A Phase 1 interventional study of Optune and Gadolinium in Glioblastoma and Newly Diagnosed Glioblastoma, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-26.
Sponsored by Stanford University · Phase 1, Interventional, and Treatment
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
1,920 studies on the registry are indexed under Glioblastoma; 450 are open to participants now.
This study's enrollment of 12 is below the median of 36 across 1,618 interventional studies indexed under Glioblastoma.
Browse Glioblastoma studies →Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adequate organ function (obtained within 14 days prior to Day 0) as evidenced by:
Exclusion Criteria:
Subjects with the following co morbid disease or incurrent illness:
Subjects receiving the following medications at the time of combined TTFields and SRS:
Day 1: Subjects will wear the Optune (TTFields device) for ≥ 18 hours/day. They will take off the device when receiving stereotactic radiosurgery and brain MRI scans. Days 1 to 8: Subjects will take oral temozolomide 75 mg/m2/day Days 2 to 8: Subjects will receive stereotactic radiosurgery (total of 35 Gy) divided equally over 5 days • After the interventional treatment, subjects will receive standard of care adjuvant chemotherapy and routine surveillance brain MRI scans.
Device: Optune · Drug: Gadolinium · Drug: Temozolomide · Radiation: Stereotactic radiosurgery (SRS)
Noninvasive, portable device which generates tumor treating fields (TTFields) manufactured by Novocure
Gadolinium contrast medium
Also known as: Contrast agent
Chemotherapy agent
Standard of Care: SRS (35 Gy in 5 fractions of 7 Gy), 5-day treatment from Day 2
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.
Time frame: 30 months
Plan to share: No
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This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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