EF-32 TRIDENT

• Research type

  Research Study

• Full title

  EF-32 (TRIDENT): A PIVOTAL RANDOMIZED, OPEN-LABEL STUDY OF OPTUNE® (TTFIELDS, 200KHZ) CONCOMITANT WITH RADIATION THERAPY AND TEMOZOLOMIDE FOR THE TREATMENT OF NEWLY DIAGNOSED GLIOBLASTOMA

• IRAS ID

  306338

• Contact name

  Andrew Brodbelt

• Contact email

  abrodbelt@doctors.org.uk

• Sponsor organisation

  Novocure GmbH

• Clinicaltrials.gov Identifier

  NCT04471844

• Duration of Study in the UK

  5 years, 0 months, 1 days

• Research summary

  This study describes a randomised open-label trial using a device called Optune® concomitant with radiation therapy and temozolomide for the treatment of newly diagnosed glioblastoma multiforme (brain cancer). Optune® is a commercial portable, battery-operated device intended for continuous home use, which delivers TTFields at a frequency of 200 kHz to the brain by means of insulated transducer arrays. The Optune® device produces electric forces intended to disrupt cancer cell division and it is intended to be used continuously for at least 18 hours per day on a monthly average.

  Optune® has been approved for the treatment of recurrent and newly diagnosed glioblastoma (GBM) by the Food and Drug Administration (FDA) in the United States and has obtained a CE mark in Europe for the same indications.
  Given the recent accumulated pre-clinical and clinical evidence, all strongly suggest that there is an advantage in starting TTFields treatment for newly diagnosed GBM patients as early as possible. Unlike in the currently approved indication, this study will start TTFields treatment concomitantly with RT and TMZ chemotherapy. Pre-clinical data have demonstrated additional benefits to start TTFields concurrently with RT and TMZ on tumor cells. Furthermore, recent pilot clinical studies also suggest that concomitant TTFields application with RT and TMZ chemotherapy is safe and feasible.

  950 people worldwide with newly diagnosed glioblastoma aged 18 and older, who are planned to have chemoradiotherapy and adjutant chemotherapy (Stupp protocol) after surgery, will participate in this study. It is proposed that at least 35 of these people will be in England. The study is expected to last for 72 months.

• REC name

  South East Scotland REC 01

• REC reference

  22/SS/0074

• Date of REC Opinion

  27 Oct 2022

• REC opinion

  Further Information Favourable Opinion