Lymph Node Removal in Treating Patients With Stage I or Stage II Non-small Cell Lung Cancer

OBJECTIVES:

- Compare whether a complete mediastinal lymph node dissection versus mediastinal lymph
node sampling improves overall survival of patients with N0 or non-hilar N1 non-small
cell lung cancer undergoing resection.

- Compare these two methods with reference to identification of occult mediastinal lymph
node involvement.

- Compare the effect of these two methods on operative time and duration of postoperative
complications, including chest tube drainage and length of hospitalization for these
patients.

- Compare the effect of these two methods on local recurrence free survival and local
regional recurrence free survival of these patients.

Inclusion Criteria:

A patient will be eligible for inclusion in this study only if ALL of the following
criteria apply:

Pre-operative:

1. Patient must be ≥18 years of age.

2. Patient must have an ECOG/Zubrod performance status of ≤ 3.

3. Patient must have tissue diagnosis of a clinically resectable T1 or T2, N0 or
non-hilar N1, M0 NSCLC (squamous cell carcinoma, large cell carcinoma or
adenocarcinoma including bronchoalveolar carcinoma) established prior to
randomization. NOTE: A patient without a pre-operative tissue diagnosis, but with
clinically suspected NSCLC that fits the above criteria is eligible provided the
tissue diagnosis is confirmed intraoperatively.

4. Patient must have pre-operative imaging procedure, CT scan of the chest and upper
abdomen to include liver and adrenal glands to determine eligibility, within 60 days
of the date of the pulmonary resection.

5. Patient that has not had a mediastinoscopy should have no mediastinal adenopathy on
the CT of the chest defined as no lymph node > 1 cm in the shortest axis.

6. Patient is a candidate for a complete resection of the carcinoma via
pneumonectomy,lobectomy, bilobectomy, or anatomic segmentectomy with or without
sleeve resection,as noted in the surgical plan.

7. Patient, or patient's legally acceptable representative, must provide a signed and
dated Z0030-specific written informed consent prior to registration and any
study-related procedures.

8. If patient is a survivor of a prior cancer, the following criteria are met:

1. Patient has undergone potentially curative therapy for all prior malignancies,

2. No evidence of any prior malignancies for at least 5 years with no evidence of
recurrence (except for effectively treated basal cell or squamous carcinoma of
the skin, carcinoma in-situ of the cervix that has been effectively treated by
surgery alone, or lobular carcinoma in-situ of the ipsilateral or contralateral
breast treated by surgery alone),

3. Patient is deemed by their treating physician to be at low risk for recurrence
from prior malignancies.

Intra-operative:

1. Patient with right-sided lesions must have at least nodal stations #2R, 4R, 7 and 10
R examined. If the nodes are found, they must be sampled and proven negative by
frozen section.

2. Patient with left-sided lesions must have at least nodal stations #5, 6, 7 and 10L
examined. If the nodes are found, they must be sampled and proven negative by frozen
section.

3. Any other suspicious mediastinal or hilar nodes must be sampled and proven negative
by frozen section. Levels 2, 4 and 7 need not be re-sampled if they were sampled at a
mediastinoscopy done within 60 days of thehoracotomy.

Exclusion Criteria:

A patient will NOT be eligible for inclusion in this study if ANY of the following
criteria apply:

1. Patient has N2 disease determined at pre-operative mediastinoscopy or on sampling.

2. Patient has T3 or T4 tumor.

3. Patient is having only a wedge resection performed for treatment.

4. Patient has received prior chemotherapy or radiotherapy for this cancer.