NCT06577792Active, not recruitingNot Applicable
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
Sun Yat-sen University26 sites in 1 country620 target enrollmentStarted: August 16, 2023Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 620
- Locations
- 26
- Primary Endpoint
- 5-year disease-free survival (DFS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Lobectomy-First group
Other
Patients with operable NSCLC received lobectomy first then received lymphadenectomy for surgical treatment.
Intervention: Lobectomy-First (Procedure)
Lymphadenectomy-First group
Other
Patients with operable NSCLC received lymphadenectomy first then received lobectomy for surgical treatment.
Intervention: Lymphadenectomy-First (Procedure)
Outcomes
Primary Outcomes
5-year disease-free survival (DFS)
Time Frame: 5 years after surgery
The disease-free survival rate 5 years after surgery
Secondary Outcomes
- Intraoperative blood loss(During the surgery)
- Operative death rate(30/90 days after surgery)
- Acesodyne (Grade III) dose(Postoperative in-hospital stay up to 30 days)
- 3-year overall survival (OS)(3 years after surgery)
- Perioperative complications rate(The day of surgery, 2/4/8/12/26/52 weeks after surgery)
- R0 rate(Postoperative in-hospital stay up to 30 days)
- 5-year overall survival (OS)(5 years after surgery)
- 3-year disease free survival (DFS)(3 years after surgery)
- Conversion rate(During the surgery)
- Postoperative hospital stays(Between the date of surgery and the date of discharge, assessed up to 30 days)
- Postoperative pain score(Daily after surgery for up to 7 days and at weeks 2/4/8/12/26/52 after discharge)
- Operative time(During the surgery)
- Chest tube duration(Postoperative in-hospital stay up to 30 days)
- Total cost of hospitalization(From the date of admission to the date of discharge, assessed up to 30 days)
- The number of resected lymph nodes(Postoperative in-hospital stay up to 30 days)
- The numbers of circulating tumor cell (CTC)/circulating tumor DNA (ctDNA) before and after operation(During the surgery)
Investigators
Hao-Xian Yang
Principal Investigator
Sun Yat-sen University
Study Sites (26)
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