<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/NCT03290209</url>
  </required_header>
  <id_info>
    <org_study_id>2017-03</org_study_id>
    <nct_id>NCT03290209</nct_id>
  </id_info>
  <brief_title>Clinical Outcomes of Laparoscopic D1 Versus D2 Lymphadenectomy for Elderly Patients With Advanced Gastric Cancer</brief_title>
  <acronym>D1D2</acronym>
  <official_title>Randomized Controlled Trials Comparing Clinical Outcomes of Laparoscopic D1 Versus D2 Lymphadenectomy for Elderly Patients With Advanced Gastric Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fujian Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fujian Medical 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 purpose of this study is to explore the clinical outcomes of laparoscopic D1&#xD;
      lymphadenectomy for elderly patients with advanced gastric adenocarcinoma（cT2-4a, N-/+, M0）&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Gastrectomy with D2 lymphadenectomy is considered the gold standard treatment for advanced&#xD;
      gastric cancer. However, some studies show that age or comorbidities is the relevant&#xD;
      predictor of postoperative complications, conditioning the safety of the surgical procedure&#xD;
      itself, thus affect the survial. Even with the advances in surgical techniques and care, age&#xD;
      still is a significant risk for postoperative morbidity and mortality. Therefore, elderly&#xD;
      patients with gastric cancer could receive minimally invasive surgery with reduced nodal&#xD;
      dissection, i.e., D1 lymphadenectomy, in order to prevent postoperative complications.&#xD;
      Laparoscopic surgery is a minimally invasive operation and is proved to be an acceptable&#xD;
      alternative to open surgery. At present, there is no RCTs to confirm the safety and&#xD;
      effectiveness of laparoscopic D1 lymphadenectomy for elderly patients with advanced gastric&#xD;
      adenocarcinoma. This study is to compare the clinical outcomes of laparoscopic D1 versus D2&#xD;
      lymphadenectomy for elderly patients with advanced gastric adenocarcinoma（cT2-4a, N-/+, M0）to&#xD;
      evaluate the safety of laparoscopic D1 lymphadenectomy, and to verify its results in terms of&#xD;
      survival in elderly patients with advanced gastric adenocarcinoma.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Anticipated">August 2023</completion_date>
  <primary_completion_date type="Anticipated">August 2020</primary_completion_date>
  <phase>Phase 2</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>3-year disease specific survival rate</measure>
    <time_frame>36 months</time_frame>
    <description>the rate of 3-year disease specific survival</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>3-year overall survival rate</measure>
    <time_frame>36 months</time_frame>
    <description>the rate of 3-year overall survival rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>3-year disease free survival rate</measure>
    <time_frame>36 months</time_frame>
    <description>the rate of 3-year disease free survival</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of retrieved lymph nodes</measure>
    <time_frame>1 day</time_frame>
    <description>number of retrieved lymph nodes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of positive lymph nodes</measure>
    <time_frame>1 day</time_frame>
    <description>number of positive lymph nodes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>intraoperative blood loss</measure>
    <time_frame>1 day</time_frame>
    <description>intraoperative blood loss</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the rate of conversion to laparotomy</measure>
    <time_frame>1 day</time_frame>
    <description>the rate of conversion to laparotomy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>overall postoperative morbidity rate</measure>
    <time_frame>30 days</time_frame>
    <description>Refers to the incidence of early postoperative complications. The early postoperative complication are defined as the event observed within 30 days after surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>overall postoperative mortality rate</measure>
    <time_frame>30 days</time_frame>
    <description>the rate of surgical mortality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to first ambulation</measure>
    <time_frame>30 days</time_frame>
    <description>Time to first ambulation in hours is used to assess the postoperative recovery course.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to first flatus</measure>
    <time_frame>30 days</time_frame>
    <description>Time to first flatus in days is used to assess the postoperative recovery course.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to first liquid diet</measure>
    <time_frame>30 days</time_frame>
    <description>Time to first liquid diet in days is used to assess the postoperative recovery course.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to first soft diet</measure>
    <time_frame>30 days</time_frame>
    <description>Time to first soft diet in days is used to assess the postoperative recovery course.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of postoperative hospital stay</measure>
    <time_frame>30 days</time_frame>
    <description>Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The variation of white blood cell count</measure>
    <time_frame>Preoperative 3 days and postoperative 1, 3, and 5 days</time_frame>
    <description>The values of white blood cell count from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The variation of hemoglobin</measure>
    <time_frame>Preoperative 3 days and postoperative 1, 3, and 5 days</time_frame>
    <description>The values of hemoglobin in gram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The variation of C-reactive protein</measure>
    <time_frame>Preoperative 3 days and postoperative 1, 3, and 5 days</time_frame>
