<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/NCT03283293</url>
  </required_header>
  <id_info>
    <org_study_id>CTV Delineation after NACT</org_study_id>
    <nct_id>NCT03283293</nct_id>
  </id_info>
  <brief_title>Target Volume Delineation After NACT in LA-NPCarcinoma Patients Treated With NACT+ CCRT</brief_title>
  <official_title>Study on Delineation of the Target Volumes and Determination of the Irradiation Doses in Untreated Nasopharyngeal Carcinoma (NPC) Treated With Intensity Modulated Radiation Therapy (IMRT)</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>
      The gross tumor volumes of the primary site and the neck nodes (GTVnx and GTVnd) could be&#xD;
      delineated according to the post-NACT tumor position and receive radical radiation dose,&#xD;
      while the tumor disappear after NACT could be encompassed in the first clinical target volume&#xD;
      (CTV1) and receive high preventive radiation dose. Through this method,it is more likely to&#xD;
      achieve the ultimate goal that maximize the chance of cure while minimize the injury of&#xD;
      surrounding normal tissues, maintaining organ function and life quality. Therefore, this&#xD;
      stage II clinical trial was designed to study the prognosis and locoregional failure patterns&#xD;
      of this target volume delineation method in LA-NPC treated with NACT plus CCRT.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 2001</start_date>
  <completion_date type="Actual">April 2008</completion_date>
  <primary_completion_date type="Actual">April 2007</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>5-year loco-regional recurrence free survival (LRRFS)</measure>
    <time_frame>Five years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>5-year local recurrence free survival (LRFS)</measure>
    <time_frame>Five years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>5-year regional recurrence free survival (RRFS)</measure>
    <time_frame>Five years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>5-year distant metastasis free survival (DMFS)</measure>
    <time_frame>Five years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>5-year disease specific survival (DSS)</measure>
    <time_frame>Five years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>5-year overall survival (OS)</measure>
    <time_frame>Five years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Locoregional failure patterns</measure>
    <time_frame>Five years</time_frame>
    <description>The failures were categorized as occurring inside or outside the high dose target volume, depending on the location of Vrecur: &quot;in field&quot; if 95% of Vrecur was within the 95% isodose; &quot;marginal&quot; if 20% to 95% of Vrecur was within the 95% isodose, or &quot;outside&quot; if less than 20% of Vrecur was inside the 95% isodose.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Late toxicities</measure>
    <time_frame>Five years</time_frame>
    <description>The late toxicities were graded according to the Radiation Therapy Oncology Group radiation morbidity scoring criteria.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">112</enrollment>
  <condition>Nasopharyngeal Carcinoma</condition>
  <arm_group>
    <arm_group_label>Target volume delineation after NACT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Target Volume Delineation after NACT</intervention_name>
    <description>The gross tumor volumes of the primary site and the neck nodes (GTVnx and GTVnd) were delineated in accordance with the head and neck magnetic resonance imaging (MRI) and endoscopy, which obtained two weeks after the last cycle of NACT. The first clinical target volume (CTV1) was defined as the GTVnx plus a 5-10mm margin (2 to 3mm margin posteriorly) to encompass the high-risk sites of microscopic extension, the whole nasopharynx, and the location and extent of the primary tumor before NACT. The second clinical target volume (CTV2) was defined as the CTV1 plus a 5-10mm margin (2 to 3mm margin posteriorly) to encompass the low-risk sites of microscopic extension, the level of the lymph node located before NACT, and the elective neck area. The prescribed dose to GTVnx, GTVnd, CTV1 and CTV2 were 68Gy/30f, 62-66Gy/30f, 60Gy/30f and 54Gy/30f, respectively.</description>
    <arm_group_label>Target volume delineation after NACT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. histologically confirmed NPC;&#xD;
&#xD;
          2. no evidence of distant metastasis;&#xD;
&#xD;
          3. no previous treatment for NPC;&#xD;
&#xD;
          4. stages III-IVb disease according to the staging system of the 6th AJCC/UICC;&#xD;
&#xD;
