NCT06524427招募中不适用
Robot-Assisted Versus Video-Assisted Lobectomy for Non-Small Cell Lung Cancer (RAVAR): A Multicenter, Open-Label, Randomized, Non-Inferiority Trial
Sun Yat-sen University45 个研究点 分布在 1 个国家目标入组 1,124 人开始时间: 2020年8月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,124
- 试验地点
- 45
- 主要终点
- 5-year disease-free survival (DFS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Age from 18 to 80 years old;
- •2. Patients with blood pressure\<160/100mmHg, 5.6\= 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;
- •3. The first clinical diagnosis before surgery was non-small cell lung cancer, including adenocarcinoma, squamous cell carcinoma, large cell carcinoma, and other unknown types;
- •4. Clinical stage T1-2N0-1 (cI-II): Maximum diameter of tumor \<= 5cm and short diameter of mediastinal lymph node \<= 1cm in thin layer CT;
- •5. Performance status of Eastern Cooperative Oncology Group (ECOG) 0-1;
- •6. All relevant examinations were completed within 28 days before the operation;
- •7. Patients who understand this study and have signed an approved Informed Consent.
排除标准
- •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.
结局指标
主要结局
5-year disease-free survival (DFS)
时间窗: 5 years after surgery
Difference of 5-year disease free survival rate between the two groups
次要结局
- 5-year overall survival (OS)(5 years after surgery)
- 3-year disease-free survival (DFS)(3 years after surgery)
- 3-year overall survival (OS)(3 years after surgery)
- Blood loss(During the surgery)
- Conversion rate(During the surgery)
- Perioperative complication(The day of surgery, 2/4/8/12/26/52 weeks after surgery)
- Operative death rate(30/90 days after surgery)
- Hospital stays after surgery(Between the date of surgery and the date of discharge, assessed up to 30 days)
- R0 rate(Postoperative in-hospital stay up to 30 days)
- Acesodyne (Grade III) dose(Postoperative in-hospital stay up to 30 days)
- Pain score after surgery(Scores were given daily after surgery and at weeks 2/4/8/12/26/52 after discharge)
- Operative time(During the surgery)
- Total cost of hospitalization(From the date of admission to the date of discharge, assessed up to 30 days)
- The number of resected lymph nodes(Postoperative in-hospital stay up to 30 days)
- Chest tube duration(Postoperative in-hospital stay up to 30 days)
研究者
Hao-Xian Yang
Principal Investigator
Sun Yat-sen University
研究点 (45)
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