Phase II trial of radiosurgery (RS) for 1 to 3 newly diagnosed brain metastases from renal cell, melanoma, and sarcoma: An Eastern Cooperative Oncology Group Study (E6397)

1507 Background: Whole brain radiation therapy (WBRT) is considered standard therapy for patients (pts.) w/ brain metastasis. Long term survivors are at risk for CNS morbidity, and the value of low doses of WBRT in radioresistant tumors is suspect. RS emerged as a treatment modality, and retrospective analyses found no difference in survival when RS is given up front. Prior to evaluating RS w/ delayed WBRT in a Phase III trial, the feasibility of RS alone was prospectively tested in this phase II trial. Methods: Pts. w/ histologically confirmed renal cell carcinoma, melanoma, or sarcoma, w/ 1–3 brain metastases, ECOG performance status (PS) of 0–2, and no previous cranial RT were enrolled. Exclusion criteria were: leptomeningeal disease; metastases in medulla, pons, or midbrain; multiple liver metastases. Based on tumor size, pts. received 24, 18, or 15 Gy RS dose. At recurrence, treatment was at the discretion of treating physicians. Results: Between 7/98 and 8/03, 36 pts. accrued; to date, 32 eligible b...