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Non Small Cell Lung CancerRAVARNCT06524427

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

A study testing Robot-assisted lobectomy and Video-assisted lobectomy in people with Non Small Cell Lung Cancer, run by Sun Yat-sen University at 23 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Non Small Cell Lung Cancer
What is being tested?
Robot-assisted lobectomy and Video-assisted lobectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,124 participants
Where
23 sitesChina
Study dates
25 Aug 2020to 31 Dec 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

23 sites in 1 country.

23 sites in 1 country

China23 sites

  • Sichuan Cancer Hospital and Research Institute

    Chengdu, Sichuan, 610041

  • West China Hospital

    Chengdu, Sichuan, 610041

  • First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400014

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, 510080

  • Guangxi Nanxishan Hospital

    Guilin, Guangxi, 541002

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012

  • Qianfoshan Hospital

    Jinan, Shandong, 250014

  • Shandong Provincial Hospital

    Jinan, Shandong, 250022

  • Gansu Provincial Hospital

    Lanzhou, Gansu, 730000

  • The Second Hospital of Lanzhou University

    Lanzhou, Gansu, 730030

  • Jiangxi Provincial People's Hopital

    Nanchang, Jiangxi, 330006

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

  • The General Hospital of Eastern Theater Command

    Nanjing, Jiangsu, 210002

  • Jiangsu Cancer Institute & Hospital

    Nanjing, Jiangsu, 210009

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong, 266003

  • Liaoning Tumor Hospital & Institute

    Shenyang, Liaoning, 110042

  • Shenzhen People's Hospital

    Shenzhen, Guangdong, 518020

  • Shenzhen Third People's Hospital

    Shenzhen, Guangdong, 518112

  • Wuhan Union Hospital

    Wuhan, Hubei, 430022

  • Wuhan TongJi Hospital

    Wuhan, Hubei, 430030

  • Tang-Du Hospital

    Xi'an, Shaanxi, 710038

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

Other trials in China

About this study

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

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.

Being tested
Robot-assisted lobectomy, Video-assisted lobectomy
Keywords
Non-small cell lung cancer, Robotic-assisted lobectomy, Video-assisted lobectomy
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Robot-assisted lobectomyProcedure or surgery

    Patients will receive robot-assisted lobectomy using Da Vinci surgical system

  • Video-assisted lobectomyProcedure or surgery

    Patients will receive video-assisted lobectomy

Study groups in NCT06524427
Study groupRoleWhat they receive
RATS groupExperimentalPatients will receive robot-assisted lobectomy
Receives: Procedure: Robot-assisted lobectomy
VATS groupActive comparatorPatients will receive video-assisted lobectomy
Receives: Procedure: Video-assisted lobectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 5-year disease-free survival (DFS)

    Difference of 5-year disease free survival rate between the two groups

    Measured: 5 years after surgery

Secondary outcomes (15)

  1. 5-year overall survival (OS)

    Difference of 5-year overall survival rate between the two groups

    Measured: 5 years after surgery

  2. 3-year disease-free survival (DFS)

    Difference of 3-year disease free survival rate between the two groups

    Measured: 3 years after surgery

  3. 3-year overall survival (OS)

    Difference of 3-year overall survival rate between the two groups

    Measured: 3 years after surgery

  4. Blood loss

    Blood loss during the surgery

    Measured: During the surgery

  5. Conversion rate

    The number of patients converted to thoracotomy divided by the total number of included patients in a group

    Measured: During the surgery

  6. Perioperative complication

    Intraoperative and postoperative complications

    Measured: The day of surgery, 2/4/8/12/26/52 weeks after surgery

  7. Operative death rate

    The number of patients died within 30/90 days after surgery divided by the total number of included patients in a group

    Measured: 30/90 days after surgery

  8. Hospital stays after surgery

    The length of stay in hospital after surgery

    Measured: Between the date of surgery and the date of discharge, assessed up to 30 days

  9. Pain score after surgery

    The degree of pain after surgery was measured using Numerical Rating Scale (NRS). The patient is asked to make three pain ratings, corresponding to current, best and worst pain experienced over the past 24 hours on a scale of 0 (no pain) to 10 (worst pain imaginable). The average of the 3 ratings was used to represent the patient's level of pain over the previous 24 hours.

    Measured: Scores were given daily after surgery and at weeks 2/4/8/12/26/52 after discharge

  10. R0 rate

    The number of patients received R0 surgery divided by the total number of included patients in a group

    Measured: Postoperative in-hospital stay up to 30 days

  11. Operative time

    The total time from skin to skin and the time of each step were recorded

    Measured: During the surgery

  12. The number of resected lymph nodes

    The number of resected lymph nodes were calculated according to the official pathological report after surgery

    Measured: Postoperative in-hospital stay up to 30 days

  13. Chest tube duration

    The number of days between the date of surgery and the date of chest tube removal

    Measured: Postoperative in-hospital stay up to 30 days

  14. Acesodyne (Grade III) dose

    The total amount of morphine used by the patient during the postoperative hospital stay, including morphine, pethidine, and fentanyl etc.

    Measured: Postoperative in-hospital stay up to 30 days

  15. Total cost of hospitalization

    The total cost of the patient from admission to discharge

    Measured: From the date of admission to the date of discharge, assessed up to 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2024
  2. Study start25 Aug 2020
  3. Primary completion31 Dec 2030 (estimated)
  4. Study completion31 Dec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,124 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06524427
Sponsor's protocol ID
SL-5010-2019-04
Other IDs
ChiCTR2000034737
Acronym
RAVAR
Status last verified
Oct 2026
First submitted
11 Jul 2024
Last updated
6 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Robot-assisted lobectomy and Video-assisted lobectomy in people with Non Small Cell Lung Cancer, run by Sun Yat-sen University at 23 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

5-year disease-free survival (DFS) (time frame: 5 years after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06524427.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026; AzTrials last refreshed its copy on 2 Nov 2026.

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