Non-small Cell Lung Cancer
Conditions
Interventions
Lymphadenectomy-First Group:Intraoperative mediastinal lymphadenectomy followed by lobectomy
Lobectomy-First Group:Intraoperative lobectomy followed by mediastinal lymphadenectomy
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Inclusion criteria
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 =40 % and DLCO>=40 %; 3) total bilirubin = 60ml/min; 5. Performance status of 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
Exclusion criteria: 1. Patients with radiotherapy, chemotherapy, targeted therapy, or immunotherapy before surgery; 2. Patients with the previous history of other malignancies or with secondary primary cancer when enrolled; 3. Patients who meet all of the following criteria are eligible for sublober resection (segmentectomy/wedge resection): 1) Mixed GGO whose solid part <= 50%; 2) Maximum diameter of tumor <= 2cm; 3) Nodule locates in the outer third of lung field; 4. Patients diagnosed as pure ground glass opacity (GGO) before surgery; 5. Patients with prior unilateral open thoracic surgical procedures; 6. Woman who is pregnant or breastfeeding; 7. Patients with an active bacterial or fungal infection that is difficult to control; 8. Patients with serious psychosis; 9. Patients with a history of severe heart attack, heart failure, myocardial infarction, or angina within the last 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 5-year disease free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| 5-year overall survival;3-year disease free survival;3-year overall survival;Intraoperative blood loss;Conversion rate;Perioperative complications;Operative death rate;Postoperative hospital stay;Postoperative pain score;R0 resection rate;Operative time;The number of resected mediastinal lymph node;Chest tube duration;The numbers of CTC before and after operation;Acesodyne (Grade III) dose;Cost; | — |
Countries
China
Contacts
Public ContactHao-Xian Yang
Sun Yat-sen University Cancer Center
Outcome results
None listed