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/NCT05992610</url>
    </required_header>
    <id_info>
      <org_study_id>iCHRTL</org_study_id>
      <nct_id>NCT05992610</nct_id>
    </id_info>
    <brief_title>Induction Treatment in SCC of the Head and Neck Region - Concomitant Chemotherapy and Low-dose Radiotherapy</brief_title>
    <acronym>iCHRTL</acronym>
    <official_title>Induction Treatment in Patients With Squamous Cell Carcinoma (SCC) of the Head and Neck Region Consisting Concomitant Chemotherapy and Low-dose Ionizing Radiotherapy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Maria Sklodowska-Curie National Research Institute of Oncology</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Medical Research Agency, Poland</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Maria Sklodowska-Curie National Research Institute of Oncology</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</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>
        Non-commercial clinical study to assess:&#xD;
  &#xD;
          1. efficacy of iCHRTL in patients with advanced squamous cell carcinoma of oral cavity,&#xD;
             pharynx carcinoma, larynx carcinoma or paranasal sinus carcinoma.&#xD;
  &#xD;
          2. tolerability of iCHRTL in patients with advanced squamous cell carcinoma of oral cavity,&#xD;
             pharynx carcinoma, larynx carcinoma or paranasal sinus carcinoma.&#xD;
  &#xD;
          3. molecular and biochemical effect of low doses of ionizing radiation.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        40 patients with squamous cell carcinoma of oral cavity, pharynx, larynx or paranasal sinuses&#xD;
        in stage III or IV, previously not treated for this reason and eligible for induction&#xD;
        chemotherapy.&#xD;
  &#xD;
        Study treatment:&#xD;
  &#xD;
        Induction phase:&#xD;
  &#xD;
        Chemotherapy based on carboplatin 6 area under the curve (AUC) + paclitaxel 75 mg/m2&#xD;
        carboplatin 6 AUC 30-minute infusion on D: 1 (maximum carboplatin dose is 700 mg) paclitaxel&#xD;
        75 mg/m2 1-hour infusion on D: 1, 8, 15&#xD;
  &#xD;
        Radiotherapy:&#xD;
  &#xD;
        D:1 - 2 x 0,5 Gy (first dose up to one hour after the end of the carboplatin infusion, second&#xD;
        dose 3 to 6 hours later), D:2 - 2 x 0,5 Gy (interval between doses not less than 3 hours),&#xD;
        D:8 and D:15 - 2 x 0,5 Gy (first dose up to one hour after the end of the chemotherapeutic&#xD;
        infusion, second dose 3 to 6 hours later).&#xD;
  &#xD;
        2 cycles of induction treatment are planned. Interval between the last day of cycle I and the&#xD;
        first day of cycle II is 7 days. After 2 weeks from second cycle Positron emission tomography&#xD;
        (PET) and Magnetic Resonance (MR), medical case conference and qualification to further&#xD;
        treatment: Radiotherapy (RT), Chemo-radiotherapy (CHRT) or other, depending on the medical&#xD;
        decision.&#xD;
  &#xD;
        Planned based on the optimal technique for a particular clinical case preferred: Intensity&#xD;
        Modulated Radiation Therapy (IMRT). Preparation of IMRT plan will be based on computed&#xD;
        tomography (CT) scans. Early tolerance of radiotherapy will be assessed for local reaction.&#xD;
        At least once every 7 days.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">February 17, 2022</start_date>
    <completion_date type="Anticipated">March 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">March 31, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>Interventional, open, allocation to concomitant chemotherapy and low-dose ionizing radiotherapy</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Objective response rate (ORR) after induction</measure>
      <time_frame>1 year post-induction</time_frame>
      <description>Complete+partial response in percent</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Objective response rate (ORR) after induction</measure>
      <time_frame>3 years post-induction</time_frame>
      <description>Complete+partial response in percent</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Loco-regional control (LRC) rate</measure>
      <time_frame>1 year post-induction</time_frame>
      <description>Rate of local lesions complete response (CR) +partial response (PR)+stable disease (SD)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Loco-regional control (LRC) rate</measure>
      <time_frame>3 years post-induction</time_frame>
      <description>Rate of local lesions CR+PR+SD</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Distant metastasis rate</measure>
