This feasibility study will assess the effects of the Nativis Voyager therapy in patients newly diagnosed with GBM. The study will enroll and treat up to 32 subjects and will be combined with standard of care radiotherapy and temozolomide.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
37
Nativis Voyager treatment combined with standard of care radiotherapy and temozolomide
Center for Neurosciences
Tucson, Arizona, United States
California Cancer Care Associates
Encinitas, California, United States
John Wayne Cancer Institute @ Providence St Johns Health Center
Santa Monica, California, United States
Associated Neurologists of Southern CT, PC
Fairfield, Connecticut, United States
Treatment-related Adverse Events (Safety)
Safety as measured by number of investigational treatment-related adverse events as assessed by CTCAE v4.0.
Time frame: Through study completion, average of 1 year
Clinical Utility PFS
Progression Free Survival
Time frame: 6 months
Clinical Utility OS
Overall Survival
Time frame: Through patient completion, expected average 8 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Boca Raton Regional Hospital
Boca Raton, Florida, United States
Cancer Care Collaborative
Austin, Texas, United States
Baylor Scott and White Health
Temple, Texas, United States