NCT01705548

Hypofractionated Stereotactic Radiosurgery in Treating Patients With Large Brain Metastasis

Phase I Dose Escalation Trial of Hypofractionated Radiosurgery for Large Brain Metastasis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies the side effects and best dose of hypofractionated radiosurgery in treating patients with large brain metastasis. Stereotactic radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue. Giving fractionated stereotactic radiosurgery may kill more tumor cells.

Detailed description

PRIMARY OBJECTIVE: To demonstrate the safety and feasibility of treating brain metastases or resection cavities greater than 3 cm with hypofractionated radiosurgery and to determine the maximum-tolerated radiation dose for hypofractionated radiosurgery (HR) delivered in 5 fractions, 2-3 fractions per week. OUTLINE: This is a dose-escalation study. Patients undergo hypofractionated stereotactic radiosurgery 2-3 times weekly (5 fractions total) for 2-3 weeks. After completion of study treatment, patients are followed up at 1 month and then every 3 months thereafter.

Conditions

• Metastatic Malignant Neoplasm to Brain
• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
RADIATION	Hypofractionated Radiosurgery	Radiation Therapy will consist of partial brain irradiation delivered to the metastatic brain tumor or resection cavity, delivered in 5 treatments with 2-3 treatments delivered per week.

Timeline

• Start date: 2012-09-24
• Primary completion: 2023-04-11
• Completion: 2023-09-18
• First posted: 2012-10-12
• Last updated: 2024-01-30

Locations

2 sites across 1 country: United States