xml: <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/NCT06005324</url>
    </required_header>
    <id_info>
      <org_study_id>IRB23-0095</org_study_id>
      <nct_id>NCT06005324</nct_id>
    </id_info>
    <brief_title>Personalized, Adaptive Treatment for Locally Advanced Head and Neck Cancer</brief_title>
    <official_title>Pilot Study of Induction Therapy Followed by Response-adaptive Treatment and Dynamic Changes in Circulating Tumor DNA in Locoregionally Advanced HPV Negative Head and Neck Squamous Cell Carcinoma</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Chicago</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Chicago</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This clinical trial will assess whether or not blood based biomarker testing can be used to&#xD;
        personalize cancer treatment for patients with locally advanced head and neck cancer.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 2023</start_date>
    <completion_date type="Anticipated">December 2026</completion_date>
    <primary_completion_date type="Anticipated">June 2026</primary_completion_date>
    <phase>Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Sequential Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Percentage of participants that complete study treatment and provide all required research blood draws.</measure>
      <time_frame>To be measured at end of treatment period (9 weeks)</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Determine if ctDNA levels is predicative of disease response</measure>
      <time_frame>To be measured at end of treatment period (9 weeks)</time_frame>
      <description>Researchers will look at amount of ctDNA in the blood to determine if it correlates to disease response based on imaging results per RECIST v1.1.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of participants with side effects related to study treatment</measure>
      <time_frame>To be measured at 3 months after end of treatment period</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Long Term Disease Response based on RECIST 1.1</measure>
      <time_frame>To be assessed at 2 years after end of treatment period</time_frame>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">36</enrollment>
    <condition>HPV-Negative Squamous Cell Carcinoma</condition>
    <arm_group>
      <arm_group_label>Induction Treatment Arm</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>All participants will receive 3 cycles (9 weeks) of chemotherapy with paclitaxel, carboplatin, and cetuximab.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>De-Escalation CRT Cohort</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>After completing induction chemotherapy, participants that have significant disease response by imaging will receive low dose radiation treatment with additional chemotherapy (CRT). Investigator will choose the appropriate chemotherapy backbone to be given during CRT.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Standard Treatment Cohort</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>After completing induction chemotherapy, participants that have limited disease response by imaging will receive standard dose radiation treatment with additional chemotherapy (CRT). Investigator will choose the appropriate chemotherapy backbone to be given during CRT.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Paclitaxel</intervention_name>
      <description>Given as part of induction chemotherapy.</description>
      <arm_group_label>Induction Treatment Arm</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Carboplatin</intervention_name>
      <description>Given as part of induction chemotherapy.</description>
      <arm_group_label>Induction Treatment Arm</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Cetuximab</intervention_name>
      <description>Given as part of induction chemotherapy.</description>
      <arm_group_label>Induction Treatment Arm</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Radiation</intervention_type>
      <intervention_name>Standard Dose Radiation</intervention_name>
      <description>Radiation given once daily for 5 days for 7 weeks as part of CRT regimen.</description>
      <arm_group_label>Standard Treatment Cohort</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Radiation</intervention_type>
      <intervention_name>Low Dose Radiation</intervention_name>
      <description>Radiation given once daily for 5 days for 6.5 weeks as part of CRT regimen.</description>
      <arm_group_label>De-Escalation CRT Cohort</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Cisplatin</intervention_name>
      <description>Given as part of CRT regimen (7 weekly doses). Investigator will choose the appropriate chemotherapy backbone to be given during CRT.</description>
      <arm_group_label>De-Escalation CRT Cohort</arm_group_label>
      <arm_group_label>Standard Treatment Cohort</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>TFHX Regimen</intervention_name>
      <description>Chemotherapy with paclitaxel, fluorouracil (5FU), and hydroxyurea given in combination with radiation therapy. Investigator will choose the appropriate chemotherapy backbone to be given during CRT.</description>
      <arm_group_label>De-Escalation CRT Cohort</arm_group_label>
      <arm_group_label>Standard Treatment Cohort</arm_group_label>
      <other_name>paclitaxel, fluorouracil (5-FU), hydroxyurea</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients must have pathologically confirmed locally advanced, non-metastatic, human&#xD;
               papillomavirus (HPV) negative head and neck squamous cell carcinoma of the oral&#xD;
               cavity, oropharynx, hypopharynx, nasopharynx, larynx, or sinuses.&#xD;
  &#xD;
            -  Stage III or IV disease based on American Joint Committee on Cancer (AJCC) staging 8th&#xD;
               edition.&#xD;
  &#xD;
            -  If a primary oropharyngeal squamous cell carcinoma is diagnosed, HPV must be ruled out&#xD;
               by immunohistochemistry.&#xD;
  &#xD;
            -  Availability of ≥10 unstained 5 micron slides. Patients who cannot fulfill this&#xD;
               requirement will need to undergo a new biopsy prior to enrollment on study.&#xD;
  &#xD;
            -  Patients must be at least 18 years of age.&#xD;
  &#xD;
            -  Measurable disease (either primary site and/or nodal disease) by RECIST 1.1 criteria.&#xD;
  &#xD;
            -  No previous radiation or chemotherapy for a head and neck cancer.&#xD;
  &#xD;
            -  No complete surgical resection for a head and neck cancer within 8 weeks of enrollment&#xD;
               (although lymph node biopsy including excision of an individual node with presence of&#xD;
               residual nodal disease, or surgical biopsy/excision of the tumor with residual&#xD;
