Status:
RECRUITING
Robot-Assisted vs. Video-Assisted Lobectomy for NSCLC (RAVAR)
Lead Sponsor:
Sun Yat-sen University
Collaborating Sponsors:
The First Affiliated Hospital of Nanchang University
The Affiliated Hospital of Qingdao University
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
18-80 years
Phase:
NA
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 ha...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2030
Estimated Enrollment :
1124 Patients enrolled
Trial Details
Trial ID
NCT06524427
Start Date
August 25 2020
End Date
December 31 2030
Last Update
December 31 2025
Active Locations (23)
Enter a location and click search to find clinical trials sorted by distance.
1
First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400014
2
Gansu Provincial Hospital
Lanzhou, Gansu, China, 730000
3
The Second Hospital of Lanzhou University
Lanzhou, Gansu, China, 730030
4
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060