Actively Recruiting
Lobectomy-First vs. Lymphadenectomy-First for Operable NSCLC (LOFTY)
Led by Sun Yat-sen University · Updated on 2025-05-16
620
Participants Needed
26
Research Sites
384 weeks
Total Duration
On this page
Sponsors
S
Sun Yat-sen University
Lead Sponsor
T
Tianjin Medical University Cancer Institute and Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Lobectomy-First vs. Lymphadenectomy-First for Operable NSCLC (LOFTY)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age from 18 to 80 years old
- 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) with tumor diameter \u2264 5 cm and mediastinal lymph node diameter \u2264 1 cm on thin layer CT
- Physical condition able to tolerate lobectomy: Goldman index 0-1; predicted FEV1 \u2265 40%; DLCO \u2265 40%; total bilirubin \u2264 1.5 times upper limit of normal; ALT/AST \u2264 2.5 times upper limit of normal; creatinine \u2264 1.25 times upper limit of normal and creatinine clearance rate \u2265 60 ml/min
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- All relevant examinations completed within 28 days before the operation
- Patients who understand the study and have signed informed consent
You will not qualify if you...
- Prior anti-tumor therapy (radiotherapy, chemotherapy, targeted therapy, immunotherapy) before surgery
- History of other malignant tumors or presence of a second primary cancer at enrollment
- Eligible for sublobar resection (segment/wedge) based on ground glass opacity (GGO) \u2264 50% solid component, nodule diameter \u2264 2 cm, and nodule located in outer third of lung
- Preoperative diagnosis of pure ground glass opacity (GGO)
- Previous unilateral thoracotomy
- Pregnant or breastfeeding women
- Active bacterial or fungal infection difficult to control
- Serious psychosis
- History of severe heart disease, heart failure, myocardial infarction, or angina pectoris in past 6 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 26 locations
1
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
2
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001
Actively Recruiting
3
Fujian Provincial Hospital
Fuzhou, Fujian, China, 350001
Actively Recruiting
4
Gansu Provincial Hospital
Lanzhou, Gansu, China, 730013
Actively Recruiting
5
Dongguan People's Hospital
Dongguan, Guangdong, China, 523059
Actively Recruiting
6
First People's Hospital of Foshan
Foshan, Guangdong, China, 528000
Actively Recruiting
7
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
8
First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, China, 510632
Actively Recruiting
9
Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510655
Not Yet Recruiting
10
Wuhan TongJi Hospital
Wuhan, Hubei, China, 430014
Actively Recruiting
11
Wuhan Union Hospital, China
Wuhan, Hubei, China, 430090
Not Yet Recruiting
12
Jiangsu Cancer Institute & Hospital
Nanjing, Jiangsu, China, 210009
Actively Recruiting
13
The General Hospital of Eastern Theater Command
Nanjing, Jiangsu, China, 210016
Actively Recruiting
14
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China, 210029
Not Yet Recruiting
15
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China, 221132
Actively Recruiting
16
Tang-Du Hospital
Xi'an, Shaanxi, China, 710032
Not Yet Recruiting
17
Shandong Provincial Hospital
Jinan, Shandong, China, 250022
Not Yet Recruiting
18
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China, 266075
Not Yet Recruiting
19
RenJi Hospital
Shanghai, Shanghai Municipality, China, 200001
Actively Recruiting
20
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China, 201209
Actively Recruiting
21
Sichuan Cancer Hospital and Research Institute
Chengdu, Sichuan, China, 610041
Actively Recruiting
22
West China Hospital
Chengdu, Sichuan, China, 610041
Not Yet Recruiting
23
Suining Central Hospital
Suining, Sichuan, China, 629099
Actively Recruiting
24
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China, 300060
Actively Recruiting
25
Tianjin Chest Hospital
Tianjin, Tianjin Municipality, China, 300222
Not Yet Recruiting
26
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China, 650032
Actively Recruiting
Research Team
H
Hao-Xian Yang, M.D.
CONTACT
M
Mu-Zi Yang, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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