The purpose of this study is to determine the safety and efficacy of the combination therapy of TTFields + SRS+ Temozolomide (TMZ) for newly diagnosed glioblastoma (GBM).
Primary Objective: Determine the safety of Tumor Treating Fields (TTFields) started concurrently with 5 fraction stereotactic radiosurgery (SRS) and temozolomide for newly diagnosed glioblastoma. secondary objective: Efficacy for the combination of TTFields started concurrently with 5
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Noninvasive, portable device which generates tumor treating fields (TTFields) manufactured by Novocure
Gadolinium contrast medium
Chemotherapy agent
Stanford University
Stanford, California, United States
Dose-limiting Toxicity (DLTs)
Dose limiting toxicities (DLTs) are defined as possibly, probably, or definitely related adverse events that are severe or medically significant, and needing topical \& systemic therapy; needing surgery intervention; needing hospitalization; needing treatment interruption; or life threatening. Late DLTs will be assessed as the number of DLTs that occur in the period from 31 days after the start of treatment through 5 months after the start of treatment. The outcome will be reported as a number without dispersion.
Time frame: 5 months
Acute dose limiting toxicity
Dose limiting toxicities (DLTs) are defined as possibly, probably, or definitely related adverse events that are severe or medically significant, and needing topical \& systemic therapy; needing surgery intervention; needing hospitalization; needing treatment interruption; or life threatening. Acute DLTs will be assessed as the number of DLTs that occur in the period from the start of treatment through 30 days after the start of treatment. The outcome will be reported as a number without dispersion.
Time frame: 1 month
Progression-free Survival (PFS) at 6 Months
Progression-free survival is defined as the number of evaluable participants who, at 6 months from the date of surgical resection or biopsy (PFS6), are alive without disease progression, death, or other defined event (study withdrawal or loss to follow up). Disease progression is defined as ≥ 25% increase in product of perpendicular diameters of the lesion; any increase in MRI T2/FLAIR lesion area from previous MRI scan; MRI detection of a new lesion; decline in clinical status not attributable to causes other than the tumor. The outcome will be reported as the number without dispersion.
Time frame: 6 months
Overall Survival (OS)
Overall survival (OS) will be assessed as the number of evaluable participants who remain alive from the date of surgical resection or biopsy. The outcome will be reported as the number without dispersion.
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Standard of Care: SRS (35 Gy in 5 fractions of 7 Gy), 5-day treatment from Day 2
Time frame: 30 months