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/NCT05978882</url>
    </required_header>
    <id_info>
      <org_study_id>NCC2023-0145</org_study_id>
      <nct_id>NCT05978882</nct_id>
    </id_info>
    <brief_title>Feasibility Study of Sentinel Navigation Surgery in Early Gastric Cancer Using Fluorescence (SENORITA4)</brief_title>
    <official_title>Feasibility Study of Sentinel Navigation Surgery in Early Gastric Cancer Using Fluorescence (SENORITA4 Trial)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>National Cancer Center, Korea</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Ajou University School of Medicine</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Chonnam National University Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Dongnam Institute of Radiological &amp; Medical Sciences</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Gyeongsang National University Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Gyeongsang National University Changwon Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Samsung Medical Center</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Severance Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Soon Chun Hyang University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>National Cancer Center, Korea</source>
    <oversight_info>
      <has_dmc>No</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>
        SENORITA 1 trial showed laparoscopic sentinel lymph node biopsy and stomach preserving&#xD;
        surgery in early gastric cancer can increase the quality of life. (Ryu KW et al. JCO 2022)&#xD;
        The radioactive isotope is difficult to use because of the hazard of radiation and shortage&#xD;
        of materials. The aim of this study is to investigate whether laparoscopic sentinel lymph&#xD;
        node biopsy and stomach-preserving surgery using only fluorescence is feasible.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        1. Injection of Indocyanine Green (ICG)&#xD;
  &#xD;
               -  Endoscopic injection of 0.25mg/ml of ICG on 4 sites around gastric cancer&#xD;
  &#xD;
               -  Identification of sentinel basin using fluorescence laparoscopy&#xD;
  &#xD;
               -  Laparoscopic sentinel basin dissection and identification of sentinel node at the&#xD;
                  back table&#xD;
  &#xD;
          2. Surgical considerations&#xD;
  &#xD;
               -  Conventional gastrectomy is performed if positive sentinel nodes are diagnosed in&#xD;
                  the frozen section.&#xD;
  &#xD;
               -  If micrometastasis or isolated tumor cells in sentinel basin lymph nodes were&#xD;
                  diagnosed in permanent pathology, re-operation of conventional gastrectomy is not&#xD;
                  performed.&#xD;
  &#xD;
               -  However, re-operation of conventional gastrectomy should be performed in case of&#xD;
                  macrometastasis, deep and lateral margin positive, more than pT2 lesion in the&#xD;
                  permanent pathology.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 17, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2030</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2025</primary_completion_date>
    <phase>N/A</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>Detection rate of Sentinel lymph nodes</measure>
      <time_frame>15 days after operation</time_frame>
      <description>number of patients whose sentinel nodes are detected / enrolled number of patients *100</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>3 year disease free survival</measure>
      <time_frame>3 year after surgery</time_frame>
      <description>A total of enrollment period is suspected to be three years and patients will be followed up for five years.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>3 year overall survival rate</measure>
      <time_frame>3 year after surgery</time_frame>
      <description>A total of enrollment period is suspected to be three years and patients will be followed up for five years.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>3 year disease specific death rate</measure>
      <time_frame>3 year after surgery</time_frame>
      <description>A total of enrollment period is suspected to be three years and patients will be followed up for five years.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>3 year recurrence free survival rate</measure>
      <time_frame>3 year after surgery</time_frame>
      <description>A total of enrollment period is suspected to be three years and patients will be followed up for five years.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>scores of global health status scale, functional scales, and symptom scales/items of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30 and STO22</measure>
      <time_frame>5 years</time_frame>
      <description>Survey for quality of life will be performed regularly for three years after surgery. Measurement tool is the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30 and STO22. In EORTC QLQ C30, there are 1 global health status scale, 5 functional scales, and 9 symptom scales/items. EORTC QLQ STO22 includes 5 symptom scales and 4 single items. Each scale and item ranges 0 to 100. Higher score of global health status and functinoal scales indicate better quality of life and lower score of symptom scales indicates better quality of life. There is no summed score in these questionnaires.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>5 year disease free survival rate</measure>
      <time_frame>5 years</time_frame>
      <description>A total of enrollment period is suspected to be three years and patients will be followed up for five years. Therefore, we can complete data collection at five year later from when the last enrolled patients underwent intervention</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>5 year overall survival rate</measure>
      <time_frame>5 years</time_frame>
