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

Sun Yat-sen University620 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

620

Conditions

Non Small Cell Lung Cancer

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (26)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

RECRUITING

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

RECRUITING

Fujian Provincial Hospital

Fuzhou, Fujian, China

RECRUITING

Gansu Provincial Hospital

Lanzhou, Gansu, China

Outcomes

Primary Outcomes

5-year disease-free survival (DFS)

The disease-free survival rate 5 years after surgery

Time frame: 5 years after surgery

Secondary Outcomes

5-year overall survival (OS)

The overall survival rate 5 years after surgery

Time frame: 5 years after surgery

3-year disease free survival (DFS)

The disease-free survival rate 3 years after surgery

Time frame: 3 years after surgery

3-year overall survival (OS)

The overall survival rate 3 years after surgery

Time frame: 3 years after surgery

Intraoperative blood loss

Total blood loss during the surgery

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 30/90 days after surgery

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

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

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

Operative time

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

Time frame: During the surgery

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

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

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

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

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

Central Contacts

Hao-Xian Yang, M.D.

CONTACT

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

Mu-Zi Yang, M.D.

CONTACT

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