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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

Full criteria on ClinicalTrials.gov

Sites (26)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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BeijingChinaUnknown status
West China Hospital
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ChengduChinaUnknown status
Sichuan Cancer Hospital and Research Institute
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ChengduChinaUnknown status
Dongguan People's Hospital
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DongguanChinaUnknown status
First People's Hospital of Foshan
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FoshanChinaUnknown status
Fujian Provincial Hospital
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FuzhouChinaUnknown status
Fujian Medical University Union Hospital
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FuzhouChinaUnknown status
Sun Yat-sen University Cancer Center
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GuangzhouChinaUnknown status
First Affiliated Hospital of Jinan University
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GuangzhouChinaUnknown status
Sixth Affiliated Hospital, Sun Yat-sen University
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GuangzhouChinaUnknown status
Shandong Provincial Hospital
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JinanChinaUnknown status
First Affiliated Hospital of Kunming Medical University
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KunmingChinaUnknown status
Gansu Provincial Hospital
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LanzhouChinaUnknown status
The First Affiliated Hospital with Nanjing Medical University
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NanjingChinaUnknown status
The General Hospital of Eastern Theater Command
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NanjingChinaUnknown status
Jiangsu Cancer Institute & Hospital
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NanjingChinaUnknown status
The Affiliated Hospital of Qingdao University
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QingdaoChinaUnknown status
RenJi Hospital
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ShanghaiChinaUnknown status
Shanghai Changzheng Hospital
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ShanghaiChinaUnknown status
Suining Central Hospital
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SuiningChinaUnknown status
Tianjin Chest Hospital
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TianjinChinaUnknown status
Tianjin Medical University Cancer Institute and Hospital
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TianjinChinaUnknown status
Wuhan Union Hospital, China
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WuhanChinaUnknown status
Wuhan Tongji Hospital
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WuhanChinaUnknown status
Tang-Du Hospital
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Xi’anChinaUnknown status
The affiliated hospital of xuzhou medical university
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XuzhouChinaUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.