Anesthesia and Non-small Cell Lung Cancer Recurrence

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Recurrence free survival [Срок оценки: Within 3 year after curative resection for NSCLC]

Вторичные конечные точки (2)

• Overall survival [Срок оценки: Within 3 year after curative resection for NSCLC]
• Postoperative complications [Срок оценки: within 7 days post-surgery or at discharge if earlier]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Профилактика

Центры проведения

South Korea · 1 центр

• Samsung Medical Center — Seoul

Публикации

• Kim J, Yoon S, Song IK, Lee K, Hwang W, Kim H, Lee DK, Lim HK, Kim SH, Lee JW, Hong B, Blank RS, Pedoto A, Popescu W, Theresa G, Martin AK, Patteril M, Pathanasethpong A, Thongsuk Y, Pisitpitayasaree T, Huang A, Yu H, Kapoor PM, Kim K, Chi SA, Ahn HJ. Recurrence-free survival after curative resection of non-small cell lung cancer between inhalational gas anesthesia and propofol-based total intrave PMID 39039548

Идентификаторы

NCT: NCT06330038 · SMC 2024-01-065

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