We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

General Anesthetics in CAncer REsection Surgery (GA-CARES) Trial (GA-CARES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03034096
Recruitment Status : Active, not recruiting
First Posted : January 27, 2017
Last Update Posted : October 17, 2022
Sponsor:
Information provided by (Responsible Party):
Elliott Bennett-Guerrero, Stony Brook University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Anesthesia, General Surgical Oncology Drug: Propofol Drug: Volatile Agent Phase 4

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1804 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: General Anesthetics in CAncer REsection Surgery (GA-CARES) Trial: Pragmatic Randomized Trial of Propofol vs Volatile Inhalational Anesthesia
Actual Study Start Date : January 31, 2017
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Propofol

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Propofol infusion
Maintenance of general anesthesia with propofol infusion
 Drug: Propofol
Maintenance of general anesthesia with propofol infusion
Experimental: Volatile agent
Maintenance of general anesthesia with volatile agent (sevoflurane, desflurane, or isoflurane)
 Drug: Volatile Agent
Maintenance of general anesthesia with volatile agent (sevoflurane, desflurane, or isoflurane)


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. All-cause mortality [ Time Frame: 2 year minimum ]
    Time to event


Secondary Outcome Measures :
  1. Recurrence free survival [ Time Frame: Minimum 2 years ]
    Time to event

  2. All-cause mortality as a binary outcome [ Time Frame: 2 years ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with known or suspected cancer and scheduled to undergo any of the following oncologic surgical procedures:

    • Lobectomy or pneumonectomy
    • Esophagectomy
    • Radical (total) cystectomy
    • Pancreatectomy
    • Partial hepatectomy
    • Hyperthermic intraperitoneal chemotherapy (HIPEC)
    • Gastrectomy (subtotal or total)
    • Cholecystectomy or bile duct resection

Exclusion Criteria:

  • Age less than 18 years
  • American Society of Anesthesiologist Class 5
  • Projected life expectancy less than 30 days
  • Known or suspected hypersensitivity to either propofol, e.g. egg or soy allergy, or volatile general anesthetic agents
  • Known or suspected history of malignant hyperthermia
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03034096


Locations
Layout table for location information
United States, New York
Roswell Park Cancer Center
Buffalo, New York, United States, 14203
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
University of Rochester Medical Center
Rochester, New York, United States, 14642
Stony Brook University Hospital
Stony Brook, New York, United States, 11794-8480
Sponsors and Collaborators
Stony Brook University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Elliott Bennett-Guerrero, Professor and Vice Chairman, Stony Brook University
ClinicalTrials.gov Identifier: NCT03034096    
Other Study ID Numbers: 967670-3
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: October 17, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
 Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics