The TRIDENT trial (also known as the “EF-32 trial”) is a randomized, controlled study, testing the safety and efficacy of Tumor Treating Fields (TTFields) from the Optune® System [About TTFields] together with radiation therapy and temozolomide in newly diagnosed glioblastoma (GBM) patients.

Patients in the study will use Optune as well as the other standard of care treatments for GBM.  The trial is expected to enroll 950 patients. Enrollment is open in multiple centers in the US, Canada, Japan, and across Europe [TRIDENT Centers].

 

The TRIDENT Trial Design

This trial is for newly diagnosed GBM patients who, after surgery or biopsy, are good candidates for radiation therapy (RT) and temozolomide (TMZ) treatments.

Final eligibility can only be determined by a clinical trial physician in one of the clinical trial sites.

All patients will be randomly assigned to one of two groups:

  • The Experimental Group: TTFields using the Optune system upfront with RT and TMZ followed by the use of Optune and TMZ
  • The Control Group: Beginning treatment of RT and TMZ, followed by the use of Optune and TMZ

Each patient will have equal chance of entering each of the two groups as determined by a “randomization process” [FAQ].

Patients will continue on TTFields for 24 months, a notable disease progression, or clinically unable to continue treatment.

Experimental Group

Patients assigned to the the Experimental Group will receive continuous TTFields treatment using Optune from the beginning of study treatment with RT and TMZfor 6 week.  Then the patient will continue treatment with Optune and TMZ for six courses, and Optune will continue until second progression.

Control Group                     

Patients assigned to the Control Group (Control) will receive standard dosing of approved therapies, RT and TMZ, according to best practice of the treating trial physician.  After 6 weeks of RT and TMZ, the patient will then begin treatment with Optune and TMZ for six courses, and continue Optune until second progression.

By participating in the study, all participants are assisting researchers in providing additional information and data used to assess the efficacy of TTFields, with the goal to assist future patients with this disease.

Using the Optune System

To receive treatment, the patient needs to wear four adhesive patches called “transducer arrays,” applied directly to their scalp [About TTFields]. Transducer array placement requires the shaving of the entire scalp before starting to use the device, and twice a week as long as the patient continues to use Optune.

The use of the device will start in an outpatient setting and will include training on the operation of the equipment by a qualified Novocure Device Support Specialist (DSS). Patients will continue to use the device at home [Living with TTFields].

Once trained, patients using Optune can setup and use the device themselves (with the help of a family member or a caregiver if needed) or receive support from Novocure.

Eligibility            

Inclusion Criteria*

  1. Histologically confirmed diagnosis of GBM according to WHO classification criteria
  2. Age ≥ 22 years in US and Age ≥ 18 years in Ex-US
  3. Recovered from maximal debulking surgery, if applicable (gross total resection, partial resection, and biopsy-only patients are all acceptable)
  4. Planned treatment with RT/TMZ followed by TTFields and maintenance TMZ (150-200 mg/m2 daily x 5 d, q28 days)
  5. Karnofsky performance status ≥ 70
  6. Life expectancy ≥ least 3 months

Exclusion Criteria* 

  1. Progressive disease (per investigator’s assessment)
  2. Infratentorial or leptomeningeal disease
  3. Participation in another clinical treatment study during the pre-treatment and/or the treatment phase of the study
  4. Pregnancy or breast-feeding
  5. Significant co-morbidities at baseline which would preclude maintenance RT or TMZ treatment, as determined by the investigator
  6. Implanted pacemaker, defibrillator, deep brain stimulator, other implanted electronic devices in the brain, or documented clinically significant arrhythmias

 

*For the complete list of eligibility criteria please go to clinicaltrials.gov or consult with a TRIDENT trial physician [TRIDENT Centers]

Enrollment

Expected total enrollment is 950 patients. The trial is active in  multiple European and North American medical centers.  Please contact one of the participating centers if you would like to participate in the TRIDENT trial [TRIDENT CENTERS].