What stage is the EF-33 trial?
The EF-33 trial for patients with recurrent GBM is a pilot study. Because Optune® with High Intensity Transducer Arrays is a device and not a drug, it does not follow the traditional Phase I, Phase II, Phase III process that an investigational new drug would follow. This Pilot Trial is similar in structure and purpose to a drug Phase II trial.
How can I take part in the EF-33 trial?
Do patients pay to participate in the EF-33 trial?
No. The trial sponsor will provide Optune® with High Intensity Transducer Arrays and all supporting accessories free of charge. See the EF-33 trial for more information.
What are the expected side effects of TTFields?
The use of Optune® with High Intensity Transducer Arrays is not expected to have systemic side effects, based on our clinical data to date for various conditions. Patients have experienced skin irritation beneath the transducer arrays. For more information, see Science of TTFields.
When TTFields are delivered, the transducer arrays may cause mild warming and tingling of the scalp.
Please consult with the clinical trial doctor at the center participating in the trial for additional information about potential side effects from using Optune® with High Intensity Transducer Arrays in the EF-33 clinical trial.
Do I need to carry the device all the time?
The device and the battery weigh about 1.2 kilograms and can be carried in a dedicated shoulder bag or backpack when walking around. Patients may not necessarily be physically carrying the device most of the time, but will rather use it while it is continuously placed in one location (e.g. on a desk, a table or on the floor inside the carrying bag). The device was designed to allow the performance of normal daily routines.
Will the use of TTFields pose any risk to family members or other people?
The use of the device should not interfere with household or standard personal electronic devices. There is no exposure of TTFields to non-users, such as co-workers and family members.
How will the device affect my social life?
The device was designed to allow patients to continue with daily routines. You can wear head covers, such as a loose weave wig or a loose-fitting hat that allows for airflow to conceal the transducer arrays, and you may place the array wires underneath your clothes. The Device Support Specialist (DSS) will offer help and support related to appearance issues if you are using TTFields. For additional information, please see [Living with TTFields].
If I enroll in the EF-33 trial, will I receive other anti-cancer therapies in addition to TTFields?
Patients on the study will receive TTFields and can also receive the best supportive care available at the discretion of their treating doctor.
Other concomitant anti-cancer therapies or procedures beyond TTFields are prohibited.
How long do I need to wear the device in the EF-33 trial?
Patients wear the device throughout the day and night, for at least 18 hours a day. Patients may remove the device for short breaks to accommodate personal needs. Treatment on the trial continues until your clinical trial doctor diagnoses progression of the GBM according to the protocol or 18 months (the earlier of the two). The treatment may be discontinued due to a serious medical condition, as assessed by the clinical trial doctor. In addition, you may decide to stop the TTFields at any point in time after starting the use of the device. For more information about the EF-33 trial, see the EF-33 Trial or contact the participating center.