drugset / Trial / NCT03906448
FORWARD Optune and Adjuvant TMZ in Grade II/III Astrocytoma
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This is a phase 2, multi-institutional, historically-controlled, study of 100 patients with newly diagnosed Grade II and III astrocytoma comparing the combination of TTFields with adjuvant temozolomide versus temozolomide alone in historical controls after the completion of definitive chemoradiotherapy. Study treatment may continue past first tumor recurrence. The primary endpoint will be overall survival.
Timeline
- Start
- 2019-05-20
- Primary completion
- 2020-06-08
- Completion
- 2020-06-08
Outcome
Outcome not reported
Stopped: “The study was terminated because the Study Chair/IDE Sponsor and Novocure determined that conducting this trial was not feasible without CMS approval.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Temozolomide | Small molecule | — | — |