UAMS - Translational Research Institute

Eligibility

Eligible Ages

Over 18 Years

Eligible Genders

All

Accepts Healthy Volunteers

No

Criteria

Pre-registration Eligibility Criteria:

1. 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.

2. The tumor location must be suitable for either lobar or sublobar resection (wedge or
segment).

3. ECOG performance status of 0-2.

4. No prior malignancy within 3 years other than non-melanoma skin cancer, superficial
bladder cancer, or CIS of the cervix.

5. No prior chemotherapy or radiation therapy for this malignancy.

6. No evidence of locally advanced or metastatic disease.

7. Age ≥ 18 years

Intra-operative Randomization Eligibility Criteria:

1. Histologic confirmation of NSCLC (if not already obtained)

2. 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.