• Survival with a WHO performance status 0-2 as measured by Logrank at 8 weeks after completion of study treatment, and then every 3 months until death [ Designated as safety issue: No ]
  

• Overall survival as measured by Logrank at 8 weeks after completion of study treatment, and then every 3 months until death [ Designated as safety issue: No ]
  
• Progression-free survival as measured by Logrank 8 weeks after completion of study treatment, and then every 3 months until death [ Designated as safety issue: No ]
  
• Time to neurological progression as measured by Logrank 8 weeks after completion of study treatment, and then every 3 months until death [ Designated as safety issue: No ]
  
• Acute toxicity as measured by EORTC and RTOG scale 8 weeks after completion of study treatment, and then every 3 months until death [ Designated as safety issue: Yes ]
  
• Late toxicity as measured by Subjective, Objective, Management and Analytic/Late Effects on Normal Tissues (SOMA/LENT) scale 8 weeks after completion of study treatment, and then every 3 months until death [ Designated as safety issue: Yes ]
  
• Quality of life as measured by QLQ-C30 and BN-25 8 weeks after completion of study treatment, and then every 3 months until death [ Designated as safety issue: No ]
  

OBJECTIVES:

Primary

• Investigate the efficacy and toxicity of adjuvant whole brain radiotherapy after prior surgical resection or radiosurgery of 1 to 3 brain metastases from solid tumor in patients with good performance status and controlled systemic cancer.

Secondary

• Determine overall survival and progression-free survival of patients treated on this protocol.
• Determine time to neurologic progression in patients treated on this protocol.
• Determine quality of life of patients treated on this protocol.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by participating center, number of brain metastases (single vs multiple), type of primary tumor (stable systemic cancer vs synchronous or unknown primary), WHO performance status (0-1 vs 2), and treatment (prior surgical resection vs planned radiosurgery).

Patients who have undergone complete surgical resection are randomized to 1 of 2 treatment arms within 4 weeks after surgery.

• Arm I: Patients undergo adjuvant whole brain radiotherapy (WBRT).
• Arm II: Patients do not receive adjuvant radiotherapy. Patients planning to undergo radiosurgery are randomized to 1 of 2 treatment arms.
• Arm III: Patients undergo radiosurgery followed by adjuvant WBRT within 4 weeks after surgery.
• Arm IV: Patients undergo radiosurgery alone. Quality of life is assessed at baseline, at 8 weeks, and then every 3 months thereafter.

After completion if study treatment, patients are followed at 8 weeks and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 340 patients (85 per treatment arm) will be accrued for this study within 3.5 years.