      <time_frame>1 year post-induction</time_frame>
      <description>Rate of patients with distant metastases</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Distant metastasis rate</measure>
      <time_frame>3 years post-induction</time_frame>
      <description>Rate of patients with distant metastases</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Overall survival time (OS)</measure>
      <time_frame>Date of treatment start - to 1 year</time_frame>
      <description>Rate of death within time from treatment start to 1 year</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Overall survival time (OS)</measure>
      <time_frame>Date of treatment start - to 3 years</time_frame>
      <description>Rate of death within time from treatment start to 3 years</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Squamous Cell Carcinoma of Oral Cavity</condition>
    <condition>Pharynx Carcinoma</condition>
    <condition>Larynx Carcinoma</condition>
    <condition>Paranasal Sinus Carcinoma</condition>
    <arm_group>
      <arm_group_label>Chemotherapy (Ch)+ Radiotherapy (RT)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Induction phase:&#xD;
  Chemotherapy based on carboplatin 6 AUC (area under the curve) + paclitaxel 75 mg/m2 carboplatin 6 AUC 30-minute infusion on D: 1 (maximum carboplatin dose is 700 mg) paclitaxel 75 mg/m2 1-hour infusion on D: 1, 8, 15&#xD;
  Radiotherapy:&#xD;
  D:1 - 2 x 0,5 Gy (first dose up to one hour after the end of the carboplatin infusion, second dose 3 to 6 hours later), D:2 - 2 x 0,5 Gy (interval between doses not less than 3 hours), D:8 and D:15 - 2 x 0,5 Gy (first dose up to one hour after the end of the chemotherapeutic infusion, second dose 3 to 6 hours later).</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Chemotherapy (carboplatin+paclitaxel) with concomitant low dose ionizing radiotherapy</intervention_name>
      <description>Chemotherapy based on carboplatin 6 AUC + paclitaxel 75 mg/m2.&#xD;
  Radiotherapy:&#xD;
  D:1 - 2 x 0,5 Gy (first dose up to one hour after the end of the carboplatin infusion, second dose 3 to 6 hours later), D:2 - 2 x 0,5 Gy (interval between doses not less than 3 hours), D:8 and D:15 - 2 x 0,5 Gy (first dose up to one hour after the end of the chemotherapeutic infusion, second dose 3 to 6 hours later).</description>
      <arm_group_label>Chemotherapy (Ch)+ Radiotherapy (RT)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patients with squamous cell carcinoma of oral cavity, upper, middle, lower pharynx&#xD;
               carcinoma, larynx carcinoma or paranasal sinus carcinoma in advanced stage III or IV&#xD;
               and previously not treated for this reason.&#xD;
  &#xD;
            2. Severity of the disease: N1 &gt; 2 cm, N2, N3 ; T2, T3, T4, M0&#xD;
  &#xD;
            3. Patient eligible for radical treatment with induction chemotherapy (at least in good&#xD;
               general condition (ZUBROD 0-1) with no significant additional diseases disqualifying&#xD;
               from induction chemotherapy).&#xD;
  &#xD;
            4. Written informed consent form to the proposed therapeutic scheme.&#xD;
  &#xD;
            5. Age over 18 years.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Subjects with known or suspected hypersensitivity to any of the study mediations.&#xD;
  &#xD;
            2. Baseline values for the following parameters (in the screening phase):&#xD;
  &#xD;
                 -  Creatinine &gt;2,0 x upper limit of normal (ULN) - unless creatinine clearance is&#xD;
                    normal&#xD;
  &#xD;
                 -  Total bilirubin &gt;1,5 x ULN (except for hyperbilirubinemia caused by Gilbert's&#xD;
                    syndrome)&#xD;
  &#xD;
                 -  Alanine Transaminase (ALT) activity, Aspartate Transaminase (ASPAT) &gt;2,5 x ULN&#xD;
  &#xD;
                 -  Alkaline phosphatase activity &gt;2,5 x ULN&#xD;
  &#xD;
            3. Prior treatment with any unauthorized medication or investigational treatment before&#xD;
               the 5 half-lives of that substance or 4 weeks prior to study entry (a longer period of&#xD;
               time should be assumed), or subjects currently enrolled to other interventional&#xD;
               clinical trials.&#xD;
  &#xD;
            4. Concomitant malignancy or history of a malignancy with a significant potential impact&#xD;
               to tolerability or effectivity of iCHRTL.&#xD;
  &#xD;
            5. Chronic or active infection requiring antibiotic, antifungal or antiviral treatment,&#xD;
