Comparison of Different Types of Surgery in Treating Patients With Stage IA Non-Small Cell Lung Cancer

Location:

Rochester, Minn.

Trial status:

Open for Enrollment

Why is this study being done?

OBJECTIVES:

     Primary

       -  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).

     Secondary

       -  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?

DISEASE CHARACTERISTICS:

         -  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

       PATIENT CHARACTERISTICS:

         -  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

Last updated:

2/15/2013

NCT ID:

NCT00499330

IRB Number:

07-005522