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

• Sponsor: Stony Brook University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03034096
• Collaborator: (none)
• Enrollment: 1,800
• Locations: 5
• Arms: 2
• Duration (Months): 83
• Patients Per Site: 360
• Patients Per Site Per Month: 4.3

Study Details

Study Description

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

• Study Type: Interventional
• Anticipated Enrollment: 1800 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
• Study Start Date: Jan 1, 2017
• Anticipated Primary Completion Date: Oct 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

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

Primary Outcome Measures

1. All-cause mortality [2 year minimum]

   Time to event

Secondary Outcome Measures

1. Recurrence free survival [Minimum 2 years]

   Time to event

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Roswell Park Cancer Center	Buffalo	New York	United States	14203
2	Long Island Jewish Medical Center	New Hyde Park	New York	United States	11040
3	Icahn School of Medicine at Mount Sinai	New York	New York	United States	10029
4	University of Rochester Medical Center	Rochester	New York	United States	14642
5	Stony Brook University Hospital	Stony Brook	New York	United States	11794-8480

Sponsors and Collaborators

• Stony Brook University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Elliott Bennett-Guerrero, Professor and Vice Chairman, Stony Brook University
• ClinicalTrials.gov Identifier: NCT03034096
• Other Study ID Numbers: 967670-3
• First Posted: Jan 27, 2017
• Last Update Posted: Dec 1, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Neoplasms; Propofol

Study Results

No Results Posted as of Dec 1, 2021