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Anesthesia and Non-small Cell Lung Cancer Recurrence
Trial Status: active
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.
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 sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06330038.
Locations matching your search criteria
United States
Connecticut
New Haven
Yale University
Status: Active
Name Not Available
Florida
Jacksonville
Mayo Clinic in Florida
Status: Active
Name Not Available
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
