<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/NCT02248519</url>
  </required_header>
  <id_info>
    <org_study_id>NL47444.041.14</org_study_id>
    <nct_id>NCT02248519</nct_id>
  </id_info>
  <brief_title>Laparoscopic Versus Open Gastrectomy for Gastric Cancer</brief_title>
  <acronym>LOGICA</acronym>
  <official_title>Laparoscopic Versus Open Gastrectomy for Gastric Cancer, a Multicenter Prospectively Randomized Controlled Trial (LOGICA-trial)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>UMC Utrecht</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>ZonMw: The Netherlands Organisation for Health Research and Development</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Johnson &amp; Johnson</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>UMC Utrecht</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is the first randomized controlled trial comparing laparoscopic and open gastrectomy for&#xD;
      resectable gastric cancer in a Western population. The hypothesis is that laparoscopic&#xD;
      gastrectomy will result in a lower post-operative burden by means of shorter post-operative&#xD;
      hospital stay. Secondarily that laparoscopic gastrectomy is hypothesized to be associated&#xD;
      with lower post-operative morbidity and readmissions, higher cost-effectiveness, and better&#xD;
      post-operative quality of life, with similar mortality and oncologic outcomes, compared to&#xD;
      open gastrectomy. The study starts on 1 December 2014. Inclusion and follow-up will take&#xD;
      three and five years respectively. Short-term results will be analyzed and published after&#xD;
      discharge of the last randomized patient.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 2014</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Actual">November 2018</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>Post-operative hospital stay</measure>
    <time_frame>During admission, an expected average of 2 weeks</time_frame>
    <description>The primary outcome of this study is the post-operative hospital stay (days), since this is considered a strong end point as it reflects the impact of the different surgical procedures.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>30 days post-operative</time_frame>
    <description>Measured as 30-day mortality rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative morbidity</measure>
    <time_frame>Up to 5 years post-operative</time_frame>
    <description>Complications will be classified according to the Clavien-Dindo system and include anastomotic leakage, anastomotic stricture, respiratory complications, cardiac complications, intra-abdominal bleeding , intra-abdominal abscess, sepsis, ileus, wound infection, fistula, urinary tract infection and dumping syndrome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost-effectiveness</measure>
    <time_frame>Up to 5 years post-operative</time_frame>
    <description>Cost-effectiveness will be calculated by comparing the direct medical cost related to both strategies up until five years after the operation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life</measure>
    <time_frame>Up to 5 years post-operative</time_frame>
    <description>The validated quality of life questionnaires EORTC QLQ-30, EORTC QLQ-STO22 and EQ-5D-5L, will be filled in pre-operative &lt;5 days and post-operative at 6 weeks, 12, 24, 36, 48 and 60 months after surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Readmissions</measure>
    <time_frame>Up to 5 years post-operative</time_frame>
    <description>The number of post-operative readmissions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oncologic outcomes (R0-resection rate and lymph node yield)</measure>
    <time_frame>Pathology report 1-2 weeks after surgery</time_frame>
    <description>R0-resection rate of the distal and proximal margin, defined according to the College of American Pathologists. Lymph node yield: the amount of harvested lymph nodes per patient.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Perioperative blood loss</measure>
    <time_frame>Post-operative day 1</time_frame>
    <description>Measured in milliliters (ml)</description>
  </other_outcome>
  <other_outcome>
    <measure>Operative time</measure>
    <time_frame>Post-operative day 1</time_frame>
    <description>The time from incision to closure of all wounds in minutes (min)</description>
  </other_outcome>
  <other_outcome>
    <measure>Conversion rate</measure>
    <time_frame>Post-operative day 1</time_frame>
    <description>The percentage (%) of laparoscopic gastrectomies that had to be converted intra-operatively to an open procedure due to any reason.</description>
  </other_outcome>
  <other_outcome>
    <measure>Survival</measure>
    <time_frame>Up to 5 years post-operative</time_frame>
    <description>Measured as 5-year disease free survival and 5-year overall survival</description>
  </other_outcome>
  <other_outcome>
    <measure>VAS-score</measure>
    <time_frame>Post-operative day 1 and 2</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Surgeons ergonomics</measure>
    <time_frame>Post-operative day 1</time_frame>
    <description>Measured with the Subjective Mental Effort Questionnaire (SMEQ)</description>
  </other_outcome>
  <other_outcome>
    <measure>Time to return to normal nutritional regime</measure>
    <time_frame>Up to 5 years post-operative</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Time to return to daily activity</measure>
    <time_frame>Up to 5 years post-operative</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">210</enrollment>
  <condition>Gastric Cancer</condition>
  <arm_group>
    <arm_group_label>Open Gastrectomy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients allocated to the 'Open Gastrectomy' group will receive distal or total gastrectomy via laparotomy. This group is considered the control group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Laparoscopic Gastrectomy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients allocated to the 'Laparoscopic Gastrectomy' group will undergo distal or total gastrectomy via laparoscopy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Open Gastrectomy</intervention_name>
