<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/NCT04425265</url>
  </required_header>
  <id_info>
    <org_study_id>SYSUCC-CMY-2020-2301</org_study_id>
    <nct_id>NCT04425265</nct_id>
  </id_info>
  <brief_title>Plasma Radiofrequency Ablation at Low Temperature Versus Electrocautery Block Resection at High Frequency for Localized Recurrent Nasopharyngeal Carcinoma</brief_title>
  <official_title>A Randomized Controlled Trial of Plasma Radiofrequency Ablation at Low Temperature Versus Electrocautery Block Resection at High Frequency for Localized Recurrent Nasopharyngeal 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>
    <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>
      This study aims at exploring whether plasma radiofrequency ablation at low temperature is&#xD;
      associated with better survival outcome in localized recurrent nasopharyngeal carcinoma by&#xD;
      conducting a randomized controlled trial of plasma radiofrequency ablation at low temperature&#xD;
      versus electrocautery block resection at high frequency for localized recurrent&#xD;
      nasopharyngeal carcinoma. If the hypothesis is confirmed, it is expected to provide a&#xD;
      convenient choice for the surgical treatment of localized recurrent nasopharyngeal carcinoma.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Anticipated">June 2020</start_date>
  <completion_date type="Anticipated">May 2025</completion_date>
  <primary_completion_date type="Anticipated">June 2024</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Progression-free survival</measure>
    <time_frame>2 years</time_frame>
    <description>Time from randomisation to the date of disease progression or death from any causes.&#xD;
whichever came first.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>2 years</time_frame>
    <description>Time from randomisation to the date of death from any causes. whichever came first.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Loco-regional relapse-free survival</measure>
    <time_frame>2 years</time_frame>
    <description>Time from randomisation to the date of loco-regional recurrence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distant metastasis-free survival</measure>
    <time_frame>2 years</time_frame>
    <description>Time from randomisation to the date of distant metastasis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of surgery related complications</measure>
    <time_frame>1 year</time_frame>
    <description>the proportion of patients with surgery related complications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0)</measure>
    <time_frame>1 year</time_frame>
    <description>Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0) before surgery, at the end of surgery, at 3 months after surgery, and at 6 months after surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&amp;N35)</measure>
    <time_frame>1 year</time_frame>
    <description>Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&amp;N35) before surgery, at the end of surgery, at 3 months after surgery, and at 6 months after surgery.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">248</enrollment>
  <condition>Surgery</condition>
  <condition>Recurrent Nasopharyngeal Carcinoma</condition>
  <arm_group>
    <arm_group_label>Plasma radiofrequency ablation arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Plasma radiofrequency ablation at low temperature for localized recurrent nasopharyngeal carcinoma</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Electrocautery block resection arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Electrocautery block resection at high frequency for localized recurrent nasopharyngeal carcinoma</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Plasma radiofrequency ablation</intervention_name>
    <description>Under the guidance of nasal endoscope, the nasopharyngeal tumor and its sufficient safety margin are completely removed through the bilateral nasal cavity. Then investigators use plasma radiofrequency ablation at low temperature to ablate the tumor tissue and normal tissue of the margin along the upper and lower surgical margin until no obvious tumor remained under the naked eye.</description>
    <arm_group_label>Plasma radiofrequency ablation arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Electrocautery block resection</intervention_name>
    <description>Under the guidance of nasal endoscope, the nasopharyngeal tumor and its sufficient safety margin are continuously and completely removed through the bilateral nasal cavity. Then investigators separate the posterior part of the nasal cavity and the top wall of the nasopharynx along the bone of the nasopharyngeal fornix, cut the pharyngeal suture, and cut the two sides along the edge of the carina, and then merge along the anterior vertebral muscle surface to the midline incision. Along the the soft palate under the inferior margin, investigators horizontally cut the mucosa of the posterior wall of the nasopharynx, and completely frees the entire soft tissue of the posterior wall of the nasopharynx.</description>
    <arm_group_label>Electrocautery block resection arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. At least 6 months disease free interval (defined as duration between the initial&#xD;
             course of radiotherapy and recurrence)&#xD;
&#xD;
          2. Histopathologically diagnosed with undifferentiated or differentiated, nonkeratinizing&#xD;
             nasopharyngeal carcinoma.&#xD;
&#xD;
          3. Resectable recurrent nasopharyngeal carcinoma:&#xD;
&#xD;
             A) recurrent T1N0M0 according to the American Joint Committee on Cancer (AJCC) 8th&#xD;
             staging B) recurrent T2N0M0(the tumor was confined to the surface of the&#xD;
             parapharyngeal space and was more than 0.5cm away from the internal carotid artery)&#xD;
             according to the American Joint Committee on Cancer (AJCC) 8th staging&#xD;
