Comparison of Different Types of Surgery in Treating Patients With Stage IA Non-Small Cell Lung Cancer
Trial status: Open for Enrollment
Why is this study being done?
- Compare the disease-free survival of patients with small (≤ 2 cm) peripheral stage IA non-small cell lung cancer undergoing lobectomy vs sublobar resection (wedge resection or segmentectomy).
- Compare the overall survival of patients undergoing lobectomy vs sublobar resection.
- Compare the rates of loco-regional and systemic recurrence in patients undergoing lobectomy vs sublobar resection.
- Compare the pulmonary function of these patients, as measured by expiratory flow rates at 6 months postoperatively.
- Explore the relationship between characteristics of the primary lung cancer, as revealed by pre-operative CT scan and positron emission tomography (PET) imaging, and outcomes.
- Determine the false-negative rate of preoperative PET scan for identification of involved hilar and mediastinal lymph nodes.
- Assess the utility of annual follow-up CT scan after surgical resection in these patients.
OUTLINE: This is a multicenter, randomized study. Patients are stratified according to tumor size (< 1 cm vs 1-1.5 cm vs > 1.5-2.0 cm) (based on the maximum dimension determined from the preoperative scan), histology (squamous cell carcinoma vs adenocarcinoma vs other), and smoking status (never smoked [smoked < 100 cigarettes over lifetime] vs former smoker [smoked > 100 cigarettes AND quit ≥ 1 year ago] vs current smoker [quit < 1 year ago or currently smokes]). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo lobectomy by open thoracotomy or video-assisted thoracoscopic surgery (VATS).
- Arm II: Patients undergo a wedge resection or anatomical segmentectomy by open thoracotomy or VATS.
After completion of study treatment, patients are followed up every 6 months for 2 years and then annually for 5 years.
Who is eligible to participate?
- Suspected or proven non-small cell lung cancer (NSCLC), meeting both preoperative and intraoperative criteria:
- Preoperative criteria
- Peripheral lung nodule ≤ 2 cm by CT scan
- Center of the tumor must be located in the outer third of the lung in either the transverse, coronal, or sagittal plan
- Tumor location must be suitable for either lobar or sublobar resection (wedge resection or segmentectomy)
- No pure ground opacities or pathologically confirmed N1 or N2 disease
- Intraoperative criteria
- Histologically confirmed NSCLC
- Confirmation of N0 status by frozen section examination of nodal levels 4, 7, and 10 on the right side and 5, 6, 7, and 10 on the left side*
- Levels 4 and 7 nodes may be sampled by mediastinoscopy, endobronchial ultrasound (EBUS), and/or endoscopic ultrasound (EUS), or at the time of thoracotomy or video-assisted thoracoscopic surgery (VATS) exploration* NOTE: *Nodes previously sampled by mediastinoscopy (or EBUS and/or EUS) either immediately before or within 6 weeks of the definitive surgical procedure (thoracotomy or VATS) do not need to be resampled
- No evidence of locally advanced or metastatic disease
- ECOG performance status 0-2
- No other malignancy within the past 3 years except for nonmelanoma skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy or radiotherapy for this malignancy