Trial details

Trial short name: Trident EF-32

Official 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

Principal Investigator: Dr. Jay Detsky

Cancer type: Central Nervous System
Cancer location: Central Nervous System
Disease stage: Early Cancer
Trial phase:
Intervention:

Registration #: NCT04471844

Trial description:
To test the effectiveness and safety of Optune® given concomitantly with radiation therapy (RT) and temozolomide (TMZ) in newly diagnosed GBM patients, compared to radiation therapy and temozolomide alone. In both arms, Optune® and maintenance temozolomide are continued following radiation therapy.

Inclusion Criteria: -Histologically confirmed diagnosis of GBM according to WHO classification criteria. -Age ≥ 22 years in US and Age ≥ 18 years in Ex-US -Recovered from maximal debulking surgery, if applicable (gross total resection, partial resection, and biopsy-only patients are all acceptable) -Planned treatment with RT/TMZ followed by TTFields and maintenance TMZ (150-200 mg/m2 daily x 5 d, q28 days) -Karnofsky performance status ≥ 70 -Life expectancy ≥ least 3 months -Participants of childbearing age must use highly effective contraception. An effective method of birth control is defined as one that results in a failure rate of less than 1% per year when used consistently and correctly. The Investigator must approve the selected method, and may consult with a gynecologist as needed. -All patients must understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted. -Stable or decreasing dose of corticosteroids for the last 7 days prior to randomization, if applicable. -Concomitant RT with TMZ treatment planned to start no later than 8 weeks from surgery -Women of childbearing potential must have a negative β-HCG pregnancy test documented within 14 days prior to registration -Is able to have MRI with contrast of the brain. Exclusion Criteria: -Progressive disease (per investigator's assessment) -Infratentorial or leptomeningeal disease -Participation in another clinical treatment study during the pre-treatment and/or the treatment phase of the study -Pregnancy or breast-feeding. -Significant co-morbidities at baseline which would preclude maintenance RT or TMZ treatment, as determined by the investigator: a.Thrombocytopenia (platelet count < 100 x 103/μL) b. Neutropenia (absolute neutrophil count < 1.5 x 103/μL) c. CTC grade 4 non-hematological Toxicity (except for alopecia, nausea, vomiting) d.Significant liver function impairment - AST or ALT > 3 times the upper limit of normal e.Total bilirubin > 1.5 x upper limit of normal f. Significant renal impairment (serum creatinine > 1.7 mg/dL, or > 150 µmol/l) g. History of any psychiatric condition that might impair patient's ability to understand or comply with the requirements of the study or to provide consent -Implanted pacemaker, defibrillator, deep brain stimulator, other implanted electronic devices in the brain, or documented clinically significant arrhythmias. -Evidence of increased intracranial pressure (midline shift > 5mm, clinically significant papilledema, vomiting and nausea or reduced level of consciousness) -History of hypersensitivity reaction to TMZ or a history of hypersensitivity to DTIC. -Any other cytotoxic or biologic anti-tumor therapy received prior to enrollment will be considered exclusion. -Admitted to an institution by administrative or court order. -Known allergies to medical adhesives or hydrogel -A skull defect (such as, missing bone with no replacement) -Prior radiation treatment to the brain for the treatment of GBM -Any serious surgical/post-operative condition that may risk the patient according to the investigator -Standard TTFields exclusion criteria include a. Active implanted medical devices b. Bullet fragments c.Skull defects