to 10 scale, with 0 corresponding to &quot;No pain&quot; and 10 corresponding to &quot;Pain as bad as it can be.&quot; Will compare the incidence rate of any mouth pain (i.e., any score greater than 0) as assessed by the NAMPS between the prevention versus early treatment approaches using a Chi-square test.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Severity of Mouth Pain Scores</measure>
    <time_frame>Up to 8 weeks</time_frame>
    <description>Average Area Under the Curve per assessment (aAUCpa) of mouth pain scores as measured by NAMPS will be computed for each patient to summarize the sequence of numerical analogue mouth pain scores over the eight week study period. Scores are reported on a 0-100 scale, where 100 = better outcome QOL (i.e. less pain). The aAUCpa is the average of each AUC between each sequential assessment from treatment-initiation to the end of the treatment at 8 weeks post-treatment-initiation and will be compared between the two treatment arms.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of Grade &gt; 2 mIAS as Measured by the SWISH Trial</measure>
    <time_frame>Up to 8 weeks</time_frame>
    <description>Original plan for collecting and analyzing this data did not occur due to study termination.&#xD;
Grade 2 mIAS is defined as having at least one of the following criteria:&gt;&#xD;
Oral intake assessed at 50 on the Normalcy of Diet Scale&#xD;
Patient's reported oral pain (using visual analogue scale 0-10) that meets one of the following: rating of 7 on two consecutive days rating of 8, 9, or 10 on any one day. The incidence of grade 2 mIAS for each treatment arm will be compared by a Chi-square test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Mouth Pain</measure>
    <time_frame>Up to 8 weeks</time_frame>
    <description>Original plan for collecting and analyzing this data did not occur due to study termination.&#xD;
Will determine if the initiation of dexamethasone at the start of everolimus is associated with the incidence and of mild (score of 1-3), moderate (score of 4-6) and severe (score of 7-10) mouth pain as measured by the NAMPS. Will be assessed by Chi-square tests.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Development of Mouth Pain</measure>
    <time_frame>Up to 8 weeks</time_frame>
    <description>Original plan for collecting and analyzing this data did not occur due to study termination.&#xD;
Will determine if the initiation of dexamethasone at the start of everolimus is associated with the time to development of mild (score of 1-3), moderate (score of 4-6) and severe (score of 7-10) mouth pain as measured by the NAMPS. Will be assessed by Kaplan-Meier and cumulative incidence curves.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life Assessed by Linear Analogue Self-Assessment</measure>
    <time_frame>Up to 8 weeks</time_frame>
    <description>Original plan for collecting and analyzing this data did not occur due to study termination.&#xD;
Will determine if the initiation of dexamethasone at the start of everolimus is associated with quality of life is by comparing numerical analogue scale scores as measured by the Linear Analogue Self-Assessment. The Linear Analogue Self Assessment for quality of life is measured on a 0 to 10 scale, with 0 corresponding to &quot;Quality of life as bad as it can be&quot; and 10 corresponding to &quot;Quality of life as good as it can be.&quot; Will be assessed by independent samples t-tests.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mouth/Throat Sore Level of Activity Interference With Daily Activities</measure>
    <time_frame>Up to 8 weeks</time_frame>
    <description>Original plan for collecting and analyzing this data did not occur due to study termination.&#xD;
Will determine if the initiation of dexamethasone at the start of everolimus is associated with the level of interference with daily activities as measured by the Patient Reported Outcome (PRO) Common Terminology criteria for Adverse Events (CTCAE) mouth/throat item regarding level of interference with daily activities. The PRO-CTCAE mouth/throat item regarding level of interference with daily activities is measured on a Likert 1-5 scale, with 1 corresponding to &quot;Not at all&quot; and 5 corresponding to &quot;Very much.&quot; Will be assessed by independent samples t-tests.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep Level of Activity Interference With Daily Activities</measure>
    <time_frame>Up to 8 weeks</time_frame>
    <description>Original plan for collecting and analyzing this data did not occur due to study termination.&#xD;
Will determine if the initiation of dexamethasone at the start of everolimus is associated with the level of interference with daily activities as measured by the PRO-CTCAE sleep item regarding level of interference with daily activities. The PRO-CTCAE sleep item regarding level of interference with daily activities is measured on a Likert 1-5 scale, with 1 corresponding to &quot;Not at all&quot; and 5 corresponding to &quot;Very much.&quot; Will be assessed by independent samples t-tests.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence to Everolimus Therapy Dose</measure>
    <time_frame>Up to 8 weeks</time_frame>
    <description>Original plan for collecting and analyzing this data did not occur due to study termination.&#xD;
Will compare mean daily dose of everolimus between the arms. The mean daily dose of everolimus over 8 weeks will be compared between study arms using independent samples t-tests.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Patients Stopping Everolimus Early</measure>
    <time_frame>Up to 8 weeks</time_frame>
    <description>Original plan for collecting and analyzing this data did not occur due to study termination.&#xD;
Will compare the number of patients who stopped everolimus early between the treatment arms. Will be compared using Chi-squared tests.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Patients Reducing Everolimus Dose</measure>
    <time_frame>Up to 8 weeks</time_frame>
    <description>Original plan for collecting and analyzing this data did not occur due to study termination.&#xD;
Will compare the number of patients who reduced their everolimus dose between the treatment arms. Will be compared using Chi-squared tests.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dexamethasone Prescription Fill Rates</measure>
    <time_frame>Up to 8 weeks</time_frame>
    <description>Original plan for collecting and analyzing this data did not occur due to study termination.&#xD;
Will compare dexamethasone prescription fill rates between the treatment groups. This will be compared using Chi-squared tests.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Dexamethasone Prescription Fill</measure>
    <time_frame>Up to 8 weeks</time_frame>
    <description>Original plan for collecting and analyzing this data did not occur due to study termination.&#xD;
Will compare the time to dexamethasone prescription fill between the treatment groups. This will be compared using Kaplan-Meier and cumulative incidence curves.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Develop Mouth Sores Per Study Arm Assessed by PRO-CTCAE Mouth/Throat Sore Item Regarding Severity</measure>
    <time_frame>Up to 8 weeks</time_frame>
    <description>Original plan for collecting and analyzing this data did not occur due to study termination.&#xD;
The time to develop at least mild, moderate, or severe (including &quot;Very severe&quot;) mouth sores per study arm as measured by the PRO-CTCAE mouth-throat sore item regarding severity. The PRO-CTCAE mouth-throat sore item regarding severity is measured on a Likert 1-5 scale, with 1 corresponding to &quot;None&quot; and 5 corresponding to &quot;Very severe&quot;. Will be assessed by Kaplan-Meier and cumulative incidence curves.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Degrees of Patient-reported Mouth Sores Per Study Arm Assessed by NAMPS</measure>
    <time_frame>Up to 8 weeks</time_frame>
    <description>Original plan for collecting and analyzing this data did not occur due to study termination.&#xD;
The mean degrees of patient-reported mouth sores per study arm as measured by the NAMPS will be assessed by independent samples t-tests.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median Degree of Patient-reported Mouth Sores Per Study Arm Assessed by NAMPS</measure>
    <time_frame>Up to 8 weeks</time_frame>
    <description>Original plan for collecting and analyzing this data did not occur due to study termination.&#xD;
The median degrees of patient-reported mouth sores per study arm as measured by the NAMPS will be assessed by independent samples t-tests.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Patients Who Experience Grade 2 Stomatitis</measure>
    <time_frame>Up to 2 months</time_frame>
    <description>Original plan for collecting and analyzing this data did not occur due to study termination.&#xD;
The proportion of patients who experience clinician-reported grade 2 stomatitis (as measured by the CTCAE and performed at 1 and 2 months post-baseline) per study arm will be assessed by Chi-squared tests.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Incidence Rate of the mTOR Inhibitor-associated Stomatitis (mIAS)-Related Pain Based on Daily Self-reports Via the Numerical Analogue Scale by Sex</measure>
    <time_frame>Up to 8 weeks</time_frame>
    <description>NIH-required analysis. The numerical analogue mouth pain score (NAMPS) is a single item measured on a 0 to 10 scale, with 0 corresponding to &quot;No pain&quot; and 10 corresponding to &quot;Pain as bad as it can be.&quot; Will compare the incidence rate of any mouth pain (i.e., any score greater than 0) as assessed by the NAMPS between the prevention versus early treatment approaches using a Chi-square test.</description>
  </other_outcome>
  <other_outcome>
    <measure>Incidence Rate of the mTOR Inhibitor-associated Stomatitis (mIAS)-Related Pain Based on Daily Self-reports Via the Numerical Analogue Scale by Race</measure>
    <time_frame>Up to 8 weeks</time_frame>
    <description>NIH-required analysis. The numerical analogue mouth pain score (NAMPS) is a single item measured on a 0 to 10 scale, with 0 corresponding to &quot;No pain&quot; and 10 corresponding to &quot;Pain as bad as it can be.&quot; Will compare the incidence rate of any mouth pain (i.e., any score greater than 0) as assessed by the NAMPS between the prevention versus early treatment approaches using a Chi-square test.</description>
  </other_outcome>
  <other_outcome>
    <measure>Incidence Rate of the mTOR Inhibitor-associated Stomatitis (mIAS)-Related Pain Based on Daily Self-reports Via the Numerical Analogue Scale by Ethnicity.</measure>
    <time_frame>Up to 8 weeks</time_frame>
    <description>NIH-required analysis. The numerical analogue mouth pain score (NAMPS) is a single item measured on a 0 to 10 scale, with 0 corresponding to &quot;No pain&quot; and 10 corresponding to &quot;Pain as bad as it can be.&quot; Will compare the incidence rate of any mouth pain (i.e., any score greater than 0) as assessed by the NAMPS between the prevention versus early treatment approaches using a Chi-square test.</description>
  </other_outcome>
  <other_outcome>
    <measure>Severity of Mouth Pain Scores by Sex</measure>
    <time_frame>Up to 8 weeks</time_frame>
    <description>Average Area Under the Curve per assessment (aAUCpa) of mouth pain scores as measured by NAMPS will be computed for each patient to summarize the sequence of numerical analogue mouth pain scores over the eight week study period. Scores are reported on a 0-100 scale, where 100 = better outcome QOL (i.e. less pain). The aAUCpa is the average of each AUC between each sequential assessment from treatment-initiation to the end of the treatment at 8 weeks post-treatment-initiation and will be compared between the two treatment arms.</description>
  </other_outcome>
  <other_outcome>
    <measure>Severity of Mouth Pain Scores by Race</measure>
    <time_frame>Up to 8 weeks</time_frame>
    <description>Average Area Under the Curve per assessment (aAUCpa) of mouth pain scores as measured by NAMPS will be computed for each patient to summarize the sequence of numerical analogue mouth pain scores over the eight week study period. Scores are reported on a 0-100 scale, where 100 = better outcome QOL (i.e. less pain). The aAUCpa is the average of each AUC between each sequential assessment from treatment-initiation to the end of the treatment at 8 weeks post-treatment-initiation and will be compared between the two treatment arms.</description>
  </other_outcome>
  <other_outcome>
    <measure>Severity of Mouth Pain Scores by Ethnicity</measure>
    <time_frame>Up to 8 weeks</time_frame>
    <description>Average Area Under the Curve per assessment (aAUCpa) of mouth pain scores as measured by NAMPS will be computed for each patient to summarize the sequence of numerical analogue mouth pain scores over the eight week study period. Scores are reported on a 0-100 scale, where 100 = better outcome QOL (i.e. less pain). The aAUCpa is the average of each AUC between each sequential assessment from treatment-initiation to the end of the treatment at 8 weeks post-treatment-initiation and will be compared between the two treatment arms.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">39</enrollment>
  <condition>Malignant Neoplasm</condition>
  <arm_group>
    <arm_group_label>Group I (dexamethasone)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive 10mg oral everolimus daily as standard of care and 10ml dexamethasone oral mouthwash, swished for 2-minutes daily, for 8 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group II (placebo)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients receive 10mg oral everolimus daily as standard of care and 10ml placebo oral mouthwash, swished for 2-minutes daily, for 8 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone</intervention_name>
    <description>Given as mouthwash</description>
    <arm_group_label>Group I (dexamethasone)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Given as mouthwash</description>
    <arm_group_label>Group II (placebo)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Group I (dexamethasone)</arm_group_label>
    <arm_group_label>Group II (placebo)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Quality-of-Life Assessment</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Group I (dexamethasone)</arm_group_label>
    <arm_group_label>Group II (placebo)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Everolimus</intervention_name>
    <description>Standard of care</description>
    <arm_group_label>Group I (dexamethasone)</arm_group_label>
    <arm_group_label>Group II (placebo)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Current cancer diagnosis, about to receive oral everolimus 10 mg/day with or without&#xD;
             an endocrine agent. Patients about to receive everolimus for off label use for any&#xD;
             cancer are also eligible.&#xD;
&#xD;
          -  Not currently receiving chemotherapy or any other agent known to cause mucositis or&#xD;
             stomatitis. Trastuzumab and ovarian function suppression are allowed.&#xD;
&#xD;
          -  Any prior chemotherapy or other stomatitis/mucositis-causing therapy must be completed&#xD;
             at least 2 weeks prior to registration.&#xD;
&#xD;
          -  Not currently suffering from stomatitis/mucositis or mouth ulcers. Patients should not&#xD;
             have had any stomatitis or mouth pain for at least 7 days prior to registration.&#xD;
&#xD;
          -  Patients should not receive any other agent which would be considered treatment for&#xD;
             stomatitis or impact the primary endpoint.&#xD;
&#xD;
          -  No history of candida infection (thrush) within the last 3 months.&#xD;
&#xD;
          -  Not currently being treated with corticosteroids.&#xD;
&#xD;
          -  No uncontrolled diabetes mellitus, defined by hemoglobin A1C greater than 8%, although&#xD;
             A1C is not needed for all patients, hemoglobin (Hgb)A1C &lt; 8 is required for everyone&#xD;
             with diabetes or suspected diabetes.&#xD;
&#xD;
          -  Patients must be able to read and comprehend English. Local translation, including&#xD;
             verbal translation of professionals (PROs) is not permitted.&#xD;
&#xD;
          -  Not pregnant and not nursing, because this study involves an investigational agent&#xD;
             whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn&#xD;
             are unknown. Therefore, for women of childbearing potential only, a negative pregnancy&#xD;
             test done =&lt; 7 days prior to registration is required.&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.&#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>Kathryn Ruddy, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alabama at Birmingham Cancer Center</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35233</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kingman Regional Medical Center</name>
      <address>
        <city>Kingman</city>
        <state>Arizona</state>
        <zip>86401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Hospital Fort Smith</name>
      <address>
        <city>Fort Smith</city>
        <state>Arkansas</state>
        <zip>72903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PCR Oncology</name>
      <address>
        <city>Arroyo Grande</city>
        <state>California</state>
        <zip>93420</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Epic Care-Dublin</name>
      <address>
        <city>Dublin</city>
        <state>California</state>
        <zip>94568</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bay Area Breast Surgeons Inc</name>
      <address>
        <city>Emeryville</city>
        <state>California</state>
        <zip>94608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Epic Care Partners in Cancer Care</name>
      <address>
        <city>Emeryville</city>
        <state>California</state>
        <zip>94608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Contra Costa Regional Medical Center</name>
      <address>
        <city>Martinez</city>
        <state>California</state>
        <zip>94553-3156</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alta Bates Summit Medical Center - Summit Campus</name>
      <address>
        <city>Oakland</city>
        <state>California</state>
        <zip>94609</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bay Area Tumor Institute</name>
      <address>
        <city>Oakland</city>
        <state>California</state>
        <zip>94609</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Epic Care Cyberknife Center</name>
      <address>
        <city>Walnut Creek</city>
        <state>California</state>
        <zip>94597</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Holy Cross Hospital</name>
      <address>
        <city>Fort Lauderdale</city>
        <state>Florida</state>
        <zip>33308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Alphonsus Cancer Care Center-Boise</name>
      <address>
        <city>Boise</city>
        <state>Idaho</state>
        <zip>83706</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Alphonsus Cancer Care Center-Caldwell</name>
      <address>
        <city>Caldwell</city>
        <state>Idaho</state>
        <zip>83605</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kootenai Medical Center</name>
      <address>
        <city>Coeur d'Alene</city>
        <state>Idaho</state>
        <zip>83814</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Walter Knox Memorial Hospital</name>