&#xD;
          4. Age: 18-70 years old.&#xD;
&#xD;
          5. Subjects must sign an informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Karnofsky score (KPS)≤70.&#xD;
&#xD;
          2. Has known Subjects with other malignant tumors.&#xD;
&#xD;
          3. Has seriously mental disease.&#xD;
&#xD;
          4. Uncontrolled clinically significant heart disease and Pulmonary dysfunction.&#xD;
&#xD;
          5. Pregnancy or breast feeding.&#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_contact>
    <last_name>Ming-Yuan Chen, MD, PhD</last_name>
    <phone>86-20-8734-3361</phone>
    <email>chmingy@mail.sysu.edu.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Rui You, MD, PhD</last_name>
    <phone>86-13580439820</phone>
    <email>yourui@sysucc.org.cn</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Sun Yat-sen University Cancer Center</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510060</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ming-Yuan Chen, Prof.</last_name>
      <phone>86-20-8734-3361</phone>
      <email>chmingy@mail.sysu.edu.cn</email>
    </contact>
    <investigator>
      <last_name>Ming-Yuan Chen, Prof.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 8, 2020</last_update_submitted>
  <last_update_submitted_qc>June 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 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>Ming-Yuan Chen</investigator_full_name>
    <investigator_title>Chief physician, Proffessor</investigator_title>
  </responsible_party>
  <keyword>recurrent nasopharyngeal carcinoma</keyword>
  <keyword>Plasma Radiofrequency Ablation</keyword>
  <keyword>Electrocautery Block Resection</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>
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04425265
org study id: SYSUCC-CMY-2020-2301
nct id: NCT04425265
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study aims at exploring whether plasma radiofrequency ablation at low temperature is
      associated with better survival outcome in localized recurrent nasopharyngeal carcinoma by
      conducting a randomized controlled trial of plasma radiofrequency ablation at low temperature
      versus electrocautery block resection at high frequency for localized recurrent
      nasopharyngeal carcinoma. If the hypothesis is confirmed, it is expected to provide a
      convenient choice for the surgical treatment of localized recurrent nasopharyngeal carcinoma.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression-free survival
time frame: 2 years
description: Time from randomisation to the date of disease progression or death from any causes.
whichever came first.
measure: Overall survival
time frame: 2 years
description: Time from randomisation to the date of death from any causes. whichever came first.
measure: Loco-regional relapse-free survival
time frame: 2 years
description: Time from randomisation to the date of loco-regional recurrence.
measure: Distant metastasis-free survival
time frame: 2 years
description: Time from randomisation to the date of distant metastasis.
measure: Incidence of surgery related complications
time frame: 1 year
description: the proportion of patients with surgery related complications
measure: Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0)
time frame: 1 year
description: Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0) before surgery, at the end of surgery, at 3 months after surgery, and at 6 months after surgery.
measure: Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35)
time frame: 1 year
description: Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35) before surgery, at the end of surgery, at 3 months after surgery, and at 6 months after surgery.
arm group label: Plasma radiofrequency ablation arm
arm group type: Experimental
description: Plasma radiofrequency ablation at low temperature for localized recurrent nasopharyngeal carcinoma
arm group label: Electrocautery block resection arm
arm group type: Active Comparator
description: Electrocautery block resection at high frequency for localized recurrent nasopharyngeal carcinoma
intervention type: Procedure
intervention name: Plasma radiofrequency ablation
description: Under the guidance of nasal endoscope, the nasopharyngeal tumor and its sufficient safety margin are completely removed through the bilateral nasal cavity. Then investigators use plasma radiofrequency ablation at low temperature to ablate the tumor tissue and normal tissue of the margin along the upper and lower surgical margin until no obvious tumor remained under the naked eye.
arm group label: Plasma radiofrequency ablation arm
intervention type: Procedure
intervention name: Electrocautery block resection
description: Under the guidance of nasal endoscope, the nasopharyngeal tumor and its sufficient safety margin are continuously and completely removed through the bilateral nasal cavity. Then investigators separate the posterior part of the nasal cavity and the top wall of the nasopharynx along the bone of the nasopharyngeal fornix, cut the pharyngeal suture, and cut the two sides along the edge of the carina, and then merge along the anterior vertebral muscle surface to the midline incision. Along the the soft palate under the inferior margin, investigators horizontally cut the mucosa of the posterior wall of the nasopharynx, and completely frees the entire soft tissue of the posterior wall of the nasopharynx.
arm group label: Electrocautery block resection arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Ming-Yuan Chen, MD, PhD
phone: 86-20-8734-3361
email: chmingy@mail.sysu.edu.cn
last name: Rui You, MD, PhD
phone: 86-13580439820
email: yourui@sysucc.org.cn
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: Ming-Yuan Chen
investigator title: Chief physician, Proffessor
mesh term: Carcinoma
mesh term: Nasopharyngeal Carcinoma
mesh term: Recurrence
sharing ipd: No