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Comparison of Different Types of Surgery in Treating Patients with Stage IA Non-small Cell Lung Cancer
Trial Status: closed to accrual and intervention
This randomized phase III trial is studying different types of surgery to compare how well they work in treating patients with stage IA non-small cell lung cancer. Wedge resection or segmentectomy may be less invasive types of surgery than lobectomy for non-small cell lung cancer and may have fewer side effects and improve recovery. It is not yet known whether wedge resection or segmentectomy are more effective than lobectomy in treating stage IA non-small cell lung cancer.
Inclusion Criteria
Peripheral lung nodule =< 2 cm on preoperative CT scan and presumed to be lung cancer; the center of the tumor, as seen on CT, must be located in the outer third of the lung in either the transverse, coronal or sagittal plane; patients with pure ground glass opacities or pathologically confirmed N1 or N2 disease are not eligible
The tumor location must be suitable for either lobar or sublobar resection (wedge or segment)
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
No prior malignancy within 3 years other than non-melanoma skin cancer, superficial bladder cancer, or carcinoma in situ (CIS) of the cervix
No prior chemotherapy or radiotherapy for this malignancy
No evidence of locally advanced or metastatic disease
Histologic confirmation of NSCLC (if not already obtained)
Confirmation of N0 status by frozen section examination; right sided tumors require that node levels 4, 7, and 10 be sampled and diagnosed as negative on frozen section; left sided tumors require that node levels 5 or 6, 7 and 10 be sampled and diagnosed as negative on frozen section; 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 VATS exploration; nodes previously sampled by mediastinoscopy (or EBUS and/or EUS) either immediately prior to or within 6 weeks of the definitive surgical procedure (thoracotomy or VATS) do not need to be resampled
Additional locations may be listed on ClinicalTrials.gov for NCT00499330.
American Fork Hospital / Huntsman Intermountain Cancer Center
Status: Active
Contact: David Reed Goff
Phone: 801-387-7426
Washington
Tacoma
MultiCare Tacoma General Hospital
Status: Temporarily closed to accrual
Contact: John A. Keech
Phone: 253-403-2394
PRIMARY OBJECTIVES:
I. To determine whether disease-free survival (DFS) after sublobar resection (segmentectomy or wedge) is non-inferior to that after lobectomy in patients with small peripheral (=< 2 cm) non-small cell lung cancer (NSCLC).
SECONDARY OBJECTIVES:
I. To determine whether overall survival (OS) (after sublobar resection) is non-inferior to that after lobectomy.
II. To determine the rates of loco-regional and systemic recurrence (exclusive of second primaries) after lobar and sublobar resection.
III. To determine the difference between the two arms of the study in pulmonary function as determined by expiratory flow rates measured at 6 months post-operatively.
IV. To explore the relationship between characteristics of the primary lung cancer, as revealed by pre-operative computed tomography (CT) and positron emission tomography (PET) imaging, and outcomes.
V. Determine the false-negative rate of preoperative PET scan for identification of involved hilar and mediastinal lymph nodes.
VI. Assess the utility of annual follow-up CT imaging after surgical resection of small stage IA NSCLC.
OUTLINE: 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.
Trial PhasePhase III
Trial Typetreatment
Lead OrganizationAlliance for Clinical Trials in Oncology
