Status:
RECRUITING
Lobectomy-First vs. Lymphadenectomy-First for Operable NSCLC (LOFTY)
Lead Sponsor:
Sun Yat-sen University
Collaborating Sponsors:
Tianjin Medical University Cancer Institute and Hospital
RenJi Hospital
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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 ly...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Patients who have undergone anti-tumor therapy (radiotherapy, chemotherapy, targeted therapy, immunotherapy) before surgery;
- Patients with previous medical history of other malignant tumors or combined with second primary cancer at the time of enrollment;
- 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 preoperative diagnosis of pure GGO;
- Patients with previous medical history of unilateral thoracotomy;
- Women who are pregnant or breastfeeding;
- Patients with active bacterial or fungal infection that is difficult to control;
- Patients with serious psychosis;
- Patients with a history of severe heart disease, heart failure, myocardial infarction or angina pectoris in the past 6 months.
Key Trial Info
Start Date :
August 16 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2030
Estimated Enrollment :
620 Patients enrolled
Trial Details
Trial ID
NCT06577792
Start Date
August 16 2023
End Date
December 31 2030
Last Update
May 16 2025
Active Locations (26)
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1
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
2
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001
3
Fujian Provincial Hospital
Fuzhou, Fujian, China, 350001
4
Gansu Provincial Hospital
Lanzhou, Gansu, China, 730013