    <description>Patients allocated to the 'Open Gastrectomy' group will receive distal or total gastrectomy via laparotomy. This group is considered the control group</description>
    <arm_group_label>Open Gastrectomy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Laparoscopic Gastrectomy</intervention_name>
    <description>Patients allocated to the 'Laparoscopic Gastrectomy' group will undergo distal or total gastrectomy via laparoscopy. If laparoscopic resection does not seem feasible during surgery, the procedure may be converted to an open gastrectomy.</description>
    <arm_group_label>Laparoscopic Gastrectomy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically proven adenocarcinoma of the stomach&#xD;
&#xD;
          -  Surgically resectable (cT1-4a, N0-3b, M0) tumor&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  European Clinical Oncology Group (ECOG) performance status 0, 1 or 2.&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Siewert type I esophagogastric junction tumor&#xD;
&#xD;
          -  Non-elective surgery&#xD;
&#xD;
          -  Previous gastric resection or recurrent gastric cancer&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Richard van Hillegersberg, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dept. of Surgery, University Medical Center Utrecht</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Zorggroep Twente Almelo</name>
      <address>
        <city>Almelo</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meander Medical Center</name>
      <address>
        <city>Amersfoort</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VU University Medical Center</name>
      <address>
        <city>Amsterdam</city>
        <zip>1081 HZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Academic Medical Center</name>
      <address>
        <city>Amsterdam</city>
        <zip>1105 AZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gelre Hospital</name>
      <address>
        <city>Apeldoorn</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Catharina Hospital</name>
      <address>
        <city>Eindhoven</city>
        <zip>5623 EJ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leiden University Medical Center</name>
      <address>
        <city>Leiden</city>
        <zip>2333 ZA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Erasmus Medical Center</name>
      <address>
        <city>Rotterdam</city>
        <zip>3015 CE</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zuyderland Medical Center</name>
      <address>
        <city>Sittard-Geleen</city>
        <zip>6162 BG</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Medical Center Utrecht</name>
      <address>
        <city>Utrecht</city>
        <zip>3584 CX</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <reference>
    <citation>Haverkamp L, Brenkman HJ, Seesing MF, Gisbertz SS, van Berge Henegouwen MI, Luyer MD, Nieuwenhuijzen GA, Wijnhoven BP, van Lanschot JJ, de Steur WO, Hartgrink HH, Stoot JH, Hulsewe KW, Spillenaar Bilgen EJ, Rutter JE, Kouwenhoven EA, van Det MJ, van der Peet DL, Daams F, Draaisma WA, Broeders IA, van Stel HF, Lacle MM, Ruurda JP, van Hillegersberg R; LOGICA study group. Laparoscopic versus open gastrectomy for gastric cancer, a multicenter prospectively randomized controlled trial (LOGICA-trial). BMC Cancer. 2015 Jul 29;15:556. doi: 10.1186/s12885-015-1551-z.</citation>
    <PMID>26219670</PMID>
  </reference>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>September 17, 2014</study_first_submitted>
  <study_first_submitted_qc>September 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>September 2, 2020</last_update_submitted>
  <last_update_submitted_qc>September 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>UMC Utrecht</investigator_affiliation>
    <investigator_full_name>Richard van Hillegersberg</investigator_full_name>
    <investigator_title>MD PhD</investigator_title>
  </responsible_party>
  <keyword>Gastric cancer</keyword>
  <keyword>Gastrectomy</keyword>
  <keyword>Laparoscopy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stomach Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Individual participant data that underlie the results reported in the primary manuscript will be shared after de-identification (text, tables, figures, and appendices).</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Immediately following publication; no end date.</ipd_time_frame>
    <ipd_access_criteria>Anyone who wishes to access the data for any purpose.</ipd_access_criteria>
  </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/NCT02248519
org study id: NL47444.041.14
nct id: NCT02248519
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
This is the first randomized controlled trial comparing laparoscopic and open gastrectomy for
      resectable gastric cancer in a Western population. The hypothesis is that laparoscopic
      gastrectomy will result in a lower post-operative burden by means of shorter post-operative
      hospital stay. Secondarily that laparoscopic gastrectomy is hypothesized to be associated
      with lower post-operative morbidity and readmissions, higher cost-effectiveness, and better
      post-operative quality of life, with similar mortality and oncologic outcomes, compared to
      open gastrectomy. The study starts on 1 December 2014. Inclusion and follow-up will take
      three and five years respectively. Short-term results will be analyzed and published after
      discharge of the last randomized patient.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Post-operative hospital stay
time frame: During admission, an expected average of 2 weeks
description: The primary outcome of this study is the post-operative hospital stay (days), since this is considered a strong end point as it reflects the impact of the different surgical procedures.
