11513 Background: Metastatic brain tumors (MBT) are the most frequent complication of systemic cancer. With conventional radiotherapy, survival remains poor, ranging from 24 to 32 weeks. Recent randomized trials suggest that surgical resection and irradiation of solitary MBT can extend survival and improve neurological quality of life. However, the role of chemotherapy remains unclear. A phase I/II trial demonstrated that interstitial chemotherapy with BCNU-impregnated wafers was well tolerated in this cohort, with an extended median survival and infrequent local recurrences. METHODS A randomized, multicenter phase III trial was begun to evaluate the ability of BCNU-impregnated wafers to improve survival and local time to progression in comparison to surgical resection and irradiation alone, with an expected accrual of 170 patients. Eligible patients were adults with systemic cancer of the lung or breast, with a solitary, accessible MBT that did not cross the midline or violate the ventricular system. RESULTS A total of 22 patients (female - 14; 20 with lung cancer), median age 60 years (range 39-77), were enrolled and randomized before the study was closed due to slow accrual. Each patient had undergone maximal surgical resection of the MBT and radiation therapy (35 Gy); wafers were placed in 12 patients (range 2-8 wafers). The median overall survival for the wafer and non-wafer groups were 35.0 and 47.4 weeks, respectively (log rank test, p = 0.54), with a 6-month survival rate of 67% and 56%, respectively (Fishers exact test, p = 0.67). Wafer placement was well tolerated. CONCLUSIONS In this small cohort limited by slow accrual, the use of BCNU-impregnated wafers did not improve survival over surgical resection and irradiation alone. The wafers were well tolerated and did not adversely impact on quality of life. Although animal studies and phase I/II data are suggestive of activity, a large, multicenter, phase III comparative trial will be necessary to determine the efficacy of BCNU-impregnated wafers in patients with solitary, resectable MBT. [Table: see text].