      <address>
        <city>Emmett</city>
        <state>Idaho</state>
        <zip>83617</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Idaho Urologic Institute-Meridian</name>
      <address>
        <city>Meridian</city>
        <state>Idaho</state>
        <zip>83642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Alphonsus Medical Center-Nampa</name>
      <address>
        <city>Nampa</city>
        <state>Idaho</state>
        <zip>83686</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kootenai Cancer Center</name>
      <address>
        <city>Post Falls</city>
        <state>Idaho</state>
        <zip>83854</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kootenai Cancer Clinic</name>
      <address>
        <city>Sandpoint</city>
        <state>Idaho</state>
        <zip>83864</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rush - Copley Medical Center</name>
      <address>
        <city>Aurora</city>
        <state>Illinois</state>
        <zip>60504</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois CancerCare-Bloomington</name>
      <address>
        <city>Bloomington</city>
        <state>Illinois</state>
        <zip>61704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois CancerCare-Canton</name>
      <address>
        <city>Canton</city>
        <state>Illinois</state>
        <zip>61520</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Hospital of Carbondale</name>
      <address>
        <city>Carbondale</city>
        <state>Illinois</state>
        <zip>62902</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SIH Cancer Institute</name>
      <address>
        <city>Carterville</city>
        <state>Illinois</state>
        <zip>62918</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois CancerCare-Carthage</name>
      <address>
        <city>Carthage</city>
        <state>Illinois</state>
        <zip>62321</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centralia Oncology Clinic</name>
      <address>
        <city>Centralia</city>
        <state>Illinois</state>
        <zip>62801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carle on Vermilion</name>
      <address>
        <city>Danville</city>
        <state>Illinois</state>
        <zip>61832</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Care Specialists of Illinois - Decatur</name>
      <address>
        <city>Decatur</city>
        <state>Illinois</state>
        <zip>62526</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Decatur Memorial Hospital</name>
      <address>
        <city>Decatur</city>
        <state>Illinois</state>
        <zip>62526</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois CancerCare-Dixon</name>
      <address>
        <city>Dixon</city>
        <state>Illinois</state>
        <zip>61021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carle Physician Group-Effingham</name>
      <address>
        <city>Effingham</city>
        <state>Illinois</state>
        <zip>62401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Crossroads Cancer Center</name>
      <address>
        <city>Effingham</city>
        <state>Illinois</state>
        <zip>62401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois CancerCare-Eureka</name>
      <address>
        <city>Eureka</city>
        <state>Illinois</state>
        <zip>61530</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois CancerCare-Galesburg</name>
      <address>
        <city>Galesburg</city>
        <state>Illinois</state>
        <zip>61401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Western Illinois Cancer Treatment Center</name>
      <address>
        <city>Galesburg</city>
        <state>Illinois</state>
        <zip>61401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois CancerCare-Kewanee Clinic</name>
      <address>
        <city>Kewanee</city>
        <state>Illinois</state>
        <zip>61443</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois CancerCare-Macomb</name>
      <address>
        <city>Macomb</city>
        <state>Illinois</state>
        <zip>61455</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carle Physician Group-Mattoon/Charleston</name>
      <address>
        <city>Mattoon</city>
        <state>Illinois</state>
        <zip>61938</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Good Samaritan Regional Health Center</name>
      <address>
        <city>Mount Vernon</city>
        <state>Illinois</state>
        <zip>62864</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Care Center of O'Fallon</name>
      <address>
        <city>O'Fallon</city>
        <state>Illinois</state>
        <zip>62269</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois CancerCare-Ottawa Clinic</name>
      <address>
        <city>Ottawa</city>
        <state>Illinois</state>
        <zip>61350</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois CancerCare-Pekin</name>
      <address>
        <city>Pekin</city>
        <state>Illinois</state>
        <zip>61554</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois CancerCare-Peoria</name>
      <address>
        <city>Peoria</city>
        <state>Illinois</state>
        <zip>61615</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Methodist Medical Center of Illinois</name>
      <address>
        <city>Peoria</city>
        <state>Illinois</state>
        <zip>61636</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois CancerCare-Peru</name>
      <address>
        <city>Peru</city>
        <state>Illinois</state>
        <zip>61354</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Valley Radiation Oncology</name>
      <address>
        <city>Peru</city>
        <state>Illinois</state>
        <zip>61354</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois CancerCare-Princeton</name>
      <address>
        <city>Princeton</city>
        <state>Illinois</state>
        <zip>61356</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern Illinois University School of Medicine</name>
      <address>
        <city>Springfield</city>
        <state>Illinois</state>
        <zip>62702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Springfield Clinic</name>
      <address>
        <city>Springfield</city>
        <state>Illinois</state>
        <zip>62702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Medical Center</name>
      <address>
        <city>Springfield</city>
        <state>Illinois</state>
        <zip>62781</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southwest Illinois Health Services LLP</name>
      <address>
        <city>Swansea</city>
        <state>Illinois</state>
        <zip>62226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carle Cancer Center</name>
      <address>
        <city>Urbana</city>
        <state>Illinois</state>
        <zip>61801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Carle Foundation Hospital</name>
      <address>
        <city>Urbana</city>
        <state>Illinois</state>
        <zip>61801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rush-Copley Healthcare Center</name>
      <address>
        <city>Yorkville</city>
        <state>Illinois</state>
        <zip>60560</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Physicians' Clinic of Iowa PC</name>
      <address>
        <city>Cedar Rapids</city>
        <state>Iowa</state>
        <zip>52402</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Iowa Methodist Medical Center</name>
      <address>
        <city>Des Moines</city>
        <state>Iowa</state>
        <zip>50309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Oncology and Hematology Associates-Des Moines</name>
      <address>
        <city>Des Moines</city>
        <state>Iowa</state>
        <zip>50309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Broadlawns Medical Center</name>
      <address>
        <city>Des Moines</city>
        <state>Iowa</state>
        <zip>50314</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Iowa Lutheran Hospital</name>
      <address>
        <city>Des Moines</city>
        <state>Iowa</state>
        <zip>50316</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Trinity Regional Medical Center</name>
      <address>
        <city>Fort Dodge</city>
        <state>Iowa</state>
        <zip>50501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Methodist West Hospital</name>
      <address>
        <city>West Des Moines</city>
        <state>Iowa</state>
        <zip>50266-7700</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ochsner LSU Health Monroe Medical Center</name>
      <address>
        <city>Monroe</city>
        <state>Louisiana</state>
        <zip>71202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LSU Health Sciences Center at Shreveport</name>
      <address>
        <city>Shreveport</city>
        <state>Louisiana</state>
        <zip>71103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lafayette Family Cancer Center-EMMC</name>
      <address>
        <city>Brewer</city>
        <state>Maine</state>
        <zip>04412</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Medical Center</name>
      <address>
        <city>Springfield</city>
        <state>Massachusetts</state>
        <zip>01104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Joseph Mercy Hospital</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bronson Battle Creek</name>
      <address>
        <city>Battle Creek</city>
        <state>Michigan</state>
        <zip>49017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IHA Hematology Oncology Consultants-Brighton</name>
      <address>
        <city>Brighton</city>
        <state>Michigan</state>
        <zip>48114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Joseph Mercy Brighton</name>
      <address>
        <city>Brighton</city>
        <state>Michigan</state>
        <zip>48114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IHA Hematology Oncology Consultants-Canton</name>
      <address>
        <city>Canton</city>
        <state>Michigan</state>
        <zip>48188</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Joseph Mercy Canton</name>
      <address>
        <city>Canton</city>
        <state>Michigan</state>
        <zip>48188</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Caro Cancer Center</name>
      <address>
        <city>Caro</city>
        <state>Michigan</state>
        <zip>48723</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IHA Hematology Oncology Consultants-Chelsea</name>
      <address>
        <city>Chelsea</city>
        <state>Michigan</state>
        <zip>48118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Joseph Mercy Chelsea</name>
      <address>
        <city>Chelsea</city>
        <state>Michigan</state>
        <zip>48118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hematology Oncology Consultants-Clarkston</name>
      <address>
        <city>Clarkston</city>
        <state>Michigan</state>
        <zip>48346</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Newland Medical Associates-Clarkston</name>
      <address>
        <city>Clarkston</city>
        <state>Michigan</state>
        <zip>48346</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ascension Saint John Hospital</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48236</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Great Lakes Cancer Management Specialists-Doctors Park</name>
      <address>
        <city>East China Township</city>
        <state>Michigan</state>
        <zip>48054</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Genesee Cancer and Blood Disease Treatment Center</name>
      <address>
        <city>Flint</city>
        <state>Michigan</state>
        <zip>48503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Genesee Hematology Oncology PC</name>
      <address>
        <city>Flint</city>
        <state>Michigan</state>
        <zip>48503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Genesys Hurley Cancer Institute</name>
      <address>
        <city>Flint</city>
        <state>Michigan</state>
        <zip>48503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hurley Medical Center</name>
      <address>
        <city>Flint</city>
        <state>Michigan</state>
        <zip>48503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Helen DeVos Children's Hospital at Spectrum Health</name>
      <address>
        <city>Grand Rapids</city>
        <state>Michigan</state>
        <zip>49503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Health Saint Mary's</name>
      <address>
        <city>Grand Rapids</city>
        <state>Michigan</state>
        <zip>49503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spectrum Health at Butterworth Campus</name>
      <address>
        <city>Grand Rapids</city>
        <state>Michigan</state>
        <zip>49503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Academic Hematology Oncology Specialists</name>
      <address>
        <city>Grosse Pointe Woods</city>
        <state>Michigan</state>
        <zip>48236</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Great Lakes Cancer Management Specialists-Van Elslander Cancer Center</name>
      <address>
        <city>Grosse Pointe Woods</city>
        <state>Michigan</state>
        <zip>48236</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Michigan Breast Specialists-Grosse Pointe Woods</name>
      <address>
        <city>Grosse Pointe Woods</city>
        <state>Michigan</state>
        <zip>48236</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bronson Methodist Hospital</name>
      <address>
        <city>Kalamazoo</city>
        <state>Michigan</state>
        <zip>49007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Michigan Cancer Center</name>
      <address>
        <city>Kalamazoo</city>
        <state>Michigan</state>
        <zip>49007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Borgess Medical Center</name>
      <address>
        <city>Kalamazoo</city>
        <state>Michigan</state>
        <zip>49048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sparrow Hospital</name>
      <address>
        <city>Lansing</city>
        <state>Michigan</state>
        <zip>48912</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hope Cancer Clinic</name>
      <address>
        <city>Livonia</city>
        <state>Michigan</state>
        <zip>48154</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Mary Mercy Hospital</name>
      <address>
        <city>Livonia</city>
        <state>Michigan</state>
        <zip>48154</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Great Lakes Cancer Management Specialists-Macomb Medical Campus</name>
      <address>
        <city>Macomb</city>
        <state>Michigan</state>
        <zip>48044</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Michigan Breast Specialists-Macomb Township</name>
      <address>
        <city>Macomb</city>
        <state>Michigan</state>
        <zip>48044</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Mary's Oncology/Hematology Associates of Marlette</name>
      <address>
        <city>Marlette</city>
        <state>Michigan</state>
        <zip>48453</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Health Mercy Campus</name>
      <address>
        <city>Muskegon</city>
        <state>Michigan</state>
        <zip>49444</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lakeland Hospital Niles</name>
      <address>
        <city>Niles</city>
        <state>Michigan</state>
        <zip>49120</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer and Hematology Centers of Western Michigan - Norton Shores</name>
      <address>
        <city>Norton Shores</city>
        <state>Michigan</state>
        <zip>49444</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>21st Century Oncology-Pontiac</name>
      <address>
        <city>Pontiac</city>
        <state>Michigan</state>
        <zip>48341</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hope Cancer Center</name>
      <address>
        <city>Pontiac</city>
        <state>Michigan</state>
        <zip>48341</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Newland Medical Associates-Pontiac</name>
      <address>
        <city>Pontiac</city>
        <state>Michigan</state>
        <zip>48341</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Joseph Mercy Oakland</name>
      <address>
        <city>Pontiac</city>
        <state>Michigan</state>
        <zip>48341</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Huron Medical Center PC</name>
      <address>
        <city>Port Huron</city>
        <state>Michigan</state>
        <zip>48060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lake Huron Medical Center</name>
      <address>
        <city>Port Huron</city>
        <state>Michigan</state>
        <zip>48060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spectrum Health Reed City Hospital</name>
      <address>
        <city>Reed City</city>
        <state>Michigan</state>
        <zip>49677</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Great Lakes Cancer Management Specialists-Rochester Hills</name>
      <address>
        <city>Rochester Hills</city>
        <state>Michigan</state>
        <zip>48309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ascension Saint Mary's Hospital</name>
      <address>
        <city>Saginaw</city>
        <state>Michigan</state>
        <zip>48601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oncology Hematology Associates of Saginaw Valley PC</name>
      <address>
        <city>Saginaw</city>
        <state>Michigan</state>
        <zip>48604</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lakeland Medical Center Saint Joseph</name>
      <address>
        <city>Saint Joseph</city>
        <state>Michigan</state>
        <zip>49085</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marie Yeager Cancer Center</name>
      <address>
        <city>Saint Joseph</city>
        <state>Michigan</state>
        <zip>49085</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bhadresh Nayak MD PC-Sterling Heights</name>
      <address>
        <city>Sterling Heights</city>
        <state>Michigan</state>
        <zip>48312</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ascension Saint Joseph Hospital</name>
      <address>
        <city>Tawas City</city>
        <state>Michigan</state>
        <zip>48764</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Munson Medical Center</name>
      <address>
        <city>Traverse City</city>
        <state>Michigan</state>
        <zip>49684</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Breast Care Center PLLC</name>
      <address>
        <city>Warren</city>
        <state>Michigan</state>
        <zip>48088</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Great Lakes Cancer Management Specialists-Macomb Professional Building</name>
      <address>
        <city>Warren</city>
        <state>Michigan</state>
        <zip>48093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Macomb Hematology Oncology PC</name>
      <address>
        <city>Warren</city>
        <state>Michigan</state>
        <zip>48093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Michigan Breast Specialists-Warren</name>
      <address>
        <city>Warren</city>
        <state>Michigan</state>
        <zip>48093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint John Macomb-Oakland Hospital</name>
      <address>
        <city>Warren</city>
        <state>Michigan</state>
        <zip>48093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Mary's Oncology/Hematology Associates of West Branch</name>
      <address>
        <city>West Branch</city>
        <state>Michigan</state>
        <zip>48661</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Metro Health Hospital</name>
      <address>
        <city>Wyoming</city>
        <state>Michigan</state>
        <zip>49519</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Huron Gastroenterology PC</name>
      <address>
        <city>Ypsilanti</city>
        <state>Michigan</state>
        <zip>48106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IHA Hematology Oncology Consultants-Ann Arbor</name>
      <address>
        <city>Ypsilanti</city>
        <state>Michigan</state>
        <zip>48197</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanford Joe Lueken Cancer Center</name>
      <address>
        <city>Bemidji</city>
        <state>Minnesota</state>
        <zip>56601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fairview Ridges Hospital</name>
      <address>
        <city>Burnsville</city>
        <state>Minnesota</state>
        <zip>55337</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cambridge Medical Center</name>
      <address>
        <city>Cambridge</city>
        <state>Minnesota</state>
        <zip>55008</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Hospital</name>
      <address>
        <city>Coon Rapids</city>
        <state>Minnesota</state>
        <zip>55433</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fairview Southdale Hospital</name>
      <address>
        <city>Edina</city>
        <state>Minnesota</state>
        <zip>55435</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unity Hospital</name>
      <address>
        <city>Fridley</city>
        <state>Minnesota</state>
        <zip>55432</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fairview Clinics and Surgery Center Maple Grove</name>
      <address>
        <city>Maple Grove</city>
        <state>Minnesota</state>
        <zip>55369</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Minnesota Oncology Hematology PA-Maplewood</name>
      <address>
        <city>Maplewood</city>
        <state>Minnesota</state>
        <zip>55109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint John's Hospital - Healtheast</name>
      <address>
        <city>Maplewood</city>
        <state>Minnesota</state>
        <zip>55109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Abbott-Northwestern Hospital</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55407</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hennepin County Medical Center</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55415</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Health Partners Inc</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55454</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Monticello Cancer Center</name>
      <address>
        <city>Monticello</city>
        <state>Minnesota</state>
        <zip>55362</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Ulm Medical Center</name>
      <address>
        <city>New Ulm</city>
        <state>Minnesota</state>
        <zip>56073</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fairview Northland Medical Center</name>
      <address>
        <city>Princeton</city>
        <state>Minnesota</state>
        <zip>55371</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Memorial Medical Health Center</name>
      <address>
        <city>Robbinsdale</city>
        <state>Minnesota</state>
        <zip>55422</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Park Nicollet Clinic - Saint Louis Park</name>
      <address>
        <city>Saint Louis Park</city>
        <state>Minnesota</state>
        <zip>55416</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regions Hospital</name>
      <address>
        <city>Saint Paul</city>
        <state>Minnesota</state>
        <zip>55101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>United Hospital</name>
      <address>
        <city>Saint Paul</city>
        <state>Minnesota</state>
        <zip>55102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Francis Regional Medical Center</name>
      <address>
        <city>Shakopee</city>
        <state>Minnesota</state>
        <zip>55379</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lakeview Hospital</name>
      <address>
        <city>Stillwater</city>
        <state>Minnesota</state>
        <zip>55082</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanford Thief River Falls Medical Center</name>
      <address>
        <city>Thief River Falls</city>
        <state>Minnesota</state>
        <zip>56701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ridgeview Medical Center</name>
      <address>
        <city>Waconia</city>
        <state>Minnesota</state>
        <zip>55387</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rice Memorial Hospital</name>
      <address>
        <city>Willmar</city>
        <state>Minnesota</state>
        <zip>56201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Minnesota Oncology Hematology PA-Woodbury</name>
      <address>
        <city>Woodbury</city>
        <state>Minnesota</state>
        <zip>55125</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanford Cancer Center Worthington</name>
      <address>
        <city>Worthington</city>
        <state>Minnesota</state>
        <zip>56187</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fairview Lakes Medical Center</name>
      <address>
        <city>Wyoming</city>
        <state>Minnesota</state>
        <zip>55092</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Louis Cancer and Breast Institute-Ballwin</name>
      <address>
        <city>Ballwin</city>
        <state>Missouri</state>
        <zip>63011</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Parkland Health Center-Bonne Terre</name>
      <address>
        <city>Bonne Terre</city>
        <state>Missouri</state>
        <zip>63628</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cox Cancer Center Branson</name>
      <address>
        <city>Branson</city>
        <state>Missouri</state>
        <zip>65616</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Francis Medical Center</name>
      <address>
        <city>Cape Girardeau</city>
        <state>Missouri</state>
        <zip>63703</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southeast Cancer Center</name>
      <address>
        <city>Cape Girardeau</city>
        <state>Missouri</state>
        <zip>63703</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Siteman Cancer Center at West County Hospital</name>
      <address>
        <city>Creve Coeur</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Parkland Health Center - Farmington</name>
      <address>
        <city>Farmington</city>
        <state>Missouri</state>
        <zip>63640</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Capital Region Southwest Campus</name>
      <address>
        <city>Jefferson City</city>
        <state>Missouri</state>
        <zip>65109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Freeman Health System</name>
      <address>
        <city>Joplin</city>
        <state>Missouri</state>
        <zip>64804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Hospital Joplin</name>
      <address>
        <city>Joplin</city>
        <state>Missouri</state>
        <zip>64804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Delbert Day Cancer Institute at PCRMC</name>
      <address>
        <city>Rolla</city>
        <state>Missouri</state>
        <zip>65401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Clinic-Rolla-Cancer and Hematology</name>
      <address>
        <city>Rolla</city>
        <state>Missouri</state>
        <zip>65401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heartland Regional Medical Center</name>
      <address>
        <city>Saint Joseph</city>
        <state>Missouri</state>
        <zip>64506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Louis Cancer and Breast Institute-South City</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Hospital South</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Siteman Cancer Center-South County</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63129</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Missouri Baptist Medical Center</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Siteman Cancer Center at Christian Hospital</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Hospital Saint Louis</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Siteman Cancer Center at Saint Peters Hospital</name>
      <address>
        <city>Saint Peters</city>
        <state>Missouri</state>
        <zip>63376</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sainte Genevieve County Memorial Hospital</name>
      <address>
        <city>Sainte Genevieve</city>
        <state>Missouri</state>
        <zip>63670</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Hospital Springfield</name>
      <address>
        <city>Springfield</city>
        <state>Missouri</state>
        <zip>65804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CoxHealth South Hospital</name>
      <address>
        <city>Springfield</city>
        <state>Missouri</state>
        <zip>65807</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Missouri Baptist Sullivan Hospital</name>
      <address>
        <city>Sullivan</city>
        <state>Missouri</state>
        <zip>63080</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Missouri Baptist Outpatient Center-Sunset Hills</name>
      <address>
        <city>Sunset Hills</city>
        <state>Missouri</state>
        <zip>63127</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Hospital Washington</name>
      <address>
        <city>Washington</city>
        <state>Missouri</state>
        <zip>63090</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Community Hospital of Anaconda</name>
      <address>
        <city>Anaconda</city>
        <state>Montana</state>
        <zip>59711</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Billings Clinic Cancer Center</name>
      <address>
        <city>Billings</city>
        <state>Montana</state>
        <zip>59101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bozeman Deaconess Hospital</name>
      <address>
        <city>Bozeman</city>
        <state>Montana</state>
        <zip>59715</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Benefis Healthcare- Sletten Cancer Institute</name>
      <address>
        <city>Great Falls</city>
        <state>Montana</state>
        <zip>59405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Great Falls Clinic</name>
      <address>
        <city>Great Falls</city>
        <state>Montana</state>
        <zip>59405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Peter's Community Hospital</name>
      <address>
        <city>Helena</city>
        <state>Montana</state>
        <zip>59601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kalispell Regional Medical Center</name>
      <address>
        <city>Kalispell</city>
        <state>Montana</state>
        <zip>59901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Community Medical Hospital</name>
      <address>
        <city>Missoula</city>
        <state>Montana</state>
        <zip>59804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nebraska Hematology and Oncology</name>
      <address>
        <city>Lincoln</city>
        <state>Nebraska</state>
        <zip>68506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southeast Nebraska Cancer Center - 68th Street Place</name>
      <address>
        <city>Lincoln</city>
        <state>Nebraska</state>
        <zip>68516</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Faith Regional Health Services Carson Cancer Center</name>
      <address>
        <city>Norfolk</city>
        <state>Nebraska</state>
        <zip>68701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Great Plains Health Callahan Cancer Center</name>
      <address>
        <city>North Platte</city>
        <state>Nebraska</state>
        <zip>69101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nebraska Cancer Specialists - Omaha</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oncology Hematology West PC</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regional West Medical Center Cancer Center</name>
      <address>
        <city>Scottsbluff</city>
        <state>Nebraska</state>
        <zip>69361</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carson Tahoe Regional Medical Center</name>
      <address>
        <city>Carson City</city>
        <state>Nevada</state>
        <zip>89703</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer and Blood Specialists-Henderson</name>
      <address>
        <city>Henderson</city>
        <state>Nevada</state>
        <zip>89052</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Comprehensive Cancer Centers of Nevada - Henderson</name>
      <address>
        <city>Henderson</city>
        <state>Nevada</state>
        <zip>89052</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Comprehensive Cancer Centers of Nevada-Horizon Ridge</name>
      <address>
        <city>Henderson</city>
        <state>Nevada</state>
        <zip>89052</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Las Vegas Cancer Center-Henderson</name>
      <address>
        <city>Henderson</city>
        <state>Nevada</state>
        <zip>89052</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OptumCare Cancer Care at Seven Hills</name>
      <address>
        <city>Henderson</city>
        <state>Nevada</state>
        <zip>89052</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>21st Century Oncology-Henderson</name>
      <address>
        <city>Henderson</city>
        <state>Nevada</state>
        <zip>89074</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Comprehensive Cancer Centers of Nevada-Southeast Henderson</name>
      <address>
        <city>Henderson</city>
        <state>Nevada</state>
        <zip>89074</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Las Vegas Urology - Green Valley</name>
      <address>
        <city>Henderson</city>
        <state>Nevada</state>
        <zip>89074</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Las Vegas Urology - Pebble</name>
      <address>
        <city>Henderson</city>
        <state>Nevada</state>
        <zip>89074</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Urology Specialists of Nevada - Green Valley</name>
      <address>
        <city>Henderson</city>
        <state>Nevada</state>
        <zip>89074</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Las Vegas Urology - Pecos</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89074</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Desert West Surgery</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OptumCare Cancer Care at Oakey</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Medical Center of Southern Nevada</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hope Cancer Care of Nevada</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer and Blood Specialists-Shadow</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radiation Oncology Centers of Nevada Central</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Urology Specialists of Nevada - Central</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>21st Century Oncology</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunrise Hospital and Medical Center</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HealthCare Partners Medical Group Oncology/Hematology-San Martin</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89113</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Las Vegas Prostate Cancer Center</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89113</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Las Vegas Urology - Sunset</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89113</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radiation Oncology Centers of Nevada Southeast</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>21st Century Oncology-Vegas Tenaya</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ann M Wierman MD LTD</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer and Blood Specialists-Tenaya</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Comprehensive Cancer Centers of Nevada - Northwest</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HealthCare Partners Medical Group Oncology/Hematology-Tenaya</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Las Vegas Urology - Cathedral Rock</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Las Vegas Urology - Smoke Ranch</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OptumCare Cancer Care at MountainView</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Urology Specialists of Nevada - Northwest</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alliance for Childhood Diseases/Cure 4 the Kids Foundation</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89135</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Comprehensive Cancer Centers of Nevada - Town Center</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Comprehensive Cancer Centers of Nevada-Summerlin</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Summerlin Hospital Medical Center</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Las Vegas Cancer Center-Medical Center</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89148-2405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>21st Century Oncology-Fort Apache</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89148</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Comprehensive Cancer Centers of Nevada</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89148</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OptumCare Cancer Care at Fort Apache</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89148</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Urology Specialists of Nevada - Southwest</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89148</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89149</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Comprehensive Cancer Centers of Nevada - Central Valley</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89169</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Cancer Center</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89169</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hope Cancer Care of Nevada-Pahrump</name>
      <address>
        <city>Pahrump</city>
        <state>Nevada</state>
        <zip>89048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Renown Regional Medical Center</name>
      <address>
        <city>Reno</city>
        <state>Nevada</state>
        <zip>89502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Mary's Regional Medical Center</name>
      <address>
        <city>Reno</city>
        <state>Nevada</state>
        <zip>89503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radiation Oncology Associates</name>
      <address>
        <city>Reno</city>
        <state>Nevada</state>
        <zip>89509</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Hampshire Oncology Hematology PA-Concord</name>
      <address>
        <city>Concord</city>
        <state>New Hampshire</state>
        <zip>03301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Solinsky Center for Cancer Care</name>
      <address>
