NCT01843413

Stereotactic Radiosurgery in Treating Patients With Large Brain Metastases

Dose Escalation for Larger Brain Metastases: Phase I/II Study

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I/II trial studies the side effects and the best dose of stereotactic radiosurgery and to see how well it works in treating patients with large brain metastases. Radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue.

Detailed description

PRIMARY OBJECTIVES: I. To determine the incidence of acute and long-term toxicities with increasing dose of stereotactic radiosurgery (SRS). (Phase I) II. To determine if local control may be improved with increasing doses of SRS. (Phase II) SECONDARY OBJECTIVES: I. To determine the risk of acute and long-term toxicity with increasing dose of SRS. (Phase II) II. To determine if there is increased neurocognitive toxicity with increased dose of SRS. III. To determine the rate of radiation necrosis/steroid dependency. IV. To determine if quality of life is affected more by tumor recurrence versus radiation necrosis. This includes assessment of progression free survival, overall survival, local failure, and number of patients who receive bevacizumab, laser interstitial thermal therapy, or surgery for presumed radiation necrosis. OUTLINE: This is a phase I dose-escalation study followed by a phase II study. Patients undergo SRS guided by computer tomography (CT) and magnetic resonance imaging (MRI). After completion of treatment, patients are followed up at 1-2, 3, 6, 9, and 12 months, every 3 months for 2 years, and then every 4 months thereafter.

Conditions

• Tumors Metastatic to Brain
• Unspecified Adult Solid Tumor

Interventions

Type	Name	Description
RADIATION	stereotactic radiosurgery	Undergo SRS
PROCEDURE	quality-of-life assessment	Ancillary studies
PROCEDURE	cognitive assessment	Ancillary studies

Timeline

• Start date: 2013-07-02
• Primary completion: 2025-08-01
• Completion: 2025-08-01
• First posted: 2013-04-30
• Last updated: 2025-07-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study