Anesthesia and Non-small Cell Lung Cancer Recurrence
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Propofol, Inhaled anesthetics.
- Who it may be relevant to
- Registry conditions: Non-small Cell Lung Cancer, Surgery, Anesthesia. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Drug Propofol
Propofol will be used for the induction and maintenance of general anesthesia. - Drug Inhaled anesthetics
Inhaled anesthetics will be used for the maintenance of general anesthesia.
Primary outcome measures
- Recurrence free survival [Time frame: Within 3 year after curative resection for NSCLC]
Secondary outcome measures (2)
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Prevention
Study locations
South Korea · 1 center
- Samsung Medical Center — Seoul
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 intrave PMID 39039548
Identifiers
NCT: NCT06330038 · SMC 2024-01-065