Brain Irradiation in Treating Patients With Limited-Stage Small Cell Lung Cancer

OBJECTIVES:

• Compare the incidence of chronic neurotoxicity in patients treated with these regimens.
• Compare quality of life of patients treated with these regimens. (phase III closed to accrual as of 12/31/05)

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (60 and under vs over 60) and time since induction therapy (90 days or less vs 91-180 days vs 181-240 days). Patients are randomized to 1 of 3 treatment arms.

• Arm I: Patients undergo prophylactic cranial irradiation (PCI) once daily 5 days a week. Treatment continues for 2 weeks in the absence of unacceptable toxicity.
• Arm II: Patients undergo PCI once daily 5 days a week. Treatment continues for 2.6 weeks in the absence of unacceptable toxicity.
• Arm III: Patients undergo PCI twice daily 5 days a week. Treatment continues for 3.4 weeks in the absence of unacceptable toxicity.

Quality of life is assessed at baseline, every 6 months for 1 year, and then annually for 3 years.

Patients are followed every 6 months for 1 year and then annually for 3 years.

PROJECTED ACCRUAL: A total of 264 patients will be accrued for this study within 3.5 years.

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed small cell lung cancer by fine needle aspiration, biopsy, or 2 positive sputa

• Limited stage (I-IIIB)

• Confined to 1 hemithorax
• No T4 based on malignant pleural effusion, or N3 disease based on contralateral hilar or contralateral supraclavicular involvement
• Complete response after induction chemotherapy (with or without thoracic radiotherapy)
• Consolidative chest radiotherapy may be initiated before study
• No radiographic evidence of any of the following:

• Brain metastases

• Normal brain CT scan or MRI less than 1 month before study
• Ipsilateral lung metastases
• Malignant pleural effusion

• Minimal pleural effusion by chest CT scan allowed, but not by chest x-ray

PATIENT CHARACTERISTICS:

Age

• Not specified

Performance status

• Zubrod 0-1

Life expectancy

• Not specified

Hematopoietic

• Absolute granulocyte count at least 1,500/mm^3
• Platelet count at least 75,000/mm^3
• Hemoglobin at least 10.0 g/dL^

Hepatic

• Not specified

Renal

• Not specified

Pulmonary

• See Disease Characteristics

Other

• Not pregnant or nursing
• Fertile patients must use effective contraception
• Neurological function class 1 or 2
• No epilepsy requiring permanent oral medication
• No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
• No other serious medical or psychiatric condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• See Disease Characteristics
• At least 1 week since prior chemotherapy
• No concurrent chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• See Disease Characteristics
• No prior external beam radiotherapy to the head or neck, including stereotactic radiotherapy
• Concurrent thoracic radiotherapy allowed

Surgery

• Not specified

Other

• No concurrent antitumor agents