drugset / Trial / NCT03906448

FORWARD Optune and Adjuvant TMZ in Grade II/III Astrocytoma

NCT03906448 ↗

Phase 2 Terminated 1 enrolled University of Florida NovoCure Ltd. · collab
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

EvaluationDrugModalityDoseRoute
Subject Temozolomide Small molecule — —