Anesthesia and Non-small Cell Lung Cancer Recurrence
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age19+
SponsorSamsung Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Propofol
DrugPropofol will be used for the induction and maintenance of general anesthesia.
Inhaled anesthetics
DrugInhaled anesthetics will be used for the maintenance of general anesthesia.
Treatment groups
5,384 Participants
are divided into 2 treatment groupsGroup A: TIVA groupExperimental treatment 1 intervention
Group B: GAS groupActive comparator 1 intervention
Trial outcomes
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
Time frame
Within 3 year after curative resection for NSCLCSecondary outcomes
1
Overall survival
Time from index surgery to death due to any causes
Time frame
Within 3 year after curative resection for NSCLC2
Postoperative complications
Rate of complications which will be assessed with Clavien-Dindo classification and postoperative complications defined by the Society of Thoracic Surgeons (STS) general thoracic surgery databases
Time frame
within 7 days post-surgery or at discharge if earlierSponsors and contacts
Click on the lead sponsor to view all of their trials.
Samsung Medical Center
Lead sponsor
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 of Texas Southwestern Medical Center
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
Source ClinicalTrials.gov