Station 4L Lymph Node Dissection Versus No Dissection in Clinical Stage I Solid Nodule-Type Invasive NSCLC
A Multicenter Prospective Randomized Controlled Trial of Station 4L Lymph Node Dissection Versus No Dissection in Clinical Stage I Solid Nodule-Type Invasive Non-Small Cell Lung Cancer
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Xuhui
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Shanghai, Xuhui, China, 200000
- Recruiting
- Fudan University Shanghai Cancer Center
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Contact:
- Yang Zhang, MD
- Phone Number: 86-18717722753
- Email: 16301050173@fudan.edu.cn
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Station 4L Lymph Node Dissection
Participants undergo complete lung resection and systematic mediastinal lymph node dissection, including surgical dissection of station 4L lymph nodes.
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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.
|
|
No Intervention: No Station 4L Lymph Node Dissection
Participants undergo complete lung resection and systematic mediastinal lymph node dissection, but station 4L lymph nodes are not surgically removed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
3-Year Disease-Free Survival
Time Frame: 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.
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From enrollment to 3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
3-Year Overall Survival
Time Frame: From enrollment to 3 years
|
Proportion of participants alive 3 years after enrollment.
Death from any cause is counted as an event.
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From enrollment to 3 years
|
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30-Day Surgery-Related Complication Rate
Time Frame: From surgery through postoperative day 30
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Proportion of participants with at least one surgery-related complication, graded according to Common Terminology Criteria for Adverse Events version 3.0.
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From surgery through postoperative day 30
|
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90-Day All-Cause Mortality
Time Frame: From surgery through postoperative day 90
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Proportion of participants who die from any cause within 90 days after surgery.
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From surgery through postoperative day 90
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Station 4L Lymph Node Metastasis Rate
Time Frame: 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.
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At postoperative pathological assessment, up to 30 days after surgery
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Haiquan Chen, Fudan University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ECTOP-1034
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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