Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04474353 | Study of Tumor Treating Fields With Hypofractionated Chemoradiotherapy in Newly Diagnosed Glioblastoma | PHASE1 | COMPLETED | 12 | — | — | May 21, 2021 | Sep 2, 2025 | Dec 26, 2025 | 1 | United States |
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.
| Arm | Type | Description |
|---|---|---|
| Novo-TTF | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| Optune | DEVICE | Noninvasive, portable device which generates tumor treating fields (TTFields) manufactured by Novocure |
| Gadolinium | DRUG | Gadolinium contrast medium |
| Temozolomide | DRUG | Chemotherapy agent |
| Stereotactic radiosurgery (SRS) | RADIATION | Standard of Care: SRS (35 Gy in 5 fractions of 7 Gy), 5-day treatment from Day 2 |
Inclusion Criteria: * Histopathologically proven newly diagnosed glioblastoma (GBM, WHO Grade IV) or molecular GBM of lower grade that will be treated as per glioblastoma (defined as IDH wild type, 1p19q not co deleted) * Age ≥ 18 years * A maximum tumor target diameter of less than 5 cm on the pos...