Table 1.
Completed clinical trials using tumor treating fields (TTF) for glioblastoma (GBM), published 1.
| Trial Name | Patient Cohort | Number of Patients | Study Design | Intervention | Endpoints | Toxicity | Ref. |
|---|---|---|---|---|---|---|---|
| EF-11 (NCT00379470) | GBM, progressed on prior therapy | 237 | Prospective, randomized (1:1) Phase III | Standard: best available CHT alone; Experimental: TTF alone (20–24 h/d) | Median OS 6.6 vs. 6.0 months (primary endpoint); 1-y OS 20% vs. 20%; 6-month PFS 21.4% vs. 15.1% (NS) | Severe adverse events 6% vs. 16% (p = 0.022). TTF-related adverse events were mild (14%) to moderate (2%) skin rash. | [12] |
| EF-14 (NCT00916409) | Newly diagnosed GBM after completion of concurrent TMZ and RT. | 695 | Prospective, randomized (2:1) Phase III | Standard: Maintenance TMZ (150–200 mg/m2/d for 5 days every 28 days for 6–12 cycles); Experimental: Maintenance TMZ with TTF (>18 h/d) | Median PFS 20.9 months vs. 16.0 months (p < 0.001) | Grade 1–2 skin toxicity 52% vs. 0%. | [6] |
1 Abbreviations: GBM: glioblastoma multiforme, CHT: chemotherapy, TMZ: temozolomide, TTF: tumor treating fields, OS: overall survival, PFS: progression-free survival.