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/NCT05994170</url>
    </required_header>
    <id_info>
      <org_study_id>ZSCPH-002</org_study_id>
      <nct_id>NCT05994170</nct_id>
    </id_info>
    <brief_title>Reducing High Risk Primary Tumor Clinical Target Volumes (CTVp1) in Non-metastatic Nasopharyngeal Carcinoma</brief_title>
    <acronym>CTVp1-NPC</acronym>
    <official_title>Reducing High Risk Primary Tumor Clinical Target Volumes (CTVp1) in Non-metastatic Nasopharyngeal Carcinoma Treated With Intensity-modulated Radiotherapy(IMRT): A Phase 3, Multicentre, Randomised Controlled Trial(CTVp1-NPC)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Zhongshan People's Hospital, Guangdong, China</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Sun Yat-sen University Cancer Centre</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Zhongshan People's Hospital, Guangdong, China</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>
    </oversight_info>
    <brief_summary>
      <textblock>
        To evaluate the long-term local control, survival rate, acute and late radiation related&#xD;
        toxicities, quality of life after reducing high risk primary tumor clinical target volumes&#xD;
        (CTVp1) in non-metastatic nasopharyngeal carcinoma treated with IMRT.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This phase 3, multicenter,randomized controlled clinical trial recruits patients with&#xD;
        newly-diagnosed non-metastatic nasopharyngeal carcinoma patients treated with IMRT. The&#xD;
        intervention is delineating high risk primary tumor clinical target volumes (CTVp1) as&#xD;
        GTV+5mm or GTV+5mm+whole nasopharynx. The objective is to compare the long-term local&#xD;
        control, survival rate, acute and late radiation related toxicities between the two groups.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 4, 2023</start_date>
    <completion_date type="Anticipated">September 1, 2029</completion_date>
    <primary_completion_date type="Anticipated">August 4, 2026</primary_completion_date>
    <phase>N/A</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>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Local Relapse-free Survival(LRFS)</measure>
      <time_frame>3 years</time_frame>
      <description>the time from randomization to documented local recurrence or death from any cause</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Incidence of hearing impairment worse than graded 2</measure>
      <time_frame>3 years</time_frame>
      <description>audiometry and symptoms graded according to the CTCAE (version 5.0).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Overall survival (OS)</measure>
      <time_frame>3 years</time_frame>
      <description>the time from randomization to documented death from any cause</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Regional Relapse-free Survival(RRFS)</measure>
      <time_frame>3 years</time_frame>
      <description>the time from randomization to documented regional recurrence or death from any cause</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Distant metastasis-free survival (DMFS)</measure>
      <time_frame>3 years</time_frame>
      <description>calculated from randomization to documented distant metastasis or death</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Acute toxicities</measure>
      <time_frame>3 months</time_frame>
      <description>Occur within 3 months after IMRT according Common Terminology Criteria for Adverse Events Version 5.0</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Late toxicities</measure>
      <time_frame>3 years</time_frame>
      <description>3 months after completion of radiotherapy graded according to both the Radiation Therapy Oncology Group criteria and the CTCAE (version 5.0)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Functional Assessment of Cancer Therapy-Head and Neck questionnaire (EORTC QLQ-H&amp;N35)</measure>
      <time_frame>3 years</time_frame>
      <description>Patient reported quality-of-life data and higher scores indicated more severe symptoms</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Functional Assessment of Cancer Therapy-Head and Neck questionnaire (EORTC QLQ-C30)</measure>
      <time_frame>3 years</time_frame>
      <description>Patient reported quality-of-life data and higher scores indicated more severe symptoms</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>radiation-induced otitis media with effusion (OME)</measure>
      <time_frame>3 years</time_frame>
      <description>Evaluated by tympanometry</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>V60Gy</measure>
      <time_frame>3 years</time_frame>
      <description>Volume that received at least 60Gy</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">454</enrollment>
    <condition>Nasopharyngeal Carcinoma</condition>
    <condition>Intensity-Modulated Radiotherapy</condition>
    <arm_group>
      <arm_group_label>Reduction CTVp1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>CTVp1=GTVp+5mm</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Non-reduction CTVp1</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>CTVp1=GTVp+5mm+whole nasopharynx</description>
    </arm_group>
    <intervention>
      <intervention_type>Radiation</intervention_type>
      <intervention_name>Reduction CTVp1</intervention_name>
      <description>High Risk Primary Tumor Clinical Target Volumes (CTVp1) is defined as 5mm margin from GTVp,including pre-induction chemotherapy tumor extension( CTVp1=GTVp+5mm)</description>
