NCT06524427

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,124

participants targeted

Target at P75+ for not_applicable

Timeline
57mo left

Started Aug 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

23 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress55%
Aug 2020Dec 2030

Study Start

First participant enrolled

August 25, 2020

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2024

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 29, 2024

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

December 31, 2025

Status Verified

December 1, 2025

Enrollment Period

10.4 years

First QC Date

July 11, 2024

Last Update Submit

December 25, 2025

Conditions

Non Small Cell Lung Cancer

Keywords

Non-small cell lung cancerRobotic-assisted lobectomyVideo-assisted lobectomy

Outcome Measures

Primary Outcomes (1)

  • 5-year disease-free survival (DFS)

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

    5 years after surgery

Secondary Outcomes (15)

  • 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

  • +10 more secondary outcomes

Study Arms (2)

RATS group

EXPERIMENTAL

Patients will receive robot-assisted lobectomy

Procedure: Robot-assisted lobectomy

VATS group

ACTIVE COMPARATOR

Patients will receive video-assisted lobectomy

Procedure: Video-assisted lobectomy

Interventions

Robot-assisted lobectomyPROCEDURE

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

RATS group
Video-assisted lobectomyPROCEDURE

Patients will receive video-assisted lobectomy

VATS group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400014, China

RECRUITING

Gansu Provincial Hospital

Lanzhou, Gansu, 730000, China

RECRUITING

The Second Hospital of Lanzhou University

Lanzhou, Gansu, 730030, China

RECRUITING

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

RECRUITING

Shenzhen People's Hospital

Shenzhen, Guangdong, 518020, China

RECRUITING

Shenzhen Third People's Hospital

Shenzhen, Guangdong, 518112, China

RECRUITING

Guangxi Nanxishan Hospital

Guilin, Guangxi, 541002, China

RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

RECRUITING

Wuhan Union Hospital

Wuhan, Hubei, 430022, China

RECRUITING

Wuhan TongJi Hospital

Wuhan, Hubei, 430030, China

RECRUITING

The General Hospital of Eastern Theater Command

Nanjing, Jiangsu, 210002, China

RECRUITING

Jiangsu Cancer Institute & Hospital

Nanjing, Jiangsu, 210009, China

RECRUITING

Jiangxi Provincial People's Hopital

Nanchang, Jiangxi, 330006, China

RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

RECRUITING

Liaoning Tumor Hospital & Institute

Shenyang, Liaoning, 110042, China

RECRUITING

Tang-Du Hospital

Xi'an, Shaanxi, 710038, China

RECRUITING

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Qianfoshan Hospital

Jinan, Shandong, 250014, China

RECRUITING

Shandong Provincial Hospital

Jinan, Shandong, 250022, China

RECRUITING

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266003, China

RECRUITING

Sichuan Cancer Hospital and Research Institute

Chengdu, Sichuan, 610041, China

RECRUITING

West China Hospital

Chengdu, Sichuan, 610041, China

RECRUITING

Related Links

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Hao-Xian Yang, M.D.

    Sun Yat-Sen University Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hao-Xian Yang, M.D.

CONTACT

+86-020-87343628yanghx@sysucc.org.cn

Mu-Zi Yang, M.D.

CONTACT

+86-020-87341456yangmz@sysucc.org.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 11, 2024

First Posted

July 29, 2024

Study Start

August 25, 2020

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Last Updated

December 31, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(23)