Non-small Cell Lung CancerPhase 4GASTIVANCT06330038
Anesthesia and Non-small Cell Lung Cancer Recurrence
A Phase 4 study testing Propofol and Inhaled anesthetics in people with Non-small Cell Lung Cancer and Surgery, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer, Surgery, Anesthesia
- What is being tested?
- Propofol and Inhaled anesthetics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,384 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Aug 2024to 31 Dec 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, Seoul-teukbyeolsi, 06351
Jeayoun Kim, MD, PhD, 821039268786, jeayoun.kim@samsung.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Non-small Cell Lung Cancer, Surgery, Anesthesia
- Being tested
- Propofol, Inhaled anesthetics
- Keywords
- Anesthesia, Desflurane, Inhalational anesthesia, Isoflurane, Lung neoplasm, Metastasis, Propofol, Recurrence, Sevoflurane, Surgery, Non-small cell lung cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Neoplasm Metastasis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Also called Propofol 1% or 2% inj.
Propofol will be used for the induction and maintenance of general anesthesia.
Inhaled anestheticsDrug
Also called Sevoflurane, Desflurane, Isoflurane
Inhaled anesthetics will be used for the maintenance of general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| TIVA group | Experimental | The TIVA group will receive propofol for both induction and maintenance of general anesthesia. Receives: Drug: Propofol |
| GAS group | Active comparator | 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. Receives: Drug: Inhaled anesthetics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence free survival
Time from surgery to the earliest date of local recurrence/metastasis or death from any cause, whichever comes first
Measured: Within 3 year after curative resection for NSCLC
Secondary outcomes (2)
Overall survival
Time from index surgery to death due to any causes
Measured: Within 3 year after curative resection for NSCLC
Postoperative complications
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
Measured: within 7 days post-surgery or at discharge if earlier
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start5 Aug 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 5,384 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Hospital, Asan Medical Center, Severance Hospital, Seoul St. Mary's Hospital, Korea University Guro Hospital, DongGuk University, Inha University Hospital, Konkuk University Medical Center, Ewha Womans University, Chungnam National University Hospital, University of Virginia, Memorial Sloan Kettering Cancer Center, Yale University, Mayo Clinic, University of Texas Southwestern Medical Center, University Hospitals Coventry and Warwickshire NHS Trust, Khon Kaen University, King Chulalongkorn Memorial Hospital, The Affiliated Hospital of Qingdao University, Beijing Hospital, All India Institute of Medical Sciences
- Responsible party
- Principal investigator, Hyun Joo Ahn, Samsung Medical Center
- Investigators
- Hyun Joo Ahn, Principal investigator, Department of Anesthesiology and Pain Medicine, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06330038
- Sponsor's protocol ID
- SMC 2024-01-065
- Acronym
- GASTIVA
- Status last verified
- Apr 2026
- First submitted
- 19 Mar 2024
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Publications
Kim J, Yoon S, Song IK, Lee K, Hwang W, Kim H, Lee DK, Lim HK, Kim SH, Lee JW, Hong B, Blank RS, Pedoto A, Popescu W, Theresa G, Martin AK, Patteril M, Pathanasethpong A, Thongsuk Y, Pisitpitayasaree T, Huang A, Yu H, Kapoor PM, Kim K, Chi SA, Ahn HJ. 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 (GAS TIVA trial): protocol description. Perioper Med (Lond). 2024 Jul 23;13(1):79. doi: 10.1186/s13741-024-00436-1.
PubMed 39039548
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06330038
- Acronym / sponsor ID
- GASTIVA / SMC 2024-01-065
- Conditions
- Non-small Cell Lung Cancer, Surgery, Anesthesia
- Keywords
- Anesthesia, Desflurane, Inhalational anesthesia, Isoflurane, Lung neoplasm, Metastasis, Propofol, Recurrence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5,384 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Seoul National University Hospital, Asan Medical Center, Severance Hospital, Seoul St. Mary's Hospital, Korea University Guro Hospital, DongGuk University, Inha University Hospital, Konkuk University Medical Center, Ewha Womans University, Chungnam National University Hospital, University of Virginia, Memorial Sloan Kettering Cancer Center, Yale University, Mayo Clinic, University of Texas Southwestern Medical Center, University Hospitals Coventry and Warwickshire NHS Trust, Khon Kaen University, King Chulalongkorn Memorial Hospital, The Affiliated Hospital of Qingdao University, Beijing Hospital, All India Institute of Medical Sciences
- Study start
- 5 Aug 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 26 Mar 2024 (actual)
- 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.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TIVA group | Experimental | Drug: PropofolThe TIVA group will receive propofol for both induction and maintenance of general anesthesia. |
| GAS group | Active comparator | Drug: Inhaled anestheticsThe 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (12 listed)
- 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
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 |
|---|---|---|
| PropofolAlso: Propofol 1% or 2% inj.Propofol will be used for the induction and maintenance of general anesthesia. | Drug | TIVA group |
| Inhaled anestheticsAlso: Sevoflurane, Desflurane, IsofluraneInhaled anesthetics will be used for the maintenance of general anesthesia. | Drug | GAS group |
Primary outcome
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
2 secondary outcomes
Overall survival
Time frame: Within 3 year after curative resection for NSCLC
Postoperative complications
Time frame: within 7 days post-surgery or at discharge if earlier
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Derived from this study: PubMed 39039548Kim J, Yoon S, Song IK, Lee K, Hwang W, Kim H, Lee DK, Lim HK, Kim SH, Lee JW, Hong B, Blank RS, Pedoto A, Popescu W, Theresa G, Martin AK, Patteril M, Pathanasethpong A, Thongsuk Y, Pisitpitayasaree T, Huang A, Yu H, Kapoor PM, Kim K, Chi SA, Ahn HJ. 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 (GAS TIVA trial): protocol description. Perioper Med (Lond). 2024 Jul 23;13(1):79. doi: 10.1186/s13741-024-00436-1.
- Individual participant dataSharing planned: Yes. 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).
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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.
Hyun Joo Ahn principal investigator
Department of Anesthesiology and Pain Medicine, Samsung Medical Center
1 site 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 Inhaled anesthetics in people with Non-small Cell Lung Cancer and Surgery, run by Samsung Medical Center at 1 site in South Korea.
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 3 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeayoun Kim, MD (8234106590, jeayoun.kim@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence free survival (time frame: Within 3 year after curative resection for NSCLC). 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 NCT06330038, which also lists 1 linked publication.
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 20 Apr 2026.