NCT06577792

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
620

participants targeted

Target at P75+ for not_applicable

Timeline
56mo left

Started Aug 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

26 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress38%
Aug 2023Dec 2030

Study Start

First participant enrolled

August 16, 2023

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 29, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Expected
Last Updated

May 16, 2025

Status Verified

May 1, 2025

Enrollment Period

2.4 years

First QC Date

July 8, 2024

Last Update Submit

May 13, 2025

Conditions

Non Small Cell Lung Cancer

Keywords

Non-small cell lung cancerLobectomyLymphadenectomy

Outcome Measures

Primary Outcomes (1)

  • 5-year disease-free survival (DFS)

    The disease-free survival rate 5 years after surgery

    5 years after surgery

Secondary Outcomes (16)

  • 5-year overall survival (OS)

    5 years after surgery

  • 3-year disease free survival (DFS)

    3 years after surgery

  • 3-year overall survival (OS)

    3 years after surgery

  • Intraoperative blood loss

    During the surgery

  • Conversion rate

    During the surgery

  • +11 more secondary outcomes

Study Arms (2)

Lobectomy-First group

OTHER

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

Procedure: Lobectomy-First

Lymphadenectomy-First group

OTHER

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

Procedure: Lymphadenectomy-First

Interventions

Lobectomy-FirstPROCEDURE

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

Lobectomy-First group
Lymphadenectomy-FirstPROCEDURE

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

Lymphadenectomy-First group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

RECRUITING

Fujian Provincial Hospital

Fuzhou, Fujian, 350001, China

RECRUITING

Gansu Provincial Hospital

Lanzhou, Gansu, 730013, China

RECRUITING

Dongguan People's Hospital

Dongguan, Guangdong, 523059, China

RECRUITING

First People's Hospital of Foshan

Foshan, Guangdong, 528000, China

RECRUITING

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

First Affiliated Hospital of Jinan University

Guangzhou, Guangdong, 510632, China

RECRUITING

Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

NOT YET RECRUITING

Wuhan TongJi Hospital

Wuhan, Hubei, 430014, China

RECRUITING

Wuhan Union Hospital, China

Wuhan, Hubei, 430090, China

NOT YET RECRUITING

Jiangsu Cancer Institute & Hospital

Nanjing, Jiangsu, 210009, China

RECRUITING

The General Hospital of Eastern Theater Command

Nanjing, Jiangsu, 210016, China

RECRUITING

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, 210029, China

NOT YET RECRUITING

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221132, China

RECRUITING

Tang-Du Hospital

Xi'an, Shaanxi, 710032, China

NOT YET RECRUITING

Shandong Provincial Hospital

Jinan, Shandong, 250022, China

NOT YET RECRUITING

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266075, China

NOT YET RECRUITING

RenJi Hospital

Shanghai, Shanghai Municipality, 200001, China

RECRUITING

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, 201209, China

RECRUITING

Sichuan Cancer Hospital and Research Institute

Chengdu, Sichuan, 610041, China

RECRUITING

West China Hospital

Chengdu, Sichuan, 610041, China

NOT YET RECRUITING

Suining Central Hospital

Suining, Sichuan, 629099, China

RECRUITING

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

Tianjin Chest Hospital

Tianjin, Tianjin Municipality, 300222, China

NOT YET RECRUITING

First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650032, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 41462323DERIVED

Related Links

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Hao-Xian Yang, M.D.

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hao-Xian Yang, M.D.

CONTACT

+86-020-87343628yanghx@sysucc.org.cn

Mu-Zi Yang, M.D.

CONTACT

+86-020-87341456yangmz@sysucc.org.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 8, 2024

First Posted

August 29, 2024

Study Start

August 16, 2023

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2030

Last Updated

May 16, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(26)