Anesthesia, GeneralPhase 4GA-CARESNCT03034096
General Anesthetics in CAncer REsection Surgery (GA-CARES) Trial
A Phase 4 study testing Propofol and Volatile Agent in people with Anesthesia, General and Surgical Oncology, run by Stony Brook University at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, General, Surgical Oncology
- What is being tested?
- Propofol and Volatile Agent
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,826 participants
- Where
- 5 sitesUnited States
- Study dates
- 31 Jan 2017to 30 Sep 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Hyperthermic intraperitoneal chemotherapy (HIPEC)
- Gastrectomy (subtotal or total)
- Cholecystectomy or bile duct resection
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Roswell Park Cancer Center
Buffalo, New York, 14203
Long Island Jewish Medical Center
New Hyde Park, New York, 11040
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
University of Rochester Medical Center
Rochester, New York, 14642
Stony Brook University Hospital
Stony Brook, New York, 11794-8480
About this study
Official title: General Anesthetics in CAncer REsection Surgery (GA-CARES) Trial: Pragmatic Randomized Trial of Propofol vs Volatile Inhalational Anesthesia
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.
- Conditions
- Anesthesia, General, Surgical Oncology
- Being tested
- Propofol, Volatile Agent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Maintenance of general anesthesia with propofol infusion
Volatile AgentDrug
Maintenance of general anesthesia with volatile agent (sevoflurane, desflurane, or isoflurane)
| Study group | Role | What they receive |
|---|---|---|
| Propofol infusion | Experimental | Maintenance of general anesthesia with propofol infusion Receives: Drug: Propofol |
| Volatile agent | Experimental | Maintenance of general anesthesia with volatile agent (sevoflurane, desflurane, or isoflurane) Receives: Drug: Volatile Agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Time to event
Measured: 2 year minimum
Secondary outcomes (2)
Recurrence free survival
Time to event
Measured: Minimum 2 years
All-cause mortality as a binary outcome
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2017 (estimated)
- Study start31 Jan 2017
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, GeneralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,826 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elliott Bennett-Guerrero, Stony Brook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03034096
- Sponsor's protocol ID
- 967670-3
- Acronym
- GA-CARES
- Status last verified
- Jan 2025
- First submitted
- 22 Jan 2017
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41363871Bennett-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.
PubMed 36631831
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- General Anesthetics in CAncer REsection Surgery (GA-CARES) Trial: Pragmatic Randomized Trial of Propofol vs Volatile Inhalational Anesthesia
- ClinicalTrials.gov ID
- NCT03034096
- Acronym / sponsor ID
- GA-CARES / 967670-3
- Conditions
- Anesthesia, General, Surgical Oncology
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,826 participants (actual)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Study start
- 31 Jan 2017 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 27 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol infusion | Experimental | Drug: PropofolMaintenance of general anesthesia with propofol infusion |
| Volatile agent | Experimental | Drug: Volatile AgentMaintenance of general anesthesia with volatile agent (sevoflurane, desflurane, or isoflurane) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with known or suspected cancer and scheduled to undergo any of the following oncologic surgical procedures:
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropofolMaintenance of general anesthesia with propofol infusion | Drug | Propofol infusion |
| Volatile AgentMaintenance of general anesthesia with volatile agent (sevoflurane, desflurane, or isoflurane) | Drug | Volatile agent |
Primary outcome
All-cause mortality
Time frame: 2 year minimum
Time to event
2 secondary outcomes
Recurrence free survival
Time frame: Minimum 2 years
All-cause mortality as a binary outcome
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
- Derived from this study: PubMed 41363871Bennett-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.
- Derived from this study: PubMed 36631831Bennett-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Propofol and Volatile Agent in people with Anesthesia, General and Surgical Oncology, run by Stony Brook University at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: 2 year minimum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03034096, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2025.