Clinical trial NCT06577792: Lobectomy-First vs. Lymphadenectomy-First for Operable NSCLC (LOFTY)
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Non Small Cell Lung Cancer
Keywords: Non-small cell lung cancer
Lobectomy
Lymphadenectomy
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Tianjin Medical University Cancer Institute and Hospital
name: RenJi Hospital
name: Sixth Affiliated Hospital, Sun Yat-sen University
name: First Affiliated Hospital of Jinan University
name: The First Affiliated Hospital with Nanjing Medical University
name: Shanghai Changzheng Hospital
name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Suining Central Hospital
name: The Affiliated Hospital of Xuzhou Medical University
name: The General Hospital of Eastern Theater Command
name: Fujian Medical University Union Hospital
name: First Affiliated Hospital of Kunming Medical University
name: Fujian Provincial Hospital
name: Tianjin Chest Hospital
name: Sichuan Cancer Hospital and Research Institute
name: Tang-Du Hospital
name: Shandong Provincial Hospital
name: Gansu Provincial Hospital
name: Wuhan Union Hospital, China
name: Wuhan TongJi Hospital
name: The Affiliated Hospital of Qingdao University
name: West China Hospital
name: Jiangsu Cancer Institute & Hospital
name: Dongguan People's Hospital
name: First People's Hospital of Foshan
First posted: 2024-08-29
Enrollment: 620
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Age from 18 to 80 years old;
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:

1. Patients who have undergone anti-tumor therapy (radiotherapy, chemotherapy, targeted therapy, immunotherapy) before surgery;
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.

Primary outcomes:
measure: 5-year disease-free survival (DFS)
timeFrame: 5 years after surgery
Secondary outcomes:
measure: 5-year overall survival (OS)
timeFrame: 5 years after surgery
measure: 3-year disease free survival (DFS)
timeFrame: 3 years after surgery
measure: 3-year overall survival (OS)
timeFrame: 3 years after surgery
measure: Intraoperative blood loss
timeFrame: During the surgery
measure: Conversion rate
timeFrame: During the surgery
measure: Perioperative complications rate
timeFrame: The day of surgery, 2/4/8/12/26/52 weeks after surgery
measure: Operative death rate
timeFrame: 30/90 days after surgery
measure: Postoperative hospital stays
timeFrame: Between the date of surgery and the date of discharge, assessed up to 30 days
measure: Postoperative pain score
timeFrame: Daily after surgery for up to 7 days and at weeks 2/4/8/12/26/52 after discharge
measure: R0 rate
timeFrame: Postoperative in-hospital stay up to 30 days
measure: Operative time
timeFrame: During the surgery
measure: Chest tube duration
timeFrame: Postoperative in-hospital stay up to 30 days
measure: The numbers of circulating tumor cell (CTC)/circulating tumor DNA (ctDNA) before and after operation
timeFrame: During the surgery
measure: Acesodyne (Grade III) dose
timeFrame: Postoperative in-hospital stay up to 30 days
measure: Total cost of hospitalization
timeFrame: From the date of admission to the date of discharge, assessed up to 30 days
measure: The number of resected lymph nodes
timeFrame: Postoperative in-hospital stay up to 30 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
state: Beijing
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
city: Fuzhou
country: China
facility: Fujian Provincial Hospital
state: Fujian
city: Lanzhou
country: China
facility: Gansu Provincial Hospital
state: Gansu
city: Dongguan
country: China
facility: Dongguan People's Hospital
state: Guangdong
city: Foshan
country: China
facility: First People's Hospital of Foshan
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Guangzhou
country: China
facility: First Affiliated Hospital of Jinan University
state: Guangdong
city: Guangzhou
country: China
facility: Sixth Affiliated Hospital, Sun Yat-sen University
state: Guangdong
city: Wuhan
country: China
facility: Wuhan TongJi Hospital
state: Hubei
city: Wuhan
country: China
facility: Wuhan Union Hospital, China
state: Hubei
city: Nanjing
country: China
facility: Jiangsu Cancer Institute & Hospital
state: Jiangsu
city: Nanjing
country: China
facility: The General Hospital of Eastern Theater Command
state: Jiangsu
city: Nanjing
country: China
facility: The First Affiliated Hospital with Nanjing Medical University
state: Jiangsu
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
city: Xi'an
country: China
facility: Tang-Du Hospital
state: Shaanxi
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
state: Shandong
city: Shanghai
country: China
facility: RenJi Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Changzheng Hospital
state: Shanghai
city: Chengdu
country: China
facility: Sichuan Cancer Hospital and Research Institute
state: Sichuan
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
city: Suining
country: China
facility: Suining Central Hospital
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Chest Hospital
state: Tianjin
city: Kunming
country: China
facility: First Affiliated Hospital of Kunming Medical University
state: Yunnan
Study officials:
affiliation: Sun Yat-sen University
name: Hao-Xian Yang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: