NCT00006259

Stereotactic Radiation Therapy in Treating Patients With Brain Metastases

A Phase II Trial of Radiosurgery Alone for Brain Metastases in Elderly Patients or Patients With Poor Performance Status

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Stereotactic radiation therapy may be able to deliver x-rays directly to the tumor and cause less damage to normal tissue. PURPOSE: Phase II trial to study the effectiveness of stereotactic radiation therapy in treating patients who have brain metastases.

Detailed description

OBJECTIVES: I. Determine the efficacy of stereotactic radiosurgery without whole brain radiotherapy in elderly patients or patients with poor performance status who have brain metastases. II. Determine the neurologic function in these patients after receiving this treatment regimen. III. Determine the quality of life in these patients with this treatment regimen. OUTLINE: Patients undergo stereotactic head frame placement, followed by stereotactic radiosurgery using Gamma Knife, on day 1. Quality of life is assessed one week prior to and one week after treatment, and then at 2, 4, 6, 8, 10, and 12 months. Patients are followed at one week, at 2, 4, 6, 8, 10, and 12 months, every 4 months for one year, and then every 6 months for 3 years. PROJECTED ACCRUAL: Approximately 52 patients will be accrued for this study within 2 years.

Conditions

• Metastatic Cancer

Interventions

Type	Name	Description
RADIATION	stereotactic radiosurgery	Patients undergo stereotactic head frame placement, followed by stereotactic radiosurgery using Gamma Knife, on day 1.

Timeline

• Start date: 2000-01-01
• Primary completion: 2001-11-01
• Completion: 2005-02-01
• First posted: 2004-03-08
• Last updated: 2020-07-27

Locations

1 site across 1 country: United States