<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/NCT04502641</url>
  </required_header>
  <id_info>
    <org_study_id>hypopharyngeal SCC 001</org_study_id>
    <nct_id>NCT04502641</nct_id>
  </id_info>
  <brief_title>Induction Chemotherapy in Locally Advanced Hypopharyngeal Carcinoma: a Randomised Phase 3 Trial</brief_title>
  <official_title>A Randomized Phase III Comparing Sequential Therapy With Induction Chemotherapy/Chemoradiation To Cisplatinum-Based Chemoradiotherapy in Locally Advanced Hypopharyngeal Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sun Yat-sen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sun Yat-sen University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hypopharyngeal cancer is an important part of head and neck cancer, with more than 80,000 new&#xD;
      cases in 2018. And it is a highly aggressive cancer often diagnosed at an advanced stage.&#xD;
      which expresses poor survival, the 5-year overall survival (OS) is about only 30%-35%. Given&#xD;
      the complexity of these tumors, their surrounding structures, the frequent comorbidities, and&#xD;
      the improvement of patients' requirements for quality of life, a multidisciplinary treatment&#xD;
      approach should be applied to achieve the best oncological outcomes and to improve functional&#xD;
      results. This benefi t of induction chemotherapy has been recorded in patients with both&#xD;
      resectable and unresectable disease. It has also been observed in patients with laryngeal&#xD;
      cancer treated for organ preservation. However, whether the addition of induction&#xD;
      chemotherapy to chemoradiotherapy improves efficacy compared with chemoradiotherapy alone is&#xD;
      unclear in hypopharyngeal cancer.We tried to observe the clinical treatment efficiency, toxic&#xD;
      and side effects, progression-free survival time, overall survival time and quality of life&#xD;
      of anlotinib in the treatment of patients with refractory head and neck carcinoma. Provide&#xD;
      patients with a more optimal treatment plan and improve survival.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We will prospectively collect 160 patients who were randomly assigned (in a 1:1 ratio) to&#xD;
      receive either induction chemotherapy followed by concurrent chemoradiotherapy (group A) or&#xD;
      definitive concurrent chemoradiotherapy (group B). Data will be stored in a private database.&#xD;
      The process of data collection will be supervised and regular data examination will be&#xD;
      performed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Anticipated">August 1, 2020</start_date>
  <completion_date type="Anticipated">August 1, 2025</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2023</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Progression-free survival (RFS)</measure>
    <time_frame>3 month</time_frame>
    <description>Measured from the date of treatment end to recurrent/residual tumor was diagnose or to the time of the last follow-up, whichever occurred first，by means of computed tomography (CT) or magnetic resonance imaging (MRI) at each follow-up.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall-survival (OS)</measure>
    <time_frame>3 month</time_frame>
    <description>Defined as the interval between the time of treatment end to death or to the last date of follow-up，by means of computed tomography (CT) or magnetic resonance imaging (MRI) at each follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events rate</measure>
    <time_frame>One month</time_frame>
    <description>Adverse events during the treatment period using Common Terminology Criteria for Adverse Events (CTCAE) (version 5.0).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">160</enrollment>
  <condition>Hypopharyngeal Cancer</condition>
  <arm_group>
    <arm_group_label>Arm I</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive induction chemotherapy with docetaxel-based, with or without cisplatin or fluorouracil. Treatment repeats every 21 days for 3 courses. Then, patients receive cisplatin on day 1 day 21, 3 weeks as one cycle and undergo concurrent radiotherapy once daily, 5 days a week, for 6 to 7 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm II</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients receive cisplatin on day 1 day 21, 3 weeks as one cycle and undergo concurrent radiotherapy once daily, 5 days a week, for 6 to 7 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Docetaxel</intervention_name>
    <description>60mg/m2 on day 1, 3 weeks as one cycle, for 3 cycles.</description>
    <arm_group_label>Arm I</arm_group_label>
    <other_name>Taxol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>5-fluorouracil</intervention_name>
    <description>600 mg/m² per day as a continuous 120 h infusion on days 1-5, 3 weeks as one cycle, for 3 cycles.</description>
    <arm_group_label>Arm I</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cisplatin</intervention_name>
    <description>60mg/m2 on day 1, 3 weeks as one cycle, for 3 cycles.</description>
    <arm_group_label>Arm I</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Intensity Modulated Radiation Therapy</intervention_name>
    <description>The treatment consisted of definitive radiotherapy with conventional fractionation, a total dose of 68-70 Gy to PTVp, 62-68 Gy to PTVn, 60-62 Gy to PTV-HR, and 50-54 Gy to PTV-LR.</description>
    <arm_group_label>Arm I</arm_group_label>
    <arm_group_label>Arm II</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Platinum</intervention_name>
    <description>100mg/m2 on day 1, 3 weeks as one cycle, during radiotherapy.</description>
    <arm_group_label>Arm I</arm_group_label>
    <arm_group_label>Arm II</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1. Male or female, aged 18 to 75 years; 2. Performance status (PS) score ≤ 2 points;&#xD;
             3. The expected survival period is more than 3 months; 4. Patients have&#xD;
             histopathologically confirmed hypopharyngeal squamous cell carcinoma, including the&#xD;
             piriform fossa, postcricoid region, and posterior pharyngeal wall with stage III and&#xD;
             IVA-B (TNM stageT1-2N1-3M0/T3-4aN0-3M0) according to the AJCC 8th edition; 5. With&#xD;
             measurable lesions: According to the evaluation criteria for the efficacy of solid&#xD;
             tumors (Response Evaluation Criteria In Solid Tumors 1.1), the patient has at least&#xD;
             one measurable lesion. The measurable lesion should not have received local treatment&#xD;
             such as radiotherapy (target lesion located in the previous radiotherapy area, if it&#xD;
             is confirmed that significant progress has occurred , And comply with evaluation&#xD;
             standard, can also be used as target lesions); 6. No previous anti-tumor therapy,&#xD;
             including anti-angiogenesis therapy, such as pazopanib, sunitinib, sorafenib,&#xD;
             regorafenib, etc.; 7. Sufficient liver function: total bilirubin ≤ upper limit of&#xD;
             normal value (ULN); glutamic oxalacetic transaminase (AST) and glutamic-pyruvic&#xD;
             transaminase (ALT) ≤ 2 times upper limit of normal value (ULN); alkaline phosphatase ≤&#xD;
             5 times upper limit of normal value (ULN); 8. Adequate renal function: creatinine&#xD;
             clearance rate ≥80 mL/min; 9. Adequate blood function: absolute neutrophil count (ANC)&#xD;
             ≥2×109/L, platelet count ≥100×109/L and hemoglobin ≥9g/dL; 10. No serious heart, lung&#xD;
             and other important organ dysfunction; 11. Women of childbearing age must have taken&#xD;
             reliable contraceptive measures; pregnancy tests (serum or urine) are negative within&#xD;
             7 days before enrollment, and must be non-lactating patients; and are willing to adopt&#xD;
             appropriate during the test and within 6 months after the last treatment Methods of&#xD;
             contraception. For men, it is necessary to agree to use appropriate methods of&#xD;
             contraception or surgical sterilization during the trial and 8 weeks after the last&#xD;
             dose; 12. The subjects voluntarily joined the study and signed an informed consent&#xD;
             form with good compliance and cooperated with the follow-up.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1. Have a history of other cancers in the past five years, radical or untreated&#xD;
             prostate cancer (Gleason score ≤ 6), or complete treatment of breast ductal carcinoma&#xD;
             in situ, except for patients with cured skin basal cell carcinoma or squamous cell&#xD;
             skin cancer; 2. Patients with target lesions who have received radiation therapy or&#xD;
             surgery (except biopsy); 3. Treatment with palliative intent; 4. A history of previous&#xD;
             radiotherapy, chemotherapy, or surgery (except diagnostic) to the primary tumor or&#xD;
             nodes; 5. Any severe coexisting disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yong Chen</last_name>
    <role>Principal Investigator</role>
    <affiliation>First Affiliated Hospital, Sun Yat-Sen University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yong Chen</last_name>
    <phone>+862087755766</phone>
    <email>chenyong@mail.sysu.edu.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Cheng-tao Wang</last_name>
    <phone>+862087755766</phone>
    <email>ct_wang@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Sun Yat-sen University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510080</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yong Chen</last_name>
      <phone>8602087338692</phone>
      <email>chenyong@mail.sysu.edu.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 4, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>August 4, 2020</last_update_submitted>
  <last_update_submitted_qc>August 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
    <investigator_full_name>Zhen-Wei Peng</investigator_full_name>
    <investigator_title>Zhen-Wei Peng</investigator_title>
  </responsible_party>
  <keyword>hypopharyngeal carcinoma</keyword>
  <keyword>chemotherapy</keyword>
  <keyword>radiotherapy</keyword>
  <keyword>prognosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Hypopharyngeal Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Docetaxel</mesh_term>
    <mesh_term>Fluorouracil</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04502641
org study id: hypopharyngeal SCC 001
nct id: NCT04502641
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Hypopharyngeal cancer is an important part of head and neck cancer, with more than 80,000 new
      cases in 2018. And it is a highly aggressive cancer often diagnosed at an advanced stage.
