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Active, Not Recruiting

NCT Number: NCT06577792

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Non Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Lobectomy-First

Procedure

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

Lymphadenectomy-First

Procedure

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

Primary outcomes

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

    Time frame: 5 years after surgery

    The disease-free survival rate 5 years after surgery

Secondary outcomes

  1. 5-year overall survival (OS)

    Time frame: 5 years after surgery

    The overall survival rate 5 years after surgery

  2. 3-year disease free survival (DFS)

    Time frame: 3 years after surgery

    The disease-free survival rate 3 years after surgery

  3. 3-year overall survival (OS)

    Time frame: 3 years after surgery

    The overall survival rate 3 years after surgery

  4. Intraoperative blood loss

    Time frame: During the surgery

    Total blood loss during the surgery

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. Operative time

    Time frame: During the surgery

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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Collaborators

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

Registry information

Official study 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

Acronym: LOFTY

Important dates

Study start
2023
Primary completion
2031
Study completion
2031
First posted
Aug 29, 2024
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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