      <description>A total of enrollment period is suspected to be three years and patients will be followed up for five years. Therefore, we can complete data collection at five year later from when the last enrolled patients underwent intervention</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>5 year disease specific death rate</measure>
      <time_frame>5 years</time_frame>
      <description>A total of enrollment period is suspected to be three years and patients will be followed up for five years. Therefore, we can complete data collection at five year later from when the last enrolled patients underwent intervention</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>5 year recurrence free survival rate</measure>
      <time_frame>5 years</time_frame>
      <description>A total of enrollment period is suspected to be three years and patients will be followed up for five years. Therefore, we can complete data collection at five year later from when the last enrolled patients underwent intervention</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">203</enrollment>
    <condition>Early Gastric Cancer</condition>
    <arm_group>
      <arm_group_label>Laparoscopic sentinel navigation surgery</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>compare the detection rate of sentinel lymph nodes to that of previous study (SENORITA1 trial)</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Laparoscopic sentinel navigation surgery using fluorescence</intervention_name>
      <description>If the frozen biopsy of sentinel lymph nodes are all negative using fluorescence, stomach-preserving surgery is performed</description>
      <arm_group_label>Laparoscopic sentinel navigation surgery</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  single lesion of adenocarcinoma in preoperative endoscopic biopsy clinical stage T1N0&#xD;
               in the preoperative evaluation of endoscopy and computed tomography&#xD;
  &#xD;
            -  tumor size: less than 3cm&#xD;
  &#xD;
            -  location: 2cm far from the pylorus or cardia&#xD;
  &#xD;
            -  aged 20 to 80&#xD;
  &#xD;
            -  ECOG 0 or 1&#xD;
  &#xD;
            -  patient who signed the agreement&#xD;
  &#xD;
            -  patient who is suspected to underwent laparoscopic or robotic gastrectomy&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  indication of endoscopic submucosal resection&#xD;
  &#xD;
            -  inoperable due to poor cardiac, and pulmonary function&#xD;
  &#xD;
            -  pregnant&#xD;
  &#xD;
            -  having allergic reaction, previous upper abdominal surgery except laparoscopic&#xD;
               cholecystectomy, previous radiation therapy to upper abdomen&#xD;
  &#xD;
            -  diagnosed as malignancy within 5 years except carcinoma in situ of cervix cancer and&#xD;
               thyroid cancer&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Hong Man Yoon, MD</last_name>
      <phone>+82-31-920-1710</phone>
      <email>red10000@ncc.re.kr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Dongnam Inst. of Radiological &amp; Medical Science</name>
        <address>
          <city>Busan</city>
          <state>Gijang-gun</state>
          <zip>46033</zip>
          <country>Korea, Republic of</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Gyeongsang National University Hospital</name>
        <address>
          <city>Gyeongsang</city>
          <state>Gingu-si</state>
          <zip>52727</zip>
          <country>Korea, Republic of</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Sevrance Hospital</name>
        <address>
          <city>Seoul</city>
          <state>Sinchon</state>
          <zip>03722</zip>
          <country>Korea, Republic of</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Ajou University Medical Center</name>
        <address>
          <city>Gyeonggi-do</city>
          <state>Suwon-si</state>
          <zip>16499</zip>
          <country>Korea, Republic of</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Gyeongsang National University Changwon Hospital</name>
        <address>
          <city>Changwon</city>
          <zip>51472</zip>
          <country>Korea, Republic of</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Samsung Medical Center</name>
        <address>
          <city>Seoul</city>
          <country>Korea, Republic of</country>
        </address>
      </facility>
      <contact>
        <last_name>Ji Yeong An</last_name>
        <email>jar319.an@samsung.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Soon Chun Hyang University Hospital Bucheon</name>
        <address>
          <city>Seoul</city>
          <country>Korea, Republic of</country>
        </address>
      </facility>
      <contact>
        <last_name>In Jo</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Korea, Republic of</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>National Cancer Center, Korea</investigator_affiliation>
      <investigator_full_name>Hong Man Yoon</investigator_full_name>
      <investigator_title>MD</investigator_title>
    </responsible_party>
    <keyword>Early gastric cancer</keyword>
    <keyword>Sentinel lymph node</keyword>
    <keyword>Fluorescence</keyword>
    <keyword>Stomach-preserving surgery</keyword>
    <keyword>Quality of life</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Stomach Neoplasms</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/NCT05978882
  org study id: NCC2023-0145
  nct id: NCT05978882
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  SENORITA 1 trial showed laparoscopic sentinel lymph node biopsy and stomach preserving
        surgery in early gastric cancer can increase the quality of life. (Ryu KW et al. JCO 2022)
        The radioactive isotope is difficult to use because of the hazard of radiation and shortage
        of materials. The aim of this study is to investigate whether laparoscopic sentinel lymph
        node biopsy and stomach-preserving surgery using only fluorescence is feasible.
  1. Injection of Indocyanine Green (ICG)
  
