Anesthesia and Non-small Cell Lung Cancer Recurrence

Non-small Cell Lung Cancer Clinical Trial

— GASTIVA  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06330038
• Other study ID #: SMC 2024-01-065
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: May 1, 2024
• Est. completion date: December 31, 2028

Study information

• Verified date: March 2024
• Source: Samsung Medical Center
• Contact: Jeayoun Kim, MD
• Phone: 8234106590
• Email: jeayoun.kim[@]samsung.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 5384
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologists physical status (ASA) ?-?

• 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 ?- ?A).

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.

Related Conditions & MeSH terms

• Anesthesia
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer
• Recurrence
• Surgery

Intervention

Drug:
• Propofol
Propofol will be used for the induction and maintenance of general anesthesia.
• Inhaled anesthetics
Inhaled anesthetics will be used for the maintenance of general anesthesia.

Locations

Country	Name	City	State
n/a

Sponsors (22)

Lead Sponsor

Collaborator

Samsung Medical Center

All India Institute of Medical Sciences, New Delhi, Asan Medical Center, Beijing Hospital, Chungnam National University Hospital, DongGuk University, Ewha Womans University, Inha University Hospital, Khon Kaen University, King Chulalongkorn Memorial Hospital, Konkuk University Medical Center, Korea University Guro Hospital, Mayo Clinic, Memorial Sloan Kettering Cancer Center, Seoul National University Hospital, Seoul St. Mary's Hospital, Severance Hospital, The Affiliated Hospital of Qingdao University, University Hospitals Coventry and Warwickshire NHS Trust, University of Texas Southwestern Medical Center, University of Virginia, Yale University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence free survival	Time from surgery to the earliest date of local recurrence/metastasis or death from any cause, whichever comes first	Within 3 year after curative resection for NSCLC
Secondary	Overall survival	Time from index surgery to death due to any causes	Within 3 year after curative resection for NSCLC
Secondary	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	within 7 days post-surgery or at discharge if earlier