Anesthesia and Non-small Cell Lung Cancer Recurrence (GASTIVA)

April 15, 2026 updated by: Hyun Joo Ahn, Samsung Medical Center

Recurrence Free Survival After Curative Resection of Non-small Cell Lung Cancer Between Inhalational Gas Anesthesia and Propofol-based Total IntraVenous Anesthesia: a Multicenter, Randomized, Clinical Trial

There has been ongoing debate about the relationship between cancer recurrence and anesthetic management. Therefore, the investigators will test the hypothesis that the recurrence free survival (RFS) after curative resection of NSCLC is higher in patient who received total intravenous anesthesia (TIVA) than volatile anesthetics in this multi-center randomized trials.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Surgery is the primary treatment for non-small cell lung cancer (NSCLC), but microscopic residual disease may be unavoidable. Preclinical studies have shown that volatile anesthetics might suppress host immunity and promote a pro-malignant environment which supports cancer cell proliferation, migration, and angiogenesis, whereas propofol may preserve cell-mediated immunity and inhibits tumor angiogenesis. However, clinical evidence that propofol-based total intravenous anesthesia (TIVA) can reduce tumor recurrence after curative resection remains inconsistent due to retrospective observational nature of previous studies. Therefore, the investigators will test the hypothesis that the recurrence free survival (RFS) after curative resection of NSCLC is higher in patient who received TIVA than volatile anesthetics in this multi-center randomized trials.

This double-blind, randomized trial will enroll patients at 22 international sites, subject to study registration, institutional review board approval, and patient written informed consent. Eligible patients are adult patients undergoing lung resection surgery with curative intent for NSCLC. At each study site, enrolled subjects will be randomly allocated into the TIVA and GAS group with a 1:1 ratio. A centralized, password-protected, and encrypted web-based electronic case report form will be used for randomization and data upload. This pragmatic trial does not standardize any aspect of patient care. However, potential confounders will be balanced between the study arms.

The primary outcome will be recurrence free survival (RFS). Secondary outcomes will be overall survival and complications within postoperative 7 days. Enrollment of 5384 patients will provide 80% power to detect a 3% treatment effect (hazard ratio of 0.83) at alpha 0.05 for RFS at 3 years.

Confirmation of the study hypothesis would demonstrate that a relatively minor and low cost alteration in anesthetic management has the potential to reduce cancer recurrence risk in NSCLC, an ultimately fatal complication. Rejection of the hypothesis would end the ongoing debate about the relationship between cancer recurrence and anesthetic management.

Study Type

Interventional

Enrollment (Estimated)

5384

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • South Korea
    • Seoul-teukbyeolsi
      • Seoul, Seoul-teukbyeolsi, South Korea, 06351
        • Recruiting
        • Samsung Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • American Society of Anesthesiologists physical status (ASA) Ⅰ-Ⅲ
  • The Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Lung resection surgery (segmentectomy, lobectomy, bilobectomy, pneumonectomy; video-assisted, robot-assisted, or open) with curative intent for NSCLC (clinical Tumor, Node, Metastasis (TNM) stage Ⅰ- ⅢA).

Exclusion Criteria:

  • Distant metastasis or malignant tumor in other organs that according to the attending surgeon is not in long-term remission
  • Severe neurologic conditions
  • Severe hepatic disease (Child-Pugh classification C)
  • Renal failure requiring renal replacement therapy
  • History of anesthesia and/or surgery within 1 yr
  • Previous surgery due to lung cancer (except diagnostic biopsies)
  • Contraindications to any study medication (history of allergy, hypersensitivity reaction, or any other contraindication)
  • Planned joint extrapulmonary procedure
  • Surgery under cardiopulmonary bypass or extracorporeal membrane oxygenation
  • Postoperative sedation
  • Pregnancy, or lactation
  • Patient refusal.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TIVA group
The TIVA group will receive propofol for both induction and maintenance of general anesthesia.
Drug: Propofol
Propofol will be used for the induction and maintenance of general anesthesia.
Other Names:
  • Propofol 1% or 2% inj.
Active Comparator: GAS group
The GAS group will receive one or more volatile anesthetics (sevoflurane, desflurane, or isoflurane) for induction and maintenance of anesthesia during the surgery. For GAS group, propofol, midazolam, remimazolam, etomidate, or ketamine can be used with inhalation agents as co-induction agents under the discretion of the attending anesthesiologist.
Drug: Inhaled anesthetics
Inhaled anesthetics will be used for the maintenance of general anesthesia.
Other Names:
  • Sevoflurane, Desflurane, Isoflurane

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence free survival
Time Frame: Within 3 year after curative resection for NSCLC
Time from surgery to the earliest date of local recurrence/metastasis or death from any cause, whichever comes first
Within 3 year after curative resection for NSCLC

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: Within 3 year after curative resection for NSCLC
Time from index surgery to death due to any causes
Within 3 year after curative resection for NSCLC
Postoperative complications
Time Frame: within 7 days post-surgery or at discharge if earlier
Rate of complications which will be assessed with Clavien-Dindo classification and postoperative complications defined by the Society of Thoracic Surgeons (STS) general thoracic surgery databases
within 7 days post-surgery or at discharge if earlier

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Collaborators

Memorial Sloan Kettering Cancer Center
Mayo Clinic
Yale University
Seoul St. Mary's Hospital
Asan Medical Center
Seoul National University Hospital
Khon Kaen University
University of Texas Southwestern Medical Center
Korea University Guro Hospital
University of Virginia
The Affiliated Hospital of Qingdao University
Beijing Hospital
Ewha Womans University
Konkuk University Medical Center
Severance Hospital
King Chulalongkorn Memorial Hospital
Chungnam National University Hospital
University Hospitals Coventry and Warwickshire NHS Trust
DongGuk University
Inha University Hospital
All India Institute of Medical Sciences

Investigators

  • Principal Investigator: Hyun Joo Ahn, Department of Anesthesiology and Pain Medicine, Samsung Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 5, 2024

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

March 19, 2024

First Submitted That Met QC Criteria

March 19, 2024

First Posted (Actual)

March 26, 2024

Study Record Updates

Last Update Posted (Actual)

April 20, 2026

Last Update Submitted That Met QC Criteria

April 15, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMC 2024-01-065

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data sharing including the full protocol, individual participant and other relevant study data will be considered upon reasonable request. Only with the permission of the Data Review Board of Samsung Medical Center, the anonymized data will be available from the principal investigator (HJA).

IPD Sharing Time Frame

within 3 years after publication

IPD Sharing Access Criteria

Data sharing including the full protocol, individual participant and other relevant study data will be considered upon reasonable request. Only with the permission of the Data Review Board of Samsung Medical Center, the anonymized data will be available from the principal investigator (HJA).

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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