NCT06577792Active, not recruiting
Lobectomy-First vs. Lymphadenectomy-First for Operable NSCLC (LOFTY)
Lobectomy-First Versus Lymphadenectomy-First Surgical Approach on Long-Term Survival in Operable Non-Small Cell Lung Cancer Patients: A Prospective, Multi-Center, Randomized Study
Source: ClinicalTrials.gov · Last updated 14 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 620 (estimated)
- First submitted
- 8 Jul 2024
- Start date
- 16 Aug 2023
- Primary completion date
- 20 Apr 2031
- Lead sponsor
- Sun Yat-sen University
- Diseases
- Lung cancer
- NCT number
- NCT06577792
What you commit to
- Study type: Interventional
- Planned participants: 620
- From 16 Aug 2023 to the primary completion date, 20 Apr 2031
- 26 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have undergone anti-tumor therapy (radiotherapy, chemotherapy, targeted therapy, immunotherapy) before surgery;
- 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;
- Patients with previous medical history of unilateral thoracotomy;
Other illness
- Patients with previous medical history of other malignant tumors or combined with second primary cancer at the time of enrollment;
- Patients with active bacterial or fungal infection that is difficult to control;
- Patients with a history of severe heart disease, heart failure, myocardial infarction or angina pectoris in the past 6 months.
Other
- Patients with preoperative diagnosis of pure GGO;
- Women who are pregnant or breastfeeding;
- Patients with serious psychosis;
Who the study is looking for
- Age from 18 to 80 years old;
- 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 \<= 5 cm and short diameter of mediastinal lymph node \<= 1cm in thin layer computed tomography (CT);
- 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;
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (26)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cancer Institute and Hospital, Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| West China Hospital Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Sichuan Cancer Hospital and Research Institute Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Dongguan People's Hospital Coordinator of this site? Confirm its status | Dongguan | China | Unknown status |
| First People's Hospital of Foshan Coordinator of this site? Confirm its status | Foshan | China | Unknown status |
| Fujian Provincial Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| Fujian Medical University Union Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| Sun Yat-sen University Cancer Center Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| First Affiliated Hospital of Jinan University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Sixth Affiliated Hospital, Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Shandong Provincial Hospital Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| First Affiliated Hospital of Kunming Medical University Coordinator of this site? Confirm its status | Kunming | China | Unknown status |
| Gansu Provincial Hospital Coordinator of this site? Confirm its status | Lanzhou | China | Unknown status |
| The First Affiliated Hospital with Nanjing Medical University Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| The General Hospital of Eastern Theater Command Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Jiangsu Cancer Institute & Hospital Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| The Affiliated Hospital of Qingdao University Coordinator of this site? Confirm its status | Qingdao | China | Unknown status |
| RenJi Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Shanghai Changzheng Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Suining Central Hospital Coordinator of this site? Confirm its status | Suining | China | Unknown status |
| Tianjin Chest Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| Tianjin Medical University Cancer Institute and Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| Wuhan Union Hospital, China Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Wuhan Tongji Hospital Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Tang-Du Hospital Coordinator of this site? Confirm its status | Xi’an | China | Unknown status |
| The affiliated hospital of xuzhou medical university Coordinator of this site? Confirm its status | Xuzhou | China | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.