Trial Information

A Randomized, Phase III Dose Response Study of Prophylactic Cranial Irradiation (PCI) for Small Cell Carcinoma of the Lung

OBJECTIVES: I. Compare the efficacy of low dose versus high dose prophylactic cranial
irradiation in preventing brain metastases in patients with small cell carcinoma of the
lung. II. Determine the neuropsychiatric status of these patients before and after
treatment.

OUTLINE: This is a randomized, multicenter study. The right or left hemisphere of each
patient's brain are randomized to one of two treatment arms. All patients receive whole
brain radiotherapy 5 days a week over 2.5 weeks for a total of 12 fractions. Arm I: Patients
receive radiotherapy to the left cerebral hemisphere daily for 6 days immediately following
completion of whole brain radiotherapy. Arm II: Patients receive radiotherapy to the right
cerebral hemisphere daily for 6 days immediately following completion of whole brain
radiotherapy. Patients with extensive disease may also receive thoracic radiotherapy, if not
administered previously. Patients are followed at 1, 3, 6, 9, and 12 months, and then every
6 months thereafter.

PROJECTED ACCRUAL: Approximately 16-40 patients will be accrued for this study within 1-4
years.