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| ID | Type | Description | Link |
|---|---|---|---|
| ChiCTR2300068586 | Registry Identifier | Chinese Clinical Trial Registry |
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| Name | Class |
|---|---|
| Tianjin Medical University Cancer Institute and Hospital | OTHER |
| RenJi Hospital | OTHER |
| Sixth Affiliated Hospital, Sun Yat-sen University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lobectomy-First group | Other | Patients with operable NSCLC received lobectomy first then received lymphadenectomy for surgical treatment. |
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| Lymphadenectomy-First group | Other | Patients with operable NSCLC received lymphadenectomy first then received lobectomy for surgical treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lobectomy-First | Procedure | During the surgical treatment for patients with NSCLC, thoracic surgeons should perform lobectomy first, and then perform lymphadenectomy next. |
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| Measure | Description | Time Frame |
|---|---|---|
| 5-year disease-free survival (DFS) | The disease-free survival rate 5 years after surgery | 5 years after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hao-Xian Yang, M.D. | Contact | +86-020-87343628 | yanghx@sysucc.org.cn | |
| Mu-Zi Yang, M.D. | Contact | +86-020-87341456 | yangmz@sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Hao-Xian Yang, M.D. | Sun Yat-Sen University Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Recruiting | Beijing | Beijing Municipality | 100021 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41462323 | Derived | Fan HR, Yang MZ, Yan XL, Chen XB, Gou YJ, You J, Lin JB, Zhou HN, Zhang H, Chen WS, Zhang N, Tang H, Lin YB, Leng XF, Qian XZ, Yi J, Su XD, Cai SW, Gu WQ, Peng ZM, Du W, Yang H, Mei JD, Sun DQ, Liao YD, Liao HY, Qiu B, Ma GW, Jiao WJ, Wang W, Wang Y, Zhao ZR, Liu QW, Sun TY, Li M, Yang HX. Lobectomy-first versus lymphadenectomy-first on long-term survival for operable non-small cell lung cancer: protocol of LOFTY trial. Trials. 2025 Dec 29;26(1):581. doi: 10.1186/s13063-025-09285-9. |
| Label | URL |
|---|---|
| This clinical trial has been registered in Chinese Clinical Trial Registry with a registration number as ChiCTR2300068586 | View source |
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| 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 |
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| Lymphadenectomy-First | Procedure | During the surgical treatment for patients with NSCLC, thoracic surgeons should perform lymphadenectomy first, and then perform lobectomy next. |
|
| 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 |
| Fujian Medical University Union Hospital | Recruiting | Fuzhou | Fujian | 350001 | China |
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| Fujian Provincial Hospital | Recruiting | Fuzhou | Fujian | 350001 | China |
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| Gansu Provincial Hospital | Recruiting | Lanzhou | Gansu | 730013 | China |
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| Dongguan People's Hospital | Recruiting | Dongguan | Guangdong | 523059 | China |
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| First People's Hospital of Foshan | Recruiting | Foshan | Guangdong | 528000 | China |
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| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
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| First Affiliated Hospital of Jinan University | Recruiting | Guangzhou | Guangdong | 510632 | China |
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| Sixth Affiliated Hospital, Sun Yat-sen University | Not yet recruiting | Guangzhou | Guangdong | 510655 | China |
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| Wuhan TongJi Hospital | Recruiting | Wuhan | Hubei | 430014 | China |
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| Wuhan Union Hospital, China | Not yet recruiting | Wuhan | Hubei | 430090 | China |
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| Jiangsu Cancer Institute & Hospital | Recruiting | Nanjing | Jiangsu | 210009 | China |
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| The General Hospital of Eastern Theater Command | Recruiting | Nanjing | Jiangsu | 210016 | China |
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| The First Affiliated Hospital with Nanjing Medical University | Not yet recruiting | Nanjing | Jiangsu | 210029 | China |
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| The Affiliated Hospital of Xuzhou Medical University | Recruiting | Xuzhou | Jiangsu | 221132 | China |
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| Tang-Du Hospital | Not yet recruiting | Xi'an | Shaanxi | 710032 | China |
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| Shandong Provincial Hospital | Not yet recruiting | Jinan | Shandong | 250022 | China |
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| The Affiliated Hospital of Qingdao University | Not yet recruiting | Qingdao | Shandong | 266075 | China |
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| RenJi Hospital | Recruiting | Shanghai | Shanghai Municipality | 200001 | China |
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| Shanghai Changzheng Hospital | Recruiting | Shanghai | Shanghai Municipality | 201209 | China |
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| Sichuan Cancer Hospital and Research Institute | Recruiting | Chengdu | Sichuan | 610041 | China |
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| West China Hospital | Not yet recruiting | Chengdu | Sichuan | 610041 | China |
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| Suining Central Hospital | Recruiting | Suining | Sichuan | 629099 | China |
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| Tianjin Medical University Cancer Institute and Hospital | Recruiting | Tianjin | Tianjin Municipality | 300060 | China |
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| Tianjin Chest Hospital | Not yet recruiting | Tianjin | Tianjin Municipality | 300222 | China |
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| First Affiliated Hospital of Kunming Medical University | Recruiting | Kunming | Yunnan | 650032 | China |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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