               measurable disease is acceptable.) No surgical procedures or core-needle or excisional&#xD;
               biopsies will occur after baseline scans are performed and measurable lesions are&#xD;
               identified. Fine-needle aspiration can be performed (i.e., to confirm extent of&#xD;
               baseline lymph node involvement) following discussion with PI if not performed on a&#xD;
               target lesion.&#xD;
  &#xD;
            -  Performance status 0-1&#xD;
  &#xD;
            -  Normal Organ Function&#xD;
  &#xD;
                 -  Leukocytes ≥ 3000/mm3&#xD;
  &#xD;
                 -  Platelets ≥ 100,000/mm3&#xD;
  &#xD;
                 -  Absolute neutrophil count ≥ 1,500&#xD;
  &#xD;
                 -  Hemoglobin ≥ 9.0 gm/dL&#xD;
  &#xD;
                 -  Aspartate Aminotransferase (AST) ≤ 2.5x upper limit of normal&#xD;
  &#xD;
                 -  Alanine aminotransferase (ALT) ≤ 2.5x upper limit of normal&#xD;
  &#xD;
                 -  Alkaline phosphatase ≤ 2.5x upper limit of normal&#xD;
  &#xD;
                 -  Albumin &gt; 2.9 gm/dL&#xD;
  &#xD;
                 -  Total bilirubin ≤ 1.5 mg/dL&#xD;
  &#xD;
                 -  Creatinine clearance (CrCl) &gt; 45 mL/min, normal within 2 weeks prior to start of&#xD;
                    treatment (Of note, the standard Cockcroft and Gault formula must be used to&#xD;
                    calculate CrCl for enrollment or dosing)&#xD;
  &#xD;
            -  Patients must sign a study-specific informed consent form prior to study entry.&#xD;
               Patients should have the ability to understand and the willingness to sign a written&#xD;
               informed consent document.&#xD;
  &#xD;
            -  Women of childbearing potential must have a negative serum or urine pregnancy test&#xD;
               (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the&#xD;
               start of study drug.&#xD;
  &#xD;
            -  Women must not be breastfeeding&#xD;
  &#xD;
            -  Women of childbearing potential must agree to follow instructions for method(s) of&#xD;
               contraception for the duration of treatment with study drug(s) plus 5 months after&#xD;
               completing chemoradiation or receiving the last dose of chemoradiation, whichever&#xD;
               occurs latest.&#xD;
  &#xD;
            -  Men who are sexually active with women of childbearing potential must agree to follow&#xD;
               instructions for method(s) of contraception for the duration of treatment with study&#xD;
               drug(s) plus 5 months after completing chemoradiation or receiving the last dose of&#xD;
               chemoradiation, whichever occurs latest.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Unequivocal demonstration of distant metastatic disease (M1 disease).&#xD;
  &#xD;
            -  Unidentifiable primary site.&#xD;
  &#xD;
            -  Intercurrent medical illnesses which would impair patient tolerance to therapy or&#xD;
               limit survival. This includes but is not limited to ongoing or active infection,&#xD;
               immunodeficiency, symptomatic congestive heart failure, pulmonary dysfunction,&#xD;
               cardiomyopathy, unstable angina pectoris, cardiac arrhythmia, or psychiatric&#xD;
               illness/social situations that would limit compliance. Patients with clinically stable&#xD;
               and/or chronically managed medical illnesses that are not symptomatic and/or are not&#xD;
               expected to impact treatment on protocol are still eligible (conditions to be reviewed&#xD;
               by the PI to confirm eligibility).&#xD;
  &#xD;
            -  Prior surgical therapy other than incisional/excisional biopsy or organ-sparing&#xD;
               procedures such as debulking of airway-compromising tumors. Residual measurable tumor&#xD;
               is required for enrollment as discussed above.&#xD;
  &#xD;
            -  Patients receiving other investigational agents.&#xD;
  &#xD;
            -  Diagnosis of immunodeficiency or is receiving systemic steroid therapy in excess of&#xD;
               physiologic dose or any other form of immunosuppressive therapy within 7 days prior to&#xD;
               the first dose of trial treatment.&#xD;
  &#xD;
            -  Known history of active tuberculosis (Bacillus Tuberculosis infection).&#xD;
  &#xD;
            -  Hypersensitivity to cetuximab or any other drug used in this protocol.&#xD;
  &#xD;
            -  Prior systemic anti-cancer treatment within the last 8 weeks.&#xD;
  &#xD;
            -  Has a known additional malignancy that is progressing or requires active treatment.&#xD;
               Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the&#xD;
               skin that has undergone potentially curative therapy or in situ cervical cancer or any&#xD;
               tumors that are not likely to influence life expectancy in the subsequent 3 years&#xD;
               without active treatment.&#xD;
  &#xD;
            -  Has a history of HIV.&#xD;
  &#xD;
            -  Has known active Hepatitis B or Hepatitis C. If eradicated, patient is eligible.&#xD;
  &#xD;
            -  Has received a live vaccine within 28 days of planned start of study therapy.&#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>Ari Rosenberg, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Chicago</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Clinical Trials Intake</last_name>
      <phone>1-855-702-8222</phone>
      <email>cancerclinicaltrials@bsd.uchicago.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of Chicago Medicine Comprehensive Cancer Center</name>
        <address>
          <city>Chicago</city>
          <state>Illinois</state>
          <zip>60637</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Clinical Trials Intake</last_name>
        <phone>855-702-8222</phone>
        <email>cancerclinicaltrials@bsd.uchicago.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</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>Carcinoma</mesh_term>
      <mesh_term>Carcinoma, Squamous Cell</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Paclitaxel</mesh_term>
      <mesh_term>Albumin-Bound Paclitaxel</mesh_term>
      <mesh_term>Carboplatin</mesh_term>
      <mesh_term>Fluorouracil</mesh_term>
      <mesh_term>Cetuximab</mesh_term>
      <mesh_term>Hydroxyurea</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06005324
  org study id: IRB23-0095
  nct id: NCT06005324
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: Yes
  is us export: No
  This clinical trial will assess whether or not blood based biomarker testing can be used to
        personalize cancer treatment for patients with locally advanced head and neck cancer.
