Anesthesia type and lung cancer recurrence after curative surgery
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
PHASE4 · Samsung Medical Center · NCT06330038
This trial will test whether using propofol-based total intravenous anesthesia (TIVA) instead of inhaled volatile anesthetics lowers the chance of cancer coming back after curative lung surgery in adults with non-small cell lung cancer.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 5384 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Samsung Medical Center (other) |
| Locations | 1 site (Seoul, Seoul-teukbyeolsi) |
| Trial ID | NCT06330038 on ClinicalTrials.gov |
What this trial studies
This double-blind, randomized, multicenter trial assigns adults undergoing curative-intent lung resection for non-small cell lung cancer 1:1 to receive either propofol-based total intravenous anesthesia (TIVA) or volatile inhaled anesthetics. Enrollment is planned across 22 international sites with centralized web-based randomization and data capture, and standard perioperative care is otherwise left to treating teams. The primary outcome is recurrence-free survival after surgery, with longitudinal follow-up for cancer recurrence. The trial is pragmatic and does not standardize perioperative management beyond the randomized anesthesia strategy.
Who should consider this trial
Good fit: Adults with non-small cell lung cancer (clinical stage I–IIIa) scheduled for curative lung resection who are ASA I–III and ECOG 0–2 are the intended participants.
Not a fit: Patients with distant metastases or other active non-remission malignancies, severe organ failure, recent major surgery, or contraindications to the study anesthetics are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, choosing TIVA could reduce cancer recurrence and improve recurrence-free survival after curative lung cancer surgery.
How similar studies have performed: Preclinical studies and retrospective clinical analyses suggest propofol may better preserve anti-tumor immunity than volatile agents, but randomized clinical evidence is inconsistent and definitive large trials are lacking.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Seoul, Seoul-teukbyeolsi
- Samsung Medical Center — Seoul, Seoul-teukbyeolsi, South Korea (RECRUITING)
Study contacts
- Principal investigator: Hyun Joo Ahn — Department of Anesthesiology and Pain Medicine, Samsung Medical Center
- Study coordinator: Jeayoun Kim, MD
- Email: jeayoun.kim@samsung.com
- Phone: 8234106590
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Non-small Cell Lung Cancer, Surgery, Anesthesia, Desflurane, Inhalational anesthesia, Isoflurane, Lung neoplasm, Metastasis