        <city>Manchester</city>
        <state>New Hampshire</state>
        <zip>03103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virtua Samson Cancer Center</name>
      <address>
        <city>Moorestown</city>
        <state>New Jersey</state>
        <zip>08057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virtua Memorial</name>
      <address>
        <city>Mount Holly</city>
        <state>New Jersey</state>
        <zip>08060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virtua Voorhees</name>
      <address>
        <city>Voorhees</city>
        <state>New Jersey</state>
        <zip>08043</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hematology Oncology Associates of Central New York-Auburn</name>
      <address>
        <city>Auburn</city>
        <state>New York</state>
        <zip>13021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hematology Oncology Associates of Central New York-East Syracuse</name>
      <address>
        <city>East Syracuse</city>
        <state>New York</state>
        <zip>13057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hematology Oncology Associates of Central New York-Onondaga Hill</name>
      <address>
        <city>Syracuse</city>
        <state>New York</state>
        <zip>13215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CaroMont Regional Medical Center</name>
      <address>
        <city>Gastonia</city>
        <state>North Carolina</state>
        <zip>28054</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanford Bismarck Medical Center</name>
      <address>
        <city>Bismarck</city>
        <state>North Dakota</state>
        <zip>58501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanford South University Medical Center</name>
      <address>
        <city>Fargo</city>
        <state>North Dakota</state>
        <zip>58103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southpointe-Sanford Medical Center Fargo</name>
      <address>
        <city>Fargo</city>
        <state>North Dakota</state>
        <zip>58103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanford Medical Center Fargo</name>
      <address>
        <city>Fargo</city>
        <state>North Dakota</state>
        <zip>58104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanford Broadway Medical Center</name>
      <address>
        <city>Fargo</city>
        <state>North Dakota</state>
        <zip>58122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanford Roger Maris Cancer Center</name>
      <address>
        <city>Fargo</city>
        <state>North Dakota</state>
        <zip>58122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Altru Cancer Center</name>
      <address>
        <city>Grand Forks</city>
        <state>North Dakota</state>
        <zip>58201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Strecker Cancer Center-Belpre</name>
      <address>
        <city>Belpre</city>
        <state>Ohio</state>
        <zip>45714</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Adena Regional Medical Center</name>
      <address>
        <city>Chillicothe</city>
        <state>Ohio</state>
        <zip>45601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Carmel East Hospital</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbus Oncology and Hematology Associates Inc</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43214</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Riverside Methodist Hospital</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43214</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Grant Medical Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Mark H Zangmeister Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Carmel Health Center West</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43222</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Doctors Hospital</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43228</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Delaware Health Center-Grady Cancer Center</name>
      <address>
        <city>Delaware</city>
        <state>Ohio</state>
        <zip>43015</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Grady Memorial Hospital</name>
      <address>
        <city>Delaware</city>
        <state>Ohio</state>
        <zip>43015</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dublin Methodist Hospital</name>
      <address>
        <city>Dublin</city>
        <state>Ohio</state>
        <zip>43016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Ohio Breast and Endocrine Surgery</name>
      <address>
        <city>Gahanna</city>
        <state>Ohio</state>
        <zip>43230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Carmel Grove City Hospital</name>
      <address>
        <city>Grove City</city>
        <state>Ohio</state>
        <zip>43123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fairfield Medical Center</name>
      <address>
        <city>Lancaster</city>
        <state>Ohio</state>
        <zip>43130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OhioHealth Mansfield Hospital</name>
      <address>
        <city>Mansfield</city>
        <state>Ohio</state>
        <zip>44903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marietta Memorial Hospital</name>
      <address>
        <city>Marietta</city>
        <state>Ohio</state>
        <zip>45750</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OhioHealth Marion General Hospital</name>
      <address>
        <city>Marion</city>
        <state>Ohio</state>
        <zip>43302</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Knox Community Hospital</name>
      <address>
        <city>Mount Vernon</city>
        <state>Ohio</state>
        <zip>43050</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Licking Memorial Hospital</name>
      <address>
        <city>Newark</city>
        <state>Ohio</state>
        <zip>43055</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Newark Radiation Oncology</name>
      <address>
        <city>Newark</city>
        <state>Ohio</state>
        <zip>43055</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern Ohio Medical Center</name>
      <address>
        <city>Portsmouth</city>
        <state>Ohio</state>
        <zip>45662</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Ann's Hospital</name>
      <address>
        <city>Westerville</city>
        <state>Ohio</state>
        <zip>43081</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Genesis Healthcare System Cancer Care Center</name>
      <address>
        <city>Zanesville</city>
        <state>Ohio</state>
        <zip>43701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Hospital Oklahoma City</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73120</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Alphonsus Medical Center-Baker City</name>
      <address>
        <city>Baker City</city>
        <state>Oregon</state>
        <zip>97814</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Legacy Mount Hood Medical Center</name>
      <address>
        <city>Gresham</city>
        <state>Oregon</state>
        <zip>97030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Alphonsus Medical Center-Ontario</name>
      <address>
        <city>Ontario</city>
        <state>Oregon</state>
        <zip>97914</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Legacy Good Samaritan Hospital and Medical Center</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Legacy Meridian Park Hospital</name>
      <address>
        <city>Tualatin</city>
        <state>Oregon</state>
        <zip>97062</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lehigh Valley Hospital-Cedar Crest</name>
      <address>
        <city>Allentown</city>
        <state>Pennsylvania</state>
        <zip>18103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lehigh Valley Hospital - Muhlenberg</name>
      <address>
        <city>Bethlehem</city>
        <state>Pennsylvania</state>
        <zip>18017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pocono Medical Center</name>
      <address>
        <city>East Stroudsburg</city>
        <state>Pennsylvania</state>
        <zip>18301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lehigh Valley Hospital-Hazleton</name>
      <address>
        <city>Hazleton</city>
        <state>Pennsylvania</state>
        <zip>18201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Self Regional Healthcare</name>
      <address>
        <city>Greenwood</city>
        <state>South Carolina</state>
        <zip>29646</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanford Cancer Center Oncology Clinic</name>
      <address>
        <city>Sioux Falls</city>
        <state>South Dakota</state>
        <zip>57104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanford USD Medical Center - Sioux Falls</name>
      <address>
        <city>Sioux Falls</city>
        <state>South Dakota</state>
        <zip>57117-5134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Overlake Medical Center</name>
      <address>
        <city>Bellevue</city>
        <state>Washington</state>
        <zip>98004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Valley Medical Center</name>
      <address>
        <city>Renton</city>
        <state>Washington</state>
        <zip>98055</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Legacy Cancer Institute Medical Oncology and Day Treatment</name>
      <address>
        <city>Vancouver</city>
        <state>Washington</state>
        <zip>98684</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Legacy Salmon Creek Hospital</name>
      <address>
        <city>Vancouver</city>
        <state>Washington</state>
        <zip>98686</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marshfield Clinic-Chippewa Center</name>
      <address>
        <city>Chippewa Falls</city>
        <state>Wisconsin</state>
        <zip>54729</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marshfield Medical Center-EC Cancer Center</name>
      <address>
        <city>Eau Claire</city>
        <state>Wisconsin</state>
        <zip>54701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic Health System-Eau Claire Clinic</name>
      <address>
        <city>Eau Claire</city>
        <state>Wisconsin</state>
        <zip>54701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic Health System Eau Claire Hospital-Luther Campus</name>
      <address>
        <city>Eau Claire</city>
        <state>Wisconsin</state>
        <zip>54703</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic Health System-Franciscan Healthcare</name>
      <address>
        <city>La Crosse</city>
        <state>Wisconsin</state>
        <zip>54601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marshfield Clinic - Ladysmith Center</name>
      <address>
        <city>Ladysmith</city>
        <state>Wisconsin</state>
        <zip>54848</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marshfield Medical Center-Marshfield</name>
      <address>
        <city>Marshfield</city>
        <state>Wisconsin</state>
        <zip>54449</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marshfield Clinic-Minocqua Center</name>
      <address>
        <city>Minocqua</city>
        <state>Wisconsin</state>
        <zip>54548</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Center of Western Wisconsin</name>
      <address>
        <city>New Richmond</city>
        <state>Wisconsin</state>
        <zip>54017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marshfield Medical Center-Rice Lake</name>
      <address>
        <city>Rice Lake</city>
        <state>Wisconsin</state>
        <zip>54868</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marshfield Clinic Stevens Point Center</name>
      <address>
        <city>Stevens Point</city>
        <state>Wisconsin</state>
        <zip>54482</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marshfield Clinic-Wausau Center</name>
      <address>
        <city>Wausau</city>
        <state>Wisconsin</state>
        <zip>54401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marshfield Clinic - Weston Center</name>
      <address>
        <city>Weston</city>
        <state>Wisconsin</state>
        <zip>54476</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marshfield Clinic - Wisconsin Rapids Center</name>
      <address>
        <city>Wisconsin Rapids</city>
        <state>Wisconsin</state>
        <zip>54494</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Billings Clinic-Cody</name>
      <address>
        <city>Cody</city>
        <state>Wyoming</state>
        <zip>82414</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Welch Cancer Center</name>
      <address>
        <city>Sheridan</city>
        <state>Wyoming</state>
        <zip>82801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>February 6, 2019</study_first_submitted>
  <study_first_submitted_qc>February 12, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <results_first_submitted>March 3, 2022</results_first_submitted>
  <results_first_submitted_qc>July 7, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">August 1, 2022</results_first_posted>
  <last_update_submitted>July 7, 2022</last_update_submitted>
  <last_update_submitted_qc>July 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Stomatitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
    <mesh_term>Everolimus</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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>August 14, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/40/NCT03839940/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Group I (Dexamethasone)</title>
          <description>Patients receive 10mg oral everolimus daily as standard of care and 10ml dexamethasone oral mouthwash, swished for 2-minutes daily, for 8 weeks.&#xD;
Dexamethasone: Given as mouthwash&#xD;
Questionnaire: Ancillary studies&#xD;
Quality-of-Life Assessment: Ancillary studies&#xD;
Everolimus: Standard of care</description>
        </group>
        <group group_id="P2">
          <title>Group II (Placebo)</title>
          <description>Patients receive 10mg oral everolimus daily as standard of care and 10ml placebo oral mouthwash, swished for 2-minutes daily, for 8 weeks.&#xD;
Placebo: Given as mouthwash&#xD;
Questionnaire: Ancillary studies&#xD;
Quality-of-Life Assessment: Ancillary studies&#xD;
Everolimus: Standard of care</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>No Post-Baseline Pain Score Data</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Group I (Dexamethasone)</title>
          <description>Patients receive 10mg oral everolimus daily as standard of care and 10ml dexamethasone oral mouthwash, swished for 2-minutes daily, for 8 weeks.&#xD;
Dexamethasone: Given as mouthwash&#xD;
Questionnaire: Ancillary studies&#xD;
Quality-of-Life Assessment: Ancillary studies&#xD;
Everolimus: Standard of care</description>
        </group>
        <group group_id="B2">
          <title>Group II (Placebo)</title>
          <description>Patients receive 10mg oral everolimus daily as standard of care and 10ml placebo oral mouthwash, swished for 2-minutes daily, for 8 weeks.&#xD;
Placebo: Given as mouthwash&#xD;
Questionnaire: Ancillary studies&#xD;
Quality-of-Life Assessment: Ancillary studies&#xD;
Everolimus: Standard of care</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="16"/>
            <count group_id="B2" value="17"/>
            <count group_id="B3" value="33"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="65.3" spread="10.71"/>
                    <measurement group_id="B2" value="65.3" spread="8.46"/>
                    <measurement group_id="B3" value="65.3" spread="9.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Age group</title>
              <category_list>
                <category>
                  <title>&lt;50 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>50 - 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="16"/>
                  </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="12"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Cancer Type</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Breast</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>ECOG Performance Status</title>
          <description>ECOG = 0: Fully active, able to carry on all pre-disease performance without restriction.&#xD;
ECOG = 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.&#xD;
ECOG = 2: Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours.&#xD;
ECOG = 0 is better. ECOG = 2 is worse.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>0</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>1</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Continuous Patient Reported Mouth-Pain Score</title>
          <description>Pain scale from 1-10. 1 is better and 10 is worse.</description>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0" spread="0"/>
                    <measurement group_id="B2" value="0.1" spread="0.24"/>
                    <measurement group_id="B3" value="0.03" spread="0.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Discrete Patient Reported Mouth-Pain Score</title>
          <description>Mouth-Pain score = 0: Patient has no pain in their mouth. Mouth-Pain score &gt; 0: Patient has pain in their mouth. Mouth-Pain score = 0 is better. Mouth-Pain score &gt; 0 is worse.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>= 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt; 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Incidence Rate of the mTOR Inhibitor-associated Stomatitis (mIAS)-Related Pain Based on Daily Self-reports Via the Numerical Analogue Scale</title>
        <description>The numerical analogue mouth pain score (NAMPS) is a single item measured on a 0 to 10 scale, with 0 corresponding to &quot;No pain&quot; and 10 corresponding to &quot;Pain as bad as it can be.&quot; Will compare the incidence rate of any mouth pain (i.e., any score greater than 0) as assessed by the NAMPS between the prevention versus early treatment approaches using a Chi-square test.</description>
        <time_frame>Up to 8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group I (Dexamethasone)</title>
            <description>Patients receive 10mg oral everolimus daily as standard of care and 10ml dexamethasone oral mouthwash, swished for 2-minutes daily, for 8 weeks.&#xD;
Dexamethasone: Given as mouthwash&#xD;
Questionnaire: Ancillary studies&#xD;
Quality-of-Life Assessment: Ancillary studies&#xD;
Everolimus: Standard of care</description>
          </group>
          <group group_id="O2">
            <title>Group II (Placebo)</title>
            <description>Patients receive 10mg oral everolimus daily as standard of care and 10ml placebo oral mouthwash, swished for 2-minutes daily, for 8 weeks.&#xD;
Placebo: Given as mouthwash&#xD;
Questionnaire: Ancillary studies&#xD;
Quality-of-Life Assessment: Ancillary studies&#xD;
Everolimus: Standard of care</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence Rate of the mTOR Inhibitor-associated Stomatitis (mIAS)-Related Pain Based on Daily Self-reports Via the Numerical Analogue Scale</title>
          <description>The numerical analogue mouth pain score (NAMPS) is a single item measured on a 0 to 10 scale, with 0 corresponding to &quot;No pain&quot; and 10 corresponding to &quot;Pain as bad as it can be.&quot; Will compare the incidence rate of any mouth pain (i.e., any score greater than 0) as assessed by the NAMPS between the prevention versus early treatment approaches using a Chi-square test.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>No Pain</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Pain</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.9999</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Severity of Mouth Pain Scores</title>
