Lobectomy-First vs. Lymphadenectomy-First for Operable NSCLC (LOFTY)
NCT Number: NCT06577792
Acronym: LOFTY
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Non Small Cell Lung Cancer
Interventions: PROCEDURE: Lobectomy-First|PROCEDURE: Lymphadenectomy-First
Sponsor: Sun Yat-sen University
Collaborators: Tianjin Medical University Cancer Institute and Hospital|RenJi Hospital|Sixth Affiliated Hospital, Sun Yat-sen University|First Affiliated Hospital of Jinan University|The First Affiliated Hospital with Nanjing Medical University|Hebei Medical University Fourth Hospital|Shanghai Changzheng Hospital|Cancer Institute and Hospital, Chinese Academy of Medical Sciences|Suining Central Hospital|Ningbo Medical Center Lihuili Hospital|Shanxi Provincial Cancer Hospital|The Affiliated Hospital of Xuzhou Medical University|The General Hospital of Eastern Theater Command|First Affiliated Hospital, Sun Yat-Sen University|Guangdong Provincial People's Hospital|Fujian Medical University Union Hospital|First Affiliated Hospital of Kunming Medical University|Fujian Provincial Hospital|Tianjin Chest Hospital|Sichuan Cancer Hospital and Research Institute|Shenzhen People's Hospital|Tang-Du Hospital|Shandong Provincial Hospital|Gansu Provincial Hospital|Wuhan Union Hospital, China|Wuhan TongJi Hospital|The Affiliated Hospital of Qingdao University|West China Hospital|The First Affiliated Hospital of Nanchang University|Jiangsu Cancer Institute & Hospital|Dongguan People's Hospital|First People's Hospital of Foshan
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 620
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-08-16
Completion Date: 2029-12-31
Locations: Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing, Beijing, 100021, China|Fujian Medical University Union Hospital, Fuzhou, Fujian, 350001, China|Fujian Provincial Hospital, Fuzhou, Fujian, 350001, China|Gansu Provincial Hospital, Lanzhou, Gansu, 730013, China|Dongguan People's Hospital, Dongguan, Guangdong, 523059, China|First People's Hospital of Foshan, Foshan, Guangdong, 528000, China|Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, 510060, China|First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, 510062, China|Guangdong Provincial People's Hospital, Guangzhou, Guangdong, 510080, China|First Affiliated Hospital of Jinan University, Guangzhou, Guangdong, 510632, China|Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, 510655, China|Shenzhen People's Hospital, Shenzhen, Guangdong, 518020, China|Hebei Medical University Fourth Hospital, Shijia Zhuang, Hebei, 050011, China|Wuhan TongJi Hospital, Wuhan, Hubei, 430014, China|Wuhan Union Hospital, China, Wuhan, Hubei, 430090, China|Jiangsu Cancer Institute & Hospital, Nanjing, Jiangsu, 210009, China|The General Hospital of Eastern Theater Command, Nanjing, Jiangsu, 210016, China|The First Affiliated Hospital with Nanjing Medical University, Nanjing, Jiangsu, 210029, China|The Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, 221132, China|The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, 330006, China|Tang-Du Hospital, Xi'an, Shaanxi, 710032, China|Shaanxi Provincial Cancer Hospital, Xi'an, Shaanxi, 710061, China|Shandong Provincial Hospital, Jinan, Shandong, 250022, China|The Affiliated Hospital of Qingdao University, Qingdao, Shandong, 266075, China|RenJi Hospital, Shanghai, Shanghai, 200001, China|Shanghai Changzheng Hospital, Shanghai, Shanghai, 201209, China|Sichuan Cancer Hospital and Research Institute, Chengdu, Sichuan, 610041, China|West China Hospital, Chengdu, Sichuan, 610041, China|Suining Central Hospital, Suining, Sichuan, 629099, China|Tianjin Medical University Cancer Institute and Hospital, Tianjin, Tianjin, 300060, China|Tianjin Chest Hospital, Tianjin, Tianjin, 300222, China|First Affiliated Hospital of Kunming Medical University, Kunming, Yunnan, 650032, China|Ningbo Medical Center Lihuili Hospital, Ningbo, Zhejiang, 315040, China

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.

Primary Outcome Measures: 5-year disease-free survival (DFS), The disease-free survival rate 5 years after surgery, 5 years after surgery
Secondary Outcome Measures: 5-year overall survival (OS), The overall survival rate 5 years after surgery, 5 years after surgery|3-year disease free survival (DFS), The disease-free survival rate 3 years after surgery, 3 years after surgery|3-year overall survival (OS), The overall survival rate 3 years after surgery, 3 years after surgery|Intraoperative blood loss, Total blood loss during the surgery, During the surgery|Conversion rate, The number of cases converted to thoracotomy in a group divided by the total number of included cases in this group, During the surgery|Perioperative complications rate, The number of cases in a group with perioperative complications divided by the total number of included cases in this group, The day of surgery, 2/4/8/12/26/52 weeks after surgery|Operative death rate, The number of cases in a group died within 30/90 days after surgery divided by the total number of cases in this group, 30/90 days after surgery|Postoperative hospital stays, The number of days between the date of surgery and the date of discharge, Between the date of surgery and the date of discharge, assessed up to 30 days|Postoperative pain score, 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, Daily after surgery for up to 7 days and at weeks 2/4/8/12/26/52 after discharge|R0 rate, The number of cases in a group received complete resection divided by the total number of cases in this group, Postoperative in-hospital stay up to 30 days|Operative time, The total time from skin to skin and the time of each step, During the surgery|Chest tube duration, The number of days between the date of surgery and the date of chest tube removal, Postoperative in-hospital stay up to 30 days|The numbers of circulating tumor cell (CTC)/circulating tumor DNA (ctDNA) before and after operation, 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, During the surgery|Acesodyne (Grade III) dose, The total amount of morphine used by the patient during the postoperative hospital period, Postoperative in-hospital stay up to 30 days|Total cost of hospitalization, The total medical cost of the patient from admission to discharge, From the date of admission to the date of discharge, assessed up to 30 days|The number of resected lymph nodes, The number of resected lymph nodes were calculated according to the official pathological report after surgery, Postoperative in-hospital stay up to 30 days