Lobectomy-First vs. Lymphadenectomy-First for Operable NSCLC (LOFTY)
- Conditions
- Non Small Cell Lung Cancer
- Interventions
- Procedure: Lobectomy-FirstProcedure: Lymphadenectomy-First
- Registration Number
- NCT06577792
- Lead Sponsor
- Sun Yat-sen University
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 620
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lobectomy-First group Lobectomy-First Patients with operable NSCLC received lobectomy first then received lymphadenectomy for surgical treatment. Lymphadenectomy-First group Lymphadenectomy-First Patients with operable NSCLC received lymphadenectomy first then received lobectomy for surgical treatment.
- Primary Outcome Measures
Name Time Method 5-year disease-free survival (DFS) 5 years after surgery The disease-free survival rate 5 years after surgery
- Secondary Outcome Measures
Name Time Method Intraoperative blood loss During the surgery Total blood loss during the surgery
Operative death rate 30/90 days after surgery The number of cases in a group died within 30/90 days after surgery divided by the total number of cases in this group
Acesodyne (Grade III) dose Postoperative in-hospital stay up to 30 days The total amount of morphine used by the patient during the postoperative hospital period
3-year overall survival (OS) 3 years after surgery The overall survival rate 3 years after surgery
Perioperative complications rate The day of surgery, 2/4/8/12/26/52 weeks after surgery The number of cases in a group with perioperative complications divided by the total number of included cases in this group
R0 rate Postoperative in-hospital stay up to 30 days The number of cases in a group received complete resection divided by the total number of cases in this group
5-year overall survival (OS) 5 years after surgery The overall survival rate 5 years after surgery
3-year disease free survival (DFS) 3 years after surgery The disease-free survival rate 3 years after surgery
Conversion rate During the surgery The number of cases converted to thoracotomy in a group divided by the total number of included cases in this group
Postoperative hospital stays Between the date of surgery and the date of discharge, assessed up to 30 days The number of days between the date of surgery and the date of discharge
Postoperative pain score Daily after surgery for up to 7 days and at weeks 2/4/8/12/26/52 after discharge The degree of pain after surgery was measured using Numerical Rating Scale (NRS). The patient is asked to make three pain ratings, corresponding to current, best and worst pain experienced over the past 24 hours on a scale of 0 (no pain) to 10 (worst pain imaginable). The average of the 3 ratings was used to represent the patient's level of pain over the previous 24 hours
Operative time During the surgery The total time from skin to skin and the time of each step
Chest tube duration Postoperative in-hospital stay up to 30 days The number of days between the date of surgery and the date of chest tube removal
Total cost of hospitalization From the date of admission to the date of discharge, assessed up to 30 days The total medical cost of the patient from admission to discharge
The number of resected lymph nodes Postoperative in-hospital stay up to 30 days The number of resected lymph nodes were calculated according to the official pathological report after surgery
The numbers of circulating tumor cell (CTC)/circulating tumor DNA (ctDNA) before and after operation During the surgery 3ml of peripheral arterial blood was drawn before surgery and immediately after chest closure, and then CTC/ctDNA was isolated by differential centrifugation for quantitative measurement
Trial Locations
- Locations (26)
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
🇨🇳Beijing, Beijing, 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, China
Shanghai Changzheng Hospital
🇨🇳Shanghai, Shanghai, 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, China
Tianjin Chest Hospital
🇨🇳Tianjin, Tianjin, China
First Affiliated Hospital of Kunming Medical University
🇨🇳Kunming, Yunnan, China