        <description>Average Area Under the Curve per assessment (aAUCpa) of mouth pain scores as measured by NAMPS will be computed for each patient to summarize the sequence of numerical analogue mouth pain scores over the eight week study period. Scores are reported on a 0-100 scale, where 100 = better outcome QOL (i.e. less pain). The aAUCpa is the average of each AUC between each sequential assessment from treatment-initiation to the end of the treatment at 8 weeks post-treatment-initiation and will be compared between the two treatment arms.</description>
        <time_frame>Up to 8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group I (Dexamethasone)</title>
            <description>Patients receive 10mg oral everolimus daily as standard of care and 10ml dexamethasone oral mouthwash, swished for 2-minutes daily, for 8 weeks.&#xD;
&gt;&gt;&#xD;
&gt;&gt; Dexamethasone: Given as mouthwash&#xD;
&gt;&gt;&#xD;
&gt;&gt; Questionnaire: Ancillary studies&#xD;
&gt;&gt;&#xD;
&gt;&gt; Quality-of-Life Assessment: Ancillary studies&#xD;
&gt;&gt;&#xD;
&gt;&gt; Everolimus: Standard of care</description>
          </group>
          <group group_id="O2">
            <title>Group II (Placebo)</title>
            <description>Patients receive 10mg oral everolimus daily as standard of care and 10ml placebo oral mouthwash, swished for 2-minutes daily, for 8 weeks.&#xD;
&gt;&gt;&#xD;
&gt;&gt; Placebo: Given as mouthwash&#xD;
&gt;&gt;&#xD;
&gt;&gt; Questionnaire: Ancillary studies&#xD;
&gt;&gt;&#xD;
&gt;&gt; Quality-of-Life Assessment: Ancillary studies&#xD;
&gt;&gt;&#xD;
&gt;&gt; Everolimus: Standard of care</description>
          </group>
        </group_list>
        <measure>
          <title>Severity of Mouth Pain Scores</title>
          <description>Average Area Under the Curve per assessment (aAUCpa) of mouth pain scores as measured by NAMPS will be computed for each patient to summarize the sequence of numerical analogue mouth pain scores over the eight week study period. Scores are reported on a 0-100 scale, where 100 = better outcome QOL (i.e. less pain). The aAUCpa is the average of each AUC between each sequential assessment from treatment-initiation to the end of the treatment at 8 weeks post-treatment-initiation and will be compared between the two treatment arms.</description>
          <units>scores on scale * days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.3" spread="14.83"/>
                    <measurement group_id="O2" value="4.6" spread="6.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3346</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence of Grade &gt; 2 mIAS as Measured by the SWISH Trial</title>
        <description>Original plan for collecting and analyzing this data did not occur due to study termination.&#xD;
Grade 2 mIAS is defined as having at least one of the following criteria:&gt;&#xD;
Oral intake assessed at 50 on the Normalcy of Diet Scale&#xD;
Patient's reported oral pain (using visual analogue scale 0-10) that meets one of the following: rating of 7 on two consecutive days rating of 8, 9, or 10 on any one day. The incidence of grade 2 mIAS for each treatment arm will be compared by a Chi-square test.</description>
        <time_frame>Up to 8 weeks</time_frame>
        <population>Original plan for collecting and analyzing this data did not occur due to study termination.</population>
        <group_list>
          <group group_id="O1">
            <title>Group I (Dexamethasone)</title>
            <description>Patients receive 10mg oral everolimus daily as standard of care and 10ml dexamethasone oral mouthwash, swished for 2-minutes daily, for 8 weeks.&#xD;
Dexamethasone: Given as mouthwash&#xD;
Questionnaire: Ancillary studies&#xD;
Quality-of-Life Assessment: Ancillary studies&#xD;
Everolimus: Standard of care</description>
          </group>
          <group group_id="O2">
            <title>Group II (Placebo)</title>
            <description>Patients receive 10mg oral everolimus daily as standard of care and 10ml placebo oral mouthwash, swished for 2-minutes daily, for 8 weeks.&#xD;
Placebo: Given as mouthwash&#xD;
Questionnaire: Ancillary studies&#xD;
Quality-of-Life Assessment: Ancillary studies&#xD;
Everolimus: Standard of care</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Grade &gt; 2 mIAS as Measured by the SWISH Trial</title>
          <description>Original plan for collecting and analyzing this data did not occur due to study termination.&#xD;
Grade 2 mIAS is defined as having at least one of the following criteria:&gt;&#xD;
Oral intake assessed at 50 on the Normalcy of Diet Scale&#xD;
Patient's reported oral pain (using visual analogue scale 0-10) that meets one of the following: rating of 7 on two consecutive days rating of 8, 9, or 10 on any one day. The incidence of grade 2 mIAS for each treatment arm will be compared by a Chi-square test.</description>
          <population>Original plan for collecting and analyzing this data did not occur due to study termination.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence of Mouth Pain</title>
        <description>Original plan for collecting and analyzing this data did not occur due to study termination.&#xD;
Will determine if the initiation of dexamethasone at the start of everolimus is associated with the incidence and of mild (score of 1-3), moderate (score of 4-6) and severe (score of 7-10) mouth pain as measured by the NAMPS. Will be assessed by Chi-square tests.</description>
        <time_frame>Up to 8 weeks</time_frame>
        <population>Original plan for collecting and analyzing this data did not occur due to study termination.</population>
        <group_list>
          <group group_id="O1">
            <title>Group I (Dexamethasone)</title>
            <description>Patients receive 10mg oral everolimus daily as standard of care and 10ml dexamethasone oral mouthwash, swished for 2-minutes daily, for 8 weeks.&#xD;
Dexamethasone: Given as mouthwash&#xD;
Questionnaire: Ancillary studies&#xD;
Quality-of-Life Assessment: Ancillary studies&#xD;
Everolimus: Standard of care</description>
          </group>
          <group group_id="O2">
            <title>Group II (Placebo)</title>
            <description>Patients receive 10mg oral everolimus daily as standard of care and 10ml placebo oral mouthwash, swished for 2-minutes daily, for 8 weeks.&#xD;
Placebo: Given as mouthwash&#xD;
Questionnaire: Ancillary studies&#xD;
Quality-of-Life Assessment: Ancillary studies&#xD;
Everolimus: Standard of care</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Mouth Pain</title>
          <description>Original plan for collecting and analyzing this data did not occur due to study termination.&#xD;
Will determine if the initiation of dexamethasone at the start of everolimus is associated with the incidence and of mild (score of 1-3), moderate (score of 4-6) and severe (score of 7-10) mouth pain as measured by the NAMPS. Will be assessed by Chi-square tests.</description>
          <population>Original plan for collecting and analyzing this data did not occur due to study termination.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Development of Mouth Pain</title>
        <description>Original plan for collecting and analyzing this data did not occur due to study termination.&#xD;
Will determine if the initiation of dexamethasone at the start of everolimus is associated with the time to development of mild (score of 1-3), moderate (score of 4-6) and severe (score of 7-10) mouth pain as measured by the NAMPS. Will be assessed by Kaplan-Meier and cumulative incidence curves.</description>
        <time_frame>Up to 8 weeks</time_frame>
        <population>Original plan for collecting and analyzing this data did not occur due to study termination.</population>
        <group_list>
          <group group_id="O1">
            <title>Group I (Dexamethasone)</title>
            <description>Patients receive 10mg oral everolimus daily as standard of care and 10ml dexamethasone oral mouthwash, swished for 2-minutes daily, for 8 weeks.&#xD;
Dexamethasone: Given as mouthwash&#xD;
Questionnaire: Ancillary studies&#xD;
Quality-of-Life Assessment: Ancillary studies&#xD;
Everolimus: Standard of care</description>
          </group>
          <group group_id="O2">
            <title>Group II (Placebo)</title>
            <description>Patients receive 10mg oral everolimus daily as standard of care and 10ml placebo oral mouthwash, swished for 2-minutes daily, for 8 weeks.&#xD;
Placebo: Given as mouthwash&#xD;
Questionnaire: Ancillary studies&#xD;
Quality-of-Life Assessment: Ancillary studies&#xD;
Everolimus: Standard of care</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Development of Mouth Pain</title>
          <description>Original plan for collecting and analyzing this data did not occur due to study termination.&#xD;
Will determine if the initiation of dexamethasone at the start of everolimus is associated with the time to development of mild (score of 1-3), moderate (score of 4-6) and severe (score of 7-10) mouth pain as measured by the NAMPS. Will be assessed by Kaplan-Meier and cumulative incidence curves.</description>
          <population>Original plan for collecting and analyzing this data did not occur due to study termination.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quality of Life Assessed by Linear Analogue Self-Assessment</title>
        <description>Original plan for collecting and analyzing this data did not occur due to study termination.&#xD;
Will determine if the initiation of dexamethasone at the start of everolimus is associated with quality of life is by comparing numerical analogue scale scores as measured by the Linear Analogue Self-Assessment. The Linear Analogue Self Assessment for quality of life is measured on a 0 to 10 scale, with 0 corresponding to &quot;Quality of life as bad as it can be&quot; and 10 corresponding to &quot;Quality of life as good as it can be.&quot; Will be assessed by independent samples t-tests.</description>
        <time_frame>Up to 8 weeks</time_frame>
        <population>Original plan for collecting and analyzing this data did not occur due to study termination.</population>
        <group_list>
          <group group_id="O1">
            <title>Group I (Dexamethasone)</title>
            <description>Patients receive 10mg oral everolimus daily as standard of care and 10ml dexamethasone oral mouthwash, swished for 2-minutes daily, for 8 weeks.&#xD;
Dexamethasone: Given as mouthwash&#xD;
Questionnaire: Ancillary studies&#xD;
Quality-of-Life Assessment: Ancillary studies&#xD;
Everolimus: Standard of care</description>
          </group>
          <group group_id="O2">
            <title>Group II (Placebo)</title>
            <description>Patients receive 10mg oral everolimus daily as standard of care and 10ml placebo oral mouthwash, swished for 2-minutes daily, for 8 weeks.&#xD;
Placebo: Given as mouthwash&#xD;
Questionnaire: Ancillary studies&#xD;
Quality-of-Life Assessment: Ancillary studies&#xD;
Everolimus: Standard of care</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of Life Assessed by Linear Analogue Self-Assessment</title>
          <description>Original plan for collecting and analyzing this data did not occur due to study termination.&#xD;
Will determine if the initiation of dexamethasone at the start of everolimus is associated with quality of life is by comparing numerical analogue scale scores as measured by the Linear Analogue Self-Assessment. The Linear Analogue Self Assessment for quality of life is measured on a 0 to 10 scale, with 0 corresponding to &quot;Quality of life as bad as it can be&quot; and 10 corresponding to &quot;Quality of life as good as it can be.&quot; Will be assessed by independent samples t-tests.</description>
          <population>Original plan for collecting and analyzing this data did not occur due to study termination.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mouth/Throat Sore Level of Activity Interference With Daily Activities</title>
        <description>Original plan for collecting and analyzing this data did not occur due to study termination.&#xD;
Will determine if the initiation of dexamethasone at the start of everolimus is associated with the level of interference with daily activities as measured by the Patient Reported Outcome (PRO) Common Terminology criteria for Adverse Events (CTCAE) mouth/throat item regarding level of interference with daily activities. The PRO-CTCAE mouth/throat item regarding level of interference with daily activities is measured on a Likert 1-5 scale, with 1 corresponding to &quot;Not at all&quot; and 5 corresponding to &quot;Very much.&quot; Will be assessed by independent samples t-tests.</description>
        <time_frame>Up to 8 weeks</time_frame>
        <population>Original plan for collecting and analyzing this data did not occur due to study termination.</population>
        <group_list>
          <group group_id="O1">
            <title>Group I (Dexamethasone)</title>
            <description>Patients receive 10mg oral everolimus daily as standard of care and 10ml dexamethasone oral mouthwash, swished for 2-minutes daily, for 8 weeks.&#xD;
Dexamethasone: Given as mouthwash&#xD;
Questionnaire: Ancillary studies&#xD;
Quality-of-Life Assessment: Ancillary studies&#xD;
Everolimus: Standard of care</description>
          </group>
          <group group_id="O2">
            <title>Group II (Placebo)</title>
            <description>Patients receive 10mg oral everolimus daily as standard of care and 10ml placebo oral mouthwash, swished for 2-minutes daily, for 8 weeks.&#xD;
Placebo: Given as mouthwash&#xD;
Questionnaire: Ancillary studies&#xD;
Quality-of-Life Assessment: Ancillary studies&#xD;
Everolimus: Standard of care</description>
          </group>
        </group_list>
        <measure>
          <title>Mouth/Throat Sore Level of Activity Interference With Daily Activities</title>
          <description>Original plan for collecting and analyzing this data did not occur due to study termination.&#xD;
Will determine if the initiation of dexamethasone at the start of everolimus is associated with the level of interference with daily activities as measured by the Patient Reported Outcome (PRO) Common Terminology criteria for Adverse Events (CTCAE) mouth/throat item regarding level of interference with daily activities. The PRO-CTCAE mouth/throat item regarding level of interference with daily activities is measured on a Likert 1-5 scale, with 1 corresponding to &quot;Not at all&quot; and 5 corresponding to &quot;Very much.&quot; Will be assessed by independent samples t-tests.</description>
          <population>Original plan for collecting and analyzing this data did not occur due to study termination.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sleep Level of Activity Interference With Daily Activities</title>
        <description>Original plan for collecting and analyzing this data did not occur due to study termination.&#xD;
Will determine if the initiation of dexamethasone at the start of everolimus is associated with the level of interference with daily activities as measured by the PRO-CTCAE sleep item regarding level of interference with daily activities. The PRO-CTCAE sleep item regarding level of interference with daily activities is measured on a Likert 1-5 scale, with 1 corresponding to &quot;Not at all&quot; and 5 corresponding to &quot;Very much.&quot; Will be assessed by independent samples t-tests.</description>
        <time_frame>Up to 8 weeks</time_frame>
        <population>Original plan for collecting and analyzing this data did not occur due to study termination.</population>
        <group_list>
          <group group_id="O1">
            <title>Group I (Dexamethasone)</title>
            <description>Patients receive 10mg oral everolimus daily as standard of care and 10ml dexamethasone oral mouthwash, swished for 2-minutes daily, for 8 weeks.&#xD;
Dexamethasone: Given as mouthwash&#xD;
Questionnaire: Ancillary studies&#xD;
Quality-of-Life Assessment: Ancillary studies&#xD;
Everolimus: Standard of care</description>
          </group>
          <group group_id="O2">
            <title>Group II (Placebo)</title>
            <description>Patients receive 10mg oral everolimus daily as standard of care and 10ml placebo oral mouthwash, swished for 2-minutes daily, for 8 weeks.&#xD;
Placebo: Given as mouthwash&#xD;
Questionnaire: Ancillary studies&#xD;
Quality-of-Life Assessment: Ancillary studies&#xD;
Everolimus: Standard of care</description>
          </group>
        </group_list>
        <measure>
          <title>Sleep Level of Activity Interference With Daily Activities</title>
          <description>Original plan for collecting and analyzing this data did not occur due to study termination.&#xD;
Will determine if the initiation of dexamethasone at the start of everolimus is associated with the level of interference with daily activities as measured by the PRO-CTCAE sleep item regarding level of interference with daily activities. The PRO-CTCAE sleep item regarding level of interference with daily activities is measured on a Likert 1-5 scale, with 1 corresponding to &quot;Not at all&quot; and 5 corresponding to &quot;Very much.&quot; Will be assessed by independent samples t-tests.</description>
          <population>Original plan for collecting and analyzing this data did not occur due to study termination.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Adherence to Everolimus Therapy Dose</title>
        <description>Original plan for collecting and analyzing this data did not occur due to study termination.&#xD;
Will compare mean daily dose of everolimus between the arms. The mean daily dose of everolimus over 8 weeks will be compared between study arms using independent samples t-tests.</description>
        <time_frame>Up to 8 weeks</time_frame>
        <population>Original plan for collecting and analyzing this data did not occur due to study termination.</population>
        <group_list>
          <group group_id="O1">
            <title>Group I (Dexamethasone)</title>
            <description>Patients receive 10mg oral everolimus daily as standard of care and 10ml dexamethasone oral mouthwash, swished for 2-minutes daily, for 8 weeks.&#xD;
Dexamethasone: Given as mouthwash&#xD;
Questionnaire: Ancillary studies&#xD;
Quality-of-Life Assessment: Ancillary studies&#xD;
Everolimus: Standard of care</description>
          </group>
          <group group_id="O2">
            <title>Group II (Placebo)</title>
            <description>Patients receive 10mg oral everolimus daily as standard of care and 10ml placebo oral mouthwash, swished for 2-minutes daily, for 8 weeks.&#xD;
Placebo: Given as mouthwash&#xD;
Questionnaire: Ancillary studies&#xD;
Quality-of-Life Assessment: Ancillary studies&#xD;
Everolimus: Standard of care</description>
          </group>
        </group_list>
        <measure>
          <title>Adherence to Everolimus Therapy Dose</title>
          <description>Original plan for collecting and analyzing this data did not occur due to study termination.&#xD;
Will compare mean daily dose of everolimus between the arms. The mean daily dose of everolimus over 8 weeks will be compared between study arms using independent samples t-tests.</description>
          <population>Original plan for collecting and analyzing this data did not occur due to study termination.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence of Patients Stopping Everolimus Early</title>
