SUNDANCE Trial: Phase II Trial of Sunitinib as Maintenance Therapy After Stereotactic Radiosurgery in Patients With 1-3 Newly Diagnosed Brain Metastases
- Determine the CNS progression-free survival rate in patients with 1-3 newly diagnosed
brain metastases treated with sunitinib malate after stereotactic radiosurgery (SRS).
- Determine the rate of local (site of SRS treatment) failure at 12 months in these
- Determine the median time to CNS disease progression in these patients.
- Determine the overall survival of these patients.
- Determine the time to progression of systemic disease in these patients.
- Evaluate the safety of sunitinib malate when administered after SRS in these patients.
- Assess the neurocognitive effects of SRS followed by sunitinib malate in these
OUTLINE: Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat
every 42 days in the absence of disease progression or unacceptable toxicity.
Patients undergo neuropsychological battery testing at baseline and periodically during
study to assess cognitive function (memory, verbal fluency, visual-motor speed, executive
function, and motor dexterity), activities of daily living, and quality of life.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
CNS progression-free survival rate
defined as the time from stereotactic radiosurgery until disease progression or death due to any cause (all-cause mortality).
6 months after radiosurgery
David M. Peereboom, MD
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
United States: Food and Drug Administration
|Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center||Cleveland, Ohio 44106-5065|
|Henry Ford Health System||Detroit, Michigan 48202|
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center||Cleveland, Ohio 44195|