UNASSIGNED: 1507 Background: Whole brain radiation therapy (WBRT) is considered standard therapy for @entity1 (pts.) w/ brain metastasis. Long term survivors are at risk for CNS morbidity, and the value of low doses of WBRT in radioresistant @entity5 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 @entity1358 , @entity320 , or @entity242 , w/ 1-3 brain @entity3 , ECOG performance status (PS) of 0-2, and no previous cranial @entity138 were enrolled. Exclusion criteria were: leptomeningeal disease; @entity3 in medulla, pons, or midbrain; multiple liver @entity3 . Based on @entity5 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 by entry criteria; 28/32 were male and the median number of lesions was 1. ECOG PS was: 44% PS 0; 34% @entity13769 ; 19% @entity13770 . With median F/U of 25 mo., @entity1349 ( @entity1349 ) was 8.3 mo. (95% CI 6.8-13.7); 22/ 32 pts. died, 7/22 (32%) from CNS @entity204 ; 3% had PR, 34% had stable disease, 41% had @entity1726 , and 13% were unevaluable (scans not performed). Three and 6 month in-field failures were 28 and 45% (includes simultaneous failures in-field and outside field), and failure rates outside the radiosurgery volume at 3 and 6 months were 4 and 17%. There were 3 >=  grade 3 CNS @entity137 , possibly related to RS. CONCLUSIONS: In this study, @entity1349 was equivalent to published surgical and concurrent RS +WBRT series and better than WBRT alone. Failures outside RS field were low and treatment was well tolerated. Response rates and failures w/ in the RS volume were higher than historic controls. Delaying WBRT may be appropriate for some subgroups of @entity1 w/ radioresistant @entity5 , but failures beyond 6 mo. have not been addressed yet. Based on these results, a phase III randomized study evaluating the RS alone in some subsets of @entity1 is warranted. No significant financial relationships to disclose.

Phase II trial of radiosurgery (RS) for 1 to 3 newly diagnosed brain @entity3 from renal cell, @entity320 , and XXXX : An Eastern Cooperative Oncology Group Study (E6397).

@entity1 :: ('9606', 'Species') :: ['patients'] @entity13770 :: ('338412', 'Gene') :: ['PS 2'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicities'] @entity242 :: ('MESH:D012509', 'Disease') :: ['sarcoma'] @entity138 :: ('MESH:C563738', 'Disease') :: ['RT'] @entity5 :: ('MESH:D009369', 'Disease') :: ['tumor', 'tumors'] @entity1726 :: ('OMIM:168600', 'Disease') :: ['PD'] @entity1358 :: ('MESH:D002292', 'Disease') :: ['renal cell carcinoma'] @entity13769 :: ('338399', 'Gene') :: ['PS 1'] @entity3 :: ('MESH:D009362', 'Disease') :: ['metastases'] @entity204 :: ('MESH:D003643', 'Disease') :: ['death'] @entity320 :: ('MESH:D008545', 'Disease') :: ['melanoma'] @entity1349 :: ('MESH:D011475', 'Disease') :: ['median survival', 'MS']
@entity242 :: (MESH:D012509,Disease) :: ['sarcoma']
