EF-32: Pivotal, Randomized, Open-Label Study of Optune® (Tumor Treating Fields, 200kHz) Concomitant With Radiation Therapy and Temozolomide for the Treatment of Newly Diagnosed Glioblastoma
Brief SummaryTo 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.
Detailed DescriptionOptune® is a medical device that has been approved for the treatment of recurrent and newly diagnosed glioblastoma (GBM) by the Food and Drug Administration (FDA) in the United States. Optune® has obtained a CE mark in Europe for recurrent and newly diagnosed GBM. The current standard of care for GBM includes the addition of Optune® to maintenance temozolomide (TMZ), following the completion of radiation therapy (RT). The purpose of the current study is to test if the earlier introduction of Optune®, at the time of radiation therapy (which is given together with temozolomide), improves clinical outcomes compared to the standard of care. The study will randomize 950 subjects equally to one of two treatment arms: 1. Treatment arm I: Patients receive TTFields at 200 kHz to the brain using the Optune® System together with RT and TMZ, followed by maintenance TMZ concomitant with the Optune® treatment. 2. Treatment arm II: Patients receive RT and TMZ alone, followed by maintenance TMZ concomitant with TTFields at 200 kHz to the brain using the Optune®. All patients are to receive standard RT and TMZ treatment followed by maintenance TMZ chemotherapy and Optune® according to the current standard of care regimen. Optune® will continue until second disease progression per RANO Criteria or 24 months (the earlier of the two) unless any of the treatment discontinuation conditions described under criteria for patient withdrawal or termination are met. After surgery or biopsy, subjects that would like to participate will be required to submit samples of their tumor to a lab for testing. The results of this test will be used for randomization into the trial. If the subject is assigned to the treatment group that will start Optune® therapy during radiation therapy, Optune® therapy will begin within 7 days of enrolling in the study and no later than the first day of RT and TMZ treatment. After the initial visit, subjects will continue treatment at home, while pursuing normal daily routines. Subjects are required to use the device for at least 18 hours a day. Short breaks in treatment for personal hygiene and other personal needs is allowed. Total usage time will be recorded and provided to the sponsor. Subjects will be required to return to the clinic every 4 weeks until study participation ends. Once every 8 weeks until the tumor potentially returns twice, subjects will have a contrast MRI of the head and neurological exam performed for the first 6 months of the study and then at least every three months until a total time period of 24 months.Once every 12 weeks until second disease progression, subjects will also fill out a quality of life questionnaire. After the second time the tumor returns, subjects will return to the clinic for one final visit approximately 30 days after the last treatment with Optune®. After discontinuing Optune® subjects will be contacted once per month by telephone to answer basic questions about their health status.
Inclusion and Exclusion 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
- 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:
- Thrombocytopenia (platelet count < 100 x 103/
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.