NCT00950001

Stereotactic Radiosurgery Compared to Observation in Treating Patients With Brain Metastases

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 132 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 4 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Malignant Neoplasm in the Brain

Interventions

Type	Name	Description
RADIATION	Stereotactic Radiosurgery	Undergo SRS

Timeline

• Start date: 2009-08-13
• Primary completion: 2027-04-30
• Completion: 2027-04-30
• First posted: 2009-07-31
• Last updated: 2026-02-20

Locations

1 site across 1 country: United States