Non Small Cell Lung Cancer
Conditions
Keywords
Non-small cell lung cancer, Lobectomy, Lymphadenectomy
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.
Interventions
PROCEDURELobectomy-First
During the surgical treatment for patients with NSCLC, thoracic surgeons should perform lobectomy first, and then perform lymphadenectomy next.
PROCEDURELymphadenectomy-First
During the surgical treatment for patients with NSCLC, thoracic surgeons should perform lymphadenectomy first, and then perform lobectomy next.
Sponsors
Sun Yat-sen University
Tianjin Medical University Cancer Institute and Hospital
RenJi Hospital
Sixth Affiliated Hospital, Sun Yat-sen University
First Affiliated Hospital of Jinan University
The First Affiliated Hospital with Nanjing Medical University
Shanghai Changzheng Hospital
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Suining Central Hospital
The Affiliated Hospital of Xuzhou Medical University
The General Hospital of Eastern Theater Command
Fujian Medical University Union Hospital
First Affiliated Hospital of Kunming Medical University
Fujian Provincial Hospital
Tianjin Chest Hospital
Sichuan Cancer Hospital and Research Institute
Tang-Du Hospital
Shandong Provincial Hospital
Gansu Provincial Hospital
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan TongJi Hospital
The Affiliated Hospital of Qingdao University
West China Hospital
Jiangsu Cancer Institute & Hospital
Dongguan People's Hospital
First People's Hospital of Foshan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 5-year disease-free survival (DFS) | 5 years after surgery | The disease-free survival rate 5 years after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 5-year overall survival (OS) | 5 years after surgery | The overall survival rate 5 years after surgery |
| 3-year disease free survival (DFS) | 3 years after surgery | The disease-free survival rate 3 years after surgery |
| 3-year overall survival (OS) | 3 years after surgery | The overall survival rate 3 years after surgery |
| Intraoperative blood loss | During the surgery | Total blood loss during the surgery |
| Conversion rate | During the surgery | The number of cases converted to thoracotomy in a group divided by the total number of included cases in this group |
| Perioperative complications rate | 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 |
| Operative death rate | 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 |
| Postoperative hospital stays | 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 |
| Postoperative pain score | 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 |
| R0 rate | 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 |
| Operative time | During the surgery | The total time from skin to skin and the time of each step |
| Chest tube duration | Postoperative in-hospital stay up to 30 days | The number of days between the date of surgery and the date of chest tube removal |
| The numbers of circulating tumor cell (CTC)/circulating tumor DNA (ctDNA) before and after operation | 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 |
| Acesodyne (Grade III) dose | Postoperative in-hospital stay up to 30 days | The total amount of morphine used by the patient during the postoperative hospital period |
| Total cost of hospitalization | 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 |
| The number of resected lymph nodes | Postoperative in-hospital stay up to 30 days | The number of resected lymph nodes were calculated according to the official pathological report after surgery |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORHao-Xian Yang, M.D.
Sun Yat-Sen University Cancer Center
Outcome results
None listed