               such as, but not limited to: chronic kidney infection, chronic respiratory tract&#xD;
               infection with bronchospasm, tuberculosis or active hepatitis C virus infection.&#xD;
  &#xD;
            6. History of significant cerebrovascular disease within 6 months or currently&#xD;
               symptomatic or its implications.&#xD;
  &#xD;
            7. Human Immunodeficiency Virus (HIV) infection.&#xD;
  &#xD;
            8. Clinically significant heart disease including unstable angina, myocardial infarction&#xD;
               within 6 months prior to study entry, severe congestive circulatory failure class New&#xD;
               York Heart Association (NYHA) III-IV, arrhythmias unless it is treated, except for&#xD;
               collateral contractions or minimal conduction disorders.&#xD;
  &#xD;
            9. Significant concomitant disease that cannot be treated, such as, but not limited to&#xD;
               kidney, liver, gastrointestinal, endocrine system, respiratory, neurological and brain&#xD;
               diseases and mental illnesses that may pose a risk to the patient in the opinion of&#xD;
               the investigator.&#xD;
  &#xD;
           10. Active hepatitis B virus (HBV) infection, defined as having a positive Hepatitis B&#xD;
               surface antigen (HBsAg) test. Moreover, in case of a negative HBsAg test result but a&#xD;
               positive Hepatitis B core Antibody (HBcAb) test result (regardless of HBsAb status),&#xD;
               HBV DNA should be determined and in case of a positive result the patient cannot be&#xD;
               included to the study.&#xD;
  &#xD;
           11. Active hepatitis C virus (HCV) infection, defined as having a positive Hepatitis C&#xD;
               Antibody (HCAb) test, in which case Hepatitis C virus recombinant immunoblot assay&#xD;
               (HCV RIBA) should be determined from the same sample to confirm the result.&#xD;
  &#xD;
           12. Pregnancy or breastfeeding (women of childbearing potential must have pregnancy test&#xD;
               performed during screening).&#xD;
  &#xD;
           13. Women of childbearing potential, including women whose last menstrual period occurred&#xD;
               in less than one year before screening, who cannot or do not want to use adequate&#xD;
               contraception methods from the beginning of the study until 6 months after the last&#xD;
               dose of study drug. Adequate contraception is defines as the use of oral hormonal&#xD;
               contraceptives, an intrauterine device, a double barrier method or sexual abstinence.&#xD;
  &#xD;
           14. Men who cannot or do not want to use adequate contraception methods from the beginning&#xD;
               of the study until 6 months after the last dose of study medication.&#xD;
  &#xD;
           15. Patients who cannot or do not want to adhere to the study Protocol.&#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>Krzysztof Składowski, MD PhD</last_name>
      <role>Study Chair</role>
      <affiliation>Maria Sklodowska-Curie National Research Institute of Oncology (MSCNRIO)</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Tomasz Rutkowski, MD PhD</last_name>
      <phone>+ 48 32 278 83 38</phone>
      <email>Tomasz.Rutkowski@io.gliwice.pl</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Agnieszka Pietruszka, MD</last_name>
      <email>agnieszka.pietruszka@io.gliwice.pl</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>The Maria Sklodowska-Curie National Research Institute of Oncology, Branch in Gliwice</name>
        <address>
          <city>Gliwice</city>
          <state>Silesia</state>
          <zip>44-102</zip>
          <country>Poland</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Tomasz Rutkowski, MD PhD</last_name>
        <phone>+ 48 32 278 83 38</phone>
        <email>tomasz.rutkowski@io.gliwice.pl</email>
      </contact>
      <contact_backup>
        <last_name>Agnieszka Pietruszka, MD</last_name>
        <email>agnieszka.pietruszka@io.gliwice.pl</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Poland</country>
    </location_countries>
    <verification_date>March 2023</verification_date>
    <study_first_submitted>March 13, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 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>Carboplatin</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/NCT05992610
  org study id: iCHRTL
  nct id: NCT05992610
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  Non-commercial clinical study to assess:
  