    <description>The values of C-reactive protein IN milligram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The variation of prealbumin</measure>
    <time_frame>Preoperative 3 days and postoperative 1, 3, and 5 days</time_frame>
    <description>The values of prealbumin in gram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>operation time</measure>
    <time_frame>1 day</time_frame>
    <description>operation time</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">160</enrollment>
  <condition>Stomach Neoplasm</condition>
  <arm_group>
    <arm_group_label>Laparoscopic D1 Lymphadenectomy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Laparoscopic D1 Lymphadenectomy will be performed for the treatment of patients assigned to this group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Laparoscopic D2 Lymphadenectomy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Laparoscopic D2 Lymphadenectomy will be performed for the treatment of patients assigned to this group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Laparoscopic D1 Lymphadenectomy</intervention_name>
    <description>After exclusion of T4b, bulky lymph nodes, or distant metastasis case, laparoscopic D1 Lymphadenectomy will be performed in the experimental group.</description>
    <arm_group_label>Laparoscopic D1 Lymphadenectomy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Laparoscopic D2 Lymphadenectomy</intervention_name>
    <description>After exclusion of T4b, bulky lymph nodes, or distant metastasis case, laparoscopic D2 Lymphadenectomy will be performed in the comparator group.</description>
    <arm_group_label>Laparoscopic D2 Lymphadenectomy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age over or equal to 75 years&#xD;
&#xD;
          2. Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or&#xD;
             poorly differentiated) confirmed pathologically by endoscopic biopsy, including&#xD;
             gastric multiple primary carcinoma&#xD;
&#xD;
          3. cT2-4a(clinical stage tumor), N-/+, M0 at preoperative evaluation according to the&#xD;
             American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition&#xD;
&#xD;
          4. expected to perform distal, total or proximal gastrectomy to obtain R0 resection&#xD;
             sugicall results.&#xD;
&#xD;
          5. Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale&#xD;
&#xD;
          6. ASA (American Society of Anesthesiology) class I to III&#xD;
&#xD;
          7. Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Severe mental disorder&#xD;
&#xD;
          2. History of previous upper abdominal surgery (except laparoscopic cholecystectomy)&#xD;
&#xD;
          3. History of previous gastric surgery (including ESD/EMR (Endoscopic Submucosal&#xD;
             Dissection/Endoscopic Mucosal Resection )for gastric cancer)&#xD;
&#xD;
          4. Enlarged or bulky regional lymph node （diameter over 3cm）supported by preoperative&#xD;
             imaging&#xD;
&#xD;
          5. History of other malignant disease within the past 5 years&#xD;
&#xD;
          6. History of previous neoadjuvant chemotherapy or radiotherapy&#xD;
&#xD;
          7. History of unstable angina or myocardial infarction within the past 6 months&#xD;
&#xD;
          8. History of cerebrovascular accident within the past 6 months&#xD;
&#xD;
          9. History of continuous systematic administration of corticosteroids within 1 month&#xD;
&#xD;
         10. Requirement of simultaneous surgery for other disease&#xD;
&#xD;
         11. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by&#xD;
             gastric cancer&#xD;
&#xD;
         12. FEV1&lt;50% of the predicted values&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>75 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Changming Huang, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fujian Medical University Union Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fujian Medical University Union Hospital</name>
      <address>
        <city>Fuzhou</city>
        <state>Fujian</state>
        <zip>350000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>September 19, 2017</study_first_submitted>
  <study_first_submitted_qc>September 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 21, 2017</study_first_posted>
  <last_update_submitted>February 4, 2020</last_update_submitted>
  <last_update_submitted_qc>February 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fujian Medical University Union Hospital</investigator_affiliation>
    <investigator_full_name>Chang-Ming Huang, Prof.</investigator_full_name>
    <investigator_title>Director, Head of gastric surgery, Principal Investigator, Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>Stomach Neoplasm</keyword>
  <keyword>Elderly Patients</keyword>
  <keyword>Laparoscopic D1 Lymphadenectomy</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>


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/NCT03290209
org study id: 2017-03
nct id: NCT03290209
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to explore the clinical outcomes of laparoscopic D1
      lymphadenectomy for elderly patients with advanced gastric adenocarcinoma（cT2-4a, N-/+, M0）
Gastrectomy with D2 lymphadenectomy is considered the gold standard treatment for advanced
      gastric cancer. However, some studies show that age or comorbidities is the relevant
      predictor of postoperative complications, conditioning the safety of the surgical procedure
      itself, thus affect the survial. Even with the advances in surgical techniques and care, age
      still is a significant risk for postoperative morbidity and mortality. Therefore, elderly
      patients with gastric cancer could receive minimally invasive surgery with reduced nodal
      dissection, i.e., D1 lymphadenectomy, in order to prevent postoperative complications.
