NCT03034096

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,826

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2017

Longer than P75 for phase_4

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 27, 2017

Completed
4 days until next milestone

Study Start

First participant enrolled

January 31, 2017

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

May 4, 2025

Status Verified

January 1, 2025

Enrollment Period

7.7 years

First QC Date

January 22, 2017

Last Update Submit

May 2, 2025

Conditions

Anesthesia, GeneralSurgical Oncology

Outcome Measures

Primary Outcomes (1)

  • All-cause mortality

    Time to event

    2 year minimum

Secondary Outcomes (2)

  • Recurrence free survival

    Minimum 2 years

  • All-cause mortality as a binary outcome

    2 years

Study Arms (2)

Propofol infusion

EXPERIMENTAL

Maintenance of general anesthesia with propofol infusion

Drug: Propofol

Volatile agent

EXPERIMENTAL

Maintenance of general anesthesia with volatile agent (sevoflurane, desflurane, or isoflurane)

Drug: Volatile Agent

Interventions

PropofolDRUG

Maintenance of general anesthesia with propofol infusion

Propofol infusion
Volatile AgentDRUG

Maintenance of general anesthesia with volatile agent (sevoflurane, desflurane, or isoflurane)

Volatile agent

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Roswell Park Cancer Center

Buffalo, New York, 14203, United States

Location

Long Island Jewish Medical Center

New Hyde Park, New York, 11040, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Stony Brook University Hospital

Stony Brook, New York, 11794-8480, United States

Location

Related Publications (2)

  • Bennett-Guerrero E, Romeiser JL, DeMaria S, Nadler JW, Quinn TD, Ponnappan SK, Wang R, Gloff MS, Lee KJ, Levin MA, Sroka RD, Stanley SL, Wang D, Sasson AR; GA-CARES Trial Group. Anesthesia Type during Cancer Surgery: Results of the GA-CARES Randomized, Multicenter Trial. Anesthesiology. 2026 Jan 1;144(1):51-62. doi: 10.1097/ALN.0000000000005769. Epub 2025 Dec 9.

    PMID: 41363871DERIVED

  • Bennett-Guerrero E, Romeiser JL, DeMaria S, Nadler JW, Quinn TD, Ponnappan SK, Yang J, Sasson AR. General Anesthetics in CAncer REsection Surgery (GA-CARES) randomized multicenter trial of propofol vs volatile inhalational anesthesia: protocol description. Perioper Med (Lond). 2023 Jan 11;12(1):2. doi: 10.1186/s13741-022-00290-z.

    PMID: 36631831DERIVED

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Vice Chairman

Study Record Dates

First Submitted

January 22, 2017

First Posted

January 27, 2017

Study Start

January 31, 2017

Primary Completion

September 30, 2024

Study Completion

September 30, 2024

Last Updated

May 4, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

US(5)