      <arm_group_label>Reduction CTVp1</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Radiation</intervention_type>
      <intervention_name>Non-reduction CTVp1</intervention_name>
      <description>High Risk Primary Tumor Clinical Target Volumes (CTVp1) is defined as whole nasopharynx as well as 5mm margin from GTVp( CTVp1=GTVp+5mm+whole nasopharynx)</description>
      <arm_group_label>Non-reduction CTVp1</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. histologic confirmation of nonkeratinizing nasopharyngeal carcinoma(WHO II-III);&#xD;
  &#xD;
            2. newly diagnosed stage I to IVa according to the American Joint Committee on&#xD;
               Cancer-Union for International Cancer Control 8th edition stage-classification system&#xD;
  &#xD;
            3. nasopharyngeal mass confined to one side of nasopharynx and did not exceed the&#xD;
               midline(the line between the nasal septum and the midpoint of spinal cord/medulla)&#xD;
               detected by electronic nasopharyngoscope (ENS) and magnetic resonance imaging (MRI).&#xD;
               Pathological biopsy was recommended if it was unclear whether tumor invaded the&#xD;
               contralateral side radiographically.&#xD;
  &#xD;
            4. planned to receive curative IMRT, Chemotherapy drugs should be administered according&#xD;
               to Chinese Society of Clinical Oncology (CSCO) guidelines depending on the TNM&#xD;
               stage;(T1N0: No chemotherapy required;T2N0：No chemotherapy or concurrent cisplatin&#xD;
               chemoradiotherapy if there are adverse prognostic indicators such as Epstein-Barr&#xD;
               virus (EBV) DNA&gt;4000 copies，node &gt;3cm or with extranodal extension;T1-2N1: concurrent&#xD;
               cisplatin chemoradiotherapy;T3N0: concurrent cisplatin chemoradiotherapy; stage&#xD;
               III-Iva: platinum-based neoadjuvant chemotherapy+ concurrent cisplatin&#xD;
               chemoradiotherapy+/-metronomic capecitabine therapy )&#xD;
  &#xD;
            5. no previous treatment for cancer；&#xD;
  &#xD;
            6. a Karnofsky performance-status score of at least 70 (on a scale from 0 to 100, with&#xD;
               lower scores indicating greater disability);&#xD;
  &#xD;
            7. between 18 and 70 years old;&#xD;
  &#xD;
            8. adequate hematologic, renal, and hepatic function: Adequate marrow function: WBC count&#xD;
               ≥ 3×10E9/L, NE count ≥ 1.5×10E9/L, HGB ≥ 90g/L, PLT count ≥ 100×10E9/L;Adequate liver&#xD;
               function: ALT and AST ≤ 2.5×ULN, TBIL ≤ 2.0×ULN;Adequate renal function: BUN and CRE ≤&#xD;
               1.5×ULN , endogenous creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula);&#xD;
  &#xD;
            9. Patients must be informed of the investigational nature of this study and give written&#xD;
               informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. receipt of treatment with palliative intent;&#xD;
  &#xD;
            2. receipt of previous treatment (radiotherapy, chemotherapy, or surgery [except&#xD;
               diagnostic procedures]) to the nasopharynx;&#xD;
  &#xD;
            3. had disease progress after neoadjuvant chemotherapy in local advantage NPC&#xD;
  &#xD;
            4. presence of distant metastasis;&#xD;
  &#xD;
            5. Keratinized squamous cell carcinoma or basal cell like squamous cell carcinoma;&#xD;
  &#xD;
            6. Prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical&#xD;
               cancer, and papillary thyroid carcinoma;&#xD;
  &#xD;
            7. Have New York Heart Association (NYHA) class 3 or 4, unstable angina, myocardial&#xD;
               -infarction within 1 year, or clinically meaningful arrhythmia that requires&#xD;
               treatment;&#xD;
  &#xD;
            8. lactation or pregnancy;&#xD;
  &#xD;
            9. Any other condition including Mental disorder,drug or alcohol addition;do not have&#xD;
               full capacity for civil acts.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Gui-qiong Xu</last_name>
      <role>Principal Investigator</role>
      <affiliation>Zhongshan People's Hospital, Guangdong, China</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Gui-qiong Xu</last_name>
      <phone>+8613528109888</phone>
      <email>donna_shee@163.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Zhongshan City People's Hospital</name>
        <address>
          <city>Zhongshan</city>
          <state>Guangdong</state>
          <zip>528403</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Guiqiong Xu</last_name>
        <phone>+8613528109888</phone>
        <email>donna_shee@163.com</email>
      </contact>
      <contact_backup>
        <last_name>Yu-long Xie, MD</last_name>
        <phone>+8615625031643</phone>
        <email>xieyl1@sysucc.org.cn</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Zhongshan People's Hospital, Guangdong, China</investigator_affiliation>
      <investigator_full_name>Gui-Qiong Xu</investigator_full_name>
      <investigator_title>Clinical Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Carcinoma</mesh_term>
      <mesh_term>Nasopharyngeal Carcinoma</mesh_term>
    </condition_browse>
    <!-- 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/NCT05994170
  org study id: ZSCPH-002
  nct id: NCT05994170
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  To evaluate the long-term local control, survival rate, acute and late radiation related
        toxicities, quality of life after reducing high risk primary tumor clinical target volumes
        (CTVp1) in non-metastatic nasopharyngeal carcinoma treated with IMRT.
