• Event-free survival [ Designated as safety issue: No ]
  
• Operability after chemotherapy [ Designated as safety issue: No ]
  

• Postoperative mortality assessed 30 days after surgery [ Designated as safety issue: No ]
  
• Toxicity [ Designated as safety issue: Yes ]
  
• Complete resection rate after surgery [ Designated as safety issue: No ]
  
• Objective response rate measured after completion of chemoradiotherapy [ Designated as safety issue: No ]
  

OBJECTIVES:

• Compare the feasibility and efficacy of neoadjuvant chemotherapy with or without radiotherapy, in terms of event-free survival, in patients with stage IIIA non-small cell lung cancer with mediastinal lymph node metastases.
• Determine the value of positron emission tomography scans for predicting pathological response and event-free survival in patients treated with these regimens.
• Compare the toxicity of these regimens in these patients.
• Compare the objective response rate, failure pattern, and overall survival in patients treated with these regimens.
• Compare the amount of serum DNA of patients treated with these regimens.
• Correlate the DNA variation with tumor response, remission duration, and overall survival.
• Evaluate specific serum DNA markers (i.e., beta-tubulin-, p53-, ras-mutation, DAP kinase-, CDKN2 hypermethylation present in the primary tumors) for predictivity.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to mediastinal bulk (5 cm or more vs less than 5 cm), weight loss in the past 6 months (5% or more vs less than 5%), and participating center. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive docetaxel IV over 1 hour followed by cisplatin IV over 1 hour on day 1. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Three weeks after the last chemotherapy administration, patients undergo radiotherapy once daily 5 days a week for 3 weeks and boost radiotherapy on days 2, 5, 9, 12, 15, 17, and 19 during the same 3 weeks.
• Arm II: Patients receive chemotherapy as in arm I. All patients undergo surgical resection and mediastinal lymph node dissection within 21-28 days after completion of radiotherapy (arm I) or within 21 days after completion of chemotherapy (arm II).

All patients undergo blood collection periodically for translational research studies.

Patients are followed at 1 month and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 120 patients (60 per treatment arm) will be accrued for this study within 4 years.

DISEASE CHARACTERISTICS:

• Histologically confirmed non-small cell lung cancer

  • Squamous, adenosquamous, large cell, or poorly differentiated

• Stage IIIA (T1-3, N2, M0)

  • N2 disease confirmed by 1 of the following:

    • Mediastinoscopy

    • Bronchoscopy with fine-needle aspiration or esophagoscopy

      • All N3 lymph nodes must be negative by positron-emission tomography (PET) AND CT scan (< 1 cm in the largest diameter)

    • PET scan

      • Both the primary tumor and at least 1 N2 lymph node must be positive in PET scan
      • At least 1 of the PET scan positive N2 lymph nodes is positive in the CT scan (> 1 cm in the largest diameter)
      • All N3 lymph nodes negative in PET scan

PATIENT CHARACTERISTICS:

Age:

• 18 to 75

Performance status:

• WHO 0-1

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 4,000/mm^3
• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin normal
• AST/ALT no greater than 1.5 times upper limit of normal (ULN)
• Alkaline phosphatase no greater than 2.5 times ULN

Renal:

• Creatinine clearance greater than 60 mL/min

Cardiovascular:

• Cardiac function normal
• No unstable cardiac disease requiring treatment
• No congestive heart failure
• No angina pectoris even if medically controlled
• No significant arrhythmia
• No myocardial infarction in the past 3 months

Pulmonary:

• Lung function appropriate

Neurologic:

• No history of significant neurologic or psychiatric disorders
• No psychotic disorders
• No dementia
• No seizures

Other:

• No other prior or concurrent malignancies except nonmelanoma skin cancer, adequately treated carcinoma in situ of the cervix, or any other neoplastic disease with a disease-free interval ≥ 5 years
• No active uncontrolled infection
• No uncontrolled diabetes mellitus
• No gastric ulcers
• No pre-existing peripheral neuropathy greater than grade 1
• No contraindications to corticosteroids
• No other serious underlying medical condition that would preclude study participation
• No socioeconomic or geographic condition that would preclude study participation
• Not pregnant or nursing
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior cytostatic chemotherapy

Endocrine therapy:

• No concurrent prednisone except for treatment of acute hypersensitivity reactions or chronic low-dose treatment initiated more than 6 months prior to study entry (i.e., no greater than 20 mg methylprednisolone or equivalent)

Radiotherapy:

• No prior radiotherapy to chest

Surgery:

• Not specified

Other:

• At least 30 days since participation in another clinical study
• No other concurrent experimental drugs