Jcog0504: A Phase Iii Randomized Trial Of Surgery With Whole Brain Radiation Therapy Versus Surgery With Salvage Stereotactic Radiosurgery In Patients With 1 To 4 Brain Metastases.

2003Background: Whether salvage stereotactic radiosurgery (SRS) alone is effective for patients with brain metastases (BM) is not yet clarified, although clinical benefits such as better preservation of cognitive function and a shorter treatment period are reported with SRS compared to whole-brain radiation therapy (WBRT). We conducted a non-inferiority, randomized study of the effectiveness of salvage SRS for residual and recurrent tumors after surgical resection in comparison to tumor resection plus WBRT. Methods: Patients between 20-79 years with ECOG performance status (PS) 0-3 and ≤4 BM with only one lesion ≥3 cm in diameter having been surgically resected were eligible. Within 21 days after surgery, patients were randomized to WBRT or salvage SRS for residual and recurrent tumors. The primary end point was overall survival (OS) and the secondary end points were intracranial progression-free survival (IC-PFS), adverse events, and proportion of non-worsening in PS and Mini Mental Status Examination (M...