      which expresses poor survival, the 5-year overall survival (OS) is about only 30%-35%. Given
      the complexity of these tumors, their surrounding structures, the frequent comorbidities, and
      the improvement of patients' requirements for quality of life, a multidisciplinary treatment
      approach should be applied to achieve the best oncological outcomes and to improve functional
      results. This benefi t of induction chemotherapy has been recorded in patients with both
      resectable and unresectable disease. It has also been observed in patients with laryngeal
      cancer treated for organ preservation. However, whether the addition of induction
      chemotherapy to chemoradiotherapy improves efficacy compared with chemoradiotherapy alone is
      unclear in hypopharyngeal cancer.We tried to observe the clinical treatment efficiency, toxic
      and side effects, progression-free survival time, overall survival time and quality of life
      of anlotinib in the treatment of patients with refractory head and neck carcinoma. Provide
      patients with a more optimal treatment plan and improve survival.
We will prospectively collect 160 patients who were randomly assigned (in a 1:1 ratio) to
      receive either induction chemotherapy followed by concurrent chemoradiotherapy (group A) or
      definitive concurrent chemoradiotherapy (group B). Data will be stored in a private database.
      The process of data collection will be supervised and regular data examination will be
      performed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression-free survival (RFS)
time frame: 3 month
description: Measured from the date of treatment end to recurrent/residual tumor was diagnose or to the time of the last follow-up, whichever occurred first，by means of computed tomography (CT) or magnetic resonance imaging (MRI) at each follow-up.
measure: Overall-survival (OS)
time frame: 3 month
description: Defined as the interval between the time of treatment end to death or to the last date of follow-up，by means of computed tomography (CT) or magnetic resonance imaging (MRI) at each follow-up.
measure: Adverse events rate
time frame: One month
description: Adverse events during the treatment period using Common Terminology Criteria for Adverse Events (CTCAE) (version 5.0).
arm group label: Arm I
arm group type: Experimental
description: Patients receive induction chemotherapy with docetaxel-based, with or without cisplatin or fluorouracil. Treatment repeats every 21 days for 3 courses. Then, patients receive cisplatin on day 1 day 21, 3 weeks as one cycle and undergo concurrent radiotherapy once daily, 5 days a week, for 6 to 7 weeks.
arm group label: Arm II
arm group type: Active Comparator
description: Patients receive cisplatin on day 1 day 21, 3 weeks as one cycle and undergo concurrent radiotherapy once daily, 5 days a week, for 6 to 7 weeks.
intervention type: Drug
intervention name: Docetaxel
description: 60mg/m2 on day 1, 3 weeks as one cycle, for 3 cycles.
arm group label: Arm I
other name: Taxol
intervention type: Drug
intervention name: 5-fluorouracil
description: 600 mg/m² per day as a continuous 120 h infusion on days 1-5, 3 weeks as one cycle, for 3 cycles.
arm group label: Arm I
intervention type: Drug
intervention name: Cisplatin
description: 60mg/m2 on day 1, 3 weeks as one cycle, for 3 cycles.
arm group label: Arm I
intervention type: Radiation
intervention name: Intensity Modulated Radiation Therapy
description: The treatment consisted of definitive radiotherapy with conventional fractionation, a total dose of 68-70 Gy to PTVp, 62-68 Gy to PTVn, 60-62 Gy to PTV-HR, and 50-54 Gy to PTV-LR.
arm group label: Arm I
arm group label: Arm II
intervention type: Drug
intervention name: Platinum
description: 100mg/m2 on day 1, 3 weeks as one cycle, during radiotherapy.
arm group label: Arm I
arm group label: Arm II
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Yong Chen
role: Principal Investigator
affiliation: First Affiliated Hospital, Sun Yat-Sen University
last name: Yong Chen
phone: +862087755766
email: chenyong@mail.sysu.edu.cn
last name: Cheng-tao Wang
phone: +862087755766
email: ct_wang@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: Zhen-Wei Peng
investigator title: Zhen-Wei Peng
mesh term: Carcinoma
mesh term: Hypopharyngeal Neoplasms
mesh term: Docetaxel
mesh term: Fluorouracil