Surgical Versus Non-surgical Staging of Lung Cancer
Lung Cancer
About this trial
This is an interventional other trial for Lung Cancer focused on measuring Lung cancer, Lung neoplasm, Pulmonary cancer, Pulmonary neoplasm, Lung cancer staging
Eligibility Criteria
Inclusion Criteria:
- Require either surgical or minimally invasive evaluation (EUS/EBUS) of the mediastinum
- Are medically fit to undergo surgery
- Possess known or suspected non-small cell carcinoma of the lung
- Have had PET/CT scan within 45 days of randomization
- Are eligible for complete mediastinal lymph node dissection at surgery if clinically indicated (determined at surgery)
Exclusion Criteria:
- Pathologically documented metastatic disease
- History of malignancy within 5 years other than (skin) basal cell carcinoma
- Bulky mediastinal lymphadenopathy defined as lymph node > 2.0 cm in short axis diameter or contralateral adenopathy or direct invasion mediastinum or great vessels (T4 disease) or have a malignant pleural effusion.
- Peripheral T1 tumors with radiographically normal mediastinum on PET/CT.
Sites / Locations
- Mayo Clinic
- Mayo Clinic
- Medical University of South Carolina
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
EUS/EBUS with FNA
Surgical Mediastinoscopy
EUS/EBUS staging will be performed to evaluate for the presence of mediastinal adenopathy. Each lymph node will be characterized according to published criteria. Staging will follow the TNM system of the AJCC. If present and accessible, at least one lymph node from each accessible station will be aspirated with a separate fine needle using routine FNA and cytological techniques. If multiple lymph nodes are present in a single station, the largest lymph node from that location will be sampled. Patients with cytologically proven mediastinal lymph node metastases (N2 or 3), or those with mediastinal invasion of tumor (T4), will be treated according to standard clinical practice (typically chemotherapy and/or radiotherapy). All complications, morbidity, length of stay attributed to the staging procedures will be recorded at 30 days, or at the time of surgery, whichever is first. All patients will will subsequently undergo surgical resection and complete mediastinal lymph node dissection.
Within two months following CT scan, surgical mediastinoscopy will be performed to evaluate for the presence of mediastinal adenopathy. Each lymph node will be characterized according to published criteria. Staging will follow the TNM system of the AJCC. Patients with cytologically proven mediastinal lymph node metastases (N2 or 3), or those with mediastinal invasion of tumor (T4), will be treated according to standard clinical practice (typically chemotherapy and/or radiotherapy). All complications, morbidity, length of stay attributed to the diagnostic method (medical or surgical) used for staging will be recorded at 30 days, or at the time of surgery, whichever is first. All patients will will subsequently undergo surgical resection and complete mediastinal lymph node dissection.