<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/NCT03034096</url>
  </required_header>
  <id_info>
    <org_study_id>967670-3</org_study_id>
    <nct_id>NCT03034096</nct_id>
  </id_info>
  <brief_title>General Anesthetics in CAncer REsection Surgery (GA-CARES) Trial</brief_title>
  <acronym>GA-CARES</acronym>
  <official_title>General Anesthetics in CAncer REsection Surgery (GA-CARES) Trial: Pragmatic Randomized Trial of Propofol vs Volatile Inhalational Anesthesia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stony Brook University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stony Brook University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a large pragmatic multicenter trial comparing maintenance of general anesthesia with&#xD;
      total intravenous anesthesia using propofol versus volatile agent (sevoflurane, isoflurane,&#xD;
      or desflurane) during cancer surgery. The primary endpoint is all-cause mortality.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 31, 2017</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">September 2024</primary_completion_date>
  <phase>Phase 4</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>All-cause mortality</measure>
    <time_frame>2 year minimum</time_frame>
    <description>Time to event</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Recurrence free survival</measure>
    <time_frame>Minimum 2 years</time_frame>
    <description>Time to event</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All-cause mortality as a binary outcome</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1804</enrollment>
  <condition>Anesthesia, General</condition>
  <condition>Surgical Oncology</condition>
  <arm_group>
    <arm_group_label>Propofol infusion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Maintenance of general anesthesia with propofol infusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Volatile agent</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Maintenance of general anesthesia with volatile agent (sevoflurane, desflurane, or isoflurane)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Propofol</intervention_name>
    <description>Maintenance of general anesthesia with propofol infusion</description>
    <arm_group_label>Propofol infusion</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Volatile Agent</intervention_name>
    <description>Maintenance of general anesthesia with volatile agent (sevoflurane, desflurane, or isoflurane)</description>
    <arm_group_label>Volatile agent</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with known or suspected cancer and scheduled to undergo any of the following&#xD;
             oncologic surgical procedures:&#xD;
&#xD;
               -  Lobectomy or pneumonectomy&#xD;
&#xD;
               -  Esophagectomy&#xD;
&#xD;
               -  Radical (total) cystectomy&#xD;
&#xD;
               -  Pancreatectomy&#xD;
&#xD;
               -  Partial hepatectomy&#xD;
&#xD;
               -  Hyperthermic intraperitoneal chemotherapy (HIPEC)&#xD;
&#xD;
               -  Gastrectomy (subtotal or total)&#xD;
&#xD;
               -  Cholecystectomy or bile duct resection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age less than 18 years&#xD;
&#xD;
          -  American Society of Anesthesiologist Class 5&#xD;
&#xD;
          -  Projected life expectancy less than 30 days&#xD;
&#xD;
          -  Known or suspected hypersensitivity to either propofol, e.g. egg or soy allergy, or&#xD;
             volatile general anesthetic agents&#xD;
&#xD;
          -  Known or suspected history of malignant hyperthermia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Roswell Park Cancer Center</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Long Island Jewish Medical Center</name>
      <address>
        <city>New Hyde Park</city>
        <state>New York</state>
        <zip>11040</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Icahn School of Medicine at Mount Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Rochester Medical Center</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stony Brook University Hospital</name>
      <address>
        <city>Stony Brook</city>
        <state>New York</state>
        <zip>11794-8480</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>January 22, 2017</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>October 13, 2022</last_update_submitted>
  <last_update_submitted_qc>October 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 17, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stony Brook University</investigator_affiliation>
    <investigator_full_name>Elliott Bennett-Guerrero</investigator_full_name>
    <investigator_title>Professor and Vice Chairman</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Propofol</mesh_term>
  </intervention_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/NCT03034096
org study id: 967670-3
nct id: NCT03034096
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This is a large pragmatic multicenter trial comparing maintenance of general anesthesia with
      total intravenous anesthesia using propofol versus volatile agent (sevoflurane, isoflurane,
      or desflurane) during cancer surgery. The primary endpoint is all-cause mortality.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: All-cause mortality
time frame: 2 year minimum
description: Time to event
measure: Recurrence free survival
time frame: Minimum 2 years
description: Time to event
measure: All-cause mortality as a binary outcome
time frame: 2 years
arm group label: Propofol infusion
arm group type: Experimental
description: Maintenance of general anesthesia with propofol infusion
arm group label: Volatile agent
arm group type: Experimental
description: Maintenance of general anesthesia with volatile agent (sevoflurane, desflurane, or isoflurane)
intervention type: Drug
intervention name: Propofol
description: Maintenance of general anesthesia with propofol infusion
arm group label: Propofol infusion
intervention type: Drug
intervention name: Volatile Agent
description: Maintenance of general anesthesia with volatile agent (sevoflurane, desflurane, or isoflurane)
arm group label: Volatile agent
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Stony Brook University
investigator full name: Elliott Bennett-Guerrero
investigator title: Professor and Vice Chairman
mesh term: Neoplasms
mesh term: Propofol
sharing ipd: No