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Trial Title: Anesthesia and Non-small Cell Lung Cancer Recurrence

NCT ID: NCT06330038

Condition: Non-small Cell Lung Cancer
Surgery
Anesthesia

Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Recurrence
Propofol
Anesthetics
Sevoflurane
Desflurane
Isoflurane

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

Study type: Interventional

Study phase: Phase 4

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Prevention

Masking: Triple (Participant, Investigator, Outcomes Assessor)

Intervention:

Intervention type: Drug
Intervention name: Propofol
Description: Propofol will be used for the induction and maintenance of general anesthesia.
Arm group label: TIVA group

Other name: Propofol 1% or 2% inj.

Intervention type: Drug
Intervention name: Inhaled anesthetics
Description: Inhaled anesthetics will be used for the maintenance of general anesthesia.
Arm group label: GAS group

Other name: Sevoflurane, Desflurane, Isoflurane

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.

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.

Criteria for 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.

Gender: All

Minimum age: 19 Years

Maximum age: N/A

Healthy volunteers: No

Start date: May 1, 2024

Completion date: December 31, 2028

Lead sponsor:
Agency: Samsung Medical Center
Agency class: Other

Collaborator:
Agency: Seoul National University Hospital
Agency class: Other

Collaborator:
Agency: Asan Medical Center
Agency class: Other

Collaborator:
Agency: Severance Hospital
Agency class: Other

Collaborator:
Agency: Seoul St. Mary's Hospital
Agency class: Other

Collaborator:
Agency: Korea University Guro Hospital
Agency class: Other

Collaborator:
Agency: DongGuk University
Agency class: Other

Collaborator:
Agency: Inha University Hospital
Agency class: Other

Collaborator:
Agency: Konkuk University Medical Center
Agency class: Other

Collaborator:
Agency: Ewha Womans University
Agency class: Other

Collaborator:
Agency: Chungnam National University Hospital
Agency class: Other

Collaborator:
Agency: University of Virginia
Agency class: Other

Collaborator:
Agency: Memorial Sloan Kettering Cancer Center
Agency class: Other

Collaborator:
Agency: Yale University
Agency class: Other

Collaborator:
Agency: Mayo Clinic
Agency class: Other

Collaborator:
Agency: University of Texas Southwestern Medical Center
Agency class: Other

Collaborator:
Agency: University Hospitals Coventry and Warwickshire NHS Trust
Agency class: Other

Collaborator:
Agency: Khon Kaen University
Agency class: Other

Collaborator:
Agency: King Chulalongkorn Memorial Hospital
Agency class: Other

Collaborator:
Agency: The Affiliated Hospital of Qingdao University
Agency class: Other

Collaborator:
Agency: Beijing Hospital
Agency class: Other

Collaborator:
Agency: All India Institute of Medical Sciences, New Delhi
Agency class: Other

Source: Samsung Medical Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06330038

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