Non-Small Cell Lung Cancer
Conditions
Keywords
Left Lower Paratracheal Lymph Node Dissection, Mediastinal Lymph Node Dissection, Solid Pulmonary Nodule, Noninferiority Trial
Brief summary
This multicenter, prospective, randomized clinical trial will enroll adults aged 18 to 75 years with resectable clinical stage I (T1-T2aN0M0) invasive non-small cell lung cancer presenting as a single solid nodule (consolidation-to-tumor ratio 1.0) in the left lung. After intraoperative frozen-section confirmation of invasive non-small cell lung cancer and completion of standard lung resection and systematic mediastinal lymph node dissection, participants will be randomly assigned 1:1 either to undergo station 4L lymph node dissection or to omit station 4L dissection. The primary hypothesis is that omitting station 4L dissection is noninferior to performing it with respect to 3-year disease-free survival. Secondary outcomes include 3-year overall survival, perioperative complications, 90-day mortality, and station 4L nodal metastasis.
Detailed description
Station 4L lymph nodes are located in a technically challenging area near the aortic arch, left pulmonary artery, thoracic duct, and left recurrent laryngeal nerve. Dissection may improve nodal staging but may also increase operative complexity and complications. This study will evaluate whether station 4L dissection can be omitted without compromising long-term outcomes in patients with early-stage left-sided invasive non-small cell lung cancer. Eligible participants will undergo complete resection by segmentectomy or lobectomy and systematic mediastinal lymph node dissection. After intraoperative frozen-section confirmation of invasive non-small cell lung cancer, participants will be randomized in a 1:1 ratio to station 4L lymph node dissection or no station 4L dissection. Randomization is stratified by tumor lobe. The planned enrollment is 384 participants, including 258 with left upper lobe tumors and 126 with left lower lobe tumors. Participants will be followed every 6 months for 3 years after surgery. The primary comparison is 3-year disease-free survival. Secondary assessments include 3-year overall survival, surgery-related complications within 30 days, all-cause mortality within 90 days, and the frequency of station 4L nodal metastasis among participants assigned to station 4L dissection.
Interventions
PROCEDUREStation 4L Lymph Node Dissection
During complete lung resection and systematic mediastinal lymph node dissection, all lymphatic and fatty tissue in the station 4L region is surgically removed and submitted for pathological examination. Other mediastinal stations are dissected according to the study protocol in both arms.
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 to 75 years. * A single solid pulmonary nodule (consolidation-to-tumor ratio of 1.0) located in the left lung. * Resectable clinical stage I (T1-T2aN0M0) non-small cell lung cancer, with a maximum tumor diameter of 4 cm or less, evaluated by positron emission tomography/computed tomography. * Planned complete lung resection by segmentectomy or lobectomy with systematic mediastinal lymph node dissection. * Intraoperative frozen-section pathological confirmation of invasive non-small cell lung cancer before randomization. * Able to provide written informed consent and willing to complete the protocol-specified follow-up.
Exclusion criteria
* Intraoperative or postoperative pathology indicates noninvasive non-small cell lung cancer. * Surgical procedure other than segmentectomy or lobectomy. * Incomplete tumor resection or residual tumor. * History of another malignant tumor. * History of previous lung surgery. * Previous radiotherapy or chemotherapy for the current lung cancer.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3-Year Disease-Free Survival | From enrollment to 3 years | Proportion of participants alive without disease recurrence. A disease-free survival event is the first documented recurrence of non-small cell lung cancer or death from any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 3-Year Overall Survival | From enrollment to 3 years | Proportion of participants alive 3 years after enrollment. Death from any cause is counted as an event. |
| 30-Day Surgery-Related Complication Rate | From surgery through postoperative day 30 | Proportion of participants with at least one surgery-related complication, graded according to Common Terminology Criteria for Adverse Events version 3.0. |
| 90-Day All-Cause Mortality | From surgery through postoperative day 90 | Proportion of participants who die from any cause within 90 days after surgery. |
| Station 4L Lymph Node Metastasis Rate | At postoperative pathological assessment, up to 30 days after surgery | Among participants assigned to station 4L lymph node dissection, the proportion with pathologically confirmed metastasis in resected station 4L lymph nodes. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORHaiquan Chen
Fudan University
Outcome results
None listed