        <description>Original plan for collecting and analyzing this data did not occur due to study termination.&#xD;
Will compare the number of patients who stopped everolimus early between the treatment arms. Will be compared using Chi-squared tests.</description>
        <time_frame>Up to 8 weeks</time_frame>
        <population>Original plan for collecting and analyzing this data did not occur due to study termination.</population>
        <group_list>
          <group group_id="O1">
            <title>Group I (Dexamethasone)</title>
            <description>Patients receive 10mg oral everolimus daily as standard of care and 10ml dexamethasone oral mouthwash, swished for 2-minutes daily, for 8 weeks.&#xD;
Dexamethasone: Given as mouthwash&#xD;
Questionnaire: Ancillary studies&#xD;
Quality-of-Life Assessment: Ancillary studies&#xD;
Everolimus: Standard of care</description>
          </group>
          <group group_id="O2">
            <title>Group II (Placebo)</title>
            <description>Patients receive 10mg oral everolimus daily as standard of care and 10ml placebo oral mouthwash, swished for 2-minutes daily, for 8 weeks.&#xD;
Placebo: Given as mouthwash&#xD;
Questionnaire: Ancillary studies&#xD;
Quality-of-Life Assessment: Ancillary studies&#xD;
Everolimus: Standard of care</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Patients Stopping Everolimus Early</title>
          <description>Original plan for collecting and analyzing this data did not occur due to study termination.&#xD;
Will compare the number of patients who stopped everolimus early between the treatment arms. Will be compared using Chi-squared tests.</description>
          <population>Original plan for collecting and analyzing this data did not occur due to study termination.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence of Patients Reducing Everolimus Dose</title>
        <description>Original plan for collecting and analyzing this data did not occur due to study termination.&#xD;
Will compare the number of patients who reduced their everolimus dose between the treatment arms. Will be compared using Chi-squared tests.</description>
        <time_frame>Up to 8 weeks</time_frame>
        <population>Original plan for collecting and analyzing this data did not occur due to study termination.</population>
        <group_list>
          <group group_id="O1">
            <title>Group I (Dexamethasone)</title>
            <description>Patients receive 10mg oral everolimus daily as standard of care and 10ml dexamethasone oral mouthwash, swished for 2-minutes daily, for 8 weeks.&#xD;
Dexamethasone: Given as mouthwash&#xD;
Questionnaire: Ancillary studies&#xD;
Quality-of-Life Assessment: Ancillary studies&#xD;
Everolimus: Standard of care</description>
          </group>
          <group group_id="O2">
            <title>Group II (Placebo)</title>
            <description>Patients receive 10mg oral everolimus daily as standard of care and 10ml placebo oral mouthwash, swished for 2-minutes daily, for 8 weeks.&#xD;
Placebo: Given as mouthwash&#xD;
Questionnaire: Ancillary studies&#xD;
Quality-of-Life Assessment: Ancillary studies&#xD;
Everolimus: Standard of care</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Patients Reducing Everolimus Dose</title>
          <description>Original plan for collecting and analyzing this data did not occur due to study termination.&#xD;
Will compare the number of patients who reduced their everolimus dose between the treatment arms. Will be compared using Chi-squared tests.</description>
          <population>Original plan for collecting and analyzing this data did not occur due to study termination.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Dexamethasone Prescription Fill Rates</title>
        <description>Original plan for collecting and analyzing this data did not occur due to study termination.&#xD;
Will compare dexamethasone prescription fill rates between the treatment groups. This will be compared using Chi-squared tests.</description>
        <time_frame>Up to 8 weeks</time_frame>
        <population>Original plan for collecting and analyzing this data did not occur due to study termination.</population>
        <group_list>
          <group group_id="O1">
            <title>Group I (Dexamethasone)</title>
            <description>Patients receive 10mg oral everolimus daily as standard of care and 10ml dexamethasone oral mouthwash, swished for 2-minutes daily, for 8 weeks.&#xD;
Dexamethasone: Given as mouthwash&#xD;
Questionnaire: Ancillary studies&#xD;
Quality-of-Life Assessment: Ancillary studies&#xD;
Everolimus: Standard of care</description>
          </group>
          <group group_id="O2">
            <title>Group II (Placebo)</title>
            <description>Patients receive 10mg oral everolimus daily as standard of care and 10ml placebo oral mouthwash, swished for 2-minutes daily, for 8 weeks.&#xD;
Placebo: Given as mouthwash&#xD;
Questionnaire: Ancillary studies&#xD;
Quality-of-Life Assessment: Ancillary studies&#xD;
Everolimus: Standard of care</description>
          </group>
        </group_list>
        <measure>
          <title>Dexamethasone Prescription Fill Rates</title>
          <description>Original plan for collecting and analyzing this data did not occur due to study termination.&#xD;
Will compare dexamethasone prescription fill rates between the treatment groups. This will be compared using Chi-squared tests.</description>
          <population>Original plan for collecting and analyzing this data did not occur due to study termination.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Dexamethasone Prescription Fill</title>
        <description>Original plan for collecting and analyzing this data did not occur due to study termination.&#xD;
Will compare the time to dexamethasone prescription fill between the treatment groups. This will be compared using Kaplan-Meier and cumulative incidence curves.</description>
        <time_frame>Up to 8 weeks</time_frame>
        <population>Original plan for collecting and analyzing this data did not occur due to study termination.</population>
        <group_list>
          <group group_id="O1">
            <title>Group I (Dexamethasone)</title>
            <description>Patients receive 10mg oral everolimus daily as standard of care and 10ml dexamethasone oral mouthwash, swished for 2-minutes daily, for 8 weeks.&#xD;
Dexamethasone: Given as mouthwash&#xD;
Questionnaire: Ancillary studies&#xD;
Quality-of-Life Assessment: Ancillary studies&#xD;
Everolimus: Standard of care</description>
          </group>
          <group group_id="O2">
            <title>Group II (Placebo)</title>
            <description>Patients receive 10mg oral everolimus daily as standard of care and 10ml placebo oral mouthwash, swished for 2-minutes daily, for 8 weeks.&#xD;
Placebo: Given as mouthwash&#xD;
Questionnaire: Ancillary studies&#xD;
Quality-of-Life Assessment: Ancillary studies&#xD;
Everolimus: Standard of care</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Dexamethasone Prescription Fill</title>
          <description>Original plan for collecting and analyzing this data did not occur due to study termination.&#xD;
Will compare the time to dexamethasone prescription fill between the treatment groups. This will be compared using Kaplan-Meier and cumulative incidence curves.</description>
          <population>Original plan for collecting and analyzing this data did not occur due to study termination.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Develop Mouth Sores Per Study Arm Assessed by PRO-CTCAE Mouth/Throat Sore Item Regarding Severity</title>
        <description>Original plan for collecting and analyzing this data did not occur due to study termination.&#xD;
The time to develop at least mild, moderate, or severe (including &quot;Very severe&quot;) mouth sores per study arm as measured by the PRO-CTCAE mouth-throat sore item regarding severity. The PRO-CTCAE mouth-throat sore item regarding severity is measured on a Likert 1-5 scale, with 1 corresponding to &quot;None&quot; and 5 corresponding to &quot;Very severe&quot;. Will be assessed by Kaplan-Meier and cumulative incidence curves.</description>
        <time_frame>Up to 8 weeks</time_frame>
        <population>Original plan for collecting and analyzing this data did not occur due to study termination.</population>
        <group_list>
          <group group_id="O1">
            <title>Group I (Dexamethasone)</title>
            <description>Patients receive 10mg oral everolimus daily as standard of care and 10ml dexamethasone oral mouthwash, swished for 2-minutes daily, for 8 weeks.&#xD;
Dexamethasone: Given as mouthwash&#xD;
Questionnaire: Ancillary studies&#xD;
Quality-of-Life Assessment: Ancillary studies&#xD;
Everolimus: Standard of care</description>
          </group>
          <group group_id="O2">
            <title>Group II (Placebo)</title>
            <description>Patients receive 10mg oral everolimus daily as standard of care and 10ml placebo oral mouthwash, swished for 2-minutes daily, for 8 weeks.&#xD;
Placebo: Given as mouthwash&#xD;
Questionnaire: Ancillary studies&#xD;
Quality-of-Life Assessment: Ancillary studies&#xD;
Everolimus: Standard of care</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Develop Mouth Sores Per Study Arm Assessed by PRO-CTCAE Mouth/Throat Sore Item Regarding Severity</title>
          <description>Original plan for collecting and analyzing this data did not occur due to study termination.&#xD;
The time to develop at least mild, moderate, or severe (including &quot;Very severe&quot;) mouth sores per study arm as measured by the PRO-CTCAE mouth-throat sore item regarding severity. The PRO-CTCAE mouth-throat sore item regarding severity is measured on a Likert 1-5 scale, with 1 corresponding to &quot;None&quot; and 5 corresponding to &quot;Very severe&quot;. Will be assessed by Kaplan-Meier and cumulative incidence curves.</description>
          <population>Original plan for collecting and analyzing this data did not occur due to study termination.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Degrees of Patient-reported Mouth Sores Per Study Arm Assessed by NAMPS</title>
        <description>Original plan for collecting and analyzing this data did not occur due to study termination.&#xD;
The mean degrees of patient-reported mouth sores per study arm as measured by the NAMPS will be assessed by independent samples t-tests.</description>
        <time_frame>Up to 8 weeks</time_frame>
        <population>Original plan for collecting and analyzing this data did not occur due to study termination.</population>
        <group_list>
          <group group_id="O1">
            <title>Group I (Dexamethasone)</title>
            <description>Patients receive 10mg oral everolimus daily as standard of care and 10ml dexamethasone oral mouthwash, swished for 2-minutes daily, for 8 weeks.&#xD;
Dexamethasone: Given as mouthwash&#xD;
Questionnaire: Ancillary studies&#xD;
Quality-of-Life Assessment: Ancillary studies&#xD;
Everolimus: Standard of care</description>
          </group>
          <group group_id="O2">
            <title>Group II (Placebo)</title>
            <description>Patients receive 10mg oral everolimus daily as standard of care and 10ml placebo oral mouthwash, swished for 2-minutes daily, for 8 weeks.&#xD;
Placebo: Given as mouthwash&#xD;
Questionnaire: Ancillary studies&#xD;
Quality-of-Life Assessment: Ancillary studies&#xD;
Everolimus: Standard of care</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Degrees of Patient-reported Mouth Sores Per Study Arm Assessed by NAMPS</title>
          <description>Original plan for collecting and analyzing this data did not occur due to study termination.&#xD;
The mean degrees of patient-reported mouth sores per study arm as measured by the NAMPS will be assessed by independent samples t-tests.</description>
          <population>Original plan for collecting and analyzing this data did not occur due to study termination.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Median Degree of Patient-reported Mouth Sores Per Study Arm Assessed by NAMPS</title>
        <description>Original plan for collecting and analyzing this data did not occur due to study termination.&#xD;
The median degrees of patient-reported mouth sores per study arm as measured by the NAMPS will be assessed by independent samples t-tests.</description>
        <time_frame>Up to 8 weeks</time_frame>
        <population>Original plan for collecting and analyzing this data did not occur due to study termination.</population>
        <group_list>
          <group group_id="O1">
            <title>Group I (Dexamethasone)</title>
            <description>Patients receive 10mg oral everolimus daily as standard of care and 10ml dexamethasone oral mouthwash, swished for 2-minutes daily, for 8 weeks.&#xD;
Dexamethasone: Given as mouthwash&#xD;
Questionnaire: Ancillary studies&#xD;
Quality-of-Life Assessment: Ancillary studies&#xD;
Everolimus: Standard of care</description>
          </group>
          <group group_id="O2">
            <title>Group II (Placebo)</title>
            <description>Patients receive 10mg oral everolimus daily as standard of care and 10ml placebo oral mouthwash, swished for 2-minutes daily, for 8 weeks.&#xD;
Placebo: Given as mouthwash&#xD;
Questionnaire: Ancillary studies&#xD;
Quality-of-Life Assessment: Ancillary studies&#xD;
Everolimus: Standard of care</description>
          </group>
        </group_list>
        <measure>
          <title>Median Degree of Patient-reported Mouth Sores Per Study Arm Assessed by NAMPS</title>
          <description>Original plan for collecting and analyzing this data did not occur due to study termination.&#xD;
The median degrees of patient-reported mouth sores per study arm as measured by the NAMPS will be assessed by independent samples t-tests.</description>
          <population>Original plan for collecting and analyzing this data did not occur due to study termination.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Patients Who Experience Grade 2 Stomatitis</title>
        <description>Original plan for collecting and analyzing this data did not occur due to study termination.&#xD;
The proportion of patients who experience clinician-reported grade 2 stomatitis (as measured by the CTCAE and performed at 1 and 2 months post-baseline) per study arm will be assessed by Chi-squared tests.</description>
        <time_frame>Up to 2 months</time_frame>
        <population>Original plan for collecting and analyzing this data did not occur due to study termination.</population>
        <group_list>
          <group group_id="O1">
            <title>Group I (Dexamethasone)</title>
            <description>Patients receive 10mg oral everolimus daily as standard of care and 10ml dexamethasone oral mouthwash, swished for 2-minutes daily, for 8 weeks.&#xD;
Dexamethasone: Given as mouthwash&#xD;
Questionnaire: Ancillary studies&#xD;
Quality-of-Life Assessment: Ancillary studies&#xD;
Everolimus: Standard of care</description>
          </group>
          <group group_id="O2">
            <title>Group II (Placebo)</title>
            <description>Patients receive 10mg oral everolimus daily as standard of care and 10ml placebo oral mouthwash, swished for 2-minutes daily, for 8 weeks.&#xD;
Placebo: Given as mouthwash&#xD;
Questionnaire: Ancillary studies&#xD;
Quality-of-Life Assessment: Ancillary studies&#xD;
Everolimus: Standard of care</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Patients Who Experience Grade 2 Stomatitis</title>
          <description>Original plan for collecting and analyzing this data did not occur due to study termination.&#xD;
The proportion of patients who experience clinician-reported grade 2 stomatitis (as measured by the CTCAE and performed at 1 and 2 months post-baseline) per study arm will be assessed by Chi-squared tests.</description>
          <population>Original plan for collecting and analyzing this data did not occur due to study termination.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Incidence Rate of the mTOR Inhibitor-associated Stomatitis (mIAS)-Related Pain Based on Daily Self-reports Via the Numerical Analogue Scale by Sex</title>
        <description>NIH-required analysis. The numerical analogue mouth pain score (NAMPS) is a single item measured on a 0 to 10 scale, with 0 corresponding to &quot;No pain&quot; and 10 corresponding to &quot;Pain as bad as it can be.&quot; Will compare the incidence rate of any mouth pain (i.e., any score greater than 0) as assessed by the NAMPS between the prevention versus early treatment approaches using a Chi-square test.</description>
        <time_frame>Up to 8 weeks</time_frame>
        <population>Population is by Sex. Male and Female population combined equals Overall Number of Participants Analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Group I (Dexamethasone)</title>
            <description>Patients receive 10mg oral everolimus daily as standard of care and 10ml dexamethasone oral mouthwash, swished for 2-minutes daily, for 8 weeks.&#xD;
Dexamethasone: Given as mouthwash&#xD;
Questionnaire: Ancillary studies&#xD;
Quality-of-Life Assessment: Ancillary studies&#xD;
Everolimus: Standard of care</description>
          </group>
          <group group_id="O2">
            <title>Group II (Placebo)</title>
            <description>Patients receive 10mg oral everolimus daily as standard of care and 10ml placebo oral mouthwash, swished for 2-minutes daily, for 8 weeks.&#xD;
Placebo: Given as mouthwash&#xD;
Questionnaire: Ancillary studies&#xD;
Quality-of-Life Assessment: Ancillary studies&#xD;
Everolimus: Standard of care</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence Rate of the mTOR Inhibitor-associated Stomatitis (mIAS)-Related Pain Based on Daily Self-reports Via the Numerical Analogue Scale by Sex</title>
          <description>NIH-required analysis. The numerical analogue mouth pain score (NAMPS) is a single item measured on a 0 to 10 scale, with 0 corresponding to &quot;No pain&quot; and 10 corresponding to &quot;Pain as bad as it can be.&quot; Will compare the incidence rate of any mouth pain (i.e., any score greater than 0) as assessed by the NAMPS between the prevention versus early treatment approaches using a Chi-square test.</description>
          <population>Population is by Sex. Male and Female population combined equals Overall Number of Participants Analyzed.</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="16"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Female</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>No Pain</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Pain</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Male</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>No Pain</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Pain</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Female Population.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.70361</p_value>
            <method>Fisher Exact</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Male population.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.4667</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Incidence Rate of the mTOR Inhibitor-associated Stomatitis (mIAS)-Related Pain Based on Daily Self-reports Via the Numerical Analogue Scale by Race</title>
        <description>NIH-required analysis. The numerical analogue mouth pain score (NAMPS) is a single item measured on a 0 to 10 scale, with 0 corresponding to &quot;No pain&quot; and 10 corresponding to &quot;Pain as bad as it can be.&quot; Will compare the incidence rate of any mouth pain (i.e., any score greater than 0) as assessed by the NAMPS between the prevention versus early treatment approaches using a Chi-square test.</description>
