Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06330038
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-28
First Post:
2024-03-19
Brief Title:
Anesthesia and Non-small Cell Lung Cancer Recurrence
Sponsor:
Samsung Medical Center
Organization:
Samsung Medical Center
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GASTIVA
Brief 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 11 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 083 at alpha 005 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
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 11 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 083 at alpha 005 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None