measure: Mortality
time frame: 30 days post-operative
description: Measured as 30-day mortality rate
measure: Post-operative morbidity
time frame: Up to 5 years post-operative
description: Complications will be classified according to the Clavien-Dindo system and include anastomotic leakage, anastomotic stricture, respiratory complications, cardiac complications, intra-abdominal bleeding , intra-abdominal abscess, sepsis, ileus, wound infection, fistula, urinary tract infection and dumping syndrome
measure: Cost-effectiveness
time frame: Up to 5 years post-operative
description: Cost-effectiveness will be calculated by comparing the direct medical cost related to both strategies up until five years after the operation
measure: Quality of Life
time frame: Up to 5 years post-operative
description: The validated quality of life questionnaires EORTC QLQ-30, EORTC QLQ-STO22 and EQ-5D-5L, will be filled in pre-operative <5 days and post-operative at 6 weeks, 12, 24, 36, 48 and 60 months after surgery.
measure: Readmissions
time frame: Up to 5 years post-operative
description: The number of post-operative readmissions
measure: Oncologic outcomes (R0-resection rate and lymph node yield)
time frame: Pathology report 1-2 weeks after surgery
description: R0-resection rate of the distal and proximal margin, defined according to the College of American Pathologists. Lymph node yield: the amount of harvested lymph nodes per patient.
measure: Perioperative blood loss
time frame: Post-operative day 1
description: Measured in milliliters (ml)
measure: Operative time
time frame: Post-operative day 1
description: The time from incision to closure of all wounds in minutes (min)
measure: Conversion rate
time frame: Post-operative day 1
description: The percentage (%) of laparoscopic gastrectomies that had to be converted intra-operatively to an open procedure due to any reason.
measure: Survival
time frame: Up to 5 years post-operative
description: Measured as 5-year disease free survival and 5-year overall survival
measure: VAS-score
time frame: Post-operative day 1 and 2
measure: Surgeons ergonomics
time frame: Post-operative day 1
description: Measured with the Subjective Mental Effort Questionnaire (SMEQ)
measure: Time to return to normal nutritional regime
time frame: Up to 5 years post-operative
measure: Time to return to daily activity
time frame: Up to 5 years post-operative
arm group label: Open Gastrectomy
arm group type: Active Comparator
description: Patients allocated to the 'Open Gastrectomy' group will receive distal or total gastrectomy via laparotomy. This group is considered the control group
arm group label: Laparoscopic Gastrectomy
arm group type: Experimental
description: Patients allocated to the 'Laparoscopic Gastrectomy' group will undergo distal or total gastrectomy via laparoscopy.
intervention type: Procedure
intervention name: Open Gastrectomy
description: Patients allocated to the 'Open Gastrectomy' group will receive distal or total gastrectomy via laparotomy. This group is considered the control group
arm group label: Open Gastrectomy
intervention type: Procedure
intervention name: Laparoscopic Gastrectomy
description: Patients allocated to the 'Laparoscopic Gastrectomy' group will undergo distal or total gastrectomy via laparoscopy. If laparoscopic resection does not seem feasible during surgery, the procedure may be converted to an open gastrectomy.
arm group label: Laparoscopic Gastrectomy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Richard van Hillegersberg, MD PhD
role: Principal Investigator
affiliation: Dept. of Surgery, University Medical Center Utrecht
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Netherlands
citation: Haverkamp L, Brenkman HJ, Seesing MF, Gisbertz SS, van Berge Henegouwen MI, Luyer MD, Nieuwenhuijzen GA, Wijnhoven BP, van Lanschot JJ, de Steur WO, Hartgrink HH, Stoot JH, Hulsewe KW, Spillenaar Bilgen EJ, Rutter JE, Kouwenhoven EA, van Det MJ, van der Peet DL, Daams F, Draaisma WA, Broeders IA, van Stel HF, Lacle MM, Ruurda JP, van Hillegersberg R; LOGICA study group. Laparoscopic versus open gastrectomy for gastric cancer, a multicenter prospectively randomized controlled trial (LOGICA-trial). BMC Cancer. 2015 Jul 29;15:556. doi: 10.1186/s12885-015-1551-z.
PMID: 26219670
responsible party type: Principal Investigator
investigator affiliation: UMC Utrecht
investigator full name: Richard van Hillegersberg
investigator title: MD PhD
mesh term: Stomach Neoplasms
sharing ipd: Yes
ipd description: Individual participant data that underlie the results reported in the primary manuscript will be shared after de-identification (text, tables, figures, and appendices).
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd info type: Analytic Code
ipd time frame: Immediately following publication; no end date.
ipd access criteria: Anyone who wishes to access the data for any purpose.