Radiation Therapy in Preventing Central Nervous System (CNS) Metastases in Patients With Non-Small Cell Lung Cancer

OBJECTIVES:

- Determine whether prophylactic cranial irradiation improves survival after effective
locoregional/systemic therapy in patients with stage IIIA or IIIB non-small cell lung
cancer.

- Determine the neuropsychologic impact of this therapy in these patients.

- Assess quality of life of patients receiving this therapy.

- Determine the impact of this therapy on the incidence of CNS metastases in these
patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
disease stage (IIIA vs IIIB), histology (non-squamous cell vs squamous cell), and prior
surgery (yes vs no). Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients undergo prophylactic cranial irradiation 5 days a week for 3 weeks.

- Arm II: Patients undergo observation.

Patients are followed 3 months during the first year, every 6 months for 2-3 years and then
annually thereafter. Quality of life is assessed at baseline and at months 6, 12, 24, 36, and
48.

PROJECTED ACCRUAL: A total of 1,058 patients (529 per treatment arm) will be accrued for this
study within 36 months.

DISEASE CHARACTERISTICS:

- Diagnosis of stage IIIA or IIIB non-small cell lung cancer

- Complete response, partial response, or stable disease after definitive
locoregional therapy (with surgery and/or radiation therapy, with or without
chemotherapy (chemotherapy alone does not constitute definitive therapy))

- No more than 16 weeks since prior therapy

- No progressive disease

- No extracranial distant metastatic disease

- No suspicion of CNS metastases by MRI or CT scan

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- Not specified

Life expectancy

- Not specified

Hematopoietic

- Not specified

Hepatic

- Not specified

Renal

- Not specified

Other

- No other malignancy within the past 3 years except nonmelanoma skin cancer

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No concurrent anticancer biologic therapy

Chemotherapy

- See Disease Characteristics

- No concurrent anticancer cytotoxic chemotherapy

Endocrine therapy

- Not specified

Radiotherapy

- See Disease Characteristics

- No prior cranial irradiation

Surgery

- See Disease Characteristics

Other

- Recovered from all prior therapies

- No concurrent enrollment on any other phase III study that has progression-free,
disease-free, or overall survival as an endpoint