          1. efficacy of iCHRTL in patients with advanced squamous cell carcinoma of oral cavity,
             pharynx carcinoma, larynx carcinoma or paranasal sinus carcinoma.
  
          2. tolerability of iCHRTL in patients with advanced squamous cell carcinoma of oral cavity,
             pharynx carcinoma, larynx carcinoma or paranasal sinus carcinoma.
  
          3. molecular and biochemical effect of low doses of ionizing radiation.
  40 patients with squamous cell carcinoma of oral cavity, pharynx, larynx or paranasal sinuses
        in stage III or IV, previously not treated for this reason and eligible for induction
        chemotherapy.
  
        Study treatment:
  
        Induction phase:
  
        Chemotherapy based on carboplatin 6 area under the curve (AUC) + paclitaxel 75 mg/m2
        carboplatin 6 AUC 30-minute infusion on D: 1 (maximum carboplatin dose is 700 mg) paclitaxel
        75 mg/m2 1-hour infusion on D: 1, 8, 15
  
        Radiotherapy:
  
        D:1 - 2 x 0,5 Gy (first dose up to one hour after the end of the carboplatin infusion, second
        dose 3 to 6 hours later), D:2 - 2 x 0,5 Gy (interval between doses not less than 3 hours),
        D:8 and D:15 - 2 x 0,5 Gy (first dose up to one hour after the end of the chemotherapeutic
        infusion, second dose 3 to 6 hours later).
  
        2 cycles of induction treatment are planned. Interval between the last day of cycle I and the
        first day of cycle II is 7 days. After 2 weeks from second cycle Positron emission tomography
        (PET) and Magnetic Resonance (MR), medical case conference and qualification to further
        treatment: Radiotherapy (RT), Chemo-radiotherapy (CHRT) or other, depending on the medical
        decision.
  
        Planned based on the optimal technique for a particular clinical case preferred: Intensity
        Modulated Radiation Therapy (IMRT). Preparation of IMRT plan will be based on computed
        tomography (CT) scans. Early tolerance of radiotherapy will be assessed for local reaction.
        At least once every 7 days.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Interventional, open, allocation to concomitant chemotherapy and low-dose ionizing radiotherapy
  primary purpose: Other
  masking: None (Open Label)
  measure: Objective response rate (ORR) after induction
  time frame: 1 year post-induction
  description: Complete+partial response in percent
  measure: Objective response rate (ORR) after induction
  time frame: 3 years post-induction
  description: Complete+partial response in percent
  measure: Loco-regional control (LRC) rate
  time frame: 1 year post-induction
  description: Rate of local lesions complete response (CR) +partial response (PR)+stable disease (SD)
  measure: Loco-regional control (LRC) rate
  time frame: 3 years post-induction
  description: Rate of local lesions CR+PR+SD
  measure: Distant metastasis rate
  time frame: 1 year post-induction
  description: Rate of patients with distant metastases
  measure: Distant metastasis rate
  time frame: 3 years post-induction
  description: Rate of patients with distant metastases
  measure: Overall survival time (OS)
  time frame: Date of treatment start - to 1 year
  description: Rate of death within time from treatment start to 1 year
  measure: Overall survival time (OS)
  time frame: Date of treatment start - to 3 years
  description: Rate of death within time from treatment start to 3 years
  arm group label: Chemotherapy (Ch)+ Radiotherapy (RT)
  arm group type: Experimental
  description: Induction phase:
  Chemotherapy based on carboplatin 6 AUC (area under the curve) + paclitaxel 75 mg/m2 carboplatin 6 AUC 30-minute infusion on D: 1 (maximum carboplatin dose is 700 mg) paclitaxel 75 mg/m2 1-hour infusion on D: 1, 8, 15
  Radiotherapy:
  D:1 - 2 x 0,5 Gy (first dose up to one hour after the end of the carboplatin infusion, second dose 3 to 6 hours later), D:2 - 2 x 0,5 Gy (interval between doses not less than 3 hours), D:8 and D:15 - 2 x 0,5 Gy (first dose up to one hour after the end of the chemotherapeutic infusion, second dose 3 to 6 hours later).
  intervention type: Other
  intervention name: Chemotherapy (carboplatin+paclitaxel) with concomitant low dose ionizing radiotherapy
  description: Chemotherapy based on carboplatin 6 AUC + paclitaxel 75 mg/m2.
  Radiotherapy:
  D:1 - 2 x 0,5 Gy (first dose up to one hour after the end of the carboplatin infusion, second dose 3 to 6 hours later), D:2 - 2 x 0,5 Gy (interval between doses not less than 3 hours), D:8 and D:15 - 2 x 0,5 Gy (first dose up to one hour after the end of the chemotherapeutic infusion, second dose 3 to 6 hours later).
  arm group label: Chemotherapy (Ch)+ Radiotherapy (RT)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Krzysztof Składowski, MD PhD
  role: Study Chair
  affiliation: Maria Sklodowska-Curie National Research Institute of Oncology (MSCNRIO)
  last name: Tomasz Rutkowski, MD PhD
  phone: + 48 32 278 83 38
  email: Tomasz.Rutkowski@io.gliwice.pl
  last name: Agnieszka Pietruszka, MD
  email: agnieszka.pietruszka@io.gliwice.pl
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Poland
  responsible party type: Sponsor
  mesh term: Carcinoma
  mesh term: Carcinoma, Squamous Cell
  mesh term: Paclitaxel
  mesh term: Carboplatin
  sharing ipd: No