Robot-Assisted vs. Video-Assisted Lobectomy for NSCLC (RAVAR)

Официальное название

Robot-Assisted Versus Video-Assisted Lobectomy for Non-Small Cell Lung Cancer (RAVAR): A Multicenter, Open-Label, Randomized, Non-Inferiority Trial

Обзор

Video-assisted thoracic surgery (VATS) has been recommended by clinical guidelines as one of the preferred surgeries for early-stage non-small cell lung cancer (NSCLC) for many years. However, VATS has inherent drawbacks, so at the beginning of this century, robotic-assisted thoracoscopic surgery (RATS) was first applied for lung resection. In recent years, RATS has developed rapidly, but there are still many unsolved scientific problems in the field of RATS. Thus, a multicenter prospective randomized controlled trial was conducted with stage I-II NSCLC patients as the study subject and 5-year DFS as the primary endpoint to compare the short-term and long-term outcomes of RATS and VATS in the treatment of early-stage NSCLC.

Вмешательства

• Процедура Robot-assisted lobectomy
  Patients will receive robot-assisted lobectomy using Da Vinci surgical system
• Процедура Video-assisted lobectomy
  Patients will receive video-assisted lobectomy

Первичные конечные точки

• 5-year disease-free survival (DFS) [Срок оценки: 5 years after surgery]

Вторичные конечные точки (12)

• 5-year overall survival (OS) [Срок оценки: 5 years after surgery]
• 3-year disease-free survival (DFS) [Срок оценки: 3 years after surgery]
• 3-year overall survival (OS) [Срок оценки: 3 years after surgery]
• Blood loss [Срок оценки: During the surgery]
• Conversion rate [Срок оценки: During the surgery]
• Perioperative complication [Срок оценки: The day of surgery, 2/4/8/12/26/52 weeks after surgery]
• Operative death rate [Срок оценки: 30/90 days after surgery]
• Hospital stays after surgery [Срок оценки: Between the date of surgery and the date of discharge, assessed up to 30 days]
• Pain score after surgery [Срок оценки: Scores were given daily after surgery and at weeks 2/4/8/12/26/52 after discharge]
• R0 rate [Срок оценки: Postoperative in-hospital stay up to 30 days]
• Operative time [Срок оценки: During the surgery]
• The number of resected lymph nodes [Срок оценки: Postoperative in-hospital stay up to 30 days]

Критерии участия

Критерии включения

• Age from 18 to 80 years old;
• Patients with blood pressure<160/100mmHg, 5.6<blood glucose<11.2mmol/L, major organs function normally: (1) Goldman index between grade 1 and 2; (2) Predicted forced expiratory volume in 1s (FEV1) >= 40 % and diffusing capacity of the lung for carbon monoxide (DLCO) >= 40 %; (3) total bilirubin <= 1.5 upper limit of normal; (4) Alanine aminotransferase (ALT)/Aspartate aminotransferase (AST) <= 2.5 upper limit of normal; (5) creatinine <= 1.25 upper limit of normal and creatinine clearance rate (CCr) >= 60ml/min;
• The first clinical diagnosis before surgery was non-small cell lung cancer, including adenocarcinoma, squamous cell carcinoma, large cell carcinoma, and other unknown types;
• Clinical stage T1-2N0-1 (cI-II): Maximum diameter of tumor <= 5cm and short diameter of mediastinal lymph node <= 1cm in thin layer CT;
• Performance status of Eastern Cooperative Oncology Group (ECOG) 0-1;
• All relevant examinations were completed within 28 days before the operation;
• Patients who understand this study and have signed an approved Informed Consent.

Критерии исключения

• Patients with radiotherapy, chemotherapy, targeted therapy, or immunotherapy before surgery.
• Patients with the previous history of other malignancies;
• Patients with secondary primary cancer when enrolled;
• Patients diagnosed as pure ground glass opacity (GGO) before surgery;
• Patients diagnosed as mixed GGO whose solid part <= 50% and Maximum diameter of tumor <= 2cm;
• Patients with small cell lung cancer;
• Patients with prior unilateral open thoracic surgical procedures;
• Woman who is pregnant or breastfeeding;
• Patients with interstitial pneumonia, pulmonary fibrosis, or severe emphysema;
• Patients with an active bacterial or fungal infection that is difficult to control;
• Patients with serious psychosis;
• Patients with a history of severe heart attack, heart failure, myocardial infarction, or angina within the last 6 months.

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

Открытое

Основная цель

Лечение

Центры проведения

Китай · 23 центра

• First Affiliated Hospital of Chongqing Medical University — Чунцин
• Gansu Provincial Hospital — Lanzhou
• The Second Hospital of Lanzhou University — Lanzhou
• Sun Yat-sen University Cancer Center — Гуанчжоу
• Guangdong Provincial People's Hospital — Гуанчжоу
• Shenzhen People's Hospital — Шэньчжэнь
• Shenzhen Third People's Hospital — Шэньчжэнь
• Guangxi Nanxishan Hospital — Guilin
• … и ещё 15 центров

Идентификаторы

NCT: NCT06524427 · SL-5010-2019-04 · ChiCTR2000034737

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)
• ChiCTR ChiCTR2000034737 (Китайский реестр КИ)

Открыть это исследование на ClinicalTrials.gov ↗