CClinicalTrials.gg
Active, not recruitingNCT06577792LOFTYUpdated Jul 14, 2026

Lobectomy-First vs. Lymphadenectomy-First for Operable NSCLC (LOFTY)

An interventional study of Lobectomy-First and Lymphadenectomy-First in Non Small Cell Lung Cancer, sponsored by Sun Yat-sen University. Active, not recruiting at 26 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-14.

Sponsored by Sun Yat-sen University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Aug 2023, registered Jul 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
620
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
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Study 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.

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Conditions studied

  • Non Small Cell Lung Cancer

Keywords

  • Non-small cell lung cancer
  • Lobectomy
  • Lymphadenectomy
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In context

Carcinoma, Non-Small-Cell Lung

6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.

This study's planned enrollment of 620 is above the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
620 participants (estimated)

Study arms

  • Other
    Lobectomy-First group

    Patients with operable NSCLC received lobectomy first then received lymphadenectomy for surgical treatment.

    Procedure: Lobectomy-First

  • Other
    Lymphadenectomy-First group

    Patients with operable NSCLC received lymphadenectomy first then received lobectomy for surgical treatment.

    Procedure: Lymphadenectomy-First

Interventions

  • ProcedureLobectomy-First

    During the surgical treatment for patients with NSCLC, thoracic surgeons should perform lobectomy first, and then perform lymphadenectomy next.

  • ProcedureLymphadenectomy-First

    During the surgical treatment for patients with NSCLC, thoracic surgeons should perform lymphadenectomy first, and then perform lobectomy next.

06

What researchers measure

Primary outcomes

  1. 5-year disease-free survival (DFS)

    The disease-free survival rate 5 years after surgery

    Time frame: 5 years after surgery

Secondary outcomes

  1. 5-year overall survival (OS)

    The overall survival rate 5 years after surgery

    Time frame: 5 years after surgery

  2. 3-year disease free survival (DFS)

    The disease-free survival rate 3 years after surgery

    Time frame: 3 years after surgery

  3. 3-year overall survival (OS)

    The overall survival rate 3 years after surgery

    Time frame: 3 years after surgery

  4. Intraoperative blood loss

    Total blood loss during the surgery

    Time frame: During the surgery

  5. Conversion rate

    The number of cases converted to thoracotomy in a group divided by the total number of included cases in this group

    Time frame: During the surgery

  6. Perioperative complications rate

    The number of cases in a group with perioperative complications divided by the total number of included cases in this group

    Time frame: The day of surgery, 2/4/8/12/26/52 weeks after surgery

  7. 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

    Time frame: 30/90 days after surgery

  8. Postoperative hospital stays

    The number of days between the date of surgery and the date of discharge

    Time frame: Between the date of surgery and the date of discharge, assessed up to 30 days

  9. 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

    Time frame: Daily after surgery for up to 7 days and at weeks 2/4/8/12/26/52 after discharge

  10. R0 rate

    The number of cases in a group received complete resection divided by the total number of cases in this group

    Time frame: Postoperative in-hospital stay up to 30 days

  11. Operative time

    The total time from skin to skin and the time of each step

    Time frame: During the surgery

  12. Chest tube duration

    The number of days between the date of surgery and the date of chest tube removal

    Time frame: Postoperative in-hospital stay up to 30 days

  13. 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

    Time frame: During the surgery

  14. Acesodyne (Grade III) dose

    The total amount of morphine used by the patient during the postoperative hospital period

    Time frame: Postoperative in-hospital stay up to 30 days

  15. Total cost of hospitalization

    The total medical cost of the patient from admission to discharge

    Time frame: From the date of admission to the date of discharge, assessed up to 30 days

  16. The number of resected lymph nodes

    The number of resected lymph nodes were calculated according to the official pathological report after surgery

    Time frame: Postoperative in-hospital stay up to 30 days

07

Study locations

26 sites
  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences
    Beijing, Beijing Municipality 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 of Jinan University
    Guangzhou, Guangdong 510632, China
  • Sixth Affiliated Hospital, Sun Yat-sen University
    Guangzhou, Guangdong 510655, 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
  • Tang-Du Hospital
    Xi'an, Shaanxi 710032, China
  • Shandong Provincial Hospital
    Jinan, Shandong 250022, China
  • The Affiliated Hospital of Qingdao University
    Qingdao, Shandong 266075, China
  • RenJi Hospital
    Shanghai, Shanghai Municipality 200001, China
  • Shanghai Changzheng Hospital
    Shanghai, Shanghai Municipality 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 Municipality 300060, China
  • Tianjin Chest Hospital
    Tianjin, Tianjin Municipality 300222, China
  • First Affiliated Hospital of Kunming Medical University
    Kunming, Yunnan 650032, China
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References and documents

Publications

  • 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. PubMed 41462323 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06577792
Lead 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, Shanghai Changzheng Hospital, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Suining Central Hospital, The Affiliated Hospital of Xuzhou Medical University, The General Hospital of Eastern Theater Command, Fujian Medical University Union Hospital, First Affiliated Hospital of Kunming Medical University, Fujian Provincial Hospital, Tianjin Chest Hospital, Sichuan Cancer Hospital and Research Institute, Tang-Du Hospital, Shandong Provincial Hospital, Gansu Provincial Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan TongJi Hospital, The Affiliated Hospital of Qingdao University, West China Hospital, Jiangsu Cancer Institute & Hospital, Dongguan People's Hospital, First People's Hospital of Foshan
Responsible party
Hao-Xian Yang (Principal Investigator, Sun Yat-sen University) — Principal investigator
First posted
Aug 29, 2024
Start date
Aug 16, 2023
Primary completion
Apr 20, 2031 (estimated)
Completion
Apr 20, 2031 (estimated)
Last update
Jul 14, 2026

Study contacts

Hao-Xian Yang, M.D.
principal investigator · Sun Yat-Sen University Cancer Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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