Combination Chemotherapy, Surgery, and Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer

OBJECTIVES:

• Determine the complete resection rate and toxic death rate of patients with locally advanced non-small cell lung cancer treated with paclitaxel, carboplatin, and radiotherapy followed by surgical resection and adjuvant paclitaxel and carboplatin.
• Determine the survival, event-free survival, and incidence of pathologic complete remission of patients treated with this regimen.
• Determine the protocol completion rate (CR) of patients treated with this regimen.
• Determine the feasibility and toxicity of this regimen in these patients.
• Determine the pathologic response rate/downstaging, pathologic near CR rate, freedom from distant metastasis rate, and freedom from local regional failure rate of patients treated with this regimen.

OUTLINE: Patients receive induction therapy comprising radiotherapy 5 days a week for 5.5-6 weeks and paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 1, 8, 15, 22, 29, and 36.

Within 1-3 weeks after completion of induction therapy, patients undergo restaging. Patients with resectable disease undergo surgical resection within 4-8 weeks after induction therapy. Patients with unresectable disease undergo additional radiotherapy 5 days a week for 3 weeks and receive paclitaxel and carboplatin as in induction therapy on days 1, 8, and 15.

Within 4-12 weeks after surgery or additional chemoradiotherapy, patients receive adjuvant therapy comprising paclitaxel and carboplatin as in induction therapy on day 1. Adjuvant treatment repeats every 4 weeks for 3 courses.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: Approximately 57 patients will be accrued for this study within 4 years.

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed, newly diagnosed, unilateral primary non-small cell lung cancer (NSCLC)

• Must have involvement of the superior sulcus, chest wall, or mediastinum
• Must have at least 1 of the following:

• Locally advanced Pancoast tumors with no documented mediastinal or supraclavicular nodal involvement (T3-T4, N0-1)
• Resectable chest wall disease (T3, N0-1)
• Marginally resectable T4, N0-1, or NX central NSCLC
• N2 patients who are potentially resectable after induction chemoradiotherapy
• No evidence of extrathoracic spread to liver, adrenals, brain, or bone
• No evidence of supraclavicular nodes, malignant pleural or pericardial effusions, or distant metastases

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Karnofsky 70-100%

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count at least 2,000/mm^3
• Platelet count at least 100,000/mm^3

Hepatic

• Bilirubin no greater than 1.5 mg/dL
• SGOT no greater than 3 times upper limit of normal

Renal

• Creatinine no greater than 2.0 mg/dL

Cardiovascular

• No superior vena cava syndrome
• No myocardial infarction within the past 6 months
• No active uncontrolled congestive heart failure
• No active uncontrolled arrhythmia within the past 6 months

Pulmonary

• FEV1 at least 800 mL

Other

• No other active invasive malignancy requiring therapy within the past 2 years
• No ongoing need for adjuvant therapy
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for at least 3 months after study entry

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• No prior pelvic or thoracic radiotherapy

Surgery

• See Disease Characteristics

Other

• Concurrent beta blockers, digitalis derivatives, or channel-blocking agents allowed provided cardiac conditions are stable