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