Randomized Trial of Mediastinal Lymph Node Sampling Versus Complete Lymphadenectomy During Pulmonary Resection in the Patient With N0 and N1 (Less Than Hilar) Non-Small Cell Carcinoma

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Biopsy proven or suspected, clinically resectable stage I or II (T1 or T2, N0 or
non-hilar N1, M0) non-small cell carcinoma of the lung (NSCLC)

- Squamous cell carcinoma, adenocarcinoma, or large cell carcinoma

- If tissue diagnosis not established preoperatively, must be established
intraoperatively prior to registration/randomization

- If preoperative mediastinoscopy has been performed, hilar lymph nodes must be
certified to be less than 1 cm in the short axis diameter by preoperative CT scan,
and no N2 disease found at mediastinoscopy

- If preoperative mediastinoscopy has not been performed, all lymph nodes in the hilum
and mediastinum must measure less than 1 cm in the short axis diameter on
preoperative CT scan

- Candidate for complete resection via pneumonectomy, bilobectomy, lobectomy, or
anatomic segmentectomy with or without sleeve resection

- Planned wedge resection only not eligible

- All sampled nodes must be negative by frozen section assessment

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-2 OR

- Zubrod 0-2

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- Not specified

Renal:

- Not specified

Other:

- Medically fit for surgery

- No prior malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer or carcinoma in situ of the cervix, and deemed to be at low
risk for recurrence from prior curatively treated malignancies

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior chemotherapy for NSCLC

Endocrine therapy:

- Not specified

Radiotherapy:

- No prior radiotherapy for NSCLC

Surgery:

- See Disease Characteristics