Comparing robotic and video-assisted surgery for lung cancer
Robot-Assisted Versus Video-Assisted Lobectomy for Non-Small Cell Lung Cancer (RAVAR): A Multicenter, Open-Label, Randomized, Non-Inferiority Trial
This study is testing whether robot-assisted surgery is better than video-assisted surgery for people with early-stage lung cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1124 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 23 sites (Chongqing, Chongqing Municipality and 22 other locations) |
| Trial ID | NCT06524427 on ClinicalTrials.gov |
What this trial studies
This clinical trial compares the outcomes of robot-assisted thoracoscopic surgery (RATS) and video-assisted thoracoscopic surgery (VATS) in patients with early-stage non-small cell lung cancer (NSCLC). It is a multicenter, prospective randomized controlled trial focusing on patients diagnosed with stage I-II NSCLC. The primary endpoint is the 5-year disease-free survival (DFS) rate, allowing researchers to evaluate both short-term and long-term surgical outcomes. The study aims to address existing scientific questions regarding the effectiveness of RATS compared to VATS.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with stage I-II non-small cell lung cancer and adequate organ function.
Not a fit: Patients with advanced-stage lung cancer or those with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into which surgical approach offers better outcomes for patients with early-stage lung cancer.
How similar studies have performed: Previous studies have shown promising results for robotic-assisted surgeries, but this specific comparison with VATS is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Chongqing, Chongqing Municipality and 22 other locations
- First Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (Recruiting)
- Gansu Provincial Hospital — Lanzhou, Gansu, China (Recruiting)
- The Second Hospital of Lanzhou University — Lanzhou, Gansu, China (Recruiting)
- Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
- Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (Recruiting)
- Shenzhen People's Hospital — Shenzhen, Guangdong, China (Recruiting)
- Shenzhen Third People's Hospital — Shenzhen, Guangdong, China (Recruiting)
- Guangxi Nanxishan Hospital — Guilin, Guangxi, China (Recruiting)
- The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (Recruiting)
- Wuhan Union Hospital — Wuhan, Hubei, China (Recruiting)
- Wuhan TongJi Hospital — Wuhan, Hubei, China (Recruiting)
- The General Hospital of Eastern Theater Command — Nanjing, Jiangsu, China (Recruiting)
- Jiangsu Cancer Institute & Hospital — Nanjing, Jiangsu, China (Recruiting)
- Jiangxi Provincial People's Hopital — Nanchang, Jiangxi, China (Recruiting)
- The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (Recruiting)
- Liaoning Tumor Hospital & Institute — Shenyang, Liaoning, China (Recruiting)
- Tang-Du Hospital — Xi'an, Shaanxi, China (Recruiting)
- Qilu Hospital of Shandong University — Jinan, Shandong, China (Recruiting)
- Qianfoshan Hospital — Jinan, Shandong, China (Recruiting)
- Shandong Provincial Hospital — Jinan, Shandong, China (Recruiting)
- The Affiliated Hospital of Qingdao University — Qingdao, Shandong, China (Recruiting)
- Sichuan Cancer Hospital and Research Institute — Chengdu, Sichuan, China (Recruiting)
- West China Hospital — Chengdu, Sichuan, China (Recruiting)
Study contacts
- Principal investigator: Hao-Xian Yang, M.D. — Sun Yat-Sen University Cancer Center
- Study coordinator: Hao-Xian Yang, M.D.
- Email: yanghx@sysucc.org.cn
- Phone: +86-020-87343628
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.