Spots Global Cancer Trial Database for Stereotactic Radiosurgery Compared to Observation in Treating Patients With Brain Metastases

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Trial Identification

Brief Title: Stereotactic Radiosurgery Compared to Observation in Treating Patients With Brain Metastases

Official Title: Efficacy of Post-Surgical Stereotactic Radiosurgery for Metastatic Brain Disease: A Randomized Trial

Study ID: NCT00950001

Conditions

Metastatic Malignant Neoplasm in the Brain

Interventions

Stereotactic Radiosurgery

Study Description

Brief Summary: This randomized phase III trial studies stereotactic radiosurgery to see how well it works compared to clinical observation after surgery in treating patients with brain metastases. Stereotactic radiosurgery, a type of radiation therapy, may be able to send x-rays directly to the tumor and cause less damage to normal tissue.

Detailed Description: PRIMARY OBJECTIVES: I. To evaluate benefit of post-surgical stereotactic radiosurgery (SRS) on the resection bed in providing 6 month local control (decreasing the risk of local tumor recurrence) when compared to surgical resection alone. SECONDARY OBJECTIVES: I. Overall survival, development of distant brain metastases and complications related to treatment. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients undergo stereotactic radiosurgery to the surgical cavity within 30 days of the craniotomy. ARM II: Patients undergo clinical observation after craniotomy. After completion of study treatment, patients are followed up at 5-8 weeks, every 6-9 weeks for 1 year, every 3-4 months for 1 year, and then every 6 months thereafter.