<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/NCT03839602</url>
  </required_header>
  <id_info>
    <org_study_id>CTV Delineation in I-II NPC</org_study_id>
    <nct_id>NCT03839602</nct_id>
  </id_info>
  <brief_title>Delineation of Reducing Clinical Target Volume for Early-stage Nasopharyngeal Carcinoma Patients</brief_title>
  <official_title>Delineation of Reducing Clinical Target Volume for Early-stage Nasopharyngeal</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>
    <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 analyze the long-term results and toxicities of the reducing clinical target volume (CTV)&#xD;
      delineation method in early-stage nasopharyngeal carcinoma (NPC) patients treated with&#xD;
      intensity modulated radiation therapy (IMRT).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators designed a prospective phase II study for early-stage NPC patients, and&#xD;
      proposed a reasonable delineation method of reducing CTV according to the clinical&#xD;
      characteristics and tumor infiltration patterns, performing therapeutic dose to tumor and&#xD;
      prophylactic dose to CTV while protecting as much normal tissues as possible, in order to&#xD;
      ensure a long-term survival with good quality of life.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2001</start_date>
  <completion_date type="Actual">January 1, 2018</completion_date>
  <primary_completion_date type="Actual">October 31, 2006</primary_completion_date>
  <phase>Phase 2</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>The CTV was divided into CTV1 (high risk) and CTV2 (low risk) according to the biological behavior and characteristics of early-stage NPC.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>LRRFS</measure>
    <time_frame>5 year</time_frame>
    <description>locoregional recurrence free survival</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Locoregional failure patterns</measure>
    <time_frame>5 year</time_frame>
    <description>To identify the locoregional failure patterns: in-field recurrence, marginal recurrence and out-field recurrence</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DMFS</measure>
    <time_frame>5 year</time_frame>
    <description>distant metastasis free survival</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DSS</measure>
    <time_frame>5 year</time_frame>
    <description>disease specific survival</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>OS</measure>
    <time_frame>5 year</time_frame>
    <description>overall survival</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute toxicity assessed with National Cancer Institute Common Toxicity Criteria for Adverse Events version 3.0 (NCI-CTCAE v3.0)</measure>
    <time_frame>3 months after IMRT</time_frame>
    <description>National Cancer Institute Common Toxicity Criteria for Adverse Events version 3.0 (NCI-CTCAE v3.0)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Late toxicity assessed with Radiation Therapy Oncology Group radiation morbidity scoring criteria</measure>
    <time_frame>5 year</time_frame>
    <description>Radiation Therapy Oncology Group radiation morbidity scoring criteria</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">103</enrollment>
  <condition>Target Volume Delineation</condition>
  <condition>Early-stage Nasopharyngeal Carcinoma</condition>
  <condition>Intensity Modulated Radiation Therapy</condition>
  <arm_group>
    <arm_group_label>reducing CTV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The gross tumor volume of the nasopharynx and neck nodes (GTVnx and GTVnd) were delineated according to the tumor extension. The CTV was divided into CTV1 (high risk) and CTV2 (low risk) according to the biological behavior and characteristics of early-stage NPC. The prescribe doses of GTVnx, GTVnd, CTV1 and CTV2 were 68Gy, 60-66Gy, 60Gy and 50-54Gy in 30 fractions, respectively.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Reducing CTV</intervention_name>
    <description>CTVs were delineated in line with tumor stage, i.e. tumor invasion.</description>
    <arm_group_label>reducing CTV</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. histologically confirmed NPC (WHO II-III)&#xD;
&#xD;
          2. stage I-IIb according to the 6th AJCC/UICC&#xD;
&#xD;
          3. no previous treatment for NPC&#xD;
&#xD;
          4. between 18 and 70 years old&#xD;
&#xD;
          5. KPS ≥ 80 scores&#xD;
&#xD;
          6. adequate organ function (white blood cell ≥ 4.0×109/L; absolute neutrophil count ≥&#xD;
             1.5×109/L; hemoglobin ≥ 100g/L; platelet count ≥ 100×109/L; total bilirubin, aspartate&#xD;
             aminotransferase and alanine aminotransferase ≤ 1.5X upper limit normal; and&#xD;
             creatinine clearance rate ≥ 30 mL/min)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. fine-needle aspiration biopsy, incisional or excisional biopsy of neck lymph node, or&#xD;
             neck dissection prior IMRT&#xD;
&#xD;
          2. disease progression during IMRT&#xD;
&#xD;
          3. presence of distant metastasis&#xD;
&#xD;
          4. pregnancy or lactation&#xD;
&#xD;
          5. previous malignancy or other concomitant malignant disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cancer Center, Sun Yat-sen University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510060</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 11, 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>
  <last_update_submitted>February 12, 2019</last_update_submitted>
  <last_update_submitted_qc>February 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
    <investigator_full_name>Zhao Chong</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>Locoregional Failure Pattern</keyword>
  <keyword>Toxicity</keyword>
  <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>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03839602
org study id: CTV Delineation in I-II NPC
nct id: NCT03839602
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To analyze the long-term results and toxicities of the reducing clinical target volume (CTV)
      delineation method in early-stage nasopharyngeal carcinoma (NPC) patients treated with
      intensity modulated radiation therapy (IMRT).
The investigators designed a prospective phase II study for early-stage NPC patients, and
      proposed a reasonable delineation method of reducing CTV according to the clinical
      characteristics and tumor infiltration patterns, performing therapeutic dose to tumor and
      prophylactic dose to CTV while protecting as much normal tissues as possible, in order to
      ensure a long-term survival with good quality of life.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: The CTV was divided into CTV1 (high risk) and CTV2 (low risk) according to the biological behavior and characteristics of early-stage NPC.
primary purpose: Treatment
masking: None (Open Label)
measure: LRRFS
time frame: 5 year
description: locoregional recurrence free survival
measure: Locoregional failure patterns
time frame: 5 year
description: To identify the locoregional failure patterns: in-field recurrence, marginal recurrence and out-field recurrence
measure: DMFS
time frame: 5 year
description: distant metastasis free survival
measure: DSS
time frame: 5 year
description: disease specific survival
measure: OS
time frame: 5 year
description: overall survival
measure: Acute toxicity assessed with National Cancer Institute Common Toxicity Criteria for Adverse Events version 3.0 (NCI-CTCAE v3.0)
time frame: 3 months after IMRT
description: National Cancer Institute Common Toxicity Criteria for Adverse Events version 3.0 (NCI-CTCAE v3.0)
measure: Late toxicity assessed with Radiation Therapy Oncology Group radiation morbidity scoring criteria
time frame: 5 year
description: Radiation Therapy Oncology Group radiation morbidity scoring criteria
arm group label: reducing CTV
arm group type: Experimental
description: The gross tumor volume of the nasopharynx and neck nodes (GTVnx and GTVnd) were delineated according to the tumor extension. The CTV was divided into CTV1 (high risk) and CTV2 (low risk) according to the biological behavior and characteristics of early-stage NPC. The prescribe doses of GTVnx, GTVnd, CTV1 and CTV2 were 68Gy, 60-66Gy, 60Gy and 50-54Gy in 30 fractions, respectively.
intervention type: Radiation
intervention name: Reducing CTV
description: CTVs were delineated in line with tumor stage, i.e. tumor invasion.
arm group label: reducing CTV
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: Zhao Chong
investigator title: Clinical Professor
mesh term: Carcinoma
mesh term: Nasopharyngeal Carcinoma
sharing ipd: Undecided