        <time_frame>Up to 8 weeks</time_frame>
        <population>Black or African American population is different than white population</population>
        <group_list>
          <group group_id="O1">
            <title>Group I (Dexamethasone)</title>
            <description>Patients receive 10mg oral everolimus daily as standard of care and 10ml dexamethasone oral mouthwash, swished for 2-minutes daily, for 8 weeks.&#xD;
Dexamethasone: Given as mouthwash&#xD;
Questionnaire: Ancillary studies&#xD;
Quality-of-Life Assessment: Ancillary studies&#xD;
Everolimus: Standard of care</description>
          </group>
          <group group_id="O2">
            <title>Group II (Placebo)</title>
            <description>Patients receive 10mg oral everolimus daily as standard of care and 10ml placebo oral mouthwash, swished for 2-minutes daily, for 8 weeks.&#xD;
Placebo: Given as mouthwash&#xD;
Questionnaire: Ancillary studies&#xD;
Quality-of-Life Assessment: Ancillary studies&#xD;
Everolimus: Standard of care</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence Rate of the mTOR Inhibitor-associated Stomatitis (mIAS)-Related Pain Based on Daily Self-reports Via the Numerical Analogue Scale by Race</title>
          <description>NIH-required analysis. The numerical analogue mouth pain score (NAMPS) is a single item measured on a 0 to 10 scale, with 0 corresponding to &quot;No pain&quot; and 10 corresponding to &quot;Pain as bad as it can be.&quot; Will compare the incidence rate of any mouth pain (i.e., any score greater than 0) as assessed by the NAMPS between the prevention versus early treatment approaches using a Chi-square test.</description>
          <population>Black or African American population is different than white population</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="16"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Black or African American</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>No Pain</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Pain</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>No Pain</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Pain</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Black or African American population</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;1.0</p_value>
            <method>Fisher Exact</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>White population</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;1.0</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Incidence Rate of the mTOR Inhibitor-associated Stomatitis (mIAS)-Related Pain Based on Daily Self-reports Via the Numerical Analogue Scale by Ethnicity.</title>
        <description>NIH-required analysis. The numerical analogue mouth pain score (NAMPS) is a single item measured on a 0 to 10 scale, with 0 corresponding to &quot;No pain&quot; and 10 corresponding to &quot;Pain as bad as it can be.&quot; Will compare the incidence rate of any mouth pain (i.e., any score greater than 0) as assessed by the NAMPS between the prevention versus early treatment approaches using a Chi-square test.</description>
        <time_frame>Up to 8 weeks</time_frame>
        <population>Population is by Ethnicity. Not Hispanic or Latino and Other population combined equals Overall Number of Participants Analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Group I (Dexamethasone)</title>
            <description>Patients receive 10mg oral everolimus daily as standard of care and 10ml dexamethasone oral mouthwash, swished for 2-minutes daily, for 8 weeks.&#xD;
Dexamethasone: Given as mouthwash&#xD;
Questionnaire: Ancillary studies&#xD;
Quality-of-Life Assessment: Ancillary studies&#xD;
Everolimus: Standard of care</description>
          </group>
          <group group_id="O2">
            <title>Group II (Placebo)</title>
            <description>Patients receive 10mg oral everolimus daily as standard of care and 10ml placebo oral mouthwash, swished for 2-minutes daily, for 8 weeks.&#xD;
Placebo: Given as mouthwash&#xD;
Questionnaire: Ancillary studies&#xD;
Quality-of-Life Assessment: Ancillary studies&#xD;
Everolimus: Standard of care</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence Rate of the mTOR Inhibitor-associated Stomatitis (mIAS)-Related Pain Based on Daily Self-reports Via the Numerical Analogue Scale by Ethnicity.</title>
          <description>NIH-required analysis. The numerical analogue mouth pain score (NAMPS) is a single item measured on a 0 to 10 scale, with 0 corresponding to &quot;No pain&quot; and 10 corresponding to &quot;Pain as bad as it can be.&quot; Will compare the incidence rate of any mouth pain (i.e., any score greater than 0) as assessed by the NAMPS between the prevention versus early treatment approaches using a Chi-square test.</description>
          <population>Population is by Ethnicity. Not Hispanic or Latino and Other population combined equals Overall Number of Participants Analyzed.</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="16"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Not Hispanic or Latino</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>No Pain</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Pain</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>No Pain</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Pain</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Not Hispanic or Latino population.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;1.0</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Severity of Mouth Pain Scores by Sex</title>
        <description>Average Area Under the Curve per assessment (aAUCpa) of mouth pain scores as measured by NAMPS will be computed for each patient to summarize the sequence of numerical analogue mouth pain scores over the eight week study period. Scores are reported on a 0-100 scale, where 100 = better outcome QOL (i.e. less pain). The aAUCpa is the average of each AUC between each sequential assessment from treatment-initiation to the end of the treatment at 8 weeks post-treatment-initiation and will be compared between the two treatment arms.</description>
        <time_frame>Up to 8 weeks</time_frame>
        <population>Population is by Sex. Male and Female population combined equals Overall Number of Participants Analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Group I (Dexamethasone)</title>
            <description>Patients receive 10mg oral everolimus daily as standard of care and 10ml dexamethasone oral mouthwash, swished for 2-minutes daily, for 8 weeks.&#xD;
Dexamethasone: Given as mouthwash&#xD;
Questionnaire: Ancillary studies&#xD;
Quality-of-Life Assessment: Ancillary studies&#xD;
Everolimus: Standard of care</description>
          </group>
          <group group_id="O2">
            <title>Group II (Placebo)</title>
            <description>Patients receive 10mg oral everolimus daily as standard of care and 10ml placebo oral mouthwash, swished for 2-minutes daily, for 8 weeks.&#xD;
Placebo: Given as mouthwash&#xD;
Questionnaire: Ancillary studies&#xD;
Quality-of-Life Assessment: Ancillary studies&#xD;
Everolimus: Standard of care</description>
          </group>
        </group_list>
        <measure>
          <title>Severity of Mouth Pain Scores by Sex</title>
          <description>Average Area Under the Curve per assessment (aAUCpa) of mouth pain scores as measured by NAMPS will be computed for each patient to summarize the sequence of numerical analogue mouth pain scores over the eight week study period. Scores are reported on a 0-100 scale, where 100 = better outcome QOL (i.e. less pain). The aAUCpa is the average of each AUC between each sequential assessment from treatment-initiation to the end of the treatment at 8 weeks post-treatment-initiation and will be compared between the two treatment arms.</description>
          <population>Population is by Sex. Male and Female population combined equals Overall Number of Participants Analyzed.</population>
          <units>scores on scale * days</units>
          <param>Mean</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Female</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.4" lower_limit="0.0" upper_limit="47.3"/>
                    <measurement group_id="O2" value="2.7" lower_limit="0.0" upper_limit="15.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Male</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.0" lower_limit="0.0" upper_limit="33.4"/>
                    <measurement group_id="O2" value="18.8" lower_limit="17.0" upper_limit="20.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Female population.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.1701</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Male population.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.4811</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Severity of Mouth Pain Scores by Race</title>
        <description>Average Area Under the Curve per assessment (aAUCpa) of mouth pain scores as measured by NAMPS will be computed for each patient to summarize the sequence of numerical analogue mouth pain scores over the eight week study period. Scores are reported on a 0-100 scale, where 100 = better outcome QOL (i.e. less pain). The aAUCpa is the average of each AUC between each sequential assessment from treatment-initiation to the end of the treatment at 8 weeks post-treatment-initiation and will be compared between the two treatment arms.</description>
        <time_frame>Up to 8 weeks</time_frame>
        <population>Population is by Race. Black or African American and White population combined equals Overall Number of Participants Analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Group I (Dexamethasone)</title>
            <description>Patients receive 10mg oral everolimus daily as standard of care and 10ml dexamethasone oral mouthwash, swished for 2-minutes daily, for 8 weeks.&#xD;
Dexamethasone: Given as mouthwash&#xD;
Questionnaire: Ancillary studies&#xD;
Quality-of-Life Assessment: Ancillary studies&#xD;
Everolimus: Standard of care</description>
          </group>
          <group group_id="O2">
            <title>Group II (Placebo)</title>
            <description>Patients receive 10mg oral everolimus daily as standard of care and 10ml placebo oral mouthwash, swished for 2-minutes daily, for 8 weeks.&#xD;
Placebo: Given as mouthwash&#xD;
Questionnaire: Ancillary studies&#xD;
Quality-of-Life Assessment: Ancillary studies&#xD;
Everolimus: Standard of care</description>
          </group>
        </group_list>
        <measure>
          <title>Severity of Mouth Pain Scores by Race</title>
          <description>Average Area Under the Curve per assessment (aAUCpa) of mouth pain scores as measured by NAMPS will be computed for each patient to summarize the sequence of numerical analogue mouth pain scores over the eight week study period. Scores are reported on a 0-100 scale, where 100 = better outcome QOL (i.e. less pain). The aAUCpa is the average of each AUC between each sequential assessment from treatment-initiation to the end of the treatment at 8 weeks post-treatment-initiation and will be compared between the two treatment arms.</description>
          <population>Population is by Race. Black or African American and White population combined equals Overall Number of Participants Analyzed.</population>
          <units>scores on scale * days</units>
          <param>Mean</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Black or African American</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.3" lower_limit="0.0" upper_limit="22.8"/>
                    <measurement group_id="O2" value="7.9" lower_limit="7.9" upper_limit="7.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.0" lower_limit="0.0" upper_limit="47.3"/>
                    <measurement group_id="O2" value="4.4" lower_limit="0.0" upper_limit="20.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Black or African American Population</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;1.0</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>White Population</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.5029</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Severity of Mouth Pain Scores by Ethnicity</title>
        <description>Average Area Under the Curve per assessment (aAUCpa) of mouth pain scores as measured by NAMPS will be computed for each patient to summarize the sequence of numerical analogue mouth pain scores over the eight week study period. Scores are reported on a 0-100 scale, where 100 = better outcome QOL (i.e. less pain). The aAUCpa is the average of each AUC between each sequential assessment from treatment-initiation to the end of the treatment at 8 weeks post-treatment-initiation and will be compared between the two treatment arms.</description>
        <time_frame>Up to 8 weeks</time_frame>
        <population>Population is by Ethnicity. Not Hispanic or Latino and Other population combined equals Overall Number of Participants Analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Group I (Dexamethasone)</title>
            <description>Patients receive 10mg oral everolimus daily as standard of care and 10ml dexamethasone oral mouthwash, swished for 2-minutes daily, for 8 weeks.&#xD;
Dexamethasone: Given as mouthwash&#xD;
Questionnaire: Ancillary studies&#xD;
Quality-of-Life Assessment: Ancillary studies&#xD;
Everolimus: Standard of care</description>
          </group>
          <group group_id="O2">
            <title>Group II (Placebo)</title>
            <description>Patients receive 10mg oral everolimus daily as standard of care and 10ml placebo oral mouthwash, swished for 2-minutes daily, for 8 weeks.&#xD;
Placebo: Given as mouthwash&#xD;
Questionnaire: Ancillary studies&#xD;
Quality-of-Life Assessment: Ancillary studies&#xD;
Everolimus: Standard of care</description>
          </group>
        </group_list>
        <measure>
          <title>Severity of Mouth Pain Scores by Ethnicity</title>
          <description>Average Area Under the Curve per assessment (aAUCpa) of mouth pain scores as measured by NAMPS will be computed for each patient to summarize the sequence of numerical analogue mouth pain scores over the eight week study period. Scores are reported on a 0-100 scale, where 100 = better outcome QOL (i.e. less pain). The aAUCpa is the average of each AUC between each sequential assessment from treatment-initiation to the end of the treatment at 8 weeks post-treatment-initiation and will be compared between the two treatment arms.</description>
          <population>Population is by Ethnicity. Not Hispanic or Latino and Other population combined equals Overall Number of Participants Analyzed.</population>
          <units>scores on scale * days</units>
          <param>Mean</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Not Hispanic or Latino</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.1" lower_limit="0.0" upper_limit="47.3"/>
                    <measurement group_id="O2" value="4.9" lower_limit="0.0" upper_limit="20.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="0.0"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Not Hispanic or Latino Population</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.2950</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>8 weeks</time_frame>
      <desc>3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.</desc>
      <group_list>
        <group group_id="E1">
          <title>Group II (Placebo)</title>
          <description>Everolimus: Standard of care</description>
        </group>
        <group group_id="E2">
          <title>Group I (Dexamethasone)</title>
          <description>Everolimus: Standard of care</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 5</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <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="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Sinus tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Lower gastrointestinal hemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Edema limbs</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Enterocolitis infectious</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Creatinine increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Hyponatremia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Tumor pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 5</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Blood and lymph sys disorders - Oth Spec</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" events="5" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Gastrointestinal disorders - Oth spec</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Mucositis oral</sub_title>
                <counts group_id="E1" events="15" subjects_affected="6" subjects_at_risk="18"/>
                <counts group_id="E2" events="29" subjects_affected="7" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="6" subjects_affected="3" subjects_at_risk="18"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Oral pain</sub_title>
                <counts group_id="E1" events="16" subjects_affected="6" subjects_at_risk="18"/>
                <counts group_id="E2" events="29" subjects_affected="7" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="57" subjects_affected="14" subjects_at_risk="18"/>
                <counts group_id="E2" events="36" subjects_affected="9" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Mucosal infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Bruising</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Alkaline phosphatase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Creatinine increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>White blood cell decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Anorexia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Hyperglycemia</sub_title>
                <counts group_id="E1" events="14" subjects_affected="6" subjects_at_risk="18"/>
                <counts group_id="E2" events="15" subjects_affected="6" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Peripheral sensory neuropathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="40" subjects_affected="9" subjects_at_risk="18"/>
                <counts group_id="E2" events="20" subjects_affected="4" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Irritability</sub_title>
                <counts group_id="E1" events="10" subjects_affected="3" subjects_at_risk="18"/>
                <counts group_id="E2" events="4" subjects_affected="2" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Breast pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Productive cough</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash acneiform</sub_title>
                <counts group_id="E1" events="4" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>Dr. Kathryn J. Ruddy</name_or_title>
      <organization>Mayo Clinic</organization>
      <phone>507-293-1732</phone>
      <email>ruddy.kathryn@mayo.edu</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/NCT03839940
org study id: A221701
secondary id: NCI-2018-02648
secondary id: UG1CA189823
nct id: NCT03839940
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This phase III trial studies how well dexamethasone works in reducing everolimus-induced oral
      stomatitis in patients with cancer. Dexamethasone may help to reduce the everolimus-induced
      oral stomatitis so as to improve quality of life in cancer patients.
