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Clinical Trials in China / NCT06577792
Active, not recruiting Not applicable

Lobectomy-First vs. Lymphadenectomy-First for Operable NSCLC (LOFTY)

NCT06577792 · tracked via the Priya Life Science China tracker
Sponsor
Sun Yat-sen University
Phase
Not applicable
Started
2023-08-16
Last updated
2026-07-14

Condition(s) studied

Non Small Cell Lung Cancer

Investigational drug(s) / intervention(s)

Lobectomy-FirstLymphadenectomy-First

Lobectomy-First: During the surgical treatment for patients with NSCLC, thoracic surgeons should perform lobectomy first, and then perform lymphadenectomy next.

Lymphadenectomy-First: During the surgical treatment for patients with NSCLC, thoracic surgeons should perform lymphadenectomy first, and then perform lobectomy next.

Study summary

During the surgery for non-small cell lung cancer (NSCLC), lymphadenectomy or lobectomy are performed first, different surgeons have different choices. Oncology textbooks require dissecting distant lymph nodes (LNs) first and then dissecting nearby LNs. According to this requirement, thoracic surgeons should first perform lymphadenectomy and then lobectomy. Unfortunately, there is no high-level evidence to prove which surgical sequence is more beneficial to the long-term survival of NSCLC patients. In this multi-center randomized controlled trial (RCT), patients with stage I-II NSCLC were enrolled as the research object to determine which surgical sequence (lymphadenectomy-first vs. lobectomy-first) is better for the short-term and long-term outcomes in NSCLC patients.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: 1. Age from 18 to 80 years old; 2. The first clinical diagnosis before surgery was non-small cell lung cancer, including adenocarcinoma, squamous cell carcinoma, large cell carcinoma, and other unknown types; 3. Clinical stage T1-2N0-1 (cI-II): Maximum diameter of tumor \<= 5 cm and short diameter of mediastinal lymph node \<= 1cm in thin layer computed tomography (CT); 4. The patient's physical condition is able to tolerate lobectomy: (1) Goldman index 0-1; (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) \>= 60 ml/min; 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 who have undergone anti-tumor therapy (radiotherapy, chemotherapy, targeted therapy, immunotherapy) before surgery; 2. Patients with previous medical history of other malignant tumors or combined with second primary cancer at the time of enrollment; 3. Patients who meet all of the following criteria are eligible for sublobar resection (segment/wedge resection): (1) Ground glass opacity (GGO) with a solid component \<= 50%; (2) The largest diameter of nodule is \<= 2 cm; (3) The nodule is located in the outer third of the lung field; 4. Patients with preoperative diagnosis of pure GGO; 5. Patients with previous medical history of unilateral thoracotomy; 6. Women who are pregnant or breastfeeding; 7. Patients with active bacterial or fungal infection that is difficult to control; 8. Patients with serious psychosis; 9. Patients with a history of severe heart disease, heart failure, myocardial infarction or angina pectoris in the past 6 months.

Primary outcome measure(s)

Trial sites (26)

FacilityCityRegionStatus
Cancer Institute and Hospital, Chinese Academy of Medical Sciences Beijing Beijing Municipality
Fujian Medical University Union Hospital Fuzhou Fujian
Fujian Provincial Hospital Fuzhou Fujian
Gansu Provincial Hospital Lanzhou Gansu
Dongguan People's Hospital Dongguan Guangdong
First People's Hospital of Foshan Foshan Guangdong
Sun Yat-sen University Cancer Center Guangzhou Guangdong
First Affiliated Hospital of Jinan University Guangzhou Guangdong
Sixth Affiliated Hospital, Sun Yat-sen University Guangzhou Guangdong
Wuhan TongJi Hospital Wuhan Hubei
Wuhan Union Hospital, China Wuhan Hubei
Jiangsu Cancer Institute & Hospital Nanjing Jiangsu
The General Hospital of Eastern Theater Command Nanjing Jiangsu
The First Affiliated Hospital with Nanjing Medical University Nanjing Jiangsu
The Affiliated Hospital of Xuzhou Medical University Xuzhou Jiangsu
Tang-Du Hospital Xi'an Shaanxi
Shandong Provincial Hospital Jinan Shandong
The Affiliated Hospital of Qingdao University Qingdao Shandong
RenJi Hospital Shanghai Shanghai Municipality
Shanghai Changzheng Hospital Shanghai Shanghai Municipality
Sichuan Cancer Hospital and Research Institute Chengdu Sichuan
West China Hospital Chengdu Sichuan
Suining Central Hospital Suining Sichuan
Tianjin Medical University Cancer Institute and Hospital Tianjin Tianjin Municipality
Tianjin Chest Hospital Tianjin Tianjin Municipality
First Affiliated Hospital of Kunming Medical University Kunming Yunnan

More Sun Yat-sen University trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06577792 on ClinicalTrials.gov ↗ ← All trials in China