Dose Escalation for Larger Brain Metastases: Phase I/II Study
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)
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
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
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum-tolerated dose based on the incidence of dose-limiting toxicity (DLT) defined as any grade III or IV toxicity as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase I)
Up to 4 months
Samuel Chao, MD
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
United States: Federal Government
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center||Cleveland, Ohio 44195|