PRIMARY OBJECTIVES:

      I. To determine if the initiation of dexamethasone at the start of everolimus treatment
      prevents mTOR inhibitor-associated stomatitis (mIAS)-associated pain, compared to the
      initiation of placebo.

      II. To determine if the initiation of dexamethasone at the start of everolimus treatment will
      be superior compared to the initiation of placebo in terms of the overall severity of
      mIAS-associated pain.

      SECONDARY OBJECTIVES:

      I. To utilize the same measurement method that was reported in the SWISH trial: A combination
      of a patient reported pain scale, data from a normalcy of diet questionnaire, and clinician
      grading of stomatitis to determine the incidence of > grade 2 mIAS.

      II. To determine if the initiation of dexamethasone at the start of everolimus increases time
      to development of mouth pain using daily numerical analog scale patient-reported data
      collection.

      III. To assess if quality of life is better when dexamethasone mouth rinse use starts at the
      same time as everolimus use versus at the time when mouth pain begins.

      IV. To investigate if starting dexamethasone mouth rinse concurrent with starting everolimus
      improves patients' ability to adhere to everolimus therapy.

      V. To compare dexamethasone prescription fill rates and timing between patients who received
      placebo versus study drug at the initiation of everolimus.

      Trial Design:

      OUTLINE: Patients are randomized to 1 of 2 groups.

      GROUP I: Patients receive everolimus orally (PO) once daily (QD) as standard of care and
      dexamethasone as mouthwash over 2 minutes 4 times per day (QID) for 8 weeks.

      GROUP II: Patients receive everolimus PO QD as standard of care and placebo as mouthwash over
      2 minutes QID for 8 weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Incidence Rate of the mTOR Inhibitor-associated Stomatitis (mIAS)-Related Pain Based on Daily Self-reports Via the Numerical Analogue Scale
time frame: Up to 8 weeks
description: The numerical analogue mouth pain score (NAMPS) is a single item measured on a 0 to 10 scale, with 0 corresponding to "No pain" and 10 corresponding to "Pain as bad as it can be." Will compare the incidence rate of any mouth pain (i.e., any score greater than 0) as assessed by the NAMPS between the prevention versus early treatment approaches using a Chi-square test.
measure: Severity of Mouth Pain Scores
time frame: Up to 8 weeks
description: Average Area Under the Curve per assessment (aAUCpa) of mouth pain scores as measured by NAMPS will be computed for each patient to summarize the sequence of numerical analogue mouth pain scores over the eight week study period. Scores are reported on a 0-100 scale, where 100 = better outcome QOL (i.e. less pain). The aAUCpa is the average of each AUC between each sequential assessment from treatment-initiation to the end of the treatment at 8 weeks post-treatment-initiation and will be compared between the two treatment arms.
measure: Incidence of Grade > 2 mIAS as Measured by the SWISH Trial
time frame: Up to 8 weeks
description: Original plan for collecting and analyzing this data did not occur due to study termination.
Grade 2 mIAS is defined as having at least one of the following criteria:>
Oral intake assessed at 50 on the Normalcy of Diet Scale
Patient's reported oral pain (using visual analogue scale 0-10) that meets one of the following: rating of 7 on two consecutive days rating of 8, 9, or 10 on any one day. The incidence of grade 2 mIAS for each treatment arm will be compared by a Chi-square test.
measure: Incidence of Mouth Pain
time frame: Up to 8 weeks
description: Original plan for collecting and analyzing this data did not occur due to study termination.
Will determine if the initiation of dexamethasone at the start of everolimus is associated with the incidence and of mild (score of 1-3), moderate (score of 4-6) and severe (score of 7-10) mouth pain as measured by the NAMPS. Will be assessed by Chi-square tests.
measure: Time to Development of Mouth Pain
time frame: Up to 8 weeks
description: Original plan for collecting and analyzing this data did not occur due to study termination.
Will determine if the initiation of dexamethasone at the start of everolimus is associated with the time to development of mild (score of 1-3), moderate (score of 4-6) and severe (score of 7-10) mouth pain as measured by the NAMPS. Will be assessed by Kaplan-Meier and cumulative incidence curves.
measure: Quality of Life Assessed by Linear Analogue Self-Assessment
time frame: Up to 8 weeks
description: Original plan for collecting and analyzing this data did not occur due to study termination.
Will determine if the initiation of dexamethasone at the start of everolimus is associated with quality of life is by comparing numerical analogue scale scores as measured by the Linear Analogue Self-Assessment. The Linear Analogue Self Assessment for quality of life is measured on a 0 to 10 scale, with 0 corresponding to "Quality of life as bad as it can be" and 10 corresponding to "Quality of life as good as it can be." Will be assessed by independent samples t-tests.
measure: Mouth/Throat Sore Level of Activity Interference With Daily Activities
time frame: Up to 8 weeks
description: Original plan for collecting and analyzing this data did not occur due to study termination.
Will determine if the initiation of dexamethasone at the start of everolimus is associated with the level of interference with daily activities as measured by the Patient Reported Outcome (PRO) Common Terminology criteria for Adverse Events (CTCAE) mouth/throat item regarding level of interference with daily activities. The PRO-CTCAE mouth/throat item regarding level of interference with daily activities is measured on a Likert 1-5 scale, with 1 corresponding to "Not at all" and 5 corresponding to "Very much." Will be assessed by independent samples t-tests.
measure: Sleep Level of Activity Interference With Daily Activities
time frame: Up to 8 weeks
description: Original plan for collecting and analyzing this data did not occur due to study termination.
Will determine if the initiation of dexamethasone at the start of everolimus is associated with the level of interference with daily activities as measured by the PRO-CTCAE sleep item regarding level of interference with daily activities. The PRO-CTCAE sleep item regarding level of interference with daily activities is measured on a Likert 1-5 scale, with 1 corresponding to "Not at all" and 5 corresponding to "Very much." Will be assessed by independent samples t-tests.
measure: Adherence to Everolimus Therapy Dose
time frame: Up to 8 weeks
description: Original plan for collecting and analyzing this data did not occur due to study termination.
Will compare mean daily dose of everolimus between the arms. The mean daily dose of everolimus over 8 weeks will be compared between study arms using independent samples t-tests.
measure: Incidence of Patients Stopping Everolimus Early
time frame: Up to 8 weeks
description: Original plan for collecting and analyzing this data did not occur due to study termination.
Will compare the number of patients who stopped everolimus early between the treatment arms. Will be compared using Chi-squared tests.
measure: Incidence of Patients Reducing Everolimus Dose
time frame: Up to 8 weeks
description: Original plan for collecting and analyzing this data did not occur due to study termination.
Will compare the number of patients who reduced their everolimus dose between the treatment arms. Will be compared using Chi-squared tests.
measure: Dexamethasone Prescription Fill Rates
time frame: Up to 8 weeks
description: Original plan for collecting and analyzing this data did not occur due to study termination.
Will compare dexamethasone prescription fill rates between the treatment groups. This will be compared using Chi-squared tests.
measure: Time to Dexamethasone Prescription Fill
time frame: Up to 8 weeks
description: Original plan for collecting and analyzing this data did not occur due to study termination.
Will compare the time to dexamethasone prescription fill between the treatment groups. This will be compared using Kaplan-Meier and cumulative incidence curves.
measure: Time to Develop Mouth Sores Per Study Arm Assessed by PRO-CTCAE Mouth/Throat Sore Item Regarding Severity
time frame: Up to 8 weeks
description: Original plan for collecting and analyzing this data did not occur due to study termination.
The time to develop at least mild, moderate, or severe (including "Very severe") mouth sores per study arm as measured by the PRO-CTCAE mouth-throat sore item regarding severity. The PRO-CTCAE mouth-throat sore item regarding severity is measured on a Likert 1-5 scale, with 1 corresponding to "None" and 5 corresponding to "Very severe". Will be assessed by Kaplan-Meier and cumulative incidence curves.
measure: Mean Degrees of Patient-reported Mouth Sores Per Study Arm Assessed by NAMPS
time frame: Up to 8 weeks
description: Original plan for collecting and analyzing this data did not occur due to study termination.
The mean degrees of patient-reported mouth sores per study arm as measured by the NAMPS will be assessed by independent samples t-tests.
measure: Median Degree of Patient-reported Mouth Sores Per Study Arm Assessed by NAMPS
time frame: Up to 8 weeks
description: Original plan for collecting and analyzing this data did not occur due to study termination.
The median degrees of patient-reported mouth sores per study arm as measured by the NAMPS will be assessed by independent samples t-tests.
measure: Proportion of Patients Who Experience Grade 2 Stomatitis
time frame: Up to 2 months
description: Original plan for collecting and analyzing this data did not occur due to study termination.
The proportion of patients who experience clinician-reported grade 2 stomatitis (as measured by the CTCAE and performed at 1 and 2 months post-baseline) per study arm will be assessed by Chi-squared tests.
measure: Incidence Rate of the mTOR Inhibitor-associated Stomatitis (mIAS)-Related Pain Based on Daily Self-reports Via the Numerical Analogue Scale by Sex
time frame: Up to 8 weeks
description: NIH-required analysis. The numerical analogue mouth pain score (NAMPS) is a single item measured on a 0 to 10 scale, with 0 corresponding to "No pain" and 10 corresponding to "Pain as bad as it can be." Will compare the incidence rate of any mouth pain (i.e., any score greater than 0) as assessed by the NAMPS between the prevention versus early treatment approaches using a Chi-square test.
measure: Incidence Rate of the mTOR Inhibitor-associated Stomatitis (mIAS)-Related Pain Based on Daily Self-reports Via the Numerical Analogue Scale by Race
time frame: Up to 8 weeks
description: NIH-required analysis. The numerical analogue mouth pain score (NAMPS) is a single item measured on a 0 to 10 scale, with 0 corresponding to "No pain" and 10 corresponding to "Pain as bad as it can be." Will compare the incidence rate of any mouth pain (i.e., any score greater than 0) as assessed by the NAMPS between the prevention versus early treatment approaches using a Chi-square test.
measure: Incidence Rate of the mTOR Inhibitor-associated Stomatitis (mIAS)-Related Pain Based on Daily Self-reports Via the Numerical Analogue Scale by Ethnicity.
time frame: Up to 8 weeks
description: NIH-required analysis. The numerical analogue mouth pain score (NAMPS) is a single item measured on a 0 to 10 scale, with 0 corresponding to "No pain" and 10 corresponding to "Pain as bad as it can be." Will compare the incidence rate of any mouth pain (i.e., any score greater than 0) as assessed by the NAMPS between the prevention versus early treatment approaches using a Chi-square test.
measure: Severity of Mouth Pain Scores by Sex
time frame: Up to 8 weeks
description: Average Area Under the Curve per assessment (aAUCpa) of mouth pain scores as measured by NAMPS will be computed for each patient to summarize the sequence of numerical analogue mouth pain scores over the eight week study period. Scores are reported on a 0-100 scale, where 100 = better outcome QOL (i.e. less pain). The aAUCpa is the average of each AUC between each sequential assessment from treatment-initiation to the end of the treatment at 8 weeks post-treatment-initiation and will be compared between the two treatment arms.
measure: Severity of Mouth Pain Scores by Race
time frame: Up to 8 weeks
description: Average Area Under the Curve per assessment (aAUCpa) of mouth pain scores as measured by NAMPS will be computed for each patient to summarize the sequence of numerical analogue mouth pain scores over the eight week study period. Scores are reported on a 0-100 scale, where 100 = better outcome QOL (i.e. less pain). The aAUCpa is the average of each AUC between each sequential assessment from treatment-initiation to the end of the treatment at 8 weeks post-treatment-initiation and will be compared between the two treatment arms.
measure: Severity of Mouth Pain Scores by Ethnicity
time frame: Up to 8 weeks
description: Average Area Under the Curve per assessment (aAUCpa) of mouth pain scores as measured by NAMPS will be computed for each patient to summarize the sequence of numerical analogue mouth pain scores over the eight week study period. Scores are reported on a 0-100 scale, where 100 = better outcome QOL (i.e. less pain). The aAUCpa is the average of each AUC between each sequential assessment from treatment-initiation to the end of the treatment at 8 weeks post-treatment-initiation and will be compared between the two treatment arms.
arm group label: Group I (dexamethasone)
arm group type: Experimental
description: Patients receive 10mg oral everolimus daily as standard of care and 10ml dexamethasone oral mouthwash, swished for 2-minutes daily, for 8 weeks.
arm group label: Group II (placebo)
arm group type: Placebo Comparator
description: Patients receive 10mg oral everolimus daily as standard of care and 10ml placebo oral mouthwash, swished for 2-minutes daily, for 8 weeks.
intervention type: Drug
intervention name: Dexamethasone
description: Given as mouthwash
arm group label: Group I (dexamethasone)
intervention type: Other
intervention name: Placebo
description: Given as mouthwash
arm group label: Group II (placebo)
intervention type: Other
intervention name: Questionnaire
description: Ancillary studies
arm group label: Group I (dexamethasone)
arm group label: Group II (placebo)
intervention type: Other
intervention name: Quality-of-Life Assessment
description: Ancillary studies
arm group label: Group I (dexamethasone)
arm group label: Group II (placebo)
intervention type: Drug
intervention name: Everolimus
description: Standard of care
arm group label: Group I (dexamethasone)
arm group label: Group II (placebo)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kathryn Ruddy, MD
role: Study Chair
affiliation: Mayo Clinic
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country: United States
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Stomatitis
mesh term: Dexamethasone
mesh term: Everolimus
sharing ipd: Undecided
provided document: 
participant flow: 
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outcome list: 
reported events: 
certain agreements: 
point of contact: 