Anesthesia and Non-small Cell Lung Cancer Recurrence

NCT06330038 | Recruiting Phase 4

• 1 other identifier: SMC 2024-01-065
• Study Type: interventional
• Target: 5,384
• Locations: 1 country
• Sites: 1

Brief 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 anesthetics in this multi-center randomized trials.

Conditions

Non-small Cell Lung Cancer; Surgery; Anesthesia

Keywords

Anesthesia; Desflurane; Inhalational anesthesia; Isoflurane; Lung neoplasm; Metastasis; Propofol; Recurrence; Sevoflurane; Surgery; Non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Recurrence free survival

  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 Outcomes (2)

• Overall survival

  Within 3 year after curative resection for NSCLC

• Postoperative complications

  within 7 days post-surgery or at discharge if earlier

Study Arms (2)

TIVA group

EXPERIMENTAL

The TIVA group will receive propofol for both induction and maintenance of general anesthesia.

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.

Drug: Inhaled anesthetics

Interventions

Propofol DRUG

Propofol will be used for the induction and maintenance of general anesthesia.

Also known as: Propofol 1% or 2% inj.

TIVA group

Inhaled anesthetics DRUG

Inhaled anesthetics will be used for the maintenance of general anesthesia.

Also known as: Sevoflurane, Desflurane, Isoflurane

GAS group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Samsung Medical Center

Seoul, Seoul-teukbyeolsi, 06351, South Korea

RECRUITING

Related Publications (1)

• 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.

  PMID: 39039548 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms; Neoplasm Metastasis; Recurrence

Interventions

Propofol; Sevoflurane; Desflurane; Isoflurane

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Ethyl Ethers

Study Officials

• Hyun Joo Ahn

  Department of Anesthesiology and Pain Medicine, Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeayoun Kim, MD

CONTACT

8234106590; jeayoun.kim@samsung.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: March 26, 2024
• Study Start: August 5, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: within 3 years after publication
• 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).

Locations

KR (1)