  allocation: Non-Randomized
  intervention model: Sequential Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Percentage of participants that complete study treatment and provide all required research blood draws.
  time frame: To be measured at end of treatment period (9 weeks)
  measure: Determine if ctDNA levels is predicative of disease response
  time frame: To be measured at end of treatment period (9 weeks)
  description: Researchers will look at amount of ctDNA in the blood to determine if it correlates to disease response based on imaging results per RECIST v1.1.
  measure: Number of participants with side effects related to study treatment
  time frame: To be measured at 3 months after end of treatment period
  measure: Long Term Disease Response based on RECIST 1.1
  time frame: To be assessed at 2 years after end of treatment period
  arm group label: Induction Treatment Arm
  arm group type: Other
  description: All participants will receive 3 cycles (9 weeks) of chemotherapy with paclitaxel, carboplatin, and cetuximab.
  arm group label: De-Escalation CRT Cohort
  arm group type: Experimental
  description: After completing induction chemotherapy, participants that have significant disease response by imaging will receive low dose radiation treatment with additional chemotherapy (CRT). Investigator will choose the appropriate chemotherapy backbone to be given during CRT.
  arm group label: Standard Treatment Cohort
  arm group type: Active Comparator
  description: After completing induction chemotherapy, participants that have limited disease response by imaging will receive standard dose radiation treatment with additional chemotherapy (CRT). Investigator will choose the appropriate chemotherapy backbone to be given during CRT.
  intervention type: Drug
  intervention name: Paclitaxel
  description: Given as part of induction chemotherapy.
  arm group label: Induction Treatment Arm
  intervention type: Drug
  intervention name: Carboplatin
  description: Given as part of induction chemotherapy.
  arm group label: Induction Treatment Arm
  intervention type: Drug
  intervention name: Cetuximab
  description: Given as part of induction chemotherapy.
  arm group label: Induction Treatment Arm
  intervention type: Radiation
  intervention name: Standard Dose Radiation
  description: Radiation given once daily for 5 days for 7 weeks as part of CRT regimen.
  arm group label: Standard Treatment Cohort
  intervention type: Radiation
  intervention name: Low Dose Radiation
  description: Radiation given once daily for 5 days for 6.5 weeks as part of CRT regimen.
  arm group label: De-Escalation CRT Cohort
  intervention type: Drug
  intervention name: Cisplatin
  description: Given as part of CRT regimen (7 weekly doses). Investigator will choose the appropriate chemotherapy backbone to be given during CRT.
  arm group label: De-Escalation CRT Cohort
  arm group label: Standard Treatment Cohort
  intervention type: Drug
  intervention name: TFHX Regimen
  description: Chemotherapy with paclitaxel, fluorouracil (5FU), and hydroxyurea given in combination with radiation therapy. Investigator will choose the appropriate chemotherapy backbone to be given during CRT.
  arm group label: De-Escalation CRT Cohort
  arm group label: Standard Treatment Cohort
  other name: paclitaxel, fluorouracil (5-FU), hydroxyurea
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Ari Rosenberg, MD
  role: Principal Investigator
  affiliation: University of Chicago
  last name: Clinical Trials Intake
  phone: 1-855-702-8222
  email: cancerclinicaltrials@bsd.uchicago.edu
  facility: 
  contact: 
  country: United States
  responsible party type: Sponsor
  mesh term: Carcinoma
  mesh term: Carcinoma, Squamous Cell
  mesh term: Paclitaxel
  mesh term: Albumin-Bound Paclitaxel
  mesh term: Carboplatin
  mesh term: Fluorouracil
  mesh term: Cetuximab
  mesh term: Hydroxyurea
  sharing ipd: No