               -  Endoscopic injection of 0.25mg/ml of ICG on 4 sites around gastric cancer
  
               -  Identification of sentinel basin using fluorescence laparoscopy
  
               -  Laparoscopic sentinel basin dissection and identification of sentinel node at the
                  back table
  
          2. Surgical considerations
  
               -  Conventional gastrectomy is performed if positive sentinel nodes are diagnosed in
                  the frozen section.
  
               -  If micrometastasis or isolated tumor cells in sentinel basin lymph nodes were
                  diagnosed in permanent pathology, re-operation of conventional gastrectomy is not
                  performed.
  
               -  However, re-operation of conventional gastrectomy should be performed in case of
                  macrometastasis, deep and lateral margin positive, more than pT2 lesion in the
                  permanent pathology.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Detection rate of Sentinel lymph nodes
  time frame: 15 days after operation
  description: number of patients whose sentinel nodes are detected / enrolled number of patients *100
  measure: 3 year disease free survival
  time frame: 3 year after surgery
  description: A total of enrollment period is suspected to be three years and patients will be followed up for five years.
  measure: 3 year overall survival rate
  time frame: 3 year after surgery
  description: A total of enrollment period is suspected to be three years and patients will be followed up for five years.
  measure: 3 year disease specific death rate
  time frame: 3 year after surgery
  description: A total of enrollment period is suspected to be three years and patients will be followed up for five years.
  measure: 3 year recurrence free survival rate
  time frame: 3 year after surgery
  description: A total of enrollment period is suspected to be three years and patients will be followed up for five years.
  measure: scores of global health status scale, functional scales, and symptom scales/items of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30 and STO22
  time frame: 5 years
  description: Survey for quality of life will be performed regularly for three years after surgery. Measurement tool is the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30 and STO22. In EORTC QLQ C30, there are 1 global health status scale, 5 functional scales, and 9 symptom scales/items. EORTC QLQ STO22 includes 5 symptom scales and 4 single items. Each scale and item ranges 0 to 100. Higher score of global health status and functinoal scales indicate better quality of life and lower score of symptom scales indicates better quality of life. There is no summed score in these questionnaires.
  measure: 5 year disease free survival rate
  time frame: 5 years
  description: A total of enrollment period is suspected to be three years and patients will be followed up for five years. Therefore, we can complete data collection at five year later from when the last enrolled patients underwent intervention
  measure: 5 year overall survival rate
  time frame: 5 years
  description: A total of enrollment period is suspected to be three years and patients will be followed up for five years. Therefore, we can complete data collection at five year later from when the last enrolled patients underwent intervention
  measure: 5 year disease specific death rate
  time frame: 5 years
  description: A total of enrollment period is suspected to be three years and patients will be followed up for five years. Therefore, we can complete data collection at five year later from when the last enrolled patients underwent intervention
  measure: 5 year recurrence free survival rate
  time frame: 5 years
  description: A total of enrollment period is suspected to be three years and patients will be followed up for five years. Therefore, we can complete data collection at five year later from when the last enrolled patients underwent intervention
  arm group label: Laparoscopic sentinel navigation surgery
  arm group type: Experimental
  description: compare the detection rate of sentinel lymph nodes to that of previous study (SENORITA1 trial)
  intervention type: Procedure
  intervention name: Laparoscopic sentinel navigation surgery using fluorescence
  description: If the frozen biopsy of sentinel lymph nodes are all negative using fluorescence, stomach-preserving surgery is performed
  arm group label: Laparoscopic sentinel navigation surgery
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Hong Man Yoon, MD
  phone: +82-31-920-1710
  email: red10000@ncc.re.kr
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  contact: 
  facility: 
  contact: 
  country: Korea, Republic of
  responsible party type: Principal Investigator
  investigator affiliation: National Cancer Center, Korea
  investigator full name: Hong Man Yoon
  investigator title: MD
  mesh term: Stomach Neoplasms