  This phase 3, multicenter,randomized controlled clinical trial recruits patients with
        newly-diagnosed non-metastatic nasopharyngeal carcinoma patients treated with IMRT. The
        intervention is delineating high risk primary tumor clinical target volumes (CTVp1) as
        GTV+5mm or GTV+5mm+whole nasopharynx. The objective is to compare the long-term local
        control, survival rate, acute and late radiation related toxicities between the two groups.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Care Provider, Outcomes Assessor)
  measure: Local Relapse-free Survival(LRFS)
  time frame: 3 years
  description: the time from randomization to documented local recurrence or death from any cause
  measure: Incidence of hearing impairment worse than graded 2
  time frame: 3 years
  description: audiometry and symptoms graded according to the CTCAE (version 5.0).
  measure: Overall survival (OS)
  time frame: 3 years
  description: the time from randomization to documented death from any cause
  measure: Regional Relapse-free Survival(RRFS)
  time frame: 3 years
  description: the time from randomization to documented regional recurrence or death from any cause
  measure: Distant metastasis-free survival (DMFS)
  time frame: 3 years
  description: calculated from randomization to documented distant metastasis or death
  measure: Acute toxicities
  time frame: 3 months
  description: Occur within 3 months after IMRT according Common Terminology Criteria for Adverse Events Version 5.0
  measure: Late toxicities
  time frame: 3 years
  description: 3 months after completion of radiotherapy graded according to both the Radiation Therapy Oncology Group criteria and the CTCAE (version 5.0)
  measure: Functional Assessment of Cancer Therapy-Head and Neck questionnaire (EORTC QLQ-H&N35)
  time frame: 3 years
  description: Patient reported quality-of-life data and higher scores indicated more severe symptoms
  measure: Functional Assessment of Cancer Therapy-Head and Neck questionnaire (EORTC QLQ-C30)
  time frame: 3 years
  description: Patient reported quality-of-life data and higher scores indicated more severe symptoms
  measure: radiation-induced otitis media with effusion (OME)
  time frame: 3 years
  description: Evaluated by tympanometry
  measure: V60Gy
  time frame: 3 years
  description: Volume that received at least 60Gy
  arm group label: Reduction CTVp1
  arm group type: Experimental
  description: CTVp1=GTVp+5mm
  arm group label: Non-reduction CTVp1
  arm group type: Placebo Comparator
  description: CTVp1=GTVp+5mm+whole nasopharynx
  intervention type: Radiation
  intervention name: Reduction CTVp1
  description: High Risk Primary Tumor Clinical Target Volumes (CTVp1) is defined as 5mm margin from GTVp,including pre-induction chemotherapy tumor extension( CTVp1=GTVp+5mm)
  arm group label: Reduction CTVp1
  intervention type: Radiation
  intervention name: Non-reduction CTVp1
  description: High Risk Primary Tumor Clinical Target Volumes (CTVp1) is defined as whole nasopharynx as well as 5mm margin from GTVp( CTVp1=GTVp+5mm+whole nasopharynx)
  arm group label: Non-reduction CTVp1
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Gui-qiong Xu
  role: Principal Investigator
  affiliation: Zhongshan People's Hospital, Guangdong, China
  last name: Gui-qiong Xu
  phone: +8613528109888
  email: donna_shee@163.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Zhongshan People's Hospital, Guangdong, China
  investigator full name: Gui-Qiong Xu
  investigator title: Clinical Professor
  mesh term: Carcinoma
  mesh term: Nasopharyngeal Carcinoma