          5. adequate liver, renal and bone marrow function;&#xD;
&#xD;
          6. Karnofsky Performance Status (KPS) ≥80 scores.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. fine-needle aspiration biopsy, incisional or excisional biopsy of neck lymph node, or&#xD;
             neck dissection prior NACT;&#xD;
&#xD;
          2. disease progression during NACT;&#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>14 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chong Zhao</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sun Yat-sen University</affiliation>
  </overall_official>
  <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>September 11, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 14, 2017</study_first_posted>
  <last_update_submitted>February 11, 2019</last_update_submitted>
  <last_update_submitted_qc>February 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 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>MD</investigator_title>
  </responsible_party>
  <keyword>Neoadjuvant Chemotherapy</keyword>
  <keyword>Intensity-modulated Radiation Therapy</keyword>
  <keyword>Target Volume Delineation</keyword>
  <keyword>Locoregional Failure Pattern</keyword>
  <keyword>Nasopharyngeal Carcinoma</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>
  <!-- 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/NCT03283293
org study id: CTV Delineation after NACT
nct id: NCT03283293
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The gross tumor volumes of the primary site and the neck nodes (GTVnx and GTVnd) could be
      delineated according to the post-NACT tumor position and receive radical radiation dose,
      while the tumor disappear after NACT could be encompassed in the first clinical target volume
      (CTV1) and receive high preventive radiation dose. Through this method,it is more likely to
      achieve the ultimate goal that maximize the chance of cure while minimize the injury of
      surrounding normal tissues, maintaining organ function and life quality. Therefore, this
      stage II clinical trial was designed to study the prognosis and locoregional failure patterns
      of this target volume delineation method in LA-NPC treated with NACT plus CCRT.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: 5-year loco-regional recurrence free survival (LRRFS)
time frame: Five years
measure: 5-year local recurrence free survival (LRFS)
time frame: Five years
measure: 5-year regional recurrence free survival (RRFS)
time frame: Five years
measure: 5-year distant metastasis free survival (DMFS)
time frame: Five years
measure: 5-year disease specific survival (DSS)
time frame: Five years
measure: 5-year overall survival (OS)
time frame: Five years
measure: Locoregional failure patterns
time frame: Five years
description: The failures were categorized as occurring inside or outside the high dose target volume, depending on the location of Vrecur: "in field" if 95% of Vrecur was within the 95% isodose; "marginal" if 20% to 95% of Vrecur was within the 95% isodose, or "outside" if less than 20% of Vrecur was inside the 95% isodose.
measure: Late toxicities
time frame: Five years
description: The late toxicities were graded according to the Radiation Therapy Oncology Group radiation morbidity scoring criteria.
arm group label: Target volume delineation after NACT
arm group type: Experimental
intervention type: Radiation
intervention name: Target Volume Delineation after NACT
description: The gross tumor volumes of the primary site and the neck nodes (GTVnx and GTVnd) were delineated in accordance with the head and neck magnetic resonance imaging (MRI) and endoscopy, which obtained two weeks after the last cycle of NACT. The first clinical target volume (CTV1) was defined as the GTVnx plus a 5-10mm margin (2 to 3mm margin posteriorly) to encompass the high-risk sites of microscopic extension, the whole nasopharynx, and the location and extent of the primary tumor before NACT. The second clinical target volume (CTV2) was defined as the CTV1 plus a 5-10mm margin (2 to 3mm margin posteriorly) to encompass the low-risk sites of microscopic extension, the level of the lymph node located before NACT, and the elective neck area. The prescribed dose to GTVnx, GTVnd, CTV1 and CTV2 were 68Gy/30f, 62-66Gy/30f, 60Gy/30f and 54Gy/30f, respectively.
arm group label: Target volume delineation after NACT
criteria: 
gender: All
minimum age: 14 Years
maximum age: 70 Years
healthy volunteers: No
last name: Chong Zhao
role: Principal Investigator
affiliation: Sun Yat-sen University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: Zhao Chong
investigator title: MD
mesh term: Carcinoma
mesh term: Nasopharyngeal Carcinoma