Non Small Cell Lung CancerLOFTYNCT06577792
Lobectomy-First vs. Lymphadenectomy-First for Operable NSCLC (LOFTY)
A study testing Lobectomy-First and Lymphadenectomy-First in people with Non Small Cell Lung Cancer, run by Sun Yat-sen University at 26 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Lobectomy-First and Lymphadenectomy-First
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 620 participants
- Where
- 26 sitesChina
- Study dates
- 16 Aug 2023to 20 Apr 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
China26 sites
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Sichuan Cancer Hospital and Research Institute
Chengdu, Sichuan, 610041
West China Hospital
Chengdu, Sichuan, 610041
Dongguan People's Hospital
Dongguan, Guangdong, 523059
First People's Hospital of Foshan
Foshan, Guangdong, 528000
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
Fujian Provincial Hospital
Fuzhou, Fujian, 350001
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, 510632
Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510655
Shandong Provincial Hospital
Jinan, Shandong, 250022
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032
Gansu Provincial Hospital
Lanzhou, Gansu, 730013
Jiangsu Cancer Institute & Hospital
Nanjing, Jiangsu, 210009
The General Hospital of Eastern Theater Command
Nanjing, Jiangsu, 210016
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, 210029
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266075
RenJi Hospital
Shanghai, Shanghai Municipality, 200001
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, 201209
Suining Central Hospital
Suining, Sichuan, 629099
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
Tianjin Chest Hospital
Tianjin, Tianjin Municipality, 300222
Wuhan TongJi Hospital
Wuhan, Hubei, 430014
Wuhan Union Hospital, China
Wuhan, Hubei, 430090
Tang-Du Hospital
Xi'an, Shaanxi, 710032
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221132
About this study
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
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.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Lobectomy-First, Lymphadenectomy-First
- Keywords
- Non-small cell lung cancer, Lobectomy, Lymphadenectomy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lobectomy-FirstProcedure or surgery
During the surgical treatment for patients with NSCLC, thoracic surgeons should perform lobectomy first, and then perform lymphadenectomy next.
Lymphadenectomy-FirstProcedure or surgery
During the surgical treatment for patients with NSCLC, thoracic surgeons should perform lymphadenectomy first, and then perform lobectomy next.
| Study group | Role | What they receive |
|---|---|---|
| Lobectomy-First group | Other | Patients with operable NSCLC received lobectomy first then received lymphadenectomy for surgical treatment. Receives: Procedure: Lobectomy-First |
| Lymphadenectomy-First group | Other | Patients with operable NSCLC received lymphadenectomy first then received lobectomy for surgical treatment. Receives: Procedure: Lymphadenectomy-First |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-year disease-free survival (DFS)
The disease-free survival rate 5 years after surgery
Measured: 5 years after surgery
Secondary outcomes (16)
5-year overall survival (OS)
The overall survival rate 5 years after surgery
Measured: 5 years after surgery
3-year disease free survival (DFS)
The disease-free survival rate 3 years after surgery
Measured: 3 years after surgery
3-year overall survival (OS)
The overall survival rate 3 years after surgery
Measured: 3 years after surgery
Intraoperative blood loss
Total blood loss during the surgery
Measured: 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
Measured: 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
Measured: 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
Measured: 30/90 days after surgery
Postoperative hospital stays
The number of days between the date of surgery and the date of discharge
Measured: 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
Measured: 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
Measured: Postoperative in-hospital stay up to 30 days
Operative time
The total time from skin to skin and the time of each step
Measured: During the surgery
Chest tube duration
The number of days between the date of surgery and the date of chest tube removal
Measured: 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
Measured: During the surgery
Acesodyne (Grade III) dose
The total amount of morphine used by the patient during the postoperative hospital period
Measured: Postoperative in-hospital stay up to 30 days
Total cost of hospitalization
The total medical cost of the patient from admission to discharge
Measured: 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
Measured: Postoperative in-hospital stay up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start16 Aug 2023
- Primary completion20 Apr 2031 (estimated)
- Study completion20 Apr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 620 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- 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
- Principal investigator, Hao-Xian Yang, Sun Yat-sen University
- Investigators
- Hao-Xian Yang, M.D., Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06577792
- Sponsor's protocol ID
- SL-B2022-443
- Other IDs
- ChiCTR2300068586
- Acronym
- LOFTY
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2024
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06577792
- Acronym / sponsor ID
- LOFTY / SL-B2022-443
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- Non-small cell lung cancer, Lobectomy, Lymphadenectomy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 620 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- 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
- Study start
- 16 Aug 2023 (actual)
- Primary completion
- 20 Apr 2031 (estimated)
- Study completion
- 20 Apr 2031 (estimated)
- First posted
- 29 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lobectomy-First group | Other | Procedure: Lobectomy-FirstPatients with operable NSCLC received lobectomy first then received lymphadenectomy for surgical treatment. |
| Lymphadenectomy-First group | Other | Procedure: Lymphadenectomy-FirstPatients with operable NSCLC received lymphadenectomy first then received lobectomy for surgical treatment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lobectomy-FirstDuring the surgical treatment for patients with NSCLC, thoracic surgeons should perform lobectomy first, and then perform lymphadenectomy next. | Procedure or surgery | Lobectomy-First group |
| Lymphadenectomy-FirstDuring the surgical treatment for patients with NSCLC, thoracic surgeons should perform lymphadenectomy first, and then perform lobectomy next. | Procedure or surgery | Lymphadenectomy-First group |
Primary outcome
5-year disease-free survival (DFS)
Time frame: 5 years after surgery
The disease-free survival rate 5 years after surgery
16 secondary outcomes
5-year overall survival (OS)
Time frame: 5 years after surgery
3-year disease free survival (DFS)
Time frame: 3 years after surgery
3-year overall survival (OS)
Time frame: 3 years after surgery
Intraoperative blood loss
Time frame: During the surgery
Conversion rate
Time frame: During the surgery
Perioperative complications rate
Time frame: The day of surgery, 2/4/8/12/26/52 weeks after surgery
Operative death rate
Time frame: 30/90 days after surgery
Postoperative hospital stays
Time frame: Between the date of surgery and the date of discharge, assessed up to 30 days
Postoperative pain score
Time frame: Daily after surgery for up to 7 days and at weeks 2/4/8/12/26/52 after discharge
R0 rate
Time frame: Postoperative in-hospital stay up to 30 days
Operative time
Time frame: During the surgery
Chest tube duration
Time frame: Postoperative in-hospital stay up to 30 days
The numbers of circulating tumor cell (CTC)/circulating tumor DNA (ctDNA) before and after operation
Time frame: During the surgery
Acesodyne (Grade III) dose
Time frame: Postoperative in-hospital stay up to 30 days
Total cost of hospitalization
Time frame: From the date of admission to the date of discharge, assessed up to 30 days
The number of resected lymph nodes
Time frame: Postoperative in-hospital stay up to 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Derived from this study: PubMed 41462323Fan 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.
- This clinical trial has been registered in Chinese Clinical Trial Registry with a registration number as ChiCTR2300068586Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hao-Xian Yang, M.D. principal investigator
Sun Yat-Sen University Cancer Center
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lobectomy-First and Lymphadenectomy-First in people with Non Small Cell Lung Cancer, run by Sun Yat-sen University at 26 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5-year disease-free survival (DFS) (time frame: 5 years after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06577792, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026; AzTrials last refreshed its copy on 28 Oct 2026.