      Laparoscopic surgery is a minimally invasive operation and is proved to be an acceptable
      alternative to open surgery. At present, there is no RCTs to confirm the safety and
      effectiveness of laparoscopic D1 lymphadenectomy for elderly patients with advanced gastric
      adenocarcinoma. This study is to compare the clinical outcomes of laparoscopic D1 versus D2
      lymphadenectomy for elderly patients with advanced gastric adenocarcinoma（cT2-4a, N-/+, M0）to
      evaluate the safety of laparoscopic D1 lymphadenectomy, and to verify its results in terms of
      survival in elderly patients with advanced gastric adenocarcinoma.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: 3-year disease specific survival rate
time frame: 36 months
description: the rate of 3-year disease specific survival
measure: 3-year overall survival rate
time frame: 36 months
description: the rate of 3-year overall survival rate
measure: 3-year disease free survival rate
time frame: 36 months
description: the rate of 3-year disease free survival
measure: number of retrieved lymph nodes
time frame: 1 day
description: number of retrieved lymph nodes
measure: number of positive lymph nodes
time frame: 1 day
description: number of positive lymph nodes
measure: intraoperative blood loss
time frame: 1 day
description: intraoperative blood loss
measure: the rate of conversion to laparotomy
time frame: 1 day
description: the rate of conversion to laparotomy
measure: overall postoperative morbidity rate
time frame: 30 days
description: Refers to the incidence of early postoperative complications. The early postoperative complication are defined as the event observed within 30 days after surgery.
measure: overall postoperative mortality rate
time frame: 30 days
description: the rate of surgical mortality
measure: Time to first ambulation
time frame: 30 days
description: Time to first ambulation in hours is used to assess the postoperative recovery course.
measure: Time to first flatus
time frame: 30 days
description: Time to first flatus in days is used to assess the postoperative recovery course.
measure: Time to first liquid diet
time frame: 30 days
description: Time to first liquid diet in days is used to assess the postoperative recovery course.
measure: Time to first soft diet
time frame: 30 days
description: Time to first soft diet in days is used to assess the postoperative recovery course.
measure: Duration of postoperative hospital stay
time frame: 30 days
description: Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.
measure: The variation of white blood cell count
time frame: Preoperative 3 days and postoperative 1, 3, and 5 days
description: The values of white blood cell count from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.
measure: The variation of hemoglobin
time frame: Preoperative 3 days and postoperative 1, 3, and 5 days
description: The values of hemoglobin in gram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.
measure: The variation of C-reactive protein
time frame: Preoperative 3 days and postoperative 1, 3, and 5 days
description: The values of C-reactive protein IN milligram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.
measure: The variation of prealbumin
time frame: Preoperative 3 days and postoperative 1, 3, and 5 days
description: The values of prealbumin in gram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.
measure: operation time
time frame: 1 day
description: operation time
arm group label: Laparoscopic D1 Lymphadenectomy
arm group type: Experimental
description: Laparoscopic D1 Lymphadenectomy will be performed for the treatment of patients assigned to this group.
arm group label: Laparoscopic D2 Lymphadenectomy
arm group type: Active Comparator
description: Laparoscopic D2 Lymphadenectomy will be performed for the treatment of patients assigned to this group.
intervention type: Procedure
intervention name: Laparoscopic D1 Lymphadenectomy
description: After exclusion of T4b, bulky lymph nodes, or distant metastasis case, laparoscopic D1 Lymphadenectomy will be performed in the experimental group.
arm group label: Laparoscopic D1 Lymphadenectomy
intervention type: Procedure
intervention name: Laparoscopic D2 Lymphadenectomy
description: After exclusion of T4b, bulky lymph nodes, or distant metastasis case, laparoscopic D2 Lymphadenectomy will be performed in the comparator group.
arm group label: Laparoscopic D2 Lymphadenectomy
criteria: 
gender: All
minimum age: 75 Years
maximum age: N/A
healthy volunteers: No
last name: Changming Huang, Professor
role: Principal Investigator
affiliation: Fujian Medical University Union Hospital
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Fujian Medical University Union Hospital
investigator full name: Chang-Ming Huang, Prof.
investigator title: Director, Head of gastric surgery, Principal Investigator, Clinical Professor
mesh term: Stomach Neoplasms