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:

• Patient must be ≥18 years of age.
• Patient must have an ECOG/Zubrod performance status of ≤ 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.
• 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.
• 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.
• 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.
• 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.
• If patient is a survivor of a prior cancer, the following criteria are met:

• Patient has undergone potentially curative therapy for all prior malignancies,
• 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),
• Patient is deemed by their treating physician to be at low risk for recurrence from prior malignancies.

Intra-operative:

• 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.
• 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.
• 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:

• Patient has N2 disease determined at pre-operative mediastinoscopy or on sampling.
• Patient has T3 or T4 tumor.
• Patient is having only a wedge resection performed for treatment.
• Patient has received prior chemotherapy or radiotherapy for this cancer.