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

May 13, 2025 updated by: Hao-Xian Yang, Sun Yat-sen University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

620

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100021
        • Recruiting
        • Cancer Institute and Hospital, Chinese Academy of Medical Sciences
        • Contact:
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Recruiting
        • Fujian Medical University Union Hospital
        • Contact:
      • Fuzhou, Fujian, China, 350001
        • Recruiting
        • Fujian Provincial Hospital
        • Contact:
    • Gansu
      • Lanzhou, Gansu, China, 730013
        • Recruiting
        • Gansu Provincial Hospital
        • Contact:
    • Guangdong
      • Dongguan, Guangdong, China, 523059
      • Foshan, Guangdong, China, 528000
        • Recruiting
        • First People's Hospital of Foshan
        • Contact:
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hao-Xian Yang, M.D.
      • Guangzhou, Guangdong, China, 510655
        • Not yet recruiting
        • Sixth Affiliated Hospital, Sun Yat-sen University
        • Contact:
      • Guangzhou, Guangdong, China, 510632
        • Recruiting
        • First Affiliated Hospital of Jinan University
        • Contact:
    • Hubei
      • Wuhan, Hubei, China, 430014
      • Wuhan, Hubei, China, 430090
        • Not yet recruiting
        • Wuhan Union Hospital, China
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
      • Nanjing, Jiangsu, China, 210029
        • Not yet recruiting
        • The First Affiliated Hospital with Nanjing Medical University
        • Contact:
      • Nanjing, Jiangsu, China, 210016
        • Recruiting
        • The General Hospital of Eastern Theater Command
        • Contact:
      • Xuzhou, Jiangsu, China, 221132
        • Recruiting
        • The Affiliated Hospital of Xuzhou Medical University
        • Contact:
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
    • Shandong
      • Jinan, Shandong, China, 250022
        • Not yet recruiting
        • Shandong Provincial Hospital
        • Contact:
      • Qingdao, Shandong, China, 266075
        • Not yet recruiting
        • The Affiliated Hospital of Qingdao University
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 200001
      • Shanghai, Shanghai, China, 201209
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • Sichuan Cancer Hospital and Research Institute
        • Contact:
      • Chengdu, Sichuan, China, 610041
      • Suining, Sichuan, China, 629099
    • Tianjin
      • Tianjin, Tianjin, China, 300060
        • Recruiting
        • Tianjin Medical University Cancer Institute and Hospital
        • Contact:
      • Tianjin, Tianjin, China, 300222
    • Yunnan
      • Kunming, Yunnan, China, 650032
        • Recruiting
        • First Affiliated Hospital of Kunming Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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:

  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Lobectomy-First group
Patients with operable NSCLC received lobectomy first then received lymphadenectomy for surgical treatment.
Procedure: Lobectomy-First
During the surgical treatment for patients with NSCLC, thoracic surgeons should perform lobectomy first, and then perform lymphadenectomy next.
Other: Lymphadenectomy-First group
Patients with operable NSCLC received lymphadenectomy first then received lobectomy for surgical treatment.
Procedure: Lymphadenectomy-First
During the surgical treatment for patients with NSCLC, thoracic surgeons should perform lymphadenectomy first, and then perform lobectomy next.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
5-year disease-free survival (DFS)
Time Frame: 5 years after surgery
The disease-free survival rate 5 years after surgery
5 years after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of resected lymph nodes
Time Frame: Postoperative in-hospital stay up to 30 days
The number of resected lymph nodes were calculated according to the official pathological report after surgery
Postoperative in-hospital stay up to 30 days
Chest tube duration
Time Frame: Postoperative in-hospital stay up to 30 days
The number of days between the date of surgery and the date of chest tube removal
Postoperative in-hospital stay up to 30 days
5-year overall survival (OS)
Time Frame: 5 years after surgery
The overall survival rate 5 years after surgery
5 years after surgery
3-year disease free survival (DFS)
Time Frame: 3 years after surgery
The disease-free survival rate 3 years after surgery
3 years after surgery
3-year overall survival (OS)
Time Frame: 3 years after surgery
The overall survival rate 3 years after surgery
3 years after surgery
Intraoperative blood loss
Time Frame: During the surgery
Total blood loss during the surgery
During the surgery
Conversion rate
Time Frame: During the surgery
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
Time Frame: The day of surgery, 2/4/8/12/26/52 weeks after surgery
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
Time Frame: 30/90 days after surgery
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
Time Frame: Between the date of surgery and the date of discharge, assessed up to 30 days
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
Time Frame: Daily after surgery for up to 7 days and at weeks 2/4/8/12/26/52 after discharge
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
Time Frame: Postoperative in-hospital stay up to 30 days
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
Time Frame: During the surgery
The total time from skin to skin and the time of each step
During the surgery
The numbers of circulating tumor cell (CTC)/circulating tumor DNA (ctDNA) before and after operation
Time Frame: During the surgery
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
Time Frame: Postoperative in-hospital stay up to 30 days
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
Time Frame: From the date of admission to the date of discharge, assessed up to 30 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Collaborators

The First Affiliated Hospital with Nanjing Medical University
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
RenJi Hospital
West China Hospital
The Affiliated Hospital of Qingdao University
Shandong Provincial Hospital
Tianjin Medical University Cancer Institute and Hospital
Jiangsu Cancer Institute & Hospital
Gansu Provincial Hospital
Sixth Affiliated Hospital, Sun Yat-sen University
Wuhan Union Hospital, China
First Affiliated Hospital of Jinan University
Fujian Medical University Union Hospital
First People's Hospital of Foshan
Tang-Du Hospital
Dongguan People's Hospital
Shanghai Changzheng Hospital
Wuhan TongJi Hospital
The Affiliated Hospital of Xuzhou Medical University
Fujian Provincial Hospital
Sichuan Cancer Hospital and Research Institute
Tianjin Chest Hospital
The General Hospital of Eastern Theater Command
Suining Central Hospital
First Affiliated Hospital of Kunming Medical University

Investigators

  • Principal Investigator: Hao-Xian Yang, M.D., Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 16, 2023

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

July 8, 2024

First Submitted That Met QC Criteria

August 27, 2024

First Posted (Actual)

August 29, 2024

Study Record Updates

Last Update Posted (Actual)

May 16, 2025

Last Update Submitted That Met QC Criteria

May 13, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SL-B2022-443
  • ChiCTR2300068586 (Registry Identifier: Chinese Clinical Trial Registry)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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