A Phase II Trial of Radiosurgery Alone for Brain Metastases in Elderly Patients or Patients With Poor Performance Status
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.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Study the effectiveness of stereotactic radiation therapy in treating patients who have brain metastases.
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.
No
Donald C. Shina, MD
Study Chair
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
United States: Federal Government
CWRU3399
NCT00006259
January 2000
February 2005
Name | Location |
---|---|
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |