Clinical trial NCT06524427: Robot-Assisted vs. Video-Assisted Lobectomy for NSCLC (RAVAR)
Official title: Robot-Assisted Versus Video-Assisted Lobectomy for Non-Small Cell Lung Cancer (RAVAR): A Multicenter, Open-Label, Randomized, Non-Inferiority Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Non Small Cell Lung Cancer
Keywords: Non-small cell lung cancer
Robotic-assisted lobectomy
Video-assisted lobectomy
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital of Nanchang University
name: The Affiliated Hospital of Qingdao University
name: The General Hospital of Eastern Theater Command
name: Gansu Provincial Hospital
name: Tang-Du Hospital
name: Wuhan TongJi Hospital
name: First Affiliated Hospital of Chongqing Medical University
name: West China Hospital
name: Wuhan Union Hospital, China
name: Shenzhen People's Hospital
name: The First Affiliated Hospital of Zhengzhou University
name: Shandong Provincial Hospital
name: Jiangsu Cancer Institute & Hospital
name: Guangdong Provincial People's Hospital
name: Liaoning Cancer Hospital & Institute
name: Qilu Hospital of Shandong University
name: Jiangxi Provincial People's Hopital
name: Sichuan Cancer Hospital and Research Institute
name: Lanzhou University Second Hospital
name: Shenzhen Third People's Hospital
name: Qianfoshan Hospital
name: Chongqing University Cancer Hospital
name: Guangxi Nanxishan Hospital
First posted: 2024-07-29
Enrollment: 1124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Age from 18 to 80 years old;
2. 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;
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.

Exclusion Criteria:

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

Primary outcomes:
measure: 5-year disease-free survival (DFS)
timeFrame: 5 years after surgery
Secondary outcomes:
measure: 5-year overall survival (OS)
timeFrame: 5 years after surgery
measure: 3-year disease-free survival (DFS)
timeFrame: 3 years after surgery
measure: 3-year overall survival (OS)
timeFrame: 3 years after surgery
measure: Blood loss
timeFrame: During the surgery
measure: Conversion rate
timeFrame: During the surgery
measure: Perioperative complication
timeFrame: The day of surgery, 2/4/8/12/26/52 weeks after surgery
measure: Operative death rate
timeFrame: 30/90 days after surgery
measure: Hospital stays after surgery
timeFrame: Between the date of surgery and the date of discharge, assessed up to 30 days
measure: Pain score after surgery
timeFrame: Scores were given daily after surgery and at weeks 2/4/8/12/26/52 after discharge
measure: R0 rate
timeFrame: Postoperative in-hospital stay up to 30 days
measure: Operative time
timeFrame: During the surgery
measure: The number of resected lymph nodes
timeFrame: Postoperative in-hospital stay up to 30 days
measure: Chest tube duration
timeFrame: Postoperative in-hospital stay up to 30 days
measure: Acesodyne (Grade III) dose
timeFrame: Postoperative in-hospital stay up to 30 days
measure: Total cost of hospitalization
timeFrame: From the date of admission to the date of discharge, assessed up to 30 days
Other outcomes:
Locations:
city: Chongqing
country: China
facility: First Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Chongqing
country: China
facility: Chongqing University Cancer Hospital
state: Chongqing
city: Lanzhou
country: China
facility: Gansu Provincial Hospital
state: Gansu
city: Lanzhou
country: China
facility: The Second Hospital of Lanzhou University
state: Gansu
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen Third People's Hospital
state: Guangdong
city: Guilin
country: China
facility: Guangxi Nanxishan Hospital
state: Guangxi
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Wuhan Union Hospital
state: Hubei
city: Wuhan
country: China
facility: Wuhan TongJi Hospital
state: Hubei
city: Nanjing
country: China
facility: The General Hospital of Eastern Theater Command
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu Cancer Institute & Hospital
state: Jiangsu
city: Nanchang
country: China
facility: Jiangxi Provincial People's Hopital
state: Jiangxi
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Shenyang
country: China
facility: Liaoning Tumor Hospital & Institute
state: Liaoning
city: Xi'an
country: China
facility: Tang-Du Hospital
state: Shaanxi
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Jinan
country: China
facility: Qianfoshan Hospital
state: Shandong
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
state: Shandong
city: Chengdu
country: China
facility: Sichuan Cancer Hospital and Research Institute
state: Sichuan
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
Study officials:
affiliation: Sun Yat-sen University
name: Hao-Xian Yang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: