Lobectomy-First vs. Lymphadenectomy-First for Operable NSCLC (LOFTY)
NCT ID: NCT06577792
Last Updated: 2025-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
620 participants
INTERVENTIONAL
2023-08-16
2030-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Lobectomy-First group
Patients with operable NSCLC received lobectomy first then received lymphadenectomy for surgical treatment.
Lobectomy-First
During the surgical treatment for patients with NSCLC, thoracic surgeons should perform lobectomy first, and then perform lymphadenectomy next.
Lymphadenectomy-First group
Patients with operable NSCLC received lymphadenectomy first then received lobectomy for surgical treatment.
Lymphadenectomy-First
During the surgical treatment for patients with NSCLC, thoracic surgeons should perform lymphadenectomy first, and then perform lobectomy next.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
80 Years
ALL
No
Sponsors
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Tianjin Medical University Cancer Institute and Hospital
OTHER
RenJi Hospital
OTHER
Sixth Affiliated Hospital, Sun Yat-sen University
OTHER
First Affiliated Hospital of Jinan University
OTHER
The First Affiliated Hospital with Nanjing Medical University
OTHER
Shanghai Changzheng Hospital
OTHER
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
OTHER
Suining Central Hospital
OTHER
The Affiliated Hospital of Xuzhou Medical University
OTHER
The General Hospital of Eastern Theater Command
OTHER
Fujian Medical University Union Hospital
OTHER
First Affiliated Hospital of Kunming Medical University
OTHER
Fujian Provincial Hospital
OTHER
Tianjin Chest Hospital
OTHER
Sichuan Cancer Hospital and Research Institute
OTHER
Tang-Du Hospital
OTHER
Shandong Provincial Hospital
OTHER_GOV
Gansu Provincial Hospital
OTHER
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
Wuhan TongJi Hospital
OTHER
The Affiliated Hospital of Qingdao University
OTHER
West China Hospital
OTHER
Jiangsu Cancer Institute & Hospital
OTHER
Dongguan People's Hospital
OTHER_GOV
First People's Hospital of Foshan
OTHER
Sun Yat-sen University
OTHER
Responsible Party
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Hao-Xian Yang
Principal Investigator
Principal Investigators
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Hao-Xian Yang, M.D.
Role: PRINCIPAL_INVESTIGATOR
Sun Yat-sen University
Locations
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Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Fujian Provincial Hospital
Fuzhou, Fujian, China
Gansu Provincial Hospital
Lanzhou, Gansu, China
Dongguan People's Hospital
Dongguan, Guangdong, China
First People's Hospital of Foshan
Foshan, Guangdong, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, China
Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Wuhan TongJi Hospital
Wuhan, Hubei, China
Wuhan Union Hospital, China
Wuhan, Hubei, China
Jiangsu Cancer Institute & Hospital
Nanjing, Jiangsu, China
The General Hospital of Eastern Theater Command
Nanjing, Jiangsu, China
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Tang-Du Hospital
Xi'an, Shaanxi, China
Shandong Provincial Hospital
Jinan, Shandong, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
RenJi Hospital
Shanghai, Shanghai Municipality, China
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China
Sichuan Cancer Hospital and Research Institute
Chengdu, Sichuan, China
West China Hospital
Chengdu, Sichuan, China
Suining Central Hospital
Suining, Sichuan, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
Tianjin Chest Hospital
Tianjin, Tianjin Municipality, China
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Countries
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Central Contacts
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Facility Contacts
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Related Links
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This clinical trial has been registered in Chinese Clinical Trial Registry with a registration number as ChiCTR2300068586
Other Identifiers
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ChiCTR2300068586
Identifier Type: REGISTRY
Identifier Source: secondary_id
SL-B2022-443
Identifier